Best PLR Article Directory Mississippi: September 2016

Thursday, September 29, 2016

Itraderm

Itraderm may be available in the countries listed below.

Ingredient matches for Itraderm

Itraconazole

Itraconazole is reported as an ingredient of Itraderm in the following countries:

Germany

Switzerland

International Drug Name Search

Imunomax-gamma

Imunomax-gamma may be available in the countries listed below.

Ingredient matches for Imunomax-gamma

Interferon gamma

Interferon gamma Interferon gamma-1a (a derivative of Interferon gamma) is reported as an ingredient of Imunomax-gamma in the following countries:

Japan

International Drug Name Search

Clozapin dura

Clozapin dura may be available in the countries listed below.

Ingredient matches for Clozapin dura

Clozapine

Clozapine is reported as an ingredient of Clozapin dura in the following countries:

Germany

International Drug Name Search

Wednesday, September 28, 2016

Mercaptyl

Mercaptyl may be available in the countries listed below.

Ingredient matches for Mercaptyl

Penicillamine

Penicillamine is reported as an ingredient of Mercaptyl in the following countries:

Switzerland

International Drug Name Search

Cortisporin Ophthalmic

Generic Name: neomycin, polymyxin b, and hydrocortisone (Ophthalmic route)

nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate, hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

Cortisporin

Available Dosage Forms:

Suspension

Therapeutic Class: Aminoglycoside/Corticosteroid Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Neomycin

Uses For Cortisporin

Neomycin, polymyxin B, and hydrocortisone is a combination antibiotic and cortisone-like medicine. It is used to treat infections of the eye and to help provide relief from redness, irritation, and discomfort of certain eye problems. It is also used to help prevent permanent damage of certain eye problems.

Neomycin, polymyxin B, and hydrocortisone combination is available only with your doctor's prescription.

Before Using Cortisporin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic neomycin, polymyxin B, and hydrocortisone combination in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alcuronium

Aldesleukin

Atracurium

Bupropion

Cidofovir

Cisatracurium

Colistimethate Sodium

Decamethonium

Doxacurium

Ethacrynic Acid

Fazadinium

Furosemide

Gallamine

Hexafluorenium

Metocurine

Mivacurium

Pancuronium

Pipecuronium

Quetiapine

Rapacuronium

Rocuronium

Sorafenib

Tacrolimus

Tubocurarine

Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin

Alcuronium

Atracurium

Balofloxacin

Bumetanide

Cinoxacin

Ciprofloxacin

Cisatracurium

Clinafloxacin

Colestipol

Doxacurium

Enoxacin

Fazadinium

Fleroxacin

Flumequine

Gallamine

Gemifloxacin

Grepafloxacin

Hexafluorenium

Itraconazole

Levofloxacin

Licorice

Lomefloxacin

Metocurine

Mivacurium

Moxifloxacin

Norfloxacin

Ofloxacin

Pancuronium

Pefloxacin

Pipecuronium

Primidone

Prulifloxacin

Rapacuronium

Rifapentine

Rocuronium

Rosoxacin

Rufloxacin

Saiboku-To

Sparfloxacin

Temafloxacin

Tosufloxacin

Trovafloxacin Mesylate

Tubocurarine

Vecuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Cortisporin

The bottle is only partially full to provide proper drop control.

To use:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.

If you think you did not get the drop of medicine into your eye properly, use another drop.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye infection:
- For ophthalmic suspension dosage forms:
  - Adults—One or two drops every three or four hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cortisporin

If you will be using this medicine for more than 10 days, your doctor should check your eyes at regular visits.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

If a rash or allergic reaction develops, you should check with your doctor right away.

You should not let anyone else use your medicine. It could cause infection to spread.

Do not use any leftover medicine for future eye problems without checking with your doctor first. This medicine should not be used on many different kinds of infection.

Cortisporin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Fainting

lightheadedness (sudden and severe)

shortness of breath or trouble breathing (severe)

swelling around face

Check with your doctor immediately if any of the following side effects occur:

More common

Itching, rash, redness, swelling, or other sign of irritation not present before use of this medicine

Rare

Blurred vision or other change in vision

delayed healing of eye infection

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning or stinging when applying medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Cortisporin Ophthalmic resources

Cortisporin Ophthalmic Use in Pregnancy & Breastfeeding
Cortisporin Ophthalmic Drug Interactions
Cortisporin Ophthalmic Support Group
0 Reviews for Cortisporin Ophthalmic - Add your own review/rating

Cortisporin Ophthalmic Concise Consumer Information (Cerner Multum)

AK-Spore HC Concise Consumer Information (Cerner Multum)

Ocu-Cort Concise Consumer Information (Cerner Multum)

Compare Cortisporin Ophthalmic with other medications

Blepharitis
Conjunctivitis, Bacterial
Keratitis
Keratoconjunctivitis
Uveitis

Medi-Lyte

Pronunciation: e-LECK-troe-lite
Generic Name: Electrolyte
Brand Name: Examples include Medi-Lyte and Temp Tabs

Medi-Lyte is used for:

Decreasing fatigue, muscle cramps, or heat exhaustion due to excessive sweating. The use of Medi-Lyte for these conditions has not been evaluated or approved by the Food and Drug Administration. It may also be used for other conditions as determined by your doctor.

Medi-Lyte is an electrolyte combination. It works by replacing electrolytes in the body.

Do NOT use Medi-Lyte if:

you are allergic to any ingredient in Medi-Lyte

you have high blood potassium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Medi-Lyte:

Some medical conditions may interact with Medi-Lyte. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have heart disease, high blood pressure, fluid retention (eg, swelling of the hands, ankles, or feet), intestinal holes or punctures, difficulty urinating, kidney problems, or unexplained rectal bleeding

if you have severe or persistent vomiting or severe diarrhea, or you are dehydrated

if you have high levels of sodium in the blood

if you are unable to properly absorb glucose from food

Some MEDICINES MAY INTERACT with Medi-Lyte. However, no specific interactions with Medi-Lyte are known at this time.

Ask your health care provider if Medi-Lyte may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Medi-Lyte:

Use Medi-Lyte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Medi-Lyte with a full glass of water (8 oz/240 mL).

If you miss a dose of Medi-Lyte, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Medi-Lyte.

Important safety information:

If vomiting, fever, or stomach pain or bloating occurs, or if you have diarrhea that continues for longer than 24 hours, check with your doctor.

Medi-Lyte should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Medi-Lyte while you are pregnant. It is not known if Medi-Lyte is found in breast milk. If you are or will be breast-feeding while you use Medi-Lyte, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Medi-Lyte:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Medi-Lyte side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Medi-Lyte:

Store Medi-Lyte at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Medi-Lyte out of the reach of children and away from pets.

General information:

If you have any questions about Medi-Lyte, please talk with your doctor, pharmacist, or other health care provider.

Medi-Lyte is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Medi-Lyte. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Medi-Lyte resources

Medi-Lyte Side Effects (in more detail)
Medi-Lyte Support Group
0 Reviews · Be the first to review/rate this drug

Fleet Sof-Lax

Ingredient matches for Fleet Sof-Lax

Docusate

Docusate Sodium is reported as an ingredient of Fleet Sof-Lax in the following countries:

United States

International Drug Name Search

Destrometorfano Bromidrato Nova Argentia

Destrometorfano Bromidrato Nova Argentia may be available in the countries listed below.

Ingredient matches for Destrometorfano Bromidrato Nova Argentia

Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Destrometorfano Bromidrato Nova Argentia in the following countries:

Italy

International Drug Name Search

Bromhist-NR

Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)

Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD

What is Bromhist-NR (brompheniramine and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Bromhist-NR (brompheniramine and pseudoephedrine)?

There are many brands and forms of this medicine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Bromhist-NR (brompheniramine and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:

kidney disease;

diabetes;

glaucoma;

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

an enlarged prostate; or

problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Bromhist-NR (brompheniramine and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Bromhist-NR (brompheniramine and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Bromhist-NR (brompheniramine and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, or nervousness;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

confusion, hallucinations, unusual thoughts or behavior;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

urinating less than usual or not at all.

Less serious side effects may include:

blurred vision;

dry mouth;

nausea, stomach pain, constipation;

mild loss of appetite, stomach upset;

warmth, tingling, or redness under your skin;

sleep problems (insomnia);

restless or excitability (especially in children);

skin rash or itching;

dizziness, drowsiness;

problems with memory or concentration; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Bromhist-NR (brompheniramine and pseudoephedrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by brompheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

medicines to treat high blood pressure;

a diuretic (water pill);

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with brompheniramine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Bromhist-NR resources

Bromhist-NR Side Effects (in more detail)
Bromhist-NR Use in Pregnancy & Breastfeeding
Bromhist-NR Drug Interactions
Bromhist-NR Support Group
0 Reviews for Bromhist-NR - Add your own review/rating

Bidhist-D Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Bromfenex Controlled-Release and Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Lodrane D MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Bromhist-NR with other medications

Hay Fever
Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about brompheniramine and pseudoephedrine.

See also: Bromhist-NR side effects (in more detail)

Anaroxyl

Anaroxyl may be available in the countries listed below.

Ingredient matches for Anaroxyl

Carbazochrome

Carbazochrome is reported as an ingredient of Anaroxyl in the following countries:

Bangladesh

International Drug Name Search

Tuesday, September 27, 2016

Jantoven

In the US, Jantoven (warfarin systemic) is a member of the drug class coumarins and indandiones and is used to treat Antiphospholipid Syndrome, Chronic Central Venous Catheterization, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis - First Event, Deep Vein Thrombosis - Recurrent Event, Heart Attack, Heart Failure, Prevention of Thromboembolism in Atrial Fibrillation, Prosthetic Heart Valves, Prosthetic Heart Valves - Mechanical Valves, Prosthetic Heart Valves - Tissue Valves, Protein S Deficiency, Pulmonary Embolism - First Event, Pulmonary Embolism - Recurrent Event and Thromboembolic Stroke Prophylaxis.

US matches:

Jantoven

Ingredient matches for Jantoven

Warfarin

Warfarin sodium salt (a derivative of Warfarin) is reported as an ingredient of Jantoven in the following countries:

United States

International Drug Name Search

Itraconazolo EG

Itraconazolo EG may be available in the countries listed below.

Ingredient matches for Itraconazolo EG

Itraconazole

Itraconazole is reported as an ingredient of Itraconazolo EG in the following countries:

Italy

International Drug Name Search

Cefamar

Cefamar may be available in the countries listed below.

Ingredient matches for Cefamar

Cefadroxil

Cefadroxil is reported as an ingredient of Cefamar in the following countries:

Argentina

Cefuroxime

Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Cefamar in the following countries:

Thailand

International Drug Name Search

Monday, September 26, 2016

Isodol

Isodol may be available in the countries listed below.

Ingredient matches for Isodol

Nimesulide

Nimesulide is reported as an ingredient of Isodol in the following countries:

Italy

International Drug Name Search

Lomudal

Lomudal may be available in the countries listed below.

Ingredient matches for Lomudal

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Lomudal in the following countries:

Belgium

Denmark

Finland

France

Greece

Iceland

Israel

Italy

Luxembourg

Netherlands

Norway

Sweden

Switzerland

International Drug Name Search

Fudosteine

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0013189-98-5

Chemical Formula

C6-H13-N-O3-S

Molecular Weight

179

Therapeutic Category

Expectorant

Chemical Names

(-)-R-2-Amino-3-(3-hydroxypropylthio)propionic acid (JAN)

(-)-3-[(3-Hydroxypropyl)thiol]-L-alanine (WHO)

L-Cysteine, S-(3-hydroxypropyl)-

Foreign Names

Fudosteinum (Latin)
Fudostein (German)
Fudostéine (French)
Fudosteina (Spanish)

Generic Names

Fudosteine (OS: JAN)
SS-320A (IS)
UNII-UR9VPI71PT (IS)

Brand Names

Cleanal
Tanabe Mitsubishi, Japan

Spelear
Hisamitsu, Japan

International Drug Name Search

Glossary

IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Isodine

Isodine may be available in the countries listed below.

Ingredient matches for Isodine

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Isodine in the following countries:

Colombia

Indonesia

Japan

Mexico

Peru

Thailand

International Drug Name Search

Baklofen Mylan

Baklofen Mylan may be available in the countries listed below.

Ingredient matches for Baklofen Mylan

Baclofen

Baclofen is reported as an ingredient of Baklofen Mylan in the following countries:

Sweden

International Drug Name Search

Itorelin

Itorelin may be available in the countries listed below.

Ingredient matches for Itorelin

Buserelin

Buserelin acetate (a derivative of Buserelin) is reported as an ingredient of Itorelin in the following countries:

Japan

International Drug Name Search

Friday, September 23, 2016

Indast

Indast may be available in the countries listed below.

Ingredient matches for Indast

Cilastatin

Cilastatin sodium salt (a derivative of Cilastatin) is reported as an ingredient of Indast in the following countries:

Japan

Imipenem

Imipenem monohydrate (a derivative of Imipenem) is reported as an ingredient of Indast in the following countries:

Japan

International Drug Name Search

liotrix

lee-voe-thye-ROX-een SOE-dee-um, lye-oh-THYE-roe-neen SOE-dee-um

Commonly used brand name(s)

In the U.S.

Euthroid

Thyrolar

Available Dosage Forms:

Tablet

Therapeutic Class: Thyroid Supplement

Uses For liotrix

Liotrix is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. It is also used to help decrease the size of enlarged thyroid glands (known as goiter) and to treat thyroid cancer .

Liotrix is also used in some medical tests to help diagnose problems with the thyroid gland .

liotrix is available only with your doctor's prescription .

Before Using liotrix

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For liotrix, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to liotrix or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of liotrix in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of liotrix in the elderly. However, elderly patients are more likely to have age-related heart and blood vessel problems, which may require caution in patients receiving liotrix .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

Levothyroxine

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Liothyronine

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking liotrix, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using liotrix with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Anisindione

Calcium Acetate

Calcium Carbonate

Calcium Citrate

Cholestyramine

Chromium

Colesevelam

Conjugated Estrogens

Dicumarol

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Eltrombopag

Esterified Estrogens

Estradiol

Estriol

Estrone

Estropipate

Imatinib

Iron

Kelp

Lanthanum Carbonate

Lopinavir

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Phenindione

Phenprocoumon

Phenytoin

Rifampin

Rifapentine

Ritonavir

Sevelamer

Simvastatin

Sodium Polystyrene Sulfonate

Soybean

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using liotrix with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use liotrix, or give you special instructions about the use of food, alcohol, or tobacco.

Enteral Nutrition

Proper Use of liotrix

liotrix usually needs to be taken for the rest of your life. Do not stop taking liotrix or change your doses without first checking with your doctor. It may take several weeks before you start to notice an improvement in your symptoms .

Dosing

The dose of liotrix will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of liotrix. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablet):
- For the treatment of hypothyroidism:
  - Adults—At first, one tablet of liotrix (Thyrolar-1/2) containing 6.25 microgram (mcg) of liothyronine and 25 mcg of levothyroxine once a day. Your doctor may increase your dose by one tablet of liotrix (Thyrolar-1/4) containing 3.1 mcg of liothyronine and 12.5 mcg of levothyroxine every 2 to 3 weeks. However, the dose is usually not more than one tablet of liotrix (Thyrolar-3) containing 37.5 mcg of liothyronine and 150 mcg of levothyroxine once a day.
  - Children—Follow dosing for the treatment of congenital hypothyroidism .
- For the treatment of congenital hypothyroidism:
  - Children 0 to 6 months of age—At first, 3.1 mcg of liothyronine and 12.5 mcg of levothyroxine once a day. Doses may be increased as needed. However, the dose is usually not more than 6.25 mcg of liothyronine and 25 mcg of levothyroxine once a day.
  - Children 6 to 12 months of age—At first, 6.25 mcg of liothyronine and 25 mcg of levothyroxine once a day. Doses may be increased as needed. However, the dose is usually not more than 9.35 mcg of liothyronine and 37.5 mcg of levothyroxine once a day.
  - Children 1 to 5 years of age—At first, 9.35 mcg of liothyronine and 37.5 mcg of levothyroxine once a day. Doses may be increased as needed. However, the dose is usually not more than 12.5 mcg of liothyronine and 50 mcg of levothyroxine once a day.
  - Children 6 to 12 years of age—At first, 12.5 mcg of liothyronine and 50 mcg of levothyroxine once a day. Doses may be increased as needed. However, the dose is usually not more than 18.75 mcg of liothyronine and 75 mcg of levothyroxine once a day.
  - Children over 12 years of age—The usual dose is 18.75 mcg of liothyronine and 75 mcg of levothyroxine once a day. Doses may be increased as needed .

Missed Dose

If you miss a dose of liotrix, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using liotrix

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects .

Liotrix should not be used for the treatment of obesity or for the purpose of losing weight. liotrix is ineffective for weight reduction and when taken in larger amount, it may cause more serious medical conditions .

Hypothyroidism can sometimes cause infertility in men and women. Liotrix should not be used for the treatment of infertility unless it is caused by hypothyroidism .

Call your doctor right away if you start to have chest pain, fast or irregular heartbeat, excessive sweating, heat intolerance, nervousness, or any other unusual medical condition .

For patients with diabetes, it is very important that you keep track of your blood or urine sugar levels as instructed by your doctor. Check with your doctor immediately if you notice any changes in your sugar levels .

A temporary loss of hair may occur during the first few months of liotrix therapy. Ask your doctor about this if you have any concerns .

liotrix Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not determined

Chest pain

constipation

depressed mood

difficulty in moving

discouragement

dryness of the eye

dry skin and hair

fast, irregular, pounding, or racing heartbeat or pulse

fear, nervousness

feeling cold

feeling sad or empty

fever

headache

hives or welts

hoarseness or husky voice

increased sweating

increased weight

increase in blood pressure

irritability

irritation

itching skin

joint pain, stiffness or swelling

lack of appetite

lack or loss of strength

loss of interest or pleasure

muscle aching or cramping

muscle pain or stiffness

nausea

redness of skin

shakiness in legs, arms, hands, feet

shortness of breath

skin rash

sleeplessness

slowed heartbeat

sluggishness

swelling of eyelids, face, lips, hands, or feet

swollen joints

tightness in chest

tiredness

trembling or shaking of hands or feet

trouble concentrating

troubled breathing or swallowing

trouble sleeping

unable to sleep

unusual tiredness or weakness

weight gain

wheezing

Incidence not determined

Hair loss, thinning of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: liotrix side effects (in more detail)

More liotrix resources

Liotrix Side Effects (in more detail)
Liotrix Use in Pregnancy & Breastfeeding
Liotrix Drug Interactions
Liotrix Support Group
0 Reviews for Liotrix - Add your own review/rating

liotrix Concise Consumer Information (Cerner Multum)

Liotrix Professional Patient Advice (Wolters Kluwer)

Liotrix Monograph (AHFS DI)

Liotrix MedFacts Consumer Leaflet (Wolters Kluwer)

Compare liotrix with other medications

Underactive Thyroid

Codotussyl Expectorant

Codotussyl Expectorant may be available in the countries listed below.

Ingredient matches for Codotussyl Expectorant

Acetylcysteine

Acetylcysteine is reported as an ingredient of Codotussyl Expectorant in the following countries:

France

International Drug Name Search

Thursday, September 22, 2016

Diclofenackalium

Diclofenackalium may be available in the countries listed below.

Ingredient matches for Diclofenackalium

Diclofenac

Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Diclofenackalium in the following countries:

Netherlands

Norway

International Drug Name Search

Itropin

Itropin may be available in the countries listed below.

Ingredient matches for Itropin

Atropine

Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Itropin in the following countries:

Bangladesh

International Drug Name Search

Imosec

Imosec may be available in the countries listed below.

Ingredient matches for Imosec

Loperamide

Loperamide is reported as an ingredient of Imosec in the following countries:

Luxembourg

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Imosec in the following countries:

Brazil

International Drug Name Search

Azithromycin AbZ

Azithromycin AbZ may be available in the countries listed below.

Ingredient matches for Azithromycin AbZ

Azithromycin

Azithromycin monohydrate (a derivative of Azithromycin) is reported as an ingredient of Azithromycin AbZ in the following countries:

Germany

International Drug Name Search

Veregen

Veregen is a brand name of sinecatechins topical, approved by the FDA in the following formulation(s):

VEREGEN (sinecatechins - ointment; topical)

Manufacturer: MEDIGENE AG

Approval date: October 31, 2006

Strength(s): 15% ^[RLD]

Has a generic version of Veregen been approved?

No. There is currently no therapeutically equivalent version of Veregen available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Veregen. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Composition for treating Condyloma acuminata
Patent 5,795,911
Issued: August 18, 1998
Inventor(s): Cheng; Shu Jun & Wang; De Chang & Hara; Yukihiko
Assignee(s): Cancer Institute (Hospital), Chinese Academy of Medical Sciences
Mitsui Norin Co., Ltd.
A composition for a treatment of HPV-infected Condyloma acuminata which comprises containing tea catechin as a main component. This medication has no danger of side-effects and may be easily applied to or inserted in the infected area by the patient themselves.
Patent expiration dates:
- October 31, 2020
  ✓
  Patent use: TREATMENT OF GENITAL WARTS

Method for treating hyperplasia
Patent 5,968,973
Issued: October 19, 1999
Inventor(s): Cheng; Shu Jun & Wang; De Chang & Hara; Yukihiko
Assignee(s): Cancer Institute (Hospital), Chinese Academy of Medical Sciences
Mitsui Norin Co., Ltd.
A method for a treatment of hyperplasia caused by papilloma virus, such as for treating Condyloma acuminata which comprises administering tea catechin. Tea catechins do not involve the risk of side-effects and may be easily applied to or inserted in the infected area by the patients themselves.
Patent expiration dates:
- April 10, 2017
  ✓
  Patent use: TREATMENT OF GENITAL WARTS

Medicament for the treatment of viral skin and tumour diseases
Patent 7,858,662
Issued: December 28, 2010
Inventor(s): Chang; Yunik & Lathrop; Robert & Böhm; Erwin & Gander-Meisterernst; Irene & Greger; Regina & Holldack; Johanna & Moebius; Ulrich
Assignee(s): MediGene AG
The invention relates to a medicament containing a compound of general formula (1), where R1=independently, a straight or branched, saturated, singly- or multiply-unsaturated, optionally substituted C11-C21 alkyl, alkylene or alkynyl group, preferably a C11-C15 alkyl, alkylene or alkynyl group, particularly a C11-C13 alkyl, alkylene or alkynyl group, most preferably a C13 alkyl group, R2=independently, a straight or branched C1-C8 alkyl, alkylene or alkynyl group, preferably a C1-C6 alkyl, alkylene or alkynyl group, in particular a C2-C4 alkyl, alkylene or alkynyl group, most preferably a C3 alkyl group, a —[CH2—(CH2)m—O]nH group with n=1 to 10, preferably n=1 to 5, m=1 to 5, preferably m=1 to 3, a —CH2—[CH—(OH)]p[CH2—(R3)]— group, where R3=independent H or OH, p=1 to 7, preferably p=1 to 4, a pentose group or a hexose group, as therapeutically active agent, alone or in combination with one or several further pharmaceutical agents as a combination preparation for the treatment of viral skin diseases and/or tumor diseases, in particular caused by human papilloma virus (HPV) and/or herpes viruses and a topically acting medicament formulation and the use thereof.
Patent expiration dates:
- October 2, 2026
  ✓
  Patent use: TREATMENT OF GENITAL WARTS
  ✓
  Drug product

Ingredient matches for Cravit Ophthalmic

Levofloxacin

Levofloxacin is reported as an ingredient of Cravit Ophthalmic in the following countries:

Thailand

International Drug Name Search

Bendarabin

Bendarabin may be available in the countries listed below.

Ingredient matches for Bendarabin

Fludarabine

Fludarabine phosphate (a derivative of Fludarabine) is reported as an ingredient of Bendarabin in the following countries:

Germany

International Drug Name Search

Induxin

Induxin may be available in the countries listed below.

Ingredient matches for Induxin

Oxytocin

Oxytocin is reported as an ingredient of Induxin in the following countries:

Indonesia

Myanmar

International Drug Name Search

Wednesday, September 21, 2016

Dexol 5

Dexol 5 may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Dexol 5

Dexamethasone

Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Dexol 5 in the following countries:

Australia

New Zealand

International Drug Name Search

Beniod

Beniod may be available in the countries listed below.

Ingredient matches for Beniod

Delapril

Delapril is reported as an ingredient of Beniod in the following countries:

Spain

International Drug Name Search

Telaprevir

Pronunciation: tel-A-pre-vir
Generic Name: Telaprevir
Brand Name: Incivek

Telaprevir is used for:

Treating chronic hepatitis C virus infection in certain patients. It must be used in combination with peginterferon and ribavirin.

Telaprevir is a hepatitis C virus protease inhibitor. It reduces the amount of hepatitis C virus in the body by preventing the spread of the hepatitis C virus within the body.

Do NOT use Telaprevir if:

you are allergic to any ingredient in Telaprevir

you have moderate to severe liver problems

you are taking alfuzosin, certain benzodiazepines (eg, oral midazolam, triazolam), cabazitaxel, cisapride, conivaptan, dronedarone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin), lurasidone, pimozide, rifabutin, rifampin, rivaroxaban, silodosin, St. John's wort, or tolvaptan

you are taking sildenafil or tadalafil to treat pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Telaprevir:

Some medical conditions may interact with Telaprevir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have HIV infection; other immune system problems; gout or high blood uric acid levels; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)

if you have other liver problems (eg, hepatitis B infection)

if you have had an organ transplant

if you will be having surgery

Some MEDICINES MAY INTERACT with Telaprevir. Tell your health care provider if you are taking any other medicines, especially any of the following:

Rifabutin, rifampin, or St. John's wort because they may decrease Telaprevir's effectiveness

Alfuzosin, certain benzodiazepines (eg, oral midazolam, triazolam), cabazitaxel, cisapride, conivaptan, dronedarone , ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin), lurasidone, pimozide, rivaroxaban, silodosin, or tolvaptan because the risk of their side effects may be increased by Telaprevir

Sildenafil or tadalafil (when used to treat PAH) because the risk of their side effects may be increased by Telaprevir

Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Telaprevir

Many prescription medicines (eg, used for asthma or breathing problems, anxiety, birth control, blood thinning, blood flow, cancer, diabetes, enlarged prostate, erectile dysfunction, gout, angina, heart problems, HIV, immune suppression, infection, inflammation, irregular heartbeat, high blood pressure, high cholesterol, mental or mood problems, pain (eg, narcotics), PAH, seizures, sleep) may interact with Telaprevir, increasing the risk of side effects or decreasing effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Telaprevir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Telaprevir:

Use Telaprevir as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Telaprevir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Telaprevir refilled.

Telaprevir must be taken with peginterferon and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.

Take Telaprevir by mouth with food (not low fat). Eat a meal or snack that contains about 20 grams of fat within 30 minutes before you take Telaprevir. Examples of some foods include: a bagel with cream cheese, 1 cup nuts, 3 tablespoons peanut butter, 1 cup ice cream; 2 ounces American or cheddar cheese, 2 ounces potato chips, or 1 cup trail mix.

Telaprevir works best if it is taken at the same time each day. Each dose should be taken 7 to 9 hours apart.

Continue to take Telaprevir even if you feel well. Do not miss any doses.

If you miss a dose of Telaprevir and you remember within 4 hours of when you usually take it, take the missed dose with food as soon as possible and go back to your regular dosing schedule. If you miss a dose of Telaprevir and it is more than 4 hours after the time you usually take it, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Telaprevir.

Important safety information:

Mild skin rashes are common with the use of Telaprevir. Sometimes these skin rashes and other skin reactions can become severe. Contact your doctor right away if you develop a rash with or without itching; fever; mouth sores or ulcers; red or irritated eyes; red, swollen, blistered, or peeling skin; or swelling of the face.

Telaprevir may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

Telaprevir may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Telaprevir does not stop you from spreading hepatitis C virus to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have hepatitis C virus infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors.

Do not change your dose without checking with your doctor.

Telaprevir is not a cure for hepatitis C virus infection. Remain under the care of your doctor.

When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Telaprevir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

Women who may become pregnant and men who use Telaprevir must use 2 effective forms of birth control while they take Telaprevir with ribavirin and for 6 months after treatment is stopped. Hormonal birth control (eg, birth control pills) may not be as effective while you are using Telaprevir and for up to 2 weeks after stopping Telaprevir. Talk with your doctor if you have questions about effective birth control.

Lab tests, including complete blood cell counts, electrolyte levels, liver and kidney function, hepatitis C virus antibody levels, thyroid function, and uric acid levels, may be performed while you use Telaprevir and for several months after you stop Telaprevir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Telaprevir with caution in the ELDERLY; they may be more sensitive to its effects.

Telaprevir should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Telaprevir must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Telaprevir. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Telaprevir while you are pregnant. It is not known if Telaprevir is found in breast milk. Do not breast-feed while taking Telaprevir.

Possible side effects of Telaprevir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anal or rectal problems (eg, burning, discomfort, itching, hemorrhoids); change in taste; diarrhea; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; dark, tarry, or bloody stools; dizziness; fast or irregular heartbeat; feeling cold, especially in the hands or feet; fever, chills, or sore throat; joint pain (especially in the big toe); mouth sores or ulcers; pale skin; rash (with or without itching); red or irritated eyes; red, swollen, blistered, or peeling skin; severe or prolonged nausea or vomiting; shortness of breath; swelling of the face; unusual tiredness or weakness; yellowing of the skin or eyes.

See also: Telaprevir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms include change in taste; decreased appetite; diarrhea; headache; nausea; vomiting.

Proper storage of Telaprevir:

Store Telaprevir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Once the bottle is opened, use within 28 days. Keep Telaprevir out of the reach of children and away from pets.

General information:

If you have any questions about Telaprevir, please talk with your doctor, pharmacist, or other health care provider.

Telaprevir is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Telaprevir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Telaprevir resources

Telaprevir Side Effects (in more detail)
Telaprevir Use in Pregnancy & Breastfeeding
Telaprevir Drug Interactions
Telaprevir Support Group
1 Review for Telaprevir - Add your own review/rating

Telaprevir Professional Patient Advice (Wolters Kluwer)

telaprevir Advanced Consumer (Micromedex) - Includes Dosage Information

Incivek Prescribing Information (FDA)

Incivek Consumer Overview

Compare Telaprevir with other medications

Hepatitis C

Itraconazol Merck

Itraconazol Merck may be available in the countries listed below.

Ingredient matches for Itraconazol Merck

Itraconazole

Itraconazole is reported as an ingredient of Itraconazol Merck in the following countries:

Netherlands

Spain

International Drug Name Search

Tensan retard

Tensan retard may be available in the countries listed below.

Ingredient matches for Tensan retard

Nilvadipine

Nilvadipine is reported as an ingredient of Tensan retard in the following countries:

Austria

International Drug Name Search

Temazepam

Dosage Form: capsule
Temazepam Capsules, USP CIV

Temazepam Description

Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:

Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP.

Temazepam capsules, 15 mg and 30 mg, are for oral administration.

Active ingredient: Temazepam, USP

Inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shells and imprinting inks contain: gelatin, iron oxide black, shellac, propylene glycol, titanium dioxide, methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate and edetate calcium disodium. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue #1.

Temazepam - Clinical Pharmacology

Pharmacokinetics

In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using 3H labeled drug, Temazepam capsules were well absorbed and found to have minimal (8%) first pass metabolism. There were no active metabolites formed and the only significant metabolite present in blood was the O-conjugate. The unchanged drug was 96% bound to plasma proteins. The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study population and method of determination. Metabolites were formed with a half-life of 10 hours and excreted with a half-life of approximately 2 hours. Thus, formation of the major metabolite is the rate limiting step in the biodisposition of Temazepam. There is no accumulation of metabolites. A dose-proportional relationship has been established for the area under the plasma concentration/time curve over the 15 to 30 mg dose range.

Temazepam was completely metabolized through conjugation prior to excretion; 80% to 90% of the dose appeared in the urine. The major metabolite was the O-conjugate of Temazepam (90%); the O-conjugate of N-desmethyl Temazepam was a minor metabolite (7%).

Bioavailability, Induction, and Plasma Levels

Following ingestion of a 30 mg Temazepam capsule, measurable plasma concentrations were achieved 10 to 20 minutes after dosing with peak plasma levels ranging from 666 to 982 ng/mL (mean 865 ng/mL) occurring approximately 1.2 to 1.6 hours (mean 1.5 hours) after dosing.

In a 7 day study, in which subjects were given a 30 mg Temazepam capsule 1 hour before retiring, steady-state (as measured by the attainment of maximal trough concentrations) was achieved by the third dose. Mean plasma levels of Temazepam (for days 2 to 7) were 260±210 ng/mL at 9 hours and 75±80 ng/mL at 24 hours after dosing. A slight trend toward declining 24 hour plasma levels was seen after day 4 in the study, however, the 24 hour plasma levels were quite variable.

At a dose of 30 mg once-a-day for 8 weeks, no evidence of enzyme induction was found in man.

Elimination Rate of Benzodiazepine Hypnotics and Profile of Common Untoward Effects

The type and duration of hypnotic effects and the profile of unwanted effects during administration of benzodiazepine hypnotics may be influenced by the biologic half-life of the administered drug and for some hypnotics, the half-life of any active metabolites formed. Benzodiazepine hypnotics have a spectrum of half-lives from short (<4 hours) to long (>20 hours). When half-lives are long, drug (and for some drugs their active metabolites) may accumulate during periods of nightly administration and be associated with impairments of cognitive and/or motor performance during waking hours; the possibility of interaction with other psychoactive drugs or alcohol will be enhanced. In contrast, if half-lives are shorter, drug (and, where appropriate, its active metabolites) will be cleared before the next dose is ingested and carry-over effects related to excessive sedation or CNS depression should be minimal or absent. However, during nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of benzodiazepine hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug, or, if appropriate, its active metabolites (i.e., in relationship to the receptor site) may occur at some point in the interval between each night’s use. This sequence of events may account for 2 clinical findings reported to occur after several weeks of nightly use of rapidly eliminated benzodiazepine hypnotics, namely, increased wakefulness during the last third of the night, and the appearance of increased signs of daytime anxiety.

Controlled Trials Supporting Efficacy

Temazepam capsules improved sleep parameters in clinical studies. Residual medication effects (“hangover”) were essentially absent. Early morning awakening, a particular problem in the geriatric patient, was significantly reduced.

Patients with chronic insomnia were evaluated in 2 week, placebo controlled sleep laboratory studies with Temazepam capsules at doses of 7.5 mg, 15 mg, and 30 mg given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time and sleep latency, with significant drug-placebo differences at 2 weeks occurring only for total sleep time at the 2 higher doses, and for sleep latency only at the highest dose.

In these sleep laboratory studies, REM sleep was essentially unchanged and slow wave sleep was decreased. No measurable effects on daytime alertness or performance occurred following Temazepam capsules treatment or during the withdrawal period, even though a transient sleep disturbance in some sleep parameters was observed following withdrawal of the higher doses. There was no evidence of tolerance development in the sleep laboratory parameters when patients were given Temazepam capsules nightly for at least 2 weeks.

In addition, normal subjects with transient insomnia associated with first night adaptation to the sleep laboratory were evaluated in 24 hour, placebo controlled sleep laboratory studies with Temazepam capsules at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time, sleep latency and number of awakenings, with significant drug-placebo differences occurring for sleep latency at all doses, for total sleep time at the 2 higher doses and for number of awakenings only at the 30 mg dose.

Indications and Usage for Temazepam

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam capsules should be used for short periods of time (7 to 10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

Contraindications

Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.

Reproduction studies in animals with Temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls.

Temazepam capsules are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Warnings

Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior. Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class. Because some of the worrisome adverse effects of benzodiazepines, including Temazepam capsules, appear to be dose related (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), it is important to use the lowest possible effective dose. Elderly patients are especially at risk.

Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol. Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with Temazepam capsules alone at therapeutic doses, the use of alcohol and other CNS depressants with Temazepam capsules appears to increase the risk of such behaviors, as does the use of Temazepam capsules at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Temazepam capsules should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Amnesia and other neuro-psychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE).

Severe Anaphylactic and Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Temazepam capsules. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.

Patients who develop angioedema after treatment with Temazepam capsules should not be rechallenged with the drug.

Precautions

General

Since the risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of Temazepam is recommended as the initial dosage for such patients.

Temazepam capsules should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary.

The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency.

If Temazepam capsules are to be combined with other drugs having known hypnotic properties or CNS-depressant effects, consideration should be given to potential additive effects.

The possibility of a synergistic effect exists with the co-administration of Temazepam capsules and diphenhydramine. One case of stillbirth at term has been reported 8 hours after a pregnant patient received Temazepam capsules and diphenhydramine. A cause and effect relationship has not yet been determined (See CONTRAINDICATIONS).

Information for Patients

The text of a patient Medication Guide is printed at the end of this insert. To assure safe and effective use of Temazepam capsules, the information and instructions provided in this patient Medication Guide should be discussed with patients.

Special Concerns

“Sleep-Driving” and Other Complex Behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when Temazepam is taken with alcohol or other central nervous system depressants (see WARNINGS). Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

Laboratory Tests

The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines.

Drug Interactions

The pharmacokinetic profile of Temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies were conducted in rats at dietary Temazepam doses up to 160 mg/kg/day for 24 months and in mice at dietary doses of 160 mg/kg/day for 18 months. No evidence of carcinogenicity was observed although hyperplastic liver nodules were observed in female mice exposed to the highest dose. The clinical significance of this finding is not known.

Fertility in male and female rats was not adversely affected by Temazepam capsules.

No mutagenicity tests have been done with Temazepam.

Pregnancy

Pregnancy Category X

(See CONTRAINDICATIONS).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Temazepam capsules are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Temazepam capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy commonly observed in this population. Temazepam capsules 7.5 mg is recommended as the initial dosage for patients aged 65 and over since the risk of the development of oversedation, dizziness, confusion, ataxia and/or falls increases substantially with larger doses of benzodiazepines in elderly and debilitated patients.

Adverse Reactions

During controlled clinical studies in which 1076 patients received Temazepam capsules at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table:

	Temazepam Capsules % incidence (n=1076)	Placebo % incidence (n=783)
Drowsiness	9.1	5.6
Headache	8.5	9.1
Fatigue	4.8	4.7
Nervousness	4.6	8.2
Lethargy	4.5	3.4
Dizziness	4.5	3.3
Nausea	3.1	3.8
Hangover	2.5	1.1
Anxiety	2.0	1.5
Depression	1.7	1.8
Dry Mouth	1.7	2.2
Diarrhea	1.7	1.1
Abdominal Discomfort	1.5	1.9
Euphoria	1.5	0.4
Weakness	1.4	0.9
Confusion	1.3	0.5
Blurred Vision	1.3	1.3
Nightmares	1.2	1.7
Vertigo	1.2	0.8

The following adverse events have been reported less frequently (0.5% to 0.9%):

Central Nervous System

anorexia, ataxia, equilibrium loss, tremor, increased dreaming

Cardiovascular

dyspnea, palpitations

Gastrointestinal

vomiting

Musculoskeletal

backache

Special Senses

hyperhidrosis, burning eyes

Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).

Drug Abuse and Dependence

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Controlled Substance

Temazepam capsules are a controlled substance in Schedule IV.

Abuse and Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal, and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of benzodiazepines. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy at doses higher than 15 mg, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. As with any hypnotic, caution must be exercised in administering Temazepam capsules to individuals known to be addiction-prone or to those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeated prescriptions without adequate medical supervision.

Overdosage

Manifestations of acute overdosage of Temazepam capsules can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. The oral LD50 of Temazepam capsules was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits.

Treatment

If the patient is conscious, vomiting should be induced mechanically or with emetics. Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications. Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension. Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used. It should be borne in mind that multiple agents may have been ingested. Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®1.

1: Trademark of Medical Economics Company, Inc.

Temazepam Dosage and Administration

While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

How is Temazepam Supplied

Temazepam capsules, USP for oral administration are available as:

15 mg: Green and white capsules, imprinted GG 531 and supplied as:

NDC 0781-2201-01 bottles of 100

NDC 0781-2201-05 bottles of 500

NDC 0781-2201-10 bottles of 1000

30 mg: White capsules, imprinted GG 532 and supplied as:

NDC 0781-2202-01 bottles of 100

NDC 0781-2202-05 bottles of 500

NDC 0781-2202-10 bottles of 1000

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture.

Dispense in a tight, light-resistant container.

MEDICATION GUIDE

Temazepam Capsules, USP CIV

Read the Medication Guide that comes with Temazepam capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Temazepam capsules?

After taking Temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Temazepam capsules. Reported activities include:

driving a car (“sleep-driving”)

making and eating food

talking on the phone

having sex

sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking Temazepam capsules.

Important:

Take Temazepam capsules exactly as prescribed
- Do not take more Temazepam capsules than prescribed.
- Take Temazepam capsules right before you get in bed, not sooner.

Do not take Temazepam capsules if you:
- drink alcohol
- take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Temazepam capsules with your other medicines
- cannot get a full night’s sleep

What are Temazepam capsules?

Temazepam capsules are a sedative-hypnotic (sleep) medicine. Temazepam capsules are used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include:

trouble falling asleep

waking up often during the night

Temazepam capsules are not for children.

Temazepam capsules are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Temazepam capsules in a safe place to prevent misuse and abuse. Selling or giving away Temazepam capsules may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Temazepam capsules?

Do not take Temazepam capsules if you are pregnant or planning to become pregnant. Temazepam capsules may cause birth defects or harm a fetus (unborn baby).

Temazepam capsules may not be right for you. Before starting Temazepam capsules, tell your doctor about all of your health conditions, including if you:

have a history of depression, mental illness, or suicidal thoughts

have a history of drug or alcohol abuse or addiction

have kidney or liver disease

have a lung disease or breathing problems

are breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take Temazepam capsules with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take Temazepam capsules?

Take Temazepam capsules exactly as prescribed. Do not take more Temazepam capsules than prescribed for you.

Take Temazepam capsules right before you get into bed.

Do not take Temazepam capsules unless you are able to get a full night’s sleep before you must be active again.

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.

If you take too many Temazepam capsules or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of Temazepam capsules?

Possible serious side effects of Temazepam capsules include:

getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about Temazepam capsules?”)

abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts.

memory loss

anxiety

severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Temazepam capsules.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Temazepam capsules.

The most common side effects of Temazepam capsules are:

drowsiness

headache

tiredness

nervousness

dizziness

nausea

“hangover” feeling the day after taking Temazepam capsules

You may still feel drowsy the next day after taking Temazepam capsules. Do not drive or do other dangerous activities after taking Temazepam capsules until you feel fully awake.

You may have withdrawal symptoms if you stop taking Temazepam capsules suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your doctor to check if you need to stop Temazepam capsules slowly.

These are not all the side effects of Temazepam capsules. Ask your doctor or pharmacist for more information.

How should I store Temazepam capsules?

Store Temazepam capsules at room temperature, 68°-77°F (20°-25°C).

Keep Temazepam capsules and all medicines out of reach of children.

General Information about Temazepam capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Temazepam capsules for a condition for which it was not prescribed.

Do not share Temazepam capsules with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Temazepam capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Temazepam capsules that is written for healthcare professionals.

What are the ingredients in Temazepam capsules?

Active ingredient: Temazepam, USP

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

08-2010M

7205

Sandoz Inc.

Princeton, NJ 08540

mg Label

NDC 0781-2201-01

Temazepam

Capsules, USP CIV

15 mg

PHARMACIST: Dispense with medication

guide provided separately.

Rx only 100 Capsules

SANDOZ

mg Label

NDC 0781-2202-01

Temazepam

Capsules, USP

30 mg

PHARMACIST: Dispense with medication

guide provided separately.

Rx only 100 Capsules

SANDOZ

Temazepam
Temazepam capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0781-2201
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Temazepam (Temazepam)	Temazepam	15 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSE 2910 (3 MPA.S)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
METHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
BENZYL ALCOHOL
SODIUM PROPIONATE
EDETATE CALCIUM DISODIUM

Product Characteristics
Color	GREEN (green & white)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	GG531
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0781-2201-01	100 CAPSULE In 1 BOTTLE	None
2	0781-2201-05	500 CAPSULE In 1 BOTTLE	None
3	0781-2201-10	1000 CAPSULE In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071427	01/12/1988

Temazepam
Temazepam capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0781-2202
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Temazepam (Temazepam)	Temazepam	30 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSE 2910 (3 MPA.S)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE

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Ingredient matches for Jantoven

Ingredient matches for Itraconazolo EG

Ingredient matches for Cefamar

Monday, September 26, 2016

Ingredient matches for Isodol

Ingredient matches for Lomudal

Scheme

CAS registry number (Chemical Abstracts Service)

Chemical Formula

Molecular Weight

Therapeutic Category

Chemical Names

Foreign Names

Generic Names

Brand Names

Ingredient matches for Isodine

Ingredient matches for Baklofen Mylan

Ingredient matches for Itorelin

Friday, September 23, 2016

Ingredient matches for Indast

Commonly used brand name(s)

Uses For liotrix

Before Using liotrix

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol