List PLR Content Directory Eritrea: April 2012

Friday, 27 April 2012

Exforge 5mg / 160mg film coated tablets

Exforge 5 mg/160 mg film-coated tablets

amlodipine/valsartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Exforge is and what it is used for

2. Before you take Exforge

3. How to take Exforge

4. Possible side effects

5. How to store Exforge

6. Further information

What Exforge Is And What It Is Used For

Exforge tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.

Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.

Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.

Exforge is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.

Before You Take Exforge

Do not take Exforge

if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type,

if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Exforge. If you think you may be allergic, talk to your doctor before taking Exforge.

if you have severe liver problems, such as biliary cirrhosis or cholestasis.

if you have severe kidney problems or if you are having dialysis.

if you are more than 3 months pregnant. (It is also better to avoid Exforge in early pregnancy - see Pregnancy section)

If any of the above applies to you, do not take Exforge and talk to your doctor.

Take special care with Exforge

if you have been sick (vomiting or diarrhoea).

if you are taking diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce).

if you are taking other medicines or substances that increase the level of potassium in your blood (e.g. some types of diuretics, potassium supplements or salt substitutes containing potassium).

if you have liver or kidney problems.

if you have a condition affecting the renal glands called “primary hyperaldosteronism”.

if you have had heart failure.

if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).

If any of these apply to you, tell your doctor before taking Exforge.

You must tell your doctor if you think that you are (or might become) pregnant. Exforge is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section Pregnancy).

The use of Exforge in children and adolescents is not recommended.

Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below:

lithium (a medicine used to treat some types of depression);

potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels;

anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, St. John’s wort;

nitroglycerin and other nitrates, or other substances called “vasodilators”;

medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole).

Taking Exforge with food and drink

You can take Exforge with or without food.

Exforge and older people

Caution is required when increasing the dosage.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge. Exforge is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

If you become pregnant during therapy with Exforge, please inform and see your doctor without delay.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Exforge is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy. This can affect how well you can concentrate. So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.

How To Take Exforge

Always take this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects.

The usual dose of Exforge is one tablet per day.

It is advisable to take your medicine at the same time each day, preferably in the morning.

Swallow the tablets with a glass of water.

You can take Exforge with or without food.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you take more Exforge than you should

If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.

If you forget to take Exforge

If you forget to take this medicine, take it as soon as you remember. Then take your next dose at its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

Possible Side Effects

Like all medicines, Exforge can cause side effects, although not everybody gets them.

Some side effects can be serious:

A few patients have experienced these serious side effects (affecting less than 1 in 1,000 patients). If any of the following happen, tell your doctor straight away:

Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).

Other possible side effects:

Common (affecting less than 1 in 10 patients): Influenza; blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; redness and warm feeling of the face and/or neck.

Uncommon (affecting less than 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.

Rare (affecting less than 1 in 1,000 patients): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light-headedness; excessive sweating; skin rash all over your body; itching; muscle spasm.

If any of these affect you severely, tell your doctor.

Side effects with amlodipine or valsartan alone which can be serious:

These side effects may occur with certain frequencies, which are defined as follows:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

Amlodipine

Common: Vomiting.

Uncommon: Hair loss; change in bowel habits, feeling bloated, indigestion, stomach discomfort after meal; stomach pain, nausea; bleeding, tender or enlarged gums; breathlessness; breast enlargement in men; runny or stuffy nose, sneezing; yellow skin and eyes, nausea, loss of appetite, light-coloured urine; high level of sugar in the blood; inability to achieve or maintain an erection; increased need to pass urine; fever, sore throat or mouth ulcers due to infections; mood swings; muscle pain; sensation of numbness or tingling in fingers and toes; severe upper stomach pain; spontaneous bleeding or bruising; rash, purplish-red spots, fever, itching; swelling mainly of the face and throat; skin reddening, blistering of lips, eyes or mouth, skin peeling.

Rare: Crushing chest pain, irregular heart beat, angina pain.

Very rare: Yellowing of the skin and eyes, changes in the results of some liver function tests; purple skin patches, rash and itching, stiff limbs, trembling hands

Valsartan

Not known: Decrease in red blood cells, fever, sore throat or mouth sores due to infections, spontaneous bleeding or bruising, high level of potassium in the blood, abnormal liver test results, decreased renal functions and severely decreased renal functions, swelling mainly of the face and the throat, muscle pain, rash, purplish-red spots, fever, itching, allergic reaction.

If you experience any of these, tell your doctor straight away.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Exforge

Keep out of the reach and sight of children.

Do not use Exforge after the expiry date stated on the carton and blister.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Do not use any Exforge pack that is damaged or shows signs of tampering.

Further Information

What Exforge contains

The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg amlodipine and 160 mg valsartan.

The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).

What Exforge looks like and contents of the pack

Exforge 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.

Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel:+44 1276 698370

This leaflet was last approved in 04/2009.

Thursday, 26 April 2012

Theraflu Warming Relief Cold & Chest Congestion Liquid

Pronunciation: a-SEET-a-MIN-oh-fen/gwye-FEN-e-sin/FEN-il-EF-rin
Generic Name: Acetaminophen/Guaifenesin/Phenylephrine
Brand Name: Theraflu Warming Relief Cold & Chest Congestion

Theraflu Warming Relief Cold & Chest Congestion Liquid is used for:

Relieving cold and flu symptoms such as minor aches and pains, headache, sore throat pain, and congestion. It may also be used for other conditions as determined by your doctor.

Theraflu Warming Relief Cold & Chest Congestion Liquid is an analgesic, decongestant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, making coughs more productive. The analgesic works in the brain to decrease pain.

Do NOT use Theraflu Warming Relief Cold & Chest Congestion Liquid if:

you are allergic to any ingredient in Theraflu Warming Relief Cold & Chest Congestion Liquid

you have severe high blood pressure, rapid heartbeat, severe heart blood vessel disease, or other severe heart problems

you are taking droxidopa or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Theraflu Warming Relief Cold & Chest Congestion Liquid:

Some medical conditions may interact with Theraflu Warming Relief Cold & Chest Congestion Liquid. 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 smoke, drink 3 or more alcohol-containing drinks per day, or have a history of alcoholism

if you have trouble sleeping

if you have a history of glaucoma, or increased pressure in the eye, an enlarged prostate or other prostate problems, heart problems (eg, fast, slow, or irregular heartbeat), diabetes, high blood pressure, blood vessel problems, adrenal gland problems (eg, pheochromocytoma), thyroid problems, trouble sleeping, seizures, a stroke, liver problems (eg, hepatitis), or kidney problems

if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), sleep apnea, or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Theraflu Warming Relief Cold & Chest Congestion Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, isoniazid, linezolid, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of Theraflu Warming Relief Cold & Chest Congestion Liquid's side effects may be increased

Anticoagulants (eg, warfarin) because the risk of bleeding may be increased

Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased

Bromocriptine because the risk of its side effects may be increased by Theraflu Warming Relief Cold & Chest Congestion Liquid

Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by Theraflu Warming Relief Cold & Chest Congestion Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Theraflu Warming Relief Cold & Chest Congestion Liquid 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 Theraflu Warming Relief Cold & Chest Congestion Liquid:

Use Theraflu Warming Relief Cold & Chest Congestion Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Theraflu Warming Relief Cold & Chest Congestion Liquid by mouth with or without food.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

Drink plenty of water while taking Theraflu Warming Relief Cold & Chest Congestion Liquid.

If you miss a dose of Theraflu Warming Relief Cold & Chest Congestion Liquid, 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 Theraflu Warming Relief Cold & Chest Congestion Liquid.

Important safety information:

Theraflu Warming Relief Cold & Chest Congestion Liquid may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Theraflu Warming Relief Cold & Chest Congestion Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take appetite suppressants while you use Theraflu Warming Relief Cold & Chest Congestion Liquid unless your doctor tells you otherwise.

Theraflu Warming Relief Cold & Chest Congestion Liquid contains acetaminophen, guaifenesin, and phenylephrine. Before you start any new medicine, check the label to see if it has any of these medicines or similar medicines in it. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use Theraflu Warming Relief Cold & Chest Congestion Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Do NOT take more than the recommended dose or use for longer than directed without checking with your doctor.

If your symptoms do not get better within 7 days, if they come back or get worse, or if new symptoms appear, check with your doctor.

If you have a sore throat that lasts more than 2 days, is severe, or is accompanied with headache, fever, rash, nausea, or vomiting, check with your doctor.

Contact your doctor if you have a fever that lasts more than 3 days or you have a cough that is accompanied by a persistent headache, fever, or rash.

Theraflu Warming Relief Cold & Chest Congestion Liquid may harm your liver. Your risk may be greater if you drink alcohol while you are using Theraflu Warming Relief Cold & Chest Congestion Liquid. Talk to your doctor before you take Theraflu Warming Relief Cold & Chest Congestion Liquid or other fever reducers if you drink more than 3 drinks with alcohol per day.

Tell your doctor or dentist that you take Theraflu Warming Relief Cold & Chest Congestion Liquid before you receive any medical or dental care, emergency care, or surgery.

Theraflu Warming Relief Cold & Chest Congestion Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Theraflu Warming Relief Cold & Chest Congestion Liquid.

Theraflu Warming Relief Cold & Chest Congestion Liquid contains acetaminophen. Adults should not take more than a total of 4 grams (4,000 mg) of acetaminophen in a 24-hour period (3 grams [3,000 mg] per day if you have liver disease). Check with your doctor before taking other pain relievers, cough and cold medicines, or allergy medicines because they may also contain acetaminophen. Acetaminophen may cause liver damage. If you drink alcohol on a daily basis, do not take Theraflu Warming Relief Cold & Chest Congestion Liquid without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage (symptoms include yellowing of the skin or eyes, stomach pain, dark urine).

Use Theraflu Warming Relief Cold & Chest Congestion Liquid with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Theraflu Warming Relief Cold & Chest Congestion Liquid in CHILDREN; they may be more sensitive to its effects.

Theraflu Warming Relief Cold & Chest Congestion Liquid should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if Theraflu Warming Relief Cold & Chest Congestion Liquid can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Theraflu Warming Relief Cold & Chest Congestion Liquid while you are pregnant. Some ingredients of Theraflu Warming Relief Cold & Chest Congestion Liquid may be found in breast milk. If you are or will be breast-feeding while you use Theraflu Warming Relief Cold & Chest Congestion Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Theraflu Warming Relief Cold & Chest Congestion Liquid:

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: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping.

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); dark urine; difficulty urinating; fast or irregular heartbeat; hallucinations; loss of appetite; pale stools; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of the skin or eyes.

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: Theraflu Warming Relief Cold & Chest Congestion 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 may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of the skin or eyes.

Proper storage of Theraflu Warming Relief Cold & Chest Congestion Liquid:

Store Theraflu Warming Relief Cold & Chest Congestion Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Theraflu Warming Relief Cold & Chest Congestion Liquid out of the reach of children and away from pets.

General information:

If you have any questions about Theraflu Warming Relief Cold & Chest Congestion Liquid, please talk with your doctor, pharmacist, or other health care provider.

Theraflu Warming Relief Cold & Chest Congestion Liquid 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 Theraflu Warming Relief Cold & Chest Congestion Liquid. 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 Theraflu Warming Relief Cold & Chest Congestion resources

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Theraflu Warming Relief Cold & Chest Congestion Use in Pregnancy & Breastfeeding
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Theraflu Warming Relief Cold & Chest Congestion Drug Interactions
Theraflu Warming Relief Cold & Chest Congestion Support Group
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Cough and Nasal Congestion

Wednesday, 25 April 2012

Isometheptene, Caffeine, and Acetaminophen Tablets

Isometheptene, Caffeine, and Acetaminophen Tablets

BOXED WARNING

WARNINGHepatotoxicityIsometheptene, Caffeine, and Acetaminophen Tablets contain acetaminophen, isometheptene mucate and caffeine. Acetaminophen has been associated with cases of acute liver failure at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often in combination with other acetaminophen-containing products.

DESCRIPTION

Each Isometheptene, Caffeine, and Acetaminophen Tablet contains:

Isometheptene Mucate ...................................... 130 mg

Caffeine ............................................................... 20 mg

Acetaminophen .................................................. 500 mg

Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Isometheptene mucate has the following structural formula:

Figure 1: Isometheptene mucate

(C9H19N)2•C6H10O8 M.W. 492.65

Caffeine is 1H-Purine-2,6-dione, 3,7-dyhydro-1,3,7-trimethyl-. It has the following structural formula:

Figure 2: Caffeine

C8H10N4O2 M.W. 194.19

Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is Acetamide, N-(4-hydroxyphenyl)-. It has the following structural formula:

Figure 3: Acetaminophen

C8H9NO2 M.W. 151.16

INACTIVE INGREDIENTS

Inactive ingredients include calcium phosphate, colloidal silicone dioxide, crospovidone polyplasdone, magnesium stearate, microcrystalline cellulose, Povidone, Prosolv, and stearic acid.

CLINICAL PHARMACOLOGY

Isometheptene mucate, a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. It is particularly desirable in patients predisposed to nausea and vomiting, and where ergotamines are precluded. Its action is similar to ergotamine but possesses a low order of toxicity.

Caffeine, also a cranial vasoconstrictor, is added to further enhance the vasoconstrictor effect. It is also used as a central stimulant for relief of headache.

Acetaminophen, an effective non-narcotic analgesic, reduces the perception of pain impulses originating from dilated cerebral vessels; no hyperacidity of stomach and less allergies than aspirin.

INDICATIONS AND USAGE

For relief of tension and vascular headaches.*

Based on a review of this drug (isometheptene mucate), the National Academy of Sciences- National Research Council and/or other information, FDA has classified the other indication as “Possibly” effective in the treatment of migraine headache. Final classification of less than effective indication requires further investigation.

CONTRAINDICATIONS

This Product is contraindicated in Glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease, and in those patients who are on monoamine oxidase inhibitor (MAOI) therapy.

WARNINGS

Hepatotoxicity - Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/Anaphylaxis – There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Isometheptene, Caffeine, and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Isometheptene, Caffeine, and Acetaminophen Tablets for patients with acetaminophen allergy.

ADVERSE REACTIONS

Hypersensitive patients have shown rash and transient dizziness, this can be eliminated by reducing dosage.

PRECAUTIONS

Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks.

Information for Patients

Do not take this product if you are allergic to any of its ingredients. If you develop signs of allergy such as rash or difficulty breathing stop taking this product and contact your healthcare provider immediately.

Do not take more than 4,000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

OVERDOSAGE

Following an acute overdosage, toxicity may result.

Acetaminophen – In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

DOSAGE AND ADMINISTRATION

FOR RELIEF OF MIGRAINE HEADACHE: The usual adult dosage is two tablets at once, followed by one tablet every hour until relieved, up to 5 tablets within a twelve hour period.

FOR RELIEF OF TENSION HEADACHE: The usual adult dosage is one or two tablets every four hours up to 8 tablets a day.

HOW SUPPLIED

Isometheptene, Caffeine, and Acetaminophen Tablets are supplied as white tablets debossed “130” on one side, and scored on the opposite side. Available in bottles of 50 tablets, NDC 50967-620-50.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Avoid exposure to heat.

Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure.

Manufactured for:

Women’s Choice Pharmaceuticals

Gilbert, AZ 85233

(877) 774-4949

500421 Rev. 09/2011

PRINCIPAL DISPLAY PANEL

Figure 4: Bottle Label

ISOMETHEPTENE MUCATE, CAFFEINE, AND ACETAMINOPHEN
isometheptene mucate, caffeine, and acetaminophen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	50967-620
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg
CAFFEINE (CAFFEINE)	CAFFEINE	20 mg
ISOMETHEPTENE MUCATE (ISOMETHEPTENE)	ISOMETHEPTENE MUCATE	130 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	130
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50967-620-50	50 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/12/2011

Labeler - Womens Choice Pharmaceuticals, LLC (833067841)

Registrant - Womens Choice Pharmaceuticals, LLC (833067841)

Establishment
Name	Address	ID/FEI	Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 08/2011Womens Choice Pharmaceuticals, LLC

More Isometheptene, Caffeine, and Acetaminophen Tablets resources

Isometheptene, Caffeine, and Acetaminophen Tablets Side Effects (in more detail)
Isometheptene, Caffeine, and Acetaminophen Tablets Dosage
Isometheptene, Caffeine, and Acetaminophen Tablets Use in Pregnancy & Breastfeeding
Isometheptene, Caffeine, and Acetaminophen Tablets Drug Interactions
Isometheptene, Caffeine, and Acetaminophen Tablets Support Group
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Headache

Tuesday, 24 April 2012

Entereg

Generic Name: alvimopan (AL vi MOE pan)

Brand Names: Entereg

What is alvimopan?

Alvimopan reduces certain side effects of narcotic medications that are often used to prevent pain caused by surgery.

Narcotic medications can cause stomach pain, bloating, nausea, vomiting, and constipation. These side effects can delay recovery in patients undergoing gastrointestinal surgery.

Alvimopan works by preventing these side effects without reducing the pain-relieving effects of the narcotic.

Alvimopan is used to speed recovery of stomach and intestinal functions after a gastrointestinal surgery and to prevent side effects caused by narcotic medications.

Alvimopan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about alvimopan?

You should not use this medication if you are allergic to alvimopan, or if you have used a narcotic medication within the past 7 days. You may be more likely to have unpleasant effects on your stomach if you have recently taken a narcotic medication.

Before you receive alvimopan, tell your doctor if you have liver or kidney disease.

Alvimopan is given only in a hospital for a short period of time.

Tell your caregivers right away if you have pale skin, easy bruising or bleeding, painful or difficult urination, or confusion with uneven heart rate, leg discomfort, muscle weakness or limp feeling, and increased urination.

What should I discuss with my health care provider before I receive alvimopan?

You should not use this medication if you are allergic to alvimopan, or if you have used a narcotic medication within the past 7 days, such as:

fentanyl (Actiq, Duragesic);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid, Palladone);

levorphanol (Levo-Dromoran);

meperidine (Demerol);

methadone (Methadose, Diskets, Dolophine);

morphine (Kadian, MS Contin, Oramorph, and others);

nalbuphine (Nubain);

oxycodone (OxyContin);

oxymorphone (Numorphan, Opana); or

pentazocine (Talwin).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using alvimopan, tell your doctor if you have:

liver disease; or

kidney disease.

FDA pregnancy category B. Alvimopan is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alvimopan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is alvimopan given?

Alvimopan is given only in a hospital for a short period of time.

You will receive your first dose of alvimopan up to 5 hours before your surgery. You will then be given additional doses two times per day for up to 7 days.

What happens if I miss a dose?

Since alvimopan is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

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

Since alvimopan is given by a healthcare professional, an overdose of this medication is not likely to occur.

What should I avoid while receiving alvimopan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving alvimopan.

Alvimopan 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. Tell your caregivers at once if you have a serious side effect such as:

pale skin, easy bruising or bleeding, weakness;

painful or difficult urination;

urinating less than usual or not at all; or

confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

stomach pain or upset;

nausea, vomiting; diarrhea;

constipation, gas; or

back pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alvimopan?

Tell your doctor about all other medications you are using. It is especially important to tell your doctor if you have taken a narcotic medication within the past 7 days. You may be more likely to have unpleasant effects on your stomach if you have recently taken a narcotic medication.

There may be other drugs that can interact with alvimopan. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Entereg resources

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

Entereg Prescribing Information (FDA)

Entereg Monograph (AHFS DI)

Entereg Advanced Consumer (Micromedex) - Includes Dosage Information

Entereg Consumer Overview

Entereg MedFacts Consumer Leaflet (Wolters Kluwer)

Alvimopan Professional Patient Advice (Wolters Kluwer)

Compare Entereg with other medications

Gastrointestinal Surgery
Postoperative Ileus

Where can I get more information?

Your doctor or pharmacist can provide more information about alvimopan

See also: Entereg side effects (in more detail)

Monday, 23 April 2012

Optivate

1. Name Of The Medicinal Product

Optivate^®, 100 IU/mL human factor VIII, a powder for solution.

2. Qualitative And Quantitative Composition

Optivate is a concentrate of human coagulation factor VIII with associated von Willebrand factor (VWF) (the natural stabiliser for FVIII). There are no added proteins as stabilisers. The product is obtained from blood from screened donors. These donors are selected from the USA.

Each vial contains nominally 250 IU, 500 IU or 1000 IU of human coagulation factor VIII. One mL of Optivate contains approximately 100 IU of human coagulation factor VIII after reconstitution with 2.5 mL (250 IU), 5 mL (500 IU) or 10 mL (1000 IU) of Sterilised Water for Injections, Ph.Eur..

The factor VIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Optivate is approximately 800 IU/mg protein when VWF is discounted and approximately 43 IU/mg protein when the presence of VWF is considered in the calculation.

The product contains approximately 172 IU VWF:RCo per mL when reconstituted with Sterilised Water for Injections as described above.

The specific activity of Optivate is approximately 75 IU of VWF:RCo/mg protein.

The VWF potency (IU) is measured according to ristocetin cofactor activity (VWF:RCo) compared to the International Standard for von Willebrand factor concentrate (WHO).

The label on each vial states the assayed amounts of factor VIII and VWF ristocetin cofactor activities.

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Powder for solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

4.2 Posology And Method Of Administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.

The dosage and duration of the substitution therapy depend on the severity of the FVIII deficiency, on the location and extent of the bleeding and the patient's clinical condition.

Posology

On demand treatment

The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor VIII in plasma).

One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma. The calculation of the required dosage of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2.2% - 2.7% of normal activity (2.2-2.7 IU/dL). The required dosage is determined using the following formula:

Required units =

body weight (kg)

desired factor VIII rise (%) (IU/dL)

0.4

The amount to be administered and the frequency of administration should always be orientated to the clinical effectiveness in the individual case.

In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal; IU/dL) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:

Degree of haemorrhage/Type of surgical procedure	Factor VIII level required (%) (IU/dL)	Frequency of doses (hours)/Duration of therapy (days)
Haemorrhage
Early haemarthrosis, muscle bleeding or oral bleeding	20-40	Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
More extensive haemarthrosis, muscle bleeding or haematoma.	30-60	Repeat infusion every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved.
Life threatening haemorrhages	60-100	Repeat infusion every 8 to 24 hours until threat resolved.
Surgery
Minor surgery Including tooth extraction	30-60	Every 24 hours, at least 1 day, until healing is achieved.
Major surgery	80-100 (pre- and postoperative)	Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).

Prophylaxis

For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.

During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.

Paediatric patients

Optivate is indicated for use in children, including those less than 6 years of age. The usual dose is 17 to 30 IU/kg. This can be given up to 3 times a week to prevent bleeding. In the clinical trials the median doses in children

Patients should be monitored for the development of factor VIII inhibitors. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of patients with haemophilia.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of human proteins other than factor VIII and VWF. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician.

In case of shock, standard medical treatment for shock should be implemented.

Standard measures are implemented to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for non-enveloped viruses HAV and parvovirus B19.

It is strongly recommended that every time that Optivate is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay. The risk of developing inhibitors is correlated to the exposure to anti-haemophilic factor VIII, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days.

Cases of recurrent inhibitor (low titre) have been observed after switching from one FVIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development. Therefore, it is recommended to monitor patients carefully for inhibitor occurrence following any product switch.

In general, all patients treated with human coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions of human coagulation factor VIII products with other medicinal products have been reported.

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.

4.7 Effects On Ability To Drive And Use Machines

Optivate has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

The following adverse reactions have been reported from 96 patients in clinical studies. Approximately 10% of patients can be expected to experience adverse reactions on long-term treatment. Frequencies are defined as: very common (

MedDRA Standard System Organ Class	Adverse Reactions	Frequency
Nervous System Disorders	Headache	Common
Somnolence	Common
Ear and Labyrinth Disorders	Vertigo (dizziness)	Common
Skin and Subcutaneous Tissue Disorders	Rash	Common
Pruritus	Common
Musculoskeletal and Connective Tissue Disorders	Muscle and joint stiffness	Common
General Disorders and Administration Site Disorders	Infusion site erythema, rash, or pain	Common
Oedema peripheral	Common
Shivering (rigors)	Common
Fever (pyrexia)	Common

In post-marketing experience, the following additional undesirable effects have been reported: sneezing, cough, throat irritation, abdominal pain and malaise.

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently, and may in some cases progress to severe anaphylaxis.

Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. One previously untreated patient (PUP) has been treated in the clinical development programme. Neither he nor any of the 95 previously treated patients (PTPs) in the clinical trials has developed inhibitors. The median number of exposure days in these patients was 97 days (range 2 to 408 days).

For information on viral safety see 4.4.

4.9 Overdose

No case of overdose has been reported.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group :

Antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.

The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions. When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

In addition to its role as a factor VIII protecting protein, von Willebrand factor mediates platelet adhesion to sites of vascular injury and plays a role in platelet aggregation.

From clinical trial experience, young children using prophylactic Optivate experienced less bleeds than those only using it on demand. For doses in children see 4.2.

5.2 Pharmacokinetic Properties

The pharmacokinetics of Optivate have been evaluated in 15 patients with severe haemophilia A after bolus doses of 50 IU/kg. The mean results were as follows:

Non-compartmental terminal half-life	12.4 hours
95%CI	10.94-13.83 hours
Mean Residence Time	17.5 hours
95%CI	15.99-18.92 hours
Clearance	3.1 mL/kg/h
95%CI	2.71-3.51 mL/kg/h
Area under curve (AUC_0-48h)	16.1 h.IU/mL
95%CI	13.97-18.28 h.IU/mL
Area under curve (AUC_0-inf)	17.31 h.IU/mL
95%CI	14.98-19.65 h.IU/mL
Volume of distribution	53.4 mL/kg
95%CI	46.2-60.52 mL/kg
Alpha half-life	2.2 hours
95%CI	1.48-2.88 hours
Beta half-life	12.6 hours
95%CI	11.33-13.92 hours
Incremental recovery	2.5 IU/dL per IU/kg
95%CI	2.22-2.74 IU/dL per IU/kg

During the clinical trials, there were 309 assessments of incremental recovery, all based on the maximum FVIII:C in the first hour (ISTH 2001). These assessments have involved 27 batches of Optivate and 70 adults with severe haemophilia A. The overall values of incremental recovery were as follows:

Mean:	2.7 IU/dL per IU/kg
95%CI:	2.53-2.80 IU/dL per IU/kg
Median:	2.6 IU/dL per IU/kg.

5.3 Preclinical Safety Data

The factor VIII and von Willebrand factor in Optivate are normal constituents of human plasma and act in the same way as the endogenous proteins. Therefore, safety testing is not relevant.

However, an acute toxicity study and a repeated dose toxicity study in mice indicated that the Optivate formulation was not toxic, even at levels up to 20 times that likely to be used in man. In these studies, the various constituents of the product were administered to the test animals in different, greater, amounts for each excipient, compared to that in a clinical dose.

It is scientifically inappropriate to conduct genotoxicity or carcinogenicity studies with plasma coagulation factor VIII with or without its natural stabiliser, VWF.

6. Pharmaceutical Particulars

6.1 List Of Excipients

The reconstituted solution contains:

Sodium chloride

Sodium citrate

Calcium chloride

Polysorbate 20

Trehalose.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Only the recommended injection/infusion sets should be used because treatment failure can occur as a consequence of human plasma coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.

6.3 Shelf Life

Unopened (at 2°C - 25°C, in the dark) 3 years.

6.4 Special Precautions For Storage

Store below 25°C. Do not freeze. Protect from light.

6.5 Nature And Contents Of Container

The product is presented as a 250 IU, 500 IU or 1000 IU presentation in Type I, Ph.Eur., glass vials. These vials are stoppered with a halobutyl rubber freeze-drying stopper under vacuum and then oversealed with a snap-off polypropylene cap and aluminium lacquered skirt.

Supplied with the product is a Transfer Device called Mix2Vial^TM to allow needle-free, easy and safe reconstitution of the product with the Sterilised Water for Injection, (Ph.Eur.).

6.6 Special Precautions For Disposal And Other Handling

Optivate should only be reconstituted with Water for Injections provided with the product. The 250 IU, 500 IU and 1000 IU presentations should be reconstituted using 2.5 mL, 5 mL and 10 mL Sterilised Water for Injections, Ph.Eur., respectively.

The container of Optivate and Water for Injections should be brought to between 20°C and 30°C prior to the removal of the flip-off closure from the product vial.

The Mix2Vial^TM Transfer Device is provided with the product for needle-free, easy and safe use.

The reconstitution is performed as follows:

Step 1: Remove the cap from the product vial and clean the top of the stopper with an alcohol swab. Repeat this step with the sterile water vial. Peel back the top of the Transfer Device package but leave the device in the package.

Step 2: Place the blue end of the Transfer Device on the water vial and push straight down until the spike penetrates the rubber stopper and snaps into place.

Remove the plastic outer packaging from the Transfer Device and discard it, taking care not to touch the exposed end of the device.

Step 3: Turn the water vial upside down with the Transfer Device still attached.

Place the clear end of the Transfer Device on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place.

Step 4: The sterile water will be pulled into the product vial by the vacuum contained within it. Gently swirl the vial to make sure the product is thoroughly mixed. Do not shake the vial. A clear or slightly pearl-like solution should be obtained, usually in about 2 to 2 ½ minutes (5 minutes maximum).

Step 5: Separate the empty water vial and blue part from the clear part by unscrewing anti-clockwise. Draw air into the syringe by pulling the plunger to the volume of water added. Connect the syringe to the white filter and push the air into the vial.

Step 6: Immediately invert the vial of solution which will be drawn into the syringe. Disconnect the filled syringe from the device. Follow normal safety practices to administer your medicine.

Note: If you have more than one vial to make up your dose, repeat Steps 1 through 6 withdrawing the solution in the vial into the same syringe.

The Transfer Device supplied with the product is sterile and cannot be used more than once. When the reconstitution process is complete, dispose of in the 'sharps box'.

Any unused product or waste material should be disposed of in accordance with local requirements.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.

7. Marketing Authorisation Holder

BPL, Bio Products Laboratory

Dagger Lane, Elstree, Herts, WD6 3BX

United Kingdom

Tel: +44 (0) 208 258 2200

Email: info@bpl.co.uk

8. Marketing Authorisation Number(S)

PL08801/0051

9. Date Of First Authorisation/Renewal Of The Authorisation

December 2004

10. Date Of Revision Of The Text

July 2009

Item code: OptSmPC5

Saturday, 21 April 2012

Taztia XT

Generic Name: diltiazem (Oral route)

dil-TYE-a-zem

Commonly used brand name(s)

In the U.S.

Cardizem

Cardizem CD

Cardizem LA

Cartia XT

Dilacor XR

Dilt-CD

Diltia XT

Dilt-XR

Diltzac

Matzim LA

Taztia XT

Tiazac

Available Dosage Forms:

Capsule, Extended Release

Tablet, Extended Release

Tablet

Capsule, Extended Release, 24 HR

Capsule, Extended Release, 12 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Benzothiazepine

Uses For Taztia XT

Diltiazem is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Diltiazem is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, diltiazem relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload .

This medicine is available only with your doctor's prescription .

Before Using Taztia XT

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

Appropriate studies have not been performed on the relationship of age to the effects of diltiazem in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of diltiazem in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving diltiazem .

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

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

Cisapride

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.

Acebutolol

Alprenolol

Amiodarone

Aprepitant

Atazanavir

Atenolol

Atorvastatin

Betaxolol

Bevantolol

Bisoprolol

Bucindolol

Carteolol

Carvedilol

Celiprolol

Clonidine

Clozapine

Colchicine

Crizotinib

Dantrolene

Dilevalol

Dronedarone

Droperidol

Erythromycin

Esmolol

Everolimus

Fentanyl

Labetalol

Levobunolol

Lurasidone

Mepindolol

Metipranolol

Metoprolol

Nadolol

Nebivolol

Oxprenolol

Penbutolol

Pindolol

Propranolol

Ranolazine

Simvastatin

Sotalol

Talinolol

Tertatolol

Timolol

Tolvaptan

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.

Alfentanil

Alfuzosin

Amlodipine

Aspirin

Buspirone

Carbamazepine

Celecoxib

Cilostazol

Cimetidine

Clopidogrel

Colestipol

Cyclosporine

Dalfopristin

Digitoxin

Digoxin

Dutasteride

Efavirenz

Enflurane

Fosaprepitant

Fosphenytoin

Guggul

Indinavir

Lithium

Lovastatin

Methylprednisolone

Midazolam

Moricizine

Nevirapine

Nifedipine

Phenytoin

Quinupristin

Rifampin

Rifapentine

Ritonavir

Sirolimus

St John's Wort

Tacrolimus

Triazolam

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.

Proper Use of diltiazem

This section provides information on the proper use of a number of products that contain diltiazem. It may not be specific to Taztia XT. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Swallow the extended-release tablet or extended-release capsule whole. Do not open, crush, or chew it. It is best to take the extended-release capsule on an empty stomach .

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 chest pain:
- For oral dosage form (tablets):
  - Adults—At first, 30 milligrams (mg) four times a day before meals and at bedtime. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (extended-release tablets):
  - Adults—At first, 180 mg once a day either in the evening or in the morning. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (extended-release capsules):
  - Adults—At first, 120 mg once a day in the morning. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .

For high blood pressure:
- For oral dosage form (extended-release tablets):
  - Adults—At first, 180 to 240 milligrams (mg) once a day either in the morning or at bedtime. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage form (extended-release capsules):
  - Adults—At first, 180 to 240 mg once a day in the morning. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, 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 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.

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

Precautions While Using Taztia XT

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem .

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness .

Taztia XT 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:

More common

Body aches or pain

congestion

cough

dryness or soreness of throat

fever

hoarseness

runny nose

tender or swollen glands in neck

trouble in swallowing

voice changes

Less common

Chest pain or discomfort

chills

diarrhea

difficult or labored breathing

feeling faint, dizzy, or lightheaded

feeling of warmth or heat

flushing or redness of skin, especially on face and neck

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

shivering

shortness of breath

slow or irregular heartbeat

sore throat

sweating

swelling of hands, ankles, feet, or lower legs

tightness in chest

trouble sleeping

unusual tiredness or weakness

vomiting

wheezing

Incidence not known

Blistering, peeling, or loosening of skin

itching

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

no heart beat

red irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in mouth or on lips

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:

More common

Sneezing

stuffy nose

Less common

Acid or sour stomach

belching

constipation

continuing ringing or buzzing or other unexplained noise in ears

degenerative disease of the joint

difficulty in moving

hearing loss

heartburn

indigestion

lack or loss of strength

muscle aching or cramping

muscle pains or stiffness

pain or tenderness around eyes and cheekbones

rash

sleeplessness

stomach discomfort, upset, or pain

swollen joints

unable to sleep

Incidence not known

Hair loss or 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: Taztia XT side effects (in more detail)

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