Wednesday, October 14, 2009

Top 10 Pharmaceuticals company :: Corversec :: Perindopril




Coversec™ Tablets (Perindopril)






Indication
Coversec tablets contain the active ingredient perindopril, which is a type of medicine called an ACE inhibitor. (NB. Perindopril is also available without a brand name, i.e. as the generic medicine.)

ACE inhibitors work by blocking the action of a compound in the body called angiotensin converting enzyme (ACE). Normally ACE produces another compound called angiotensin II, as part of the body's natural control of blood pressure. Angiotensin II causes blood vessels to constrict and narrow, which increases the pressure within the blood vessels.

As perindopril blocks the action of ACE, it reduces the production of angiotensin II. This means that the blood vessels are allowed to relax and widen. The overall effect of this is a drop in blood pressure, hence perindopril can be used to lower high blood pressure.

The reduced pressure within the blood vessels means that the heart doesn't have to work as hard to pump the blood around the body. This means that ACE inhibitors can be used to improve the symptoms of heart failure, where the heart is not pumping as efficiently, and to improve survival following a heart attack.

It is recommended that Coversec tablets are taken in the morning before breakfast.


What is it used for?

* Heart failure.
* High blood pressure (hypertension).
* Reducing the risk of further heart attacks in people with stable coronary heart disease who have had a heart attack or heart bypass surgery.

Warning
Coversec tablets contain a different salt of perindopril to the old Coversec tablets (perindopril arginine instead of perindopril tert-butylamine). This new salt has an extended shelf-life and greater stability. Coversec is equivalent to the old Coversec in terms of safety and effectiveness, and the action of the medicine has not changed. However, the new tablets come in different packaging and in different strengths to the old Coversec tablets. Coversec 2.5mg tablets are equivalent to the old Coversec 2mg tablets. Coversec 5mg tablets are equivalent to the old Coversec 4mg tablets and Coversec 10mg tablets are equivalent to the old Coversec 8mg tablets. Generic perindopril tablets remain available; these contain the tert-butylamine salt. Coversec 2.5mg tablets are equivalent to generic perindopril 2mg tablets. Coversec 5mg tablets are equivalent to generic perindopril 4mg tablets and Coversec 10mg tablets are equivalent to generic perindopril 8mg tablets. If you have any questions or concerns about this change you should talk to your pharmacist.

Some people may experience dizziness caused by low blood pressure in the first few days of taking this medicine and in particular the first dose. For this reason, the first dose should preferably be taken at bedtime. Your doctor may want you to take the first dose of this medicine under medical supervision in hospital if you are aged over 70 years, have low blood pressure, low levels of fluids or salt in your blood (eg due to dehydration), severe or unstable heart failure, kidney problems, or are taking high doses of diuretic medicines, multiple diuretic medicines, or certain other medicines that dilate your blood vessels.

Alcohol may enhance the blood pressure lowering effect of this medicine, which can increase dizziness and may increase the risk of fainting.

ACE inhibitors can sometimes cause an allergic reaction called angioedema. Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue, throat, hands, feet or ankles while taking this medicine. This type of allergic reaction has been reported more frequently in people of Afro-Caribbean origin.

Your blood pressure, kidney function and the amount of potassium in your blood should be regularly monitored while you are taking this medicine.


Use with caution in
* Elderly people.
* Decreased liver function.
* Decreased kidney function.
* Narrowing of the arteries that supply blood to the kidneys (renal artery stenosis).
* High blood pressure caused by compression or blockage of the arteries that carry blood to the kidneys (renovascular hypertension).
* People with low fluid volume or salt levels in the body, eg due to diuretic therapy, low-sodium diet, diarrhoea or vomiting.
* People taking other medicines for high blood pressure, particularly diuretics (see end of factsheet).
* People with hardening of the arteries (athersclerosis) in the heart (cardiovascular disease), brain (cerebrovascular disease) or legs (peripheral vascular disease).
* Narrowing of the main artery of the body (aortic stenosis).
* Heart valve disease (mitral valve stenosis).
* Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
* Diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus or rheumatoid arthritis (collagen vascular diseases).
* Diabetes.
* People with kidney failure requiring a certain type of haemodialysis (high-flux membrane).
* People undergoing therapy to decrease allergy to bee or wasp stings (desensitisation).
* People receiving therapy to remove certain types of fat from the blood using a machine (LDL apheresis).

Not to be used in
* Allergy to other ACE inhibitor medicines.
* History of swelling of the lips, face or tongue (angioedema) with no known cause, or caused by previous use of an ACE inhibitor medicine.
* Hereditary angioedema (angioneurotic oedema).
* Pregnancy.
* Breastfeeding.
* Rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency (Coversec tablets contain lactose).
* The safety and efficacy of this medicine in children have not been studied. It is not recommended for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Side effects
Common
* Headache.
* Pins and needles sensations.
* Low blood pressure (hypotension).
* Dizziness.
* Visual disturbances.
* Sensation of ringing or other noise in the ears (tinnitus).
* Dry cough.
* Shortness of breath.
* Disturbances of the gut such as diarrhoea, constipation, indigestion, nausea, vomiting or abdominal pain.
* Alteration in taste.
* Rash or itching.
* Muscle cramps.
* Feeling of weakness.

Presentation
Phedrax Tablets Blister of 10 Tablets






Note :
This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.



Why is this medication prescribed?

Perindopril is used alone or in combination with other medications to treat high blood pressure. Perindopril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It makes blood flow more smoothly by preventing the production of certain natural chemicals that tighten the blood vessels.

How should this medicine be used? Return to top

Perindopril comes as a tablet to take by mouth. It is usually taken once or twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take perindopril exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of perindopril and gradually increase your dose.

Perindopril controls high blood pressure but does not cure it. Continue to take perindopril even if you feel well. Do not stop taking perindopril without talking to your doctor.

Other uses for this medicine Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Before taking perindopril,

* tell your doctor and pharmacist if you are allergic to perindopril, benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik), or any other medications.

* tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: cyclosporine (Neoral, Sandimmune), diuretics ('water pills'), heparin, indomethacin (Indocin), lithium (Eskalith, Lithobid), and potassium supplements (K-Dur, Klor-Con, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

* tell your doctor if you are on dialysis and if have or have ever had heart failure; lupus (SLE); scleroderma; diabetes; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, and/or lower legs (angioedema); or kidney or liver disease.

* tell your doctor if you plan to become pregnant or are breast-feeding.

* you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting.

What special dietary instructions should I follow? Return to top

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should I do if I forget a dose? Return to top

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause? Return to top

Perindopril may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

* cough

* headache

* weakness

* dizziness

* diarrhea

* stomach pain

* upset stomach

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

* swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

* hoarseness

* difficulty swallowing or breathing

* lightheadedness

* fainting

* fever, sore throat, chills, and other signs of infection

* irregular or rapid heartbeats

Perindopril may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Indications

* Essential hypertension.

* Stable coronary artery disease: reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularization.

* Treatment of symptomatic heart disease or failure.

[edit] Dosage and administration

Perindopril should be taken in the morning before food.

[edit] For hypertension

4 mg once daily, then the dose may be increased to 8 mg after 1 month of treatment to improve blood pressure control or in case of concomitant stable coronary artery disease.

In Australia, perindopril arginine is available as Coversyl, the generic form perindopril erbumine is also available. The two formulations are equivalent and may be freely substituted for each other[1]. In hypertension, the initiation dose is 5 mg perindopril arginine (or 4 mg perindopril erbumine) once daily, then the dose may be increased to 10 mg perindopril arginine (or 8 mg perindopril erbumine) after 1 month of treatment to improve blood pressure control or in case of concomitant stable coronary artery disease.

The Anglo-Scandinavian Cardiac Outcomes Trial showed the benefits of taking the two drugs Coversyl and amlodipine together. The 9000 British patients aged 40 to 79 were involved in the five-year trial. Half were given the new drug combination, the rest were given traditional drugs. Coversyl and amlodipine were found to be so effective that the trial was stopped early so that all patients could receive the combination.[2][3]

[edit] For stable coronary artery disease

A starting dose of 4 mg for 2 weeks is recommended, then uptitration to 8 mg once daily, depending on acceptability.

In Australia and the UK, Coversyl is only available as perindopril arginine. A starting dose of 5 mg for 2 weeks is recommended, then uptitration to 10 mg once daily, depending on acceptability.

[edit] Congestive heart disease

Coversyl (perindopril) should be started under close medical supervision at a starting dose of 2 mg. This may be increased to 4 mg once blood pressure acceptability has been demonstrated.

In Australia, Coversyl (perindopril arginine) should be started under close medical supervision at a starting dose of 2.5 mg. This may be increased to 5 mg once blood pressure acceptability has been demonstrated.

Elderly patients should start treatment at 2 mg daily (2.5 mg daily (perindopril arginine) in Australia).

Contraindications include; children, pregnancy, lactation and situations where a patient has a history of hypersensitivity to Coversyl (perindopril).

Composition

Each tablet contains 2 mg, 4 mg or 8 mg of the tert-butylamine salt of perindopril. Perindopril is also available under the trade name Coversyl Plus, containing 4 mg of perindopril combined with 1.25 mg indapamide.

In Australia, each tablet contains 2.5 mg, 5 mg or 10 mg of arginine. Perindopril is also available under the trade name Coversyl Plus and Coversyl Plus LD, containing 5 mg of perindopril combined with 1.25 mg indapamide and 2.5 mg of perindopril combined with 0.625 mg indapamide respectively.

The efficacy and tolerability of a fixed-dose combination of perindopril 4mg and amlodipine 5mg, a calcium channel antagonist, has recently been confirmed in a prospective, observational multicenter trial 1250 hypertensive patients.

Presentation

Packs of 30 tablets of Coversyl (perindopril) 2 mg. Packs of 30 tablets of Coversyl (perindopril) 4 mg (scored). Packs of 30 tablets of Coversyl (perindopril) 8 mg.

Also available under the brand names:

* Aceon

* Acertil

* Armix

* Coverene

* Coverex

* Coversum

* Prestarium

* Prexanil

* Prexum

* Procaptan

Side Effects

Asthenia, dizziness, headache, mood swings and/or sleep disturbances, cramps, hypotension, allergic reactions, skin rashes, gastrointestinal disorders, dry cough, dry mouth, risk of dehydration in the elderly and in patients suffering from heart failure; changes in blood test results may occur.

ACEON® (perindopril erbumine) Tablets is the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is chemically described as (2S,3S,7S)-1-[(S)-N-[(S)-1-Carboxy-butyl]alanyl]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester, compound with tert-butylamine (1:1),

Perindopril erbumine is a white, crystalline powder with a molecular weight of 368.47 (free acid) or 441.61 (salt form). It is freely soluble in water (60% w/w), alcohol and chloroform.

Perindopril is the free acid form of perindopril erbumine, is a pro-drug and metabolized in vivo by hydrolysis of the ester group to form perindoprilat, the biologically active metabolite.

ACEON® Tablets is available in 2 mg, 4 mg and 8 mg strengths for oral administration. In addition to perindopril erbumine, each tablet contains the following inactive ingredients: colloidal silica (hydrophobic), lactose, magnesium stearate and microcrystalline cellulose. The 4 and 8 mg tablets also contain iron oxide.

How does it work?

Coversyl arginine tablets contain the active ingredient perindopril, which is a type of medicine called an ACE inhibitor. (NB. Perindopril is also available without a brand name, ie as the generic medicine.)

ACE inhibitors work by blocking the action of a compound in the body called angiotensin converting enzyme (ACE). Normally ACE produces another compound called angiotensin II, as part of the body's natural control of blood pressure. Angiotensin II causes blood vessels to constrict and narrow, which increases the pressure within the blood vessels.

As perindopril blocks the action of ACE, it reduces the production of angiotensin II. This means that the blood vessels are allowed to relax and widen. The overall effect of this is a drop in blood pressure, hence perindopril can be used to lower high blood pressure.

The reduced pressure within the blood vessels means that the heart doesn't have to work as hard to pump the blood around the body. This means that ACE inhibitors can be used to improve the symptoms of heart failure, where the heart is not pumping as efficiently, and to improve survival following a heart attack.

It is recommended that Coversyl arginine tablets are taken in the morning before breakfast.

What is it used for?

* Heart failure.

* High blood pressure (hypertension).

* Reducing the risk of further heart attacks in people with stable coronary heart disease who have had a heart attack or heart bypass surgery.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

This medicine will have an additive effect with other medicines that decrease blood pressure, particularly other medicines used to treat high blood pressure (antihypertensives). In people taking antihypertensive medicines it may cause a large drop in blood pressure with the first dose or after any dose increases, particularly in people taking diuretic medicines such as furosemide. This may cause dizziness, which can usually be relieved by lying down until the symptoms pass. If you are taking a diuretic medicine, your doctor may reduce your dose or ask you to stop taking it for a few days before starting perindopril. This is to prevent your blood pressure from dropping too low. If you frequently feel dizzy while taking this medicine in combination with other blood pressure lowering medicines you should let your doctor know, as your doses may need adjusting. Other medicines that decrease blood pressure include the following:

* ACE inhibitors such as enalapril

* alpha-blockers such as prazosin

* alprostadil

* angiotensin II receptor antagonists such as losartan

* antipsychotics

* baclofen

* benzodiazepines, eg diazepam, temazepam

* beta-blockers such as propranolol

* calcium channel blockers such as nifedipine, diltiazem

* clonidine

* diazoxide

* diuretics, eg furosemide, bendroflumethiazide

* dopamine agonists, eg bromocriptine, apomorphine

* hydralazine

* levodopa

* MAOI antidepressants, eg phenelzine

* methyldopa

* minoxidil

* moxonidine

* nicorandil

* nitrates, eg glyceryl trinitrate.

Non-steroidal anti-inflammatory drugs (nsaids, eg indometacin, aspirin, ibuprofen) may reduce the blood pressure lowering effect of perindopril, and may increase the risk of a decline in kidney function.

There may be a risk of raised potassium levels in the blood (hyperkalaemia) if any of the following medicines are taken with perindopril, hence these are not normally recommended for use in combination with perindopril. If you are taking any of the following with this medicine you should have regular blood tests to monitor the amount of potassium in your blood:

* angiotensin II receptor antagonists, eg losartan

* ciclosporin

* drospirenone

* heparin

* potassium-containing salt substitutes (eg Lo-Salt)

* potassium salts, eg potassium citrate for cystitis

* potassium-sparing diuretics (eg spironolactone, triamterene, amiloride)

* potassium supplements.

Perindopril may increase the blood level of the medicine lithium and for this reason, it is not normally recommended for people taking lithium. People taking this medicine in combination with lithium should have the level of lithium in their blood closely monitored.

Perindopril may enhance the blood sugar lowering effect of insulin and oral antidiabetic medicines, and may increase the risk of low blood sugar (hypoglycaemia). People with diabetes should therefore carefully monitor their blood sugar while taking this medicine, particularly in the first few weeks of treatment.

There may be an increased risk of a drop in the normal numbers of blood cells in the blood if this medicine is used in combination with any of the following medicines:

* allopurinol

* azathioprine

* immunosuppressant therapy

* procainamide.

If you are taking any of these in combination with this medicine, you should have regular blood tests to monitor the levels of your blood cells, particularly if you also have any kidney problems or diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus or rheumatoid arthritis (collagen vascular diseases). Tell your doctor if you experience any signs of infection, such as fever, sore throat or mouth ulcers, as these could be signs of problems with your white blood cells.

Benefits of perindopril all along the cardiovascular continuum: the level of evidence{dagger}

Kim Fox*

Cardiology Department, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK

* Corresponding author. Tel: +44 207 352 8121; fax: +44 207 351 8629. E-mail address: k.fox@rbh.nthames.nhs.uk

Cardiovascular risk factors such as hypertension and diabetes are understood to trigger a sequence of pathological events starting from hypertension and atherosclerosis, which if left unmanaged can ultimately progress to end-stage cardiovascular disease. This chain of events is termed the cardiovascular continuum. The angiotensin-converting enzyme inhibitor, perindopril, has marked restorative effects on endothelial dysfunction and this translates into clinical benefits for patients at all stages of the continuum, making it a highly effective treatment in cardiovascular disease. In hypertensive patients, large-scale clinical trials have shown that perindopril-based treatments reduce morbidity and mortality and reduce the onset of stroke, renal failure, and diabetes when compared with other anti-hypertensive therapies. In patients at more advanced stages of the cardiovascular continuum, the use of perindopril on top of other standard management practices further improves long-term prognosis in coronary artery disease. Perindopril also reduces cardiac remodelling following myocardial infarction and improves patient symptoms and prognosis in diastolic heart failure. Current trial evidence confirms the clinical benefits of perindopril throughout the cardiovascular continuum, thus slowing the progression of cardiovascular disease and improving patient prognosis.

Why is Perindopril prescribed?

Perindopril is used in the treatment of high blood pressure. It can be taken alone or in combination with thiazide diuretics that help rid the body of excess water. Perindopril belongs to a family of drugs called angiotensin converting enzyme (ACE) inhibitors. It works by preventing a chemical in your blood called angiotensin I from converting into a more potent form that increases salt and water retention in your body. Perindopril also improves the flow of blood through the circulatory system.

Where can I order Perindopril from? Can I buy Perindopril at Canadian Prices?

Yes, if you are from the U.S. then you can buy Perindopril at Canadian prices. Currently we will only accept an order for Perindopril from U.S. and Canadian residents. Both U.S. and Canadian residents require a prescription to purchase Perindopril and when you order Perindopril it will be delivered with express shipping.

Most important fact about Perindopril

You must take Perindopril regularly for it to be effective. Since blood pressure declines gradually, it may be several weeks before you get the full benefit of the drug; and you must continue taking it even if you are feeling well. Perindopril does not cure blood pressure; it merely keeps it under control.

How should you take Perindopril?

Perindopril can be taken with or without food.--If you miss a dose...Take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.--Storage instructions...

Store at room temperature, protected from moisture.

What side effects may occur with Perindopril?

If any Perindopril side effects develop, they are usually mild and are likely to disappear as therapy continues. However, if any do appear, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Perindopril.

More common Perindopril side effects may include:

Cough, dizziness, headache, leg pain, light-headedness, nasal inflammation, sore throat, upper respiratory infection, weakness

Rare Perindopril side effects may include:

Angioedema (swelling of the face, lips, tongue, throat, arms, or legs, and difficulty swallowing), arm pain, fever, heart palpitations, indigestion, muscle tension, purple spots on the skin, sinusitis, viral infection

Possible food and drug interactions when taking Perindopril

If Perindopril is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Perindopril with the following:

Cyclosporine (Neoral, Sandimmune)

Diuretics such as Aldactone, Diuril, Dyazide, Lasix, and Moduretic

Indomethacin (Indocin)

Potassium supplements such K-Lyte, K-Tab, and Slow-K

Lithium (Eskalith, Lithobid, Lithonate)

Digoxin (Lanoxin)

Gentamicin (Garamycin)

Special information if you are pregnant or breastfeeding while taking Perindopril

Perindopril can cause injury or death to the developing baby when used during the last 6 months of pregnancy. Perindopril should be stopped as soon as you know that you're pregnant; contact your doctor immediately.

Perindopril may appear in breast milk and could affect a nursing infant. It should be used with caution if you are breastfeeding.

Recommended Perindopril dosage

ADULTS

The usual starting dosage is 4 milligrams daily, taken as a single dose or divided into two smaller doses. Your doctor may increase the dosage until your blood pressure is under control, up to a maximum of 16 milligrams per day. A dose of 4 to 8 milligrams a day is usually sufficient.If you have been taking a diuretic, your doctor may tell you to stop taking it 2 or 3 days before you start taking Perindopril. If you need to continue the diuretic without interruption, the doctor may start you on Perindopril at a reduced dose of 2 to 4 milligrams daily, then gradually increase the dosage if necessary.If your blood pressure is not adequately controlled with Perindopril alone, the doctor may add a diuretic to your regimen.Perindopril has not been tested in people with severe kidney disease. If you have mild kidney problems, the usual starting dosage is 2 milligrams or less per day. The dosage may be increased gradually to not more than 8 milligrams per day.

CHILDREN

Perindopril has not been tested in children.

OLDER ADULTS

Higher doses (above 8 milligrams a day) are prescribed for older adults only with extra caution.







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