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COVAPRILE 4

COMPOSITION:
Each COVAPRILE 4 tablet contains:
Active ingredients: Perindopril tertbutylamin ... 4 mg
Excipients: Avicel, lactose, Aerosil, Chlorophyl lake, magnesium stearate q.s for one tablet.

 

Rx PRESCRIPTION ONLY MEDICINE
COMPOSITION:

Each COVAPRILE 4 tablet contains:
Active ingredients: Perindopril tertbutylamin ... 4 mg
Excipients: Avicel, lactose, Aerosil, Chlorophyl lake, magnesium stearate q.s for one tablet.
PHARMACODYNAMICS:
Perindopril is an angiotensin converting enzyme inhibitor (ACE inhibitor) effect through the activity of metabolites as perindoprilate.
Anti-hypertensive effect: Perindopril effect with all levels of hypertension, lowering systolic and diastolic in both standing and on back positions. Perindopril has vasodilatory properties, restore the elasticity of large arteries and reduces left ventricular hypertrophy. Anti-hypertensive effect reached a maximum after 4 - 6 hours and maintained over 24 hours.
Effects on heart failure: Perindopril reduces the load for the heart by relaxing veins (reducing preload) and reduces the total peripheral resistance (reducing afterload). So drugs are effective for reducing filling pressures in the left atrium and right atrium, increasing cardiac output, increasing the myocardial region blood flow and improving cardiac index.
PHARMACOKINETICS:
After administration about 65 - 70% perindopril absorbed (reaching peak concentrations approximately 1 hour) and strong metabolic, mainly in the liver into active metabolites as perindoprilate and some other inactive metabolites.
Half-life about 1 hour. About 20% is biological converted into perindoprilate.
Food reduces the biological transformation into perindoprilate and thereby reducing bioavailability. Drugs associated with less protein, less than 30% but depends on the concentration.
Perindoprilate is excreted through urine and the excretion time of free part about 3 - 5 hours.
Perindoprilate reduced the excretion in humans with heart failure, kidney failure. Both perindopril and perindoprilate were eliminated by dialysis.
INDICATIONS:
For treatment of hypertension.
Congestive heart failure.
Stable coronary artery disease.
DOSAGE AND USAGE:
How to use: oral route, should take in the morning before eating.
Dose: Usual dose is 4 mg each time, daily. Depending on response, may adjust the dose within 3 - 4 weeks to maximum dose of 8 mg each time, daily. Needed dose reduction for elderly patients and cases of kidney failure.
In any case, must comply with strict dosage specified by doctors.
CONTRAINDICATIONS:
Hypersensitivity to any component of the drug.
There was a history of angioedema (Quincke oedema) is related to using the angiotensin convertion enzyme inhibitor.
Women during pregnancy or breastfeeding.
Children under 15 years old.
PRECAUTIONS:
Need to stop using drugs and conducting medical intervention if the patient were tongue edema, glottis edema, or larynx edema.
Should be used with caution in patients with a history of angioedema unrelated to the use of angiotensin conversion enzyme inhibitors.
Should monitor kidney function in the first few weeks of treatment for hypertension patients with renal artery stenosis both sides.
Dry cough usually occurs when using the angiotensin conversion enzyme inhibitors. Dry cough, lasting and disappeared after cessation of treatment.
In the case of renal impairment (creatinine clearance < 60 ml / min) should adjust the initial dose according to creatinine clearance of patients and then depending on the response to treatment of patients.
    In patients with diabetes treated with oral medications or insulin, should monitor blood sugar closely during the first month of treatment with angiotension conversion enzyme inhibitors.
Generally, doctors must notify the adequate treatment of medical conditions, especially when diseases such as kidney failure, heart failure, diabetes, atherosclerosis, renal artery stenosis, hypotension or salt diet ...
The safety and effectiveness have not been proven to children under 15 years old.
INTERACTIONS:
Avoid combination of Perindopril with other medications as follows:
Keep potassium diuretics, except when treating heart failure.
Hyperkalemia drugs because of potentially fatal, especially in cases of renal failure
Lithium because they can cause increased blood lithium to toxic levels.
Estramustin: because of increased risk of unwanted effects such as nerve-angioedema.
The types of coordination need special caution:
Non steroidal anti-inflammatory drugs (NSAIDs) may reduce the anti-hypertensive effects and cause acute kidney failure.
Treatment of diabetes: could reduce blood glucose with the risk of hypoglycemia.
Baclofen: increased anti-hypertensive effects.
The types of coordination should be careful:
With amifostin: increased anti-hypertensive effects.
With strong sedatives, antidepressants of the group of  third round: increased anti-hypertension effects and increased risk of standing hypotension.
With corticosteroides, tetracosactides: reduced anti-hypertensive effects.
ADVERSE EFFECTS:
Feelings of fatigue, dizziness, headaches, sleep disturbances, cramps, low standing blood pressure, skin reactions on the type of allergies, hives, stomach pain, loss of appetite, nausea, abdominal pain, taste disorders.
Dry cough, dry mouth, increased risk of dehydration in elderly patients and patients with heart failure.
Rare: angioedema.
Notify your physicians if you should experience any of adverse effects
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Because drugs can cause dizziness should be especially cautious when driving or operating machinery.
PREGNANT WOMEN AND LACTATION:
Do not use for pregnant women or breastfeeding
OVERDOSE AND TREATMENT:  
The most common symptoms in cases of overdose is hypotension.
If hypotension occurs significantly, can be treated by put patients on back with lower head and higher feet.
Treatment: measures of gastric washing can be used, take activated charcoal, supplement of water and electrolytes to increase the volume of blood. Perindoprilat may be removed by hemodialysis.
STORAGE: in a dry place, below 30oC, protect from light.
SHELF-LIFE: 36 months from the date of manufacturing. Do not use after the expiry date.
PACKAGING: Box of 2 blisters x 30 tablets.
SPECIFICATIONS: manufacturer’s specifications.
KEEP OUT OF REACH OF CHILDREN
USE ONLY AS DIRECTED BY YOUR PHYSICIAN
CAREFULLY READ THE PACKAGE INSERT BEFORE USE
FOR FURTHER INFORMATION, DO NOT HESISTATE TO ASK YOUR PHYSICIANS


Manufactured by:
BOSTON VIETNAM PHARMACEUTICAL JOINT STOCK COMPANY
No. 43, Street No. 8, VSIP, Thuan An, Binh Duong, Vietnam
Tel: 06503 769 606 - Fax: 06503 769 601


                                                                                                        

 


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