Medicinal Products

PERINDOPRIL BIOGARAN 4 mg

Generic drug of Coversyl
Therapeutic class: Cardiology and angiology
Active ingredients: Perindopril
laboratory: Biogaran

Tablet breackable
Box of 90
All forms

Indication

Hypertension

Treatment of high blood pressure.

Heart failure

Treatment of symptomatic heart failure

Stable coronary disease

Reduced risk of cardiac events in patients with a history of myocardial infarction and / or revascularization.

Dosage PERINDOPRIL BIOGARAN 4 mg scored tablet Box of 90

It is recommended to take PERINDOPRIL BIOGARAN once daily in the morning before the meal.

The dosage should be appropriate to the patient's profile (see Warnings and Precautions for Use section ) and his or her blood pressure response.

Hypertension

PERINDOPRIL BIOGARAN can be used alone or in combination with other antihypertensive medications.

The recommended starting dose is 4 mg daily in one morning dose.

Patients whose renin-angiotensin-aldosterone system is highly stimulated (in particular, renovascular hypertension, water-soluble depletion, cardiac decompensation or severe hypertension) may experience a sudden fall in blood pressure after the first dose.

An initial dose of 2 mg is recommended in these patients and initiation of treatment will be under medical supervision.

The dosage may be increased to 8 mg once daily after one month of treatment.

Symptomatic hypotension may occur after the start of treatment with PERINDOPRIL BIOGARAN; especially in patients treated with diuretics. Special attention is warranted in these patients who may experience water-soluble depletion.

If possible, diuretic therapy should be discontinued 2 to 3 days prior to initiation of PERINDOPRIL BIOGARAN therapy (see Warnings and Precautions for Use section ).

In hypertensive patients for whom the diuretic can not be stopped, treatment with PERINDOPRIL BIOGARAN should be initiated at a dose of 2 mg. Renal function and serum potassium should be monitored. The dosage of PERINDOPRIL BIOGARAN will then be adjusted according to the blood pressure response. If necessary, treatment with diuretic will be reintroduced.

In the elderly, the treatment will be initiated at a dosage of 2 mg then it may be gradually increased to 4 mg after one month of treatment and then to 8 mg if necessary, depending on the state of renal function (see table below). below).

Symptomatic heart failure

It is recommended to initiate treatment with PERINDOPRIL BIOGARAN, generally used in combination with a non-potassium-sparing diuretic and / or digoxin and / or a beta-blocker, under strict medical supervision, at the initial dose of 2 mg once daily. morning. Depending on the tolerance, this dosage may be increased to 4 mg daily after 2 weeks. The dosage will be adapted according to the patient's response to the treatment.

In patients with severe heart failure, and in those considered at high risk (patients with renal failure and a tendency to have electrolyte disturbances, patients receiving concomitant treatment with diuretics and / or vasodilators), treatment should be under strict medical supervision (see Warnings and Precautions for Use section ).

Patients at high risk of symptomatic hypotension, such as patients with water-soluble depletion with or without hyponatremia, patients with hypovolemia or patients treated with high-dose diuretics should be equilibrated, if possible before initiation of treatment with PERINDOPRIL BIOGARAN. Blood pressure, renal function and serum potassium should be tightly controlled, both before and during treatment with PERINDOPRIL BIOGARAN (see Warnings and Precautions for Use section ).

Stable coronary disease

Treatment with PERINDOPRIL BIOGARAN should be initiated at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and whether the 4 mg dose is well tolerated. Elderly patients will receive 2 mg once daily for one week, then 4 mg once daily the following week, then the dose will be increased to 8 mg once daily depending on renal function (see Table 1, kidney failure "). The dosage will be increased only if the previous dose is well tolerated.

Dosage adjustment in renal failure

The dosage in patients with renal impairment should be adjusted according to creatinine clearance as outlined in Table 1 below:

Table 1: Dosage Adjustment in Renal Failure

Creatinine clearance (ml / min)

Recommended dosage

Cl CR ³ 60

4 mg daily

30 <Cl cr <60

2 mg daily

15 <Cl cr <30

2 mg every other day

Hemodialysis patients *

Cl CR < 15

2 mg on days of dialysis

* The dialysis clearance of perindoprilat is 70 ml / min. For hemodialysis patients, the drug should be taken after dialysis.

Dosage adjustment in hepatic insufficiency

No dose adjustment is required for patients with hepatic impairment (see Warnings and Precautions and Pharmacokinetic Properties sections).

Children and adolescents (under 18 years old)

Efficacy and safety of use have not been established in children and adolescents. As a result, use in children and adolescents is not recommended.

Against indications

· Hypersensitivity to perindopril, any of the excipients, or other angiotensin-converting enzyme (ACE) inhibitors;

· History of angioedema related to taking an ACE;

· Hereditary or idiopathic angioedema;

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Side effects Perindopril Biogaran

The following side effects have been observed during treatment with perindopril and are classified according to their frequency.

Very common (³ 1/10); frequent (³ 1/100, <1/10); uncommon (³ 1/1000, <1/100); rare (³ 1/10000, <1/1000); very rare (<1/10000); unknown (can not be estimated from the available data).

Blood and lymphatic system disorders

Decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, and cases of agranulocytosis or pancytopenia have been reported very rarely. In patients with congenital G6-PDH deficiency, very rare cases of haemolytic anemia have been reported (see Warnings and Precautions section ).

Metabolism and nutrition disorders

Unknown: hypoglycaemia (see sections Warnings and precautions for use, and Interactions with other medicinal products and other forms of interaction ).

Psychiatric disorders

Uncommon: mood or sleep disorders

Nervous system disorders

Common: headache, dizziness, vertigo, paresthesia.

Very rare: confusion.

Eye disorders

Common : blurred vision

Ear and labyrinth disorders

Frequent : tinnitus.

Cardiac disorders

Very rare: arrhythmia, angina pectoris and myocardial infarction, possibly secondary to excessive hypotension in high-risk patients (see Warnings and Precautions for Use section ).

Vascular disorders

Common: hypotension and effects related to hypotension.

Very rare : cerebral vascular accident, possibly secondary to excessive hypotension in high-risk patients (see section Warnings and precautions for use ).

Unknown : vasculitis.

Respiratory, thoracic and mediastinal disorders

Frequent: cough, dyspnea.

Uncommon : bronchospasm.

Very rare : eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders

Frequent: nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea, constipation.

Uncommon : dry mouth

Very rare: pancreatitis.

Hepatobiliary disorders

Very rare: cytolytic or cholestatic hepatitis (see Warnings and precautions for use ).

Skin and tissue disorders

Frequent: rash, pruritus.

Uncommon: angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, urticaria (see Warnings and Precautions for Use section ).

Very rare: erythema multiforme.

Muscular and connective tissue disorders

Frequent: muscle cramps.

Renal and urinary disorders

Uncommon : renal failure.

Very rare : acute renal failure.

Disorders of the reproductive organs and breast

Uncommon : impotence

General disorders

Frequent : asthenia.

Uncommon : sweating.

Biological parameters

Increases in uremia and serum creatinine, reversible hyperkalaemia upon discontinuation of therapy may occur, particularly in the presence of renal insufficiency, severe heart failure and renovascular hypertension. Elevated liver enzymes and bilirubinemia have been reported rarely.

Clinical tests

During the randomisation period of the EUROPA study, only serious adverse events were collected. Few patients experienced serious adverse events: 16 (0.3%) of 6, 122 patients receiving perindopril and 12 (0.2%) of 6, 107 patients receiving placebo. In patients treated with perindopril, hypotension was observed in 6 patients, angioedema in 3 patients and cardiac arrest in 1 patient. Stopping treatment due to cough, hypotension or other intolerance was observed in more patients receiving perindopril than placebo, respectively 6% (n = 366) versus 2.1% (n = 366). = 129).

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