Medicinal Products

PERINDOPRIL ACTAVIS 2 mg

Generic drug of Coversyl
Therapeutic class: Cardiology and angiology
Active ingredients: Perindopril
laboratory: Actavis Group Ptc Ehf

Compressed
Box of 90
All forms

Indication

Hypertension

Treatment of hypertension.

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 ACTAVIS 2 mg Tablet Box of 90

It is recommended to take Perindopril once a day in the morning before meals.

The dosage should be adjusted individually according to the patient's profile and blood pressure response (see Warnings and Precautions section ).

Hypertension:

Perindopril can be used alone or in combination with other classes of antihypertensive drugs.

The recommended starting dose is 4 mg once a day in the morning.

If there is significant stimulation of the renin-angiotensin-aldosterone system (especially in cases of renovascular hypertension, sodium and / or fluid depletion, cardiac decompensation or severe hypertension), too high a fall in blood pressure may occur. opportunity of the first take.

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

After 1 month of treatment, the dosage may be increased to 8 mg once daily.

Symptomatic hypotension may occur after initiation of treatment with Perindopril; especially in patients treated in parallel with diuretics.

Special attention is therefore recommended in these patients because they may have water and / or salt depletion.

If possible, the diuretic should be stopped 2 to 3 days before initiation of treatment with Perindopril (see Warnings and Precautions section ).

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

The treatment of elderly patients should be initiated at a dose of 2 mg which can be gradually increased to 4 mg after one month of treatment and up to 8 mg if necessary, depending on the state of renal function (see table below). ).

Symptomatic heart failure:

It is recommended that perindopril, usually given in combination with a non-potassium sparing diuretic and / or digoxin and / or a beta-blocker, be administered under close medical supervision with an initial intake of 2 mg in the morning. This dose may be increased in increments of 2 mg at intervals of at least 2 weeks to 4 mg once daily if tolerated. The dosage should be adjusted according to the clinical response observed in each patient.

In cases of severe heart failure and in patients considered to be at high risk (renal insufficiency and electrolyte disturbances, patients on diuretic and / or vasodilator-associated treatments), treatment should be initiated under close medical supervision (see section 4.4). and precautions for use "Special warnings and precautions for use").

Patients at high risk of symptomatic hypotension, eg patients with sodium depletion with or without hyponatremia, patients with hypovolemia or who have received high dose diuretic therapy, should, if possible, have these situations corrected before starting treatment with perindopril. Blood pressure, renal function and serum potassium should be closely monitored both before and during treatment with perindopril (see Warnings and Precautions ).

Stable coronary disease:

Perindopril will be administered at a dose of 4 mg once daily, then after 2 weeks increased to 8 mg once daily, depending on the state of renal function and provided that the 4 mg dose is well tolerated. .

Elderly patients will receive 2 mg once daily in the first week, then 4 mg once daily the following week before increasing the dose to 8 mg once daily depending on the state of renal function. (see Table 1: "Dosage Adjustment for Renal Failure").

The dosage will be increased only if the tolerance of the previous dose is good.

Dosage adjustment in case of renal insufficiency:

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

Table 1: Dosage Adjustment in Renal Impairment

Creatinine clearance (ml / min)

Recommended dose

Cl Cr ≥ 60

4mg / day

30 <Cl Cr <60

2mg / day

15 <Cl Cr <30

2 mg every other day

Hemodialysis patient *, Cl Cr <15

2 mg on the day of dialysis

* The dialysis clearance of perindoprilat is 70 ml / min. Patients on hemodialysis should take the dose after the dialysis session.

Dosage adjustment in case of hepatic insufficiency:

No dose adjustment is necessary in patients with hepatic impairment (see Warnings and Precautions for Use and Pharmacokinetics ).

Use in children

Efficiency and job safety have not been fully established. Therefore, use in children is not recommended.

Against indications

· Hypersensitivity to perindopril, any of the excipients, or other inhibitors of the conversion enzyme (IEC);

· History of angioedema associated with previous treatment with IEC;

· Hereditary or idiopathic angioedema;

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

Adverse effects Perindopril Actavis

The following adverse reactions have been observed during treatment with perindopril and are classified in the following order of frequency: very common (> 1/10); frequent (≥1 / 100 - <1/10); infrequent (≥1 / 1000 - <1/100); rare (≥1 / 10000 - <1/1000); very rare (<1/10000), unknown (can not be estimated from available data)

Blood and lymphatic system disorders

Cases of decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia and agranulocytosis or pancytopenia have been very rarely described. In patients with congenital glucose-6-phosphate dehydrogenase deficiency, very rare cases of haemolytic anemia have been reported (see Warnings and Precautions ).

Psychiatric disorders

Uncommon: Mood or sleep disorders.

Nervous system disorders:

Frequent: Headache, dizziness, vertigo, paresthesia.

Very rare: Mental confusion.

Eye disorders

Frequent: Visual disturbances

Affections of the ear and labyrinth:

Frequent: Tinnitus

Cardiovascular disorders

Frequent: hypotension and effects related to hypotension.

Very rare: Rhythmic disorders, angina, myocardial infarction and stroke, which may be secondary to excessive hypotension in high-risk patients (see Warnings and Precautions section ).

Respiratory, thoracic and mediastinal disorders

Common: Cough, dyspnea

Uncommon: Bronchospasm

Very rare: Eosinophilic pneumonia, rhinitis

Gastrointestinal disorders

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

Rare: Dry mouth

Very rare: Pancreatitis

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

Common: 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

Musculoskeletal and systemic disorders

Frequent: Muscle cramps

Renal and urinary disorders

Rare: Renal insufficiency

Very rare: Acute renal failure

Disorders of reproductive organs and breast

Uncommon: Impotence

General disorders

Frequent: Asthenia

Uncommon: Sweating

Investigations (biological examinations)

Increases in uremia and serum creatinine and reversible hyperkalaemia at discontinuation may occur, particularly in the presence of renal failure, severe heart failure, or renovascular hypertension. Elevations of liver enzymes and bilirubinemia have been observed rarely.

Clinical tests

Only serious adverse events were recorded during the randomized phase of the EUROPA study. Some patients experienced serious adverse events: 16 (0.3%) of the 6122 perindopril group and 12 (0.2%) of the 6107 placebo group. In the perindopril group, hypotension occurred in 6 patients, angioedema in 3 and cardiac arrest in 1. Patients discontinued due to cough, hypotension, or other Intolerance was higher in the perindopril group than in the placebo group (6.0% [n≥366] and 2.1% [n≥129] respectively).

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