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אסריל 50 ACERIL 50 (CAPTOPRIL)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליה : TABLETS

Posology : מינונים

4.2 Posology and method of administration
For oral administration.
Dose should be individualised according to patient's profile (see section 4.4) and blood pressure response. The recommended maximum daily dose is 150 mg.
Aceril may be taken before, during and after meals.
Adults
Hypertension: Treatment with captopril should be at the lowest effective dose which should be titrated according to the needs of the patient.
The recommended starting dose is 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure. Captopril can be used alone or with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). A once-daily dosing regimen may be appropriate when concomitant antihypertensive medication such as thiazide diuretics is added.
In patients with a strongly active renin-angiotensin-aldosterone system (hypovolaemia, renovascular hypertension, cardiac decompensation) it is preferable to commence with a single dose of 12.5 mg. The inauguration of this treatment should preferably take place under close medical supervision. These doses will then be administered at a rate of two per day. The dosage can be gradually increased to 50 mg per day in one or two doses and if necessary to 100 mg per day in one or two doses.
Congestive heart failure: Captopril therapy must be started under close medical supervision. The usual starting dose is 12.5 mg BID or TID. Titration to the maintenance dose (75-150 mg per day) should be carried out based on patient's response, clinical status and tolerability, up to a maximum of 150 mg per day in divided doses. The dose should be increased incrementally, with intervals of at least 2 weeks to evaluate patient's response.
Myocardial infarction:
- short-term treatment: Captopril treatment should begin in hospital as soon as possible following the appearance of the signs and/or symptoms in patients with stable haemodynamics. A 6.25 mg test dose should be administered, with a 12.5 mg dose being administered 2 hours afterwards and a 25 mg dose 12 hours later (If 6.25 mg dose is not available, consider to start with a 12.5 mg dose or alternative therapy). From the following day, captopril should be administered in a 100 mg/day dose, in two daily administrations, for 4 weeks, if warranted by the absence of adverse haemodynamic reactions. At the end of the 4 weeks of treatment, the patient's state should be reassessed before a decision is taken concerning treatment for the post-myocardial infarction stage.
- chronic treatment: if captopril treatment has not begun during the first 24 hours of the acute myocardial infarction stage, it is suggested that treatment be instigated between the 3rd and 16th day post-infarction once the necessary treatment conditions have been attained (stable haemodynamics and management of any residual ischaemia). Treatment should be started in hospital under strict surveillance (particularly of blood pressure) until the 75 mg dose is reached.
The initial dose must be low (see section 4.4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy. Treatment should be initiated with a dose of 6.25 mg followed by 12.5 mg 3 times daily for 2 days and then 25 mg 3 times daily if warranted by the absence of adverse haemodynamic reactions (If 6.25 mg dose is not available, consider to start with a 12.5 mg dose or alternative therapy). The recommended dose for effective cardioprotection during long-term treatment is 75 to 150 mg daily in two or three doses. In cases of symptomatic hypotension, as in heart failure, the dosage of diuretics and/or other concomitant vasodilators may be reduced in order to attain the steady state dose of captopril. Where necessary, the dose of captopril should be adjusted in accordance with the patient's clinical reactions. Captopril may be used in combination with other treatments for myocardial infarction such as thrombolytic agents, beta-blockers and acetylsalicylic acid.
Type I Diabetic nephropathy: The recommended dose is 75-100 mg daily in divided doses.
Captopril may be used in combination with other antihypertensive agents, i.e. diuretics, beta blockers, centrally acting agents or vasodilators if the reduction in blood pressure is inadequate with captopril alone.
Patients with renal impairment
Since captopril is excreted primarily via the kidneys, dosage should be reduced or the dosage interval should be increased in patients with impaired renal function. When concomitant diuretic therapy is required, a loop diuretic (e.g. furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment.
In patients with impaired renal function, the following daily dose may be recommended to avoid accumulation of captopril.

Creatinine clearance           Daily starting dose             Daily maximum dose (ml/min/1.73 m2)                    (mg)                             (mg) >40                          25-50                             150
21-40                           25                              100
10-20                          12.5                              75
*<10                          6.25                             37.5
*If 6.25 mg dose is not available, consider alternative therapy.
Elderly
As with other antihypertensive agents, consideration should be given to initiating therapy with a lower starting dose (6.25 mg BID) in elderly patients who may have reduced renal function and other organ dysfunctions (see above 'renal impairment' and section 4.4). If 6.25 mg dose is not available, consider to start with a 12.5 mg dose or alternative therapy.
Dosage should be titrated against blood pressure response and kept as low as possible to achieve adequate control.
Children and adolescents
The efficacy and safety of captopril have not been fully established.
שימוש לפי פנקס קופ''ח כללית 1994 Hypertension, congestive heart failure, renovascular hypertension
תאריך הכללה מקורי בסל 01/01/1995
הגבלות תרופה שאושרה לשימוש כללי בקופ'ח

בעל רישום

DEXCEL LTD, ISRAEL

רישום

106 51 29063 00

מחיר

0 ₪

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