The dosage is based on the desired effect and on how the patient tolerates this product. Therapy with this product is usually long term therapy; the doctor determines the duration of treatment individually for each patient.
Hypertension: The recommended initial dose: 2.5 mg once daily. Depending on the response, the dose may be increased. Any increase should be implemented by doubling the dose at intervals of 2-3 weeks.
Usual maintenance dose: 2.5-5 mg daily.
Maximum Dose: 10 mg daily.
In impaired renal function, i.e. a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial dose is generally 1.25 mg and the maximum daily dose is 5 mg.
When creatinine clearance cannot be measured, it can be calculated based on the serum creatinine level using the following formulation (Cockcroft's equation): (See equation.)
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In patients with incompletely corrected fluid or salt deficiency, those with severe hypertension, as well as in those for whom a hypotensive reaction would constitute a particular risk (eg, patients with haemodynamically relevant stenoses of the coronary arteries or of the blood vessels supplying the brain) and in the elderly, a reduced initial dose of 1.25 mg daily must be considered.
In patients pre-treated with diuretic, consideration must be given to discontinuing the diuretic for at least 2-3 days or depending on the duration of action of the diuretic, longer before starting treatment with this product, or at least to reducing the diuretic dose. The doctor will decide in each individual case whether such discontinuation or dose reduction is possible and how long it should last. The initial dose in such patients is generally 1.25 mg.
In impaired liver function, response to treatment may be either increased or reduced. Therefore, treatment must be initiated only under close medical supervision. Maximum daily dose: 2.5 mg.
Congestive Heart Failure: Recommended initial dose: 1.25 mg once daily. Depending on the response, the dose may be increased. Any increase should be implemented by doubling the dose at intervals of 1-2 weeks.
Maximum daily dose: 10 mg.
The required daily dose, if equaling or exceeding 2.5 mg, may be taken as a single dose or in 2 separate doses.
In impaired liver or renal function and in patients pre-treated with a diuretic, dosage recommendations for this product are identical to those mentioned previously in the treatment of hypertension. The recommendations given there in conjunction with diuretic pre-treatment also apply.
Myocardial Infarction: Recommended initial dose: 5 mg daily, divided into 2 single doses of 2.5 mg each, one in the morning and one in the evening. If this dose is not well tolerated, 1.25 mg should be taken twice daily over 2 days. In either event, depending on the response, the dose may then be increased. Any increase should be implemented by doubling the dose at intervals of 1-3 days. As treatment progresses, the total daily dose may be taken as a single dose.
Maximum daily dose: 10 mg.
Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Treatment, if nevertheless given, should be started with 1.25 mg once daily, and increased only with particular caution.
In patients with impaired liver or renal function, with incompletely corrected fluid or salt deficiency, or with severe hypertension, and in those for whom a hypotensive reaction would constitute a particular risk (eg. patients with haemodynamically relevant stenoses of the coronary arteries or of the blood vessels supplying the brain), as well as in those pre-treated with a diuretic and in the elderly, the recommendations are identical to those given previously in the treatment of hypertension.
Prevention of progressive renal failure in patients with persistent proteinuria: The recommended initial dose is 1.25 mg once daily. This should be doubled at intervals of 2-3 weeks, depending on how the drug is tolerated. There are no efficacy data regarding doses above 5 mg/day in patients with nephropathy.
In hypertensive patients, a target diastolic blood pressure of <90 mmHg should be pursued. In patients pre-treated with a diuretic, consideration must be given to discontinuing the diuretic for at least 2-3 days or longer (depending on duration of action) or at least consideration should be given to reducing the dose, before initiating this product.
Patients at increased cardiovascular risk: Recommended initial dose: 2.5 mg once daily. Depending on the tolerability, the dose should be doubled after 1 week of treatment and after 3 weeks, should be increased to 10 mg.
Usual maintenance dose: 10 mg daily.
Patients with impaired renal function: In hypertensive patients with creatinine clearance levels of ≥50 mL/min (serum creatinine <1.5 mg/dL) a dosage adjustment is not required.
For patients with creatinine clearance levels between 20 and 50 mL/min (serum creatinine between 1.5 and 3 mg/dL), the recommended initial dose is 1.25 mg once daily. This should be doubled at intervals of 2-3 weeks, depending on how the drug is tolerated.
Particular care should be exercise in patients with impaired renal function who are to be treated for heart failure post-myocardial infarction as such patients may be susceptible to hypotension. Patients with impaired renal function treated for heart failure post MI have not been studied systemically.
Patients with impaired liver function: In patients with impaired liver function, the metabolism of ramipril and therefore, the formation of the bioactive metabolite ramiprilat, is delayed due to diminished activity of the esterases in the liver, resulting in elevated plasma ramipril levels. Treatment with this product should therefore be initiated under close medical supervision and should not exceed 2.5 mg daily.
Elderly: Recommended starting dose: 1.25 mg once daily, which can then be increased according to the individual patient's blood pressure response.
Paediatric population: This product is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Mode of Administration: To be taken orally. It is recommended that this product is taken each day at the same time of the day. Can be taken before, with or after meals. The tablet has to be swallowed with liquid. It must not be chewed or crushed.