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 Ramtace (TM)- Ramipril Tablets Taj Pharmaceuticals Limited


Ramipril Tablets
 
COMPOSITION
RAMTACE-1.25 Tablets
Each tablet contains……….Ramipril 1.25 mg

RAMTACE-2.5 Tablets
Each tablet contains……….Ramipril 2.5 mg

RAMTACE-5 Tablets
Each tablet contains……….Ramipril 5 mg

 
INDICATIONS
  • Reduction in risk of myocardial infarction, stroke and death from cardiovascular causes
  • Hypertension
  • Heart failure post myocardial infarction
 
DOSAGE AND ADMINISTRATION
Reduction in risk of myocardial infarction, stroke and death from cardiovascular causes
RAMTACE
should be given at an initial dose of 2.5 mg, once a day for 1 week, 5 mg, once a day for the next 3 weeks and then increased as tolerated, to a maintenance dose of 10 mg, once daily. If the patient is hypertensive or recently post myocardial infarction, it can be given as a divided dose.

Hypertension
The recommended initial dose of RAMTACE is 2.5 mg once daily in patients not receiving a diuretic. Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg/day administered as a single dose or in two equally divided doses. If blood pressure is not controlled with ramipril alone, a diuretic can be added.

Heart failure post myocardial infarction
The recommended starting dose of RAMTACE is 2.5 mg twice daily. A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily, and after one week at the starting dose, patients should be titrated (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart. After the initial dose of ramipril, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension.

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of ramipril. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with ramipril. Then, if blood pressure is not controlled with ramipril alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 1.25 mg ramipril should be used to avoid excess hypotension.

Dosage in renal impairment
In patients with creatinine clearance less than 40 mL/min/1.73m 2 (serum creatinine approximately more than 2.5 mg/dl) doses only 25% of those normally used should be expected to induce full therapeutic levels of ramiprilat.

Hypertension
For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ramipril once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg.

Heart failure post myocardial infarction
For patients with heart failure and renal impairment, the recommended initial dose is 1.25 mg ramipril once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.

 
CONTRAINDICATIONS
Hypersensitivity to ramipril or any other ACE inhibitor (e.g. a patient who has experienced angioedema during therapy with any other ACE inhibitor).
 
PACKAGING INFORMATION
 
RAMTACE-1.25 ...........Strip of 10 tablets
RAMTACE-2.5 ..............Strip of 10 tablets
RAMTACE-5 ..................Strip of 10 tablets



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