Information about Ramp
COMPOSITION:

Each capsule contains:

2.5 mg Ramipril

or 5 mg Ramipril

or 10 mg Ramipril.

INDICATIONS AND USEgE:

Reduction in risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes:

RAMP is indicated inpatients 55 years or older at high risk of developing a major cardiovascularevent because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels,low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes.

Hypertension:

RAMP is indicated forthe treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In considering use of RAMP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.

 Heart Failure Post Myocardial Infarction:

RAMP is indicated instable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction.Administration of RAMP to such patients has been shown to decrease the risk of death and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure.

CONTRAINDICATIONS:

RAMP is contraindicated in patients who are hypersensitive to this product or any other angiotensin converting enzyme inhibitor.

ADVERSE REACTIONS:

The most frequent clinical side effects reported by patients receiving RAMP were: headache,dizziness, fatigue or asthenia.

Generally, the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 to 20 mg.

DOSAGE AND ADMINISTRATION:

Blood pressure decreases associated with any dose of RAMP depend, in part, on the presence orabsence of voume depletion (e.g.,past and current  diuretic use) or the presence or absence ofrenal artery stenosis. If such circumstances are suspected to be present, theinitial starting dose should be 1.25 mg once daily.

Reduction in Risk of Myocardial Infarction, Stroke and Death from cardiovascular causes:

RAMP should be given at an initial dose of 2.5 mg once a day for 1 week, 5 mg once a day for thenext 3 weeks, and then increased as tolerated, to a maintenance dose of 10 mgonce a day. If the patient is hypertensive or recently post myocardial infarction, it can also be given as a divided dose.

Hypertension:

The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day.

Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with RAMP alone, a diuretic can be added.

Heart Failure Post Myocardial Infarction:

For the treatment of post-infarction patients who have shown signs of congestive failure, the recommended starting dose of RAMP is 2.5 mg twice daily (5 mg per day). Apatient 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 then 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 RAMP, 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. RAMP Capsule is usually swallowed whole. RAMP Capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of apple sauce or mixed in 4 oz. (120ml) of water or apple juice. To be sure that ramipril is not lost when such amixture is used, the mixture should be consumed in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration. Concomitant administration of RAMP with potassium supplements, potassium salt substitutes,or potassium-sparing diuretics can lead to increases of serum potassium. Inpatients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of RAMP. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinuedtwo to three days prior to beginning therapy with RAMP. Then, if blood pressureis not controlled with RAMP alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, the dose of RAMP should be reduced to avoid excess hypotension.

 Dosage Adjustment in Renal Impairment:

In patients with creatinine clearance < 40 ml/min doses only 25% of those normally used should be expected to induce full therapeutic levels of Ramipril.

 Hypertension:

For patients with hypertension and renal impairment, the  recommended 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 dose may by increased up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.

STORAGE:

Store at controlled room temperature below 25°C.

Protect from moisture.

PACKAGING:

RAMP is available in14 or 28 capsules.