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LOYPRIL
Composition Ramipril 2.5 and 5mg tablets.
Indication

Hypertension,HeartFailure,post Myocardial Infarction and

Prophylaxis of cardiovascular events in high-risk patients

Mechanism of Action

Ramipril, a prodrug of ramiprilat, competitively inhibits ACE from converting angiotensin I to angiotensin II (a potent vasoconstrictor) resulting in increased plasma renin activity and reduced aldosterone (a hormone that causes water and Na retention) secretion. This promotes vasodilation thus producing a hypotensive effect and a beneficial effect in CHF.

Pharmacokinetic's

Onset: 1-2 hr.

Duration: 24 hr.

Absorption: Well absorbed from the GI tract (50-60%). Bioavailability: 28% (ramipril); 44% (ramiprilat). Time to peak plasma concentration: 2-4 hr (ramiprilat).

Distribution: Plasma protein binding: Approx 56% (ramiprilat); 73% (ramipril).

Metabolism: Undergoes enzymatic saponification by esterases to form ramiprilat (active metabolite).

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Excretion: Mainly via urine (60%, as ramiprilat); faeces (approx 40%). Elimination half-life: 13-17 hr (ramiprilat).

Side effects

Laryngeal stridor, angioedema of the face and tongue, glottis; intestinal angioedema. Cholestatic jaundice. Asthenia/fatigue, headache, dizziness, hypotension, persistent and non-productive cough, syncope, nausea, vomiting, vertigo, abnormal kidney function, and diarrhoea. Hyperkalemia. Anaemia, neutropenia/agranulocytosis, pancytopenia, leukopenia, thrombocytopenia. Increased BUN and serum creatinine levels. Potentially Fatal: Severe anaphylactic reactions and angioedema. Rarely, hepatic necrosis.

Precaution

Patients w/ bilateral renal artery stenosis or a single kidney w/ unilateral renal artery stenosis; at risk for hypotension (e.g. patients w/ volume or salt depletion); aortic or mitral valve stenosis. Renal and hepatic impairment. Patient

Counselling Inform patients to refrain from activities involving mental alertness and physical coordination after drug intake. Monitoring Parameters Correct volume and/or salt depletion prior to treatment. Monitor BP, serum creatinine and K levels. Monitor renal function during the 1st few wk of treatment and periodically thereafter.

Dosage

Oral

Hypertension

Adult: Initially, 2.5 mg once daily, 1st dose preferably given at bedtime. Maintenance: 2.5-5 mg/day as a single dose, up to 10 mg/day as needed.

Renal impairment:

CrCl (ml/min)

Dosage Recommendation

10-30

Initially, 1.25 mg/day. Max: 5 mg/day.

30-60

Not necessary to adjust the initial dose. Max: 5 mg/day.

Hepatic impairment: Max: 2.5 mg/day.

Heart failure

Oral

Renal impairment: Initially, 1.25 mg once daily. Max: 10 mg daily. Doses ≥2.5 mg may be given in 2 divided doses.

Max Dosage: 10 mg daily in 1-2 divided doses

Renal impairment:

CrCl (ml/min)

Dosage Recommendation

10-30

Initially, 1.25 mg/day. Max: 5 mg/day.

30-60

Not necessary to adjust the initial dose. Max maintenance dose: 5 mg/day.

Hepatic impairment: Max: 2.5 mg/day.

Oral

Post myocardial infarction

Adult: Initially, 2.5 mg two time a day, may increase to 5 mg two time a day after 2 days. Start treatment: 3-10 days after infarction. Maintenance: 2.5-5 mg two time a day.

Renal impairment:

CrCl (ml/min)

Dosage Recommendation

10-30

Initially, 1.25 mg/day. Max: 5 mg/day.

30-60

Not necessary to adjust the initial dose. Max: 5 mg/day.

Hepatic impairment: Max: 2.5 mg/day.

Oral

Prophylaxis of cardiovascular events in high-risk patients

Adult: Initially, 2.5 mg once daily, may increase to 5 mg once daily after 1 wk if tolerated. Maintenance: 10 mg once daily after a further 3 wk.

Renal impairment:

CrCl (ml/min)

Dosage Recommendation

10-30

Initially, 1.25 mg/day. Max: 5 mg/day.

30-60

Not necessary to adjust the initial dose. Max: 5m g/day.

Hepatic impairment: Max: 2.5 mg/day.