Ramitace Ramipril 2.5 mg and 5 mg Tablets

RAMITACE®

Proprietary Name: (Ramipril 2.5mg, 5mg)

Ramitace

 

Composition

2.5mg per tablet

5mg per tablet

 

Pharmacological Classification

Hypotensive

 

Pharmacological Action

Ramitace is a long-action inhibitor of the angiotensin-converting enzyme (ACE). Ramipril is a pro-drug, which is hydrolyzed in the liver after absorption from the gastro-intestinal tract to form the active angiotensin converting enzyme inhibitor, ramiprilat. Ramitace increases plasma rennin activity and decrease plasma concentration of angiotensin II and aldosterone.

ACE inhibition and consequent reduction in angiotensin II results in dilation of peripheral vessels and reduction in vascular resistance causing the beneficial haemodynamic effects. Ramitace binds to angiotensin converting enzyme at both plasma and tissue levels.

Following oral administration, Ramitace is rapidly absorbed from the gastrointestinal tract and peak plasma concentrations of ramipril are reached within one hour. Ramipril is a pro-drug, which in the liver is converted to its diacidic metabolite-ramiprilat, by cleavage of an ester group. Peak plasma concentrations are reached two to four hours after drug intake. Based on the urinary recovery of ramipril and its metabolite, the extent of absorption is estimated to be 30% to 60%.

Food intake has no relevant influence on the extent of absorption.

 

Indications

Mild to moderate hypertension.

Cardiac failure following myocardial infarction.

To reduce proteinuria and the decline in glomerular filteration rate in patients with diabetic nephropathy and hypertension.

To reduce the risk of myocardial infarction, stroke or cardiovascular death in diabetic patients and to reduce the need for revascularization procedures in patients with an increased cardiovascular risk, a history of stroke or a history of peripheral vascular disease.

 

Contra-indications

Hypersensitivity to ramipril and starch.

History of angioneurotic oedema.

Ramitace is not recommended for use in children, pregnancy and lactation.

 

Warnings

Pregnancy and Lactation: Teratogenicity has been shown in animals.
Hypertensive women receiving ACE-inhibitors should take care to ensure that they do not become pregnant while taking ACE-inhibitors.

ACE-inhibitors pass through the placenta and can be presumed to cause disturbances in fetal blood pressure regulatory mechanisms. Oligohydiamnios as well as hypotension, oliguria and anuria in newborn have been reported after administration of ACE-inhibitors in the second and third trimester. Cases of defective skull ossification have been observed. Prematurity and low birth mass can occur.

The treatment of hypertension with this preparation must be carried out under regular medical supervision.

Treatment with Ramitace may impair the ability to drive or operate machinery, particularly at the start of treatment, when changing over from other preparations and during concomitant use of alcohol.

In patients with impaired liver function, the metabolism of the parent compound ramipril and therefore the formation of the bioactive metabolite ramiprilat is decelerated resulting in markedly elevated plasma ramipril levels due to a diminished activity of esterases in the liver. Use of Ramitace in patients with impaired liver functions is not recommended.

 

Dosage and Direction for Use

Ramitace should be taken with half a glass of liquid during or after meals. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the dose of Ramitace. The diuretic if possible should be discontinued for two to three days before beginning therapy with Ramitace to reduce the likelihood of hypotension. In case the diuretic theraphy cannot be discontinued the initial dose of Ramitace should be 1.25mg.

 

Side Effects

Cardiovascular disturbances, impairment of renal function, neutropenia and proteinuria, hyperkalaemia, gastrointestinal disorders, angioneurotic oedema, allergic reactions.

 

Storage

Store in a cool, dark and dry place.

Keep this medication out of the reach of children.

 

Presentation

Ramitace 2.5mg and 5mg tablets by 30 s.

 

Manufactured by

May & Baker Nigeria Plc.

May & Baker Avenue, Off Idiroko Road,

(Opposite Covenant University)

Ota, Ogun State, Nigeria.

www.may-baker.com

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