LODIPIN

Amlodipine

Description:

Lodipin (Amlodipine) is a dihydropyridine calcium antagonist, with a long duration of action, used for the treatment of hypertension and angina pectoris.

Composition:

Each tablet contains Amlodipine besylate INN equivalent to Amlodipine INN 5 mg.

Indications:

1. Hypertension: Lodipin is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

2. Stable Angina: Lodipin is indicated for the treatment of stable angina. It may be used alone or in combination with other antianginal agents.

3. Vasospastic Angina: Lodipin is indicated for the treatment of confirmed or suspected vasospastic angina. It may be used as monotherapy or in combination with other antianginal agents.

Dosage & administration:

The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile or elderly individuls or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used administering Lodipin with other antihyertensive agents.

Dosage should be adjusted according to each patient's need.

The recommended dose for stable or vasospastic angina is 5-10 mg with the lower dose suggested in the elderly and in patients with hepatic insufficiency.

Contraindications:

Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine.

Precautions:

General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypertension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe heart failure.

Use in patients with congestive heart failure:

Although haemodynamic studies and a controlled trial in class II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection factor and clinical symptomatology in general, all calcium channel blockers should be used with caution in patients with heart failure.

Beta-blocker withdrawal: Amlodipine gives no protection against the danger of abrupt beta-blocker withdrawal, any such withdrawal should be gradual reduction of the dose of beta-blocker.

Hepatic failure: Since Amlodipine is extensively metabolized by the liver, so caution should be exercised when administering Amlodipine to patients with hepatic impairment.

Drug Interaction:

Digoxin: Absence of any interaction between Amlodipine and digoxin in healthy volunteers has been documented in controlled clinical study.

Cimetidine: An unpublished clinical study indicated no interaction between Amlodipine and cimetidine in healthy volunteers.

Warfarin: An unpublished study in healthy volunteers indicates that Amlodipine did not significantly alter the effect of warfarin on prothrombin time.

Food: Food does not alter the rate or extent of absorption of Amlodipine.

Side-effects:

Peripheral oedema may occasionally be severe but is fully reversible. And as with other calcium antagonist drugs, peripheral oedema and skin erythema occur in a proportion of patients (5-10%) and facial flushing in 2.5% of patients. Complaints of fatigue was also reported more frequently than in placebo-treated patients. There is evidence that these effects are more common in patients treated with doses greater that 10 mg daily. Clinical experience with Amlodipine is still relatively limited and as this increases, a more reliable assessment of toxicity and side effects can be provided.

Overdose: In humans, experience with intentional overdose of Amlodipine is limited. If massive overdose occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential.

Packing:

Lodipin-5: Box containing 5 x 10's tablets in blister pack.