SOFVASC Tablets DESCRIPTION, indication and dosage


SOFVASC Tablets DESCRIPTION, indication and dosage


COMPOSITION:

Each tablet contains: Amlodipine besylate eq. to ......... 5 & 10 mg respectively.


SOFVASC (Amlodipine) DESCRIPTION:

Amlodipine is a calcium ion influx inhibitor (slow calcium channel blocker and inhibits the transmembrane influx of calcium ions into cardiac and smooth muscles). The antihypertensive action is due to direct relaxant effect on vascular smooth muscles. The exact mechanism of action with regard to angina has not been fully determined but amlodipine reduces total ischemic burden by the following two actions:

1. Amlodipine dilates peripheral arterioles thus reduces the total peripheral resistance (after load) against which the heart works. Since there is no associated reflex tachycardia, this unloading of the heart reduces myocardial energy consumption and oxygen requirements and probably accounts for the effectiveness of amlodipine in myocardial ischemia.

2. The mechanism of action of amlodipine probably involves dilatation of the main coronary arteries and coronary arterioles both in normal and ischemic regions. This dilatation increments myocardial oxygen conveyance in patients with coronary course fit (prinzmetal's or variation angina.


PHARMACOLOGY:

After oral administration of therapeutic doses, amlodipine is well absorbed.

The terminal plasma elimination half-life is about 35-65 hours (depending on age, blood pressure and liver function)" and is consistent with once daily dosing.

Steady state plasma levels are achieved after 7-8 days of consecutive dosing.

Amlodipine is extensively metabolised by the liver to inactive metabolites with 10% of parent compound and 60% of metabolites excreted in the urine. In patients with hypertension once daily dosing provides clinically significant reduction of blood pressure in both supine and standing positions throughout the 24 hours interval. Due to slow onset of action acute hypertension is not a feature of amlodipine administration.

In patients with angina once daily administration of amlodipine increases total exercise time and decreases both angina attack frequency and nitroglycerine tablet consumption. Amlodipine has not been related with any unfavorable metabolic impacts or changes in plasma lipids and is reasonable for utilize in patients with asthma, diabetes and gou t. In vitro thinks about have appeared that around 97.5% of circulating amlodipine is bound to plasma proteins.


INDICATIONS: Hypertension: SOFVASC (Amlodipine) tablets are:

indicated for the first line treatment of hypertension and can control blood pressure as a sole agent in majority of patients, although thiazide diuretics, beta blockers or an ACE inhibitor may be given in addition if required. Myocardial Ischemia: SOFVASC (Amlodipine) tablets are indicated for the first line treatment of myocardial ischemia either alone or in combination with other anti-anginal drugs.


CONTRAINDICATIONS:

Amlodipine is contraindicated in patients with known hypersensitivity to dihydropyridines.


POSSIBLE ADVERSE EFFECTS:

Amlodipine is generally well tolerated while most commonly observed side effects were headache, edema, fatigue, nausea, flushing and dizziness.

Clinically Significant Adverse Reactions"

• Fulminant hepatitis

• Rhabdomyolysis

• Agranulocytosis


DRUG INTERACTIONS:

Amlodipine has been safely administered with thiazide diuretics, beta blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs.


WARNINGS:

Use in Pregnancy and Lactation: Safety of the drug has not been established in pregnancy & lactation. Use in Elderly.

Normal dosage regimens are recommended in elderly patients.

Use in Renal Failure: Amlodipine is extensively metabolised to inactive metabolites with 10% excreted as unchanged in the urine. Therefore amlodipine may be used in such patients at normal doses.

Use in Hepatic Impairment: Half-life of the drug is prolonged in patients with hepatic impairment and dosage recommendations in such patients have not been established. The drug should therefore be administered with caution in such patients.


DOSAGE & ADMINISTRATION:

For both hypertension and angina usual initial dose is 1 tablet of SOFVASC 5 mg daily, which may be increased to a maximum of 10 mg depending upon the patient's response. No dose adjustment is required upon concomitant administration of thiazide diuretics, beta-blockers and ACE inhibitors. An initial anthypertensive dose of Amlodipine 2.5 mg (1/2 tablet of SOFVASC 5 mg) is recommended for small, fragile, or elderly patients & patients with hepatic function impairment, or when adding amlodipine to other antihypertensive therapy. An initial antianginal dose of SOFVASC 5 mg tablet is recommended for the elderly and for patients with hepatic function impairment. The drug should be used under strict medical professional advice.


STORAGE/PRECAUTIONS:

Protect from sunlight, moisture and heat Store below 30 °C. Keep all medicines out of the children's reach. To be sold and used on prescription of Registered health care professional  only.


PRESENTATION:

SOFVASC 5 & 10 mg tablets are available in packing containing 30 tablets.

Manufactured by:

WILSON'S PHARMACEUTICALS Industrial Area, Islamabad-Pakistan.


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