B Vasc 10 Amlodipine Besylate Tablets

B VASC 10 TABLETS
Amlodipine Besylate Tablets USP 10 mg

 

Composition

Each uncoated tablet contains:
Amlodipine Besylate USP equivalent to Amlodipine 10mg
Excipients q.s.

 

Pharmacology/Activity

Amlodipine is a dihydropyridine calcium – channel blocker.

It is a peripheral and coronary vasodiIator. Amlodipine has a direct relaxant effect on the vascular smooth muscle, dilating the peripheral arterioles and thus reducing the total peripheral resistance. Amlodipine also dilates the main coronary arteries and the coronary arterioles.

 

Therapeutic Indications

Amlodipine is used in the treatment of

1. Hypertension
Amlodipine is indicated for the first line treatment of hypertension. It can be used as the sole agent to control blood pressure in the majority of patients. It can also be used in combination with thiazide diuretic and beta blockers.

2. Angina pectoris
Amlodipine is indicated for the first line treatment of myocardial ischemia, whether due to fixed obstruction and/or vasopasm/vaso-constriction.

 

Dosage

Adults: In hypertension the usual initial dose is 5mg once daily and increased to 10 mg once daily depending on the patient’s response. Similar doses are given in the treatment of angina pectoris.

Children: As advised by the physician.

 

Pharmacokinetics

Amlodipine is well absorbed after oral dose and peak blood concentrations occur after 6 to 8 hours. The bioavailability varies but is usually 60 to 65%. Amlodipine is 98% bound to plasma proteins. It has a prolonged terminal elimination half life of 35 to 50 hours and steady state plasma concentrations are not achieved until after 7 to 8 days of use.

Amlodipine is extensively metabolized in the liver; metabolites are mostly excreted in urine, with less than 10% of the dose as unchanged drug.

 

Drug Interactions

Amlodipine has been safely administered with thiazide diuretics, beta – adrenoceptor blocking drugs, angiotensin converting enzyme inhibitor, non – steroidal anti- inflammatory drugs, antibiotics and oral hypoglycaemic agents.

 

Special Precautions

Use in patients with heart failure
Calcium channel blockers are normally avoided in patients with heart failure but amlodipine has not been found to have any adverse effects in morbidity or mortality in patients with severe heart failure receiving the drug. Therefore its use to treat angina pectoris or hypertension may be possible such patients [Packer M; it al. New England J. Med. 1996; 335, 1107-14]

Use In patients with Impaired hepatic function
The clearance of amlodipine is reduced in patients with hepatic impairment and lower doses should be considered. [Martindale 37th edition. 1337]

 

Side Effects

The most commonly observed side effects include headache, oedema, fatigue, nausea, flushing and dizziness.

 

Storage

Store at a temperature not exceeding 30°C.
Protect from light.
Keep medicine out of the reach of children.

 

Presentation

Alu – alu blister pack of 10 tablets.

 

NAFDAC Reg. No.: B4-2877

 

Manufactured In India by

Coral Laboratories Ltd.

Plot No. 57/1 (16), Bhenslore, Dunetha,

Nani Daman-396 210. INDIA.

exports @corallab.com

www.corallab.com

 

Manufactured for

Boucia Limited

1, Serah Arobieke Street, Amuwo Odofin,

Lagos, Nigeria.

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