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National Drug Formulary

AMLODANE 10 TABLET 10MG [SIN16427P]

Active ingredients: AMLODIPINE BESILATE EQV AMLODIPINE

View product's general information
Last updated on 9 October 2026

Product Info

AMLODANE 10 TABLET 10MG

[SIN16427P]

Product information

Active Ingredient and Strength

AMLODIPINE BESILATE EQV AMLODIPINE - 10 MG

Dosage Form

TABLET

Manufacturer and Country

IND-SWIFT LABORATORIES LTD - INDIA

Registration Number

SIN16427P

Licence Holder

HALDANE PHARMACEUTICALS PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

C08CA01

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

INDICATIONS & USAGE:
Hypertension:
Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Coronary Artery disease (CAD)
Chronic Stable Angina
Amlodipine is indicated for the symptomatic treatment of chronic stable angina and may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Amlodipine is indicated for the treatment of confirmed or suspected vasospastic and may be used as monotherapy or in combination with other antianginal drugs.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.

Dosing

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 individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine to other antihypertensive therapy. Dosage should be adjusted according to each patient's need. In-general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
The recommended dose for chronic or vasospastic angina is 5–10 mg with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
The recommended dose range for patients with coronary artery disease is 5–10 mg once daily.
Children: The effective antihypertensive oral dose in pediatric patients aged 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
Co-administration with Other Antihypertensive and/or Antianginal Drugs: Amlodipine has been safely administered with thiazides, ACE inhibitors, beta- blockers, long-acting nitrates, and/or sublingual nitroglycerin.

Contraindications

CONTRAINDICATIONS: Amlodipine Besilate is contraindicated in patients with known sensitivity to Amlodipine.