Sidopin 5 tablet: Each tablet contains amlodipine besilate BP equivalent to 5 mg amlodipine.
Sidopin is a preparation of amlodipine. Amlodipine is a calcium antagonist (calcium blocker, calcium slow channel blocker) of the dihydropyridine group and inhibits the transmembrane influx of calcium ions into cardiac and smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle.
Adults : For both hypertension and angina, the recommended initial dose is 5 mg orally once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response.
The dose does not need adjusting when is given concurrently with thiazide diuretics, beta- adrenoceptor blocking agents or angiotensin-converting enzyme inhibitors. Sidopin can be administered with or without food.
Use in children : Since there is no clinical experience in patients of less than 18 years, use in children is not currently recommended.
Use in the elderly : Although elderly patients may have higher plasma concentrations of Sidopin than younger patients, the terminal elimination half-lives are similar. Sidopin is similarly well-tolerated in elderly or younger patients. Therefore the normal dosage is recommended.
Use with renal impairment : Amlodipine is extensively metabolised to inactive metabolites with 10% excreted as unchanged drug in the urine. Changes in amlodipine plasma concentration are not correlated with the degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Use in patients with impaired hepatic function : The half-life of amlodipine is prolonged in patients with impaired liver function and dosage recommendations have not been established. Amlodipine should therefore be administered with caution in these patients.
Amlodipine has been safely administered with thiazide diuretics, beta-adrenoceptor blocking drugs, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycaemic agents.
Co-administration of amlodipine with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers. Co-administration of cimetidine did not alter the pharmacokinetics of amlodipine.
In healthy volunteers, co-administration of amlodipine did not significantly alter the effect of warfarin on prothrombin time. The introduction of amlodipine is not likely to result in the need for modification of an established warfarin regimen.
In vitro data from studies with human plasma indicates that amlodipine has no effect on protein binding of digoxin, phenytoin, warfarin or indomethacin.
Use during pregnancy and lactation : Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for amlodipine provide no evidence for a teratogenic effect. There is, however no clinical experience with amlodipine in pregnancy or lactation. Accordingly, amlodipine should not be administered during pregnancy or lactation or to women of child-bearing potential unless effective contraception is used.
Driving/use of machinery: Clinical experience with amlodipine indicates that it is unlikely to impair a patient's ability to drive or use machinery.
Do not store above 30°C. Keep away from light and wet place. Keep out of reach of children.