Amdocal 10 Tablet
Amdocal 10 Tablet is manufactured by Beximco Pharmaceuticals Ltd. Amdocal 10 Tablet contains 10 mg Amlodipine. It is Calcium-channel blockers class drug.
Amdocal 10 is a Dihydropyridine Calcium antagonist that inhibits the transmembrane influx of Calcium ions into cardiac and vascular smooth muscle. It has greater affinity towards vascular smooth muscle than on cardiac muscle. Amdocal 10 is peripheral vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and thereby reduces blood pressure. Amdocal 10 reduces tone, decreases coronary vasoreactivity and lowers cardiac oxygen demand by reducing after load.
Patients with mild to moderate hypertension (alone or in combination with other antihypertensives).
The treatment of chronic stable and vasospastic angina.
|Brand Name:||Amdocal 10|
|Therapeutic Class:||Calcium-channel blockers|
|Manufacturer:||Beximco Pharmaceuticals Ltd|
|Last Updated:||November 21, 2020 at 6:15 pm|
Table Of contents
Amdocal 10 contains Amlodipine 10 mg. Amdocal 10 Dosage:
For treatment of both hypertension and angina pectoris, the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose may be increased to a maximum dose of 10 mg once daily. Amdocal 10 10 mg once daily provides symptomatic improvement in patients with Raynaud's disease.
Use in children: Use of Amdocal 10 in children (under 12 years of age) is not recommended.
Amdocal 10 is generally well tolerated. The most commonly observed side effects are headache, peripheral oedema, palpitations, flushing, dizziness, nausea, abdominal pain.
Hypotension: Since the vasodilUse in renal failure
Although Amdocal 10 is excreted primarily via kidney, mild renal impairment does not appear to have an effect on the plasma concentrations. Severe renal impairment may however require a dosage reduction. Amdocal 10 is not dialyzable.
Use in patients with impaired hepatic function
Amdocal 10 half-life is prolonged in patient with impaired hepatic function. Amdocal 10 should therefore be administered at lower (5mg) initial dose in these patients.
Use in heart failure
An increased number of pulmonary oedema has been reported.atation induced by Amdocal 10 is gradual in onset, acute hypotension has rarely been reported after oral administration of Amdocal 10. Nonetheless, caution should be exercised when administering the drug with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Cardiac failure: Patients with heart failure should be treated with caution. Calcium channel blockers, including Amdocal 10, should be usedwith caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Beta blocker withdrawal: Amdocal 10 gives no protection against the danger of abrupt beta blocker withdrawal; any such withdrawal should be gradualreduction of the dose of beta blocker.
Hepatic failure: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function. Amdocal 10 should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment.
Use of Amdocal 10 together with thiazide diuretics or angiotensin-converting-enzyme inhibitors in the treatment of hypertension is additive. There are no hazardous interaction of Amdocal 10 with Digoxin, Cimetidine, Warfarin and food.
Pregnancy Lactation use
Pregnancy: Safety in pregnancy has not been established.
Lactation: It is not known whether Amdocal 10 is excreted in breast milk. It is advised to stop breastfeeding during treatment with Amdocal 10.
Amdocal 10 is contraindicated in patients with-
- Hypersensitivity to amlodipine, dihydropyridine derivatives or any of the excipients
- Shock (including cardiogenic shock)
- Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis)
- Unstable angina
- Hemodynamically unstable heart failure after acute myocardial infarction (during the first 28 days)
- Severe hypotension
Children with hypertension from 6 years to 17 years of age: 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients.
Children under 6 years old: The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
Elderly: Amdocal 10 used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care.
Renal impairment: Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amdocal 10 is not dialysable.
Hepatic impairment: Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautions and should start at the lower end of the dosing range. The pharmacokinetics of Amdocal 10 have not been studied in severe hepatic impairment. Amdocal 10 should be initiated at the lowest dose (2.5 mg once daily) and titrated slowly in patients with severe hepatic impairment.
There is no well documented experience with Amdocal 10 overdosage. In case of clinically significant hypotension due to Amdocal 10 over dosage, calls for active cardiovascular support including monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output. Since Amdocal 10 is highly protein-bound, dialysis is unlikely to be of benefit.
Interaction with other Medicine
Keep out of the reach of children. Store below 30° C. Keep in the original package in a cool & dry place in order to protect from light and moisture.