Amloboston 5

Amloboston 5

Amloboston 5

201912-0039 • 9435 Views • Box of 05 blisters x 10 capsules
COMPOSITION

Each AMLOBOSTON 5 tablet contains:

Active ingredient:

Amlodipine 5 mg

(*) Bioequivalence of Generic Drugs

Hypertension

Chronic stable anginal pectoris

Vasospastic (Prinzmetal's) angina

Posology

Adults:

For both hypertension and angina the usual initial dose is 5 mg amlodipine once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. 

For angina, Amlodipine may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta-blockers.

In hypertensive patients, Amlodipine has been used in combination with a thiazide diuretic, Alpha-blocker, beta-blockers, or an angiotensin-converting enzyme inhibitors

No dose adjustment of Amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors.

Special populations:

Elderly

The tolerability of elderly and young patients is similar when using similar amlodipine dose levels. The usual dose is recommended for use in the elderly, and caution should be exercised when increasing the dose (see Warnings and Precautions for Use and Pharmacokinetics)

Patients with hepatic impairment

Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections Special warnings and precautions for use and Pharmacokinetic properties). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment

Patients with renal impairment

Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.

Children with hypertension 

Children with hypertension from 6 years to 17 years of age.

The recommended antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily the blood pressure goal is not achieved after 4 weeks. Doses over 5 mg daily have not been studied in pediatric patients (see Pharmacodynamic Properties and Pharmacokinetic Properties).

The 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg and 10mg as these tablets are not manufactured to break into two halves.

Children under 6 years old

Not  available

Contraindications

Amlodipine is contraindicated in patients with:

Hypersensitivity to dihydropyridines derivatives, amlodipine or any any of the excipients listed in Composition

Severe hypotension

Shock (including cardiogenic shock)

Obstruction of the outflow tract of the left ventricle (e.g., high-grade aortic stenosis), unstable angina (excluding Prinzmetal's angina)

Haemodynamically unstable heart failure after acute myocardial infarction.

Warnings and precaution

Use in patients with  heart failure

In long-term, placebo-controlled studies (study PRAISE-2) using amlodipine in patients with heart failure of non-ischemic origin, New York Heart Association Class III and IV (Study PRAISE-2). New York Heart Association (NYHA), amlodipine has been reported to be associated with an increased incidence of pulmonary edema. However, there was no significant difference in the proportion of patients with worsening heart failure in the amlodipine group compared with the placebo group (see Pharmacodynamic properties)

Use for patients with impaired liver function

As with all calcium channel blockers, the half-life of amlodipine is prolonged in patients with impaired liver function and dose recommendations for these patients have not been established. Therefore, amlodipine should be used with caution in these patients.

Cautions with excipients

The drug contains lactose; therefore, it should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption

Shelf life

36 months from the manufacturing date. Do not use after the expiry date

 

Box of 05 blisters x 10 capsules
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