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– Hypertension
– Chronic stable angina pectoris
– Vasospastic (Prinzmetal’s) angina
For oral administration.
This product should not be mixed with food or beverages before use.
Adults:
For both hypertension and angina the usual initial dose is 5 mg (5 ml) of amlodipine once daily which may be increased to a maximum dose of 10 mg (10 ml) depending on the individual patient’s response.
In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. 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.
No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors.
Elderly: Amlodipine 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.
The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue. Palpitations, Uncommon: Arrhythmia (including bradycardia, ventricular tachycardia and atrial. Ankle swelling, muscle cramps, Uncommon: Arthralgia, myalgia back pain
The safety and efficacy of amlodipine in hypertensive crisis has not been established.
Patients with cardiac failure: Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Use in patients with impaired hepatic function: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. Amlodipine 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 in elderly patients: In the elderly increase of the dosage should take place with care
Use in renal failure: Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable.
Store in a refrigerator (2-8°C). Do not freeze.
Keep the bottle stored upright.
Keep out of reach of children.
Amlodipine Oral Solution BP (1 mg/ml) is available as 150 ml in an Amber Pet bottle. Such 01 bottle in a unit carton with package insert.
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