Apotex

[Patriot]

Regulatory Class: Rx

C: Amlodipine besilate

I: Management of HTN & prophylaxis of angina.

D: Adult Usual dose: 5-10 mg once daily. Elderly & patient w/ hepatic function impairment Initially 2.5 mg. Angina Initially 5 mg. Childn 6-17 yr 2.5-5 mg once daily.

A: 

CI: Severe hypotension.

SP: Hypersensitivity. Aortic stenosis; CHF. Monitor BP, ECG readings, heart rate; reduced frequency or severity of anginal attacks; decreased nitrate consumption. Gingival hyperplasia. W/drawal prior to surgery. Increased angina &/or MI rarely in patients w/ severe obstructive CAD. Concomitant use w/ SL nitroglycerin, long-acting nitrates, β-blockers or other anti-anginal agents. Hepatic impairment. May prolong labor duration. Pregnancy & lactation. Childn. Elderly.

AR: Headache, edema, dizziness, flushing, palpitations; fatigue, nausea, abdominal pain, somnolence; muscle cramps, pruritus, rash.

INT: Additive hypotension w/ anesth & hydrocarbon inhalation; β-adrenergic blocking agents. Reduced antihypertensive effects w/ NSAIDs (indomethacin) & sympathomimetics. Increase BP due to induced fluid retention w/ estrogen. Changes in serum conc of free unbound medications w/ highly-protein bound medications (anticoagulants, coumarin & indandione derivatives, anticonvulsants, hydantoin, NSAIDs, quinine, salicylates, sulfinpyrazone). Potentiated antihypertensive effects w/ hypotension-producing medications. Neurotoxicity w/ lithium.

P/P: Tab 5 mg x 30's, 100's. 10 mg x 30's , 100's.

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