Rx Item-Amlodipine Besylate 5mg 500 Tab by Unichem Lab

NORVASC- amlodipine besylate tablet
Pfizer Laboratories Div Pfizer Inc
DESCRIPTION
NORVASC is the besylate salt of amlodipine, long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (?)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20 H25 CIN2 O5 ?C6 H6 O3 S,
Mechanism of Action
Amlodipine is dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.
Amlodipine is peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause reduction in peripheral vascular resistance and reduction in blood pressure.
INDICATIONS AND USAGE
1.1 Hypertension
NORVASC? is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from wide variety of pharmacologic classes including NORVASC.
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
NORVASC is indicated for the symptomatic treatment of chronic stable angina. NORVASC may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal?s or Variant Angina)
NORVASC is indicated for the treatment of confirmed or suspected vasospastic angina. NORVASC may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CADIn patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, NORVASC is indicated to reduce the risk of hospitalization for angina and to reduce the risk of coronary revascularization procedure.
2 DOSAGE AND ADMINISTRATION
2.1 Adults
The usual initial antihypertensive oral dose of NORVASC is mg once daily, and the maximum dose is 10 mg once daily.
3 DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg white, diamond, flat-faced, beveled edged, with ?NORVASC? on one side and ?2.5? on the other Tablets: mg white, elongated octagon, flat-faced, beveled edged, with ?NORVASC? on one side and ?5? on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with ?NORVASC? on one side and ?10? on the other
WARNINGS AND PRECAUTIONS
5.1 Hypotension
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
5.2 Increased Angina or Myocardial Infarction
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORVASC, particularly in patients with severe obstructive coronary artery disease.
5.3 Patients with Hepatic Failure
Because NORVASC is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 is 56 hours in patients with impaired hepatic function, titrate slowly when administering NORVASC to patients with severe hepatic impairment.
DRUG INTERACTIONS
7.1 Impact of Other Drugs on Amlodipine
CYP3A Inhibitors
Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.
CYP3A Inducers
No info. is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
Sildenafil
Monitor for hypotension when sildenafil is co-administered with amlodipine
7.2 Impact of Amlodipine on Other Drugs
Simvastatin
Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
Immunosuppressants
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate
Storage
Store bottles at controlled room temperature, 59? to 86?F (15? to 30?C) and dispense in tight, light-resistant containers (USP).

Amlodipine Besylate 5mg 500 Tab by Unich
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