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Norvasc - Side Effects & Drug Interactions

[Amlodipine]



NORVASC has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Drug Interactions

In vitro data in human plasma indicate that NORVASC has no effect on the protein binding of drugs tested (digoxin, phenytoin, warfarin, and indomethacin).

Special Studies: Effect of other agents on NORVASC.
CIMETIDINE: Co-administration of NORVASC with cimetidine did not alter the pharmacokinetics of NORVASC.

GRAPEFRUIT JUICE

Co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.

MAALOX (antacid)

Co-administration of the antacid Maalox with a single dose of NORVASC had no significant effect on the pharmacokinetics of NORVASC.

SILDENAFIL

A single 100 mg dose of sildenafil (Viagra®) in subjects with essential hypertension had no effect on the pharmacokinetic parameters of NORVASC. When NORVASC and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.

Special Studies

Effect of NORVASC on other agents.

ATORVASTATIN

Co-administration of multiple 10 mg doses of NORVASC with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin.

DIGOXIN

Co-administration of NORVASC with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.

ETHANOL (alcohol)

Single and multiple 10 mg doses of NORVASC had no significant effect on the pharmacokinetics of ethanol.

WARFARIN

Co-administration of NORVASC with warfarin did not change the warfarin prothrombin response time.

In clinical trials, NORVASC has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
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