DRUG INTERACTIONS
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Drug Interactions with Azor
The pharmacokinetics of amlodipine and olmesartan medoxomil are
not altered when the drugs are co-administered.
No drug interaction studies have been conducted with Azor and other drugs,
although studies have been conducted with the individual amlodipine and
olmesartan medoxomil components of Azor, as described below, and no significant
drug interactions have been observed.
Drug Interactions with Amlodipine
In vitro data indicate that amlodipine
has no effect on the human plasma protein binding of digoxin, phenytoin,
warfarin, and indomethacin.
Effect of Other Agents on Amlodipine
Cimetidine: Co-administration of amlodipine
with cimetidine did not alter the pharmacokinetics of amlodipine.
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 amlodipine
had no significant effect on the pharmacokinetics of amlodipine.
Sildenafil: A single 100 mg dose of sildenafil in subjects
with essential hypertension had no effect on the pharmacokinetic parameters of
amlodipine. When amlodipine and sildenafil were used in combination, each agent
independently exerted its own blood pressure lowering effect.
Effect of Amlodipine on Other Agents
Atorvastatin: Co-administration of multiple 10
mg doses of amlodipine with 80 mg of atorvastatin resulted in no significant
change in the steady state pharmacokinetic parameters of
atorvastatin.
Digoxin: Co-administration of
amlodipine with digoxin did not change serum digoxin levels or digoxin renal
clearance in normal volunteers.
Ethanol (alcohol):
Single and multiple 10 mg doses of amlodipine had no significant effect
on the pharmacokinetics of ethanol.
Warfarin:
Co-administration of amlodipine with warfarin did not change the warfarin
prothrombin response time.
In clinical trials, amlodipine 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.
Drug Interactions with Olmesartan Medoxomil
No significant drug interactions were reported in studies in
which olmesartan medoxomil was co-administered with digoxin or warfarin in
healthy volunteers.
The bioavailability of olmesartan medoxomil was not significantly altered by
the co-administration of antacids [Al(OH)3/Mg(OH)2].
Olmesartan medoxomil is not metabolized by the cytochrome P450 system and has
no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce,
or are metabolized by those enzymes are not expected.
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