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Studies were completed to determine the potential for drug interactions
between MICARDIS and several drugs that are likely to be used at the same
time.
If patients are taking MICARDIS and digoxin, it is recommended that digoxin
levels be monitored when initiating, adjusting, and discontinuing MICARDIS
to avoid possible over- or under-digitalization.
In a study of 12 healthy male volunteers, there was no evidence of digoxin toxicity.
Coadministration of MICARDIS did not result in clinically significant
interaction with acetaminophen, amlodipine, glibenclamide, hydrochlorothiazide,
or ibuprofen.
However, patients who are already taking diuretics should make sure to inform their doctor because of the possibility of hypotension (low blood pressure).
When administered concurrently, alcohol, barbiturates, narcotics, antidiabetic
drugs, cholestyramine and colestipol resins, corticosteroids, pressor
amines, skeletal muscle relaxants, lithium, and non-steroidal anti-inflammatory
drugs (NSAIDs) may interact with thiazide diuretics. MICARDIS HCT contains the thiazide diuretic hydrochlorothiazide (HCTZ).
MICARDIS should be used with caution in any patient who has a disorder of the liver or gallbladder, because these conditions can be expected to cause reduced clearance of drugs from the body.
Selected important cautionary information
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Lithium generally should not be given with thiazides.
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USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, MICARDIS and MICARDIS HCT Tablets should be discontinued as soon as possible (see WARNINGS, Fetal/Neonatal Morbidity and Mortality).
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