"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Metopirone (metyrapone) may induce acute adrenal insufficiency in patients with reduced adrenal secretory capacity.
Ability of adrenals to respond to exogenous ACTH should be demonstrated before Metopirone (metyrapone) is employed as a test. In the presence of hypo- or hyperthyroidism, response to the Metopirone (metyrapone) test may be subnormal.
Since Metopirone (metyrapone) may cause dizziness and sedation, patients should exercise caution when driving or operating machinery.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity and reproduction studies in animals have not been conducted. Metopirone (metyrapone) was not mutagenic with or without metabolic activation in three strains of bacteria.
Pregnancy Category C
A subnormal response to Metopirone (metyrapone) may occur in pregnant women. Animal reproduction studies have not been conducted with Metopirone (metyrapone) . The Metopirone (metyrapone) test was administered to 20 pregnant women in their second and third trimester of pregnancy and evidence was found that the fetal pituitary responded to the enzymatic block. It is not known if Metopirone (metyrapone) can affect reproduction capacity. Metopirone (metyrapone) should be given to a pregnant woman only if needed.
Animal reproduction studies adequate to evaluate teratogenicity and postnatal development have not been conducted with Metopirone (metyrapone) .
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Metopirone (metyrapone) is administered to a nursing woman.
Clinical studies of Metopirone (metyrapone) did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Last reviewed on RxList: 12/14/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Metopirone Information
- Metopirone Drug Interactions Center: metyrapone oral
- Metopirone Side Effects Center
- Metopirone Overview including Precautions
- Metopirone FDA Approved Prescribing Information including Dosage
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