Acetaminophen / dichloralphenazone / isometheptene mucate Pregnancy and Breastfeeding Warnings
Acetaminophen / dichloralphenazone / isometheptene mucate is also known as: Alidrin, Amidrine, Diacetazone, Duradrin, Epidrin, IDA, Iso-Acetazone, Isocom, LarkaDrin, Midchlor, Midrin, Migquin, Migragesic IDA, Migrapap, Migratine, Migrazone, Migrex, Migrin-A, Mitride, Nodolor
Acetaminophen / dichloralphenazone / isometheptene mucate Pregnancy Warnings
Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Dichloralphenazone has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Isometheptene has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/dichloralphenazone/isometheptene should only be given during pregnancy when need has been clearly established.
Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to non-pregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.
Acetaminophen / dichloralphenazone / isometheptene mucate Breastfeeding Warnings
One small study on acetaminophen has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.
Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Dichloralphenazone is a prodrug composed of phenazone and chloral hydrate. Both phenazone and the active metabolite of chloral hydrate, trichloroethanol, are excreted into human milk. Milk concentrations of trichoroethanol have been reported at 60% to 80% of maternal serum levels. The only effect reported in the infant was mild morning drowsiness. There are no data on the excretion of isometheptene into human milk.
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