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The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. Every drug has specific information listed in its product literature.
[96] [97] [98] In 2014, however, the FDA has developed a "Pregnancy and Lactation Labeling Rule (PLLR)" which requires product labels to include specific information related to the safety and effectiveness of medications to pregnant and lactating women. This ruling has removed the requirement of stating pregnancy categories in prescription drug ...
The regular dosage is 60 mg tablets every four hours. If the patient is unable to take tablets orally, it was previously given via intravenous infusion at a rate of 1–2 mg/hour (lower dosage if the body weight is <70 kg or blood pressure is too low), [7] but since the withdrawal of the IV preparation, administration by nasogastric tube is an alternative.
Furosemide is a known ototoxic agent generally causing transient hearing loss but can be permanent. Reported cases of furosemide-induced hearing loss appeared to be associated with rapid intravenous administration, high dosages, concomitant renal disease, and coadministration with other ototoxic medication.
Vaccines suitable for nearly all persons in an age- or risk-factor-based group are assigned Category A. Category B recommendations are made for individual clinical decision-making between the patient and physician. Both Category A and Category B vaccines must be covered by insurance companies (following the ACA). [8]
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The FDA has assigned lacosamide to pregnancy category C. Animal studies have reported incidences of fetal mortality and growth deficit. Lacosamide has not been tested during human pregnancy, and should be administered with caution. In addition, it has not been determined whether the excretion of lacosamide occurs in breast milk. [7]
The FDA modified its labeling in February 2009 to include a precaution of drug interaction with gold. "Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold ( sodium aurothiomalate ) and concomitant ACE inhibitor therapy including Monopril ...