Consists of cefixime, ofloxacin
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Cetes PLUS Pregnancy |
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Consists of cefixime, ofloxacin
Cefixime (Cetes PLUS) has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Cefixime (Cetes PLUS) is only recommended for use during pregnancy when benefit outweighs risk.
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There are no data on the excretion of Cefixime (Cetes PLUS) into human milk. Other cephalosporins are excreted into human milk in small amounts. While adverse effects are unlikely, the infant should be monitored closely. The manufacturer recommends considering temporary discontinuation of nursing during treatment with Cefixime (Cetes PLUS). Other cephalosporins have been classified as compatible with breast-feeding by the American Academy of Pediatrics.
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Ofloxacin (Cetes PLUS) has been assigned to pregnancy category C by the FDA. Animal studies using high doses have revealed evidence of fetotoxicity and teratogenicity. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects. However, cartilage damage and arthropathy are reported in immature animals giving rise to concern over effects on bone formation in the developing fetus. Because safer alternatives are available, some experts consider Ofloxacin (Cetes PLUS) contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of Ofloxacin (Cetes PLUS) during pregnancy when benefit outweighs risk.
Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including Ofloxacin (Cetes PLUS)), congenital malformations were reported in 4.8%; however, this was not higher than the background rate.
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Ofloxacin (Cetes PLUS) is excreted into human milk. Breast milk concentrations approximate maternal serum concentrations. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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