Consists of Clobetasol, Ofloxacin, Ornidazole, Terbinafine
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Zinclovil OT Pregnancy |
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Consists of Clobetasol, Ofloxacin, Ornidazole, Terbinafine
There is no data on adverse effects of Clobetasol (Zinclovil OT) on pregnancy and fetal development.
However, in the I trimester of pregnancy this medication is contraindicated, in II and III trimester can be used for prescription. If necessary to use during lactation it should be considered that with breast milk in small amounts canrenone (metabolite of spironolactone) excretes.
Category of the fetus by FDA - C.
Ofloxacin (Zinclovil OT) 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 (Zinclovil OT) contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of Ofloxacin (Zinclovil OT) during pregnancy when benefit outweighs risk.
Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including Ofloxacin (Zinclovil OT)), congenital malformations were reported in 4.8%; however, this was not higher than the background rate.
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Ofloxacin (Zinclovil OT) 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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Terbinafine (Zinclovil OT) has been assigned to pregnancy category B by the FDA. High dose reproduction studies in rats and rabbits have failed to reveal evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy. Because treatment of onychomycosis or tinea capitis can be postponed until after pregnancy is completed, the manufacturer recommends that Terbinafine (Zinclovil OT) not be started during pregnancy. Terbinafine (Zinclovil OT) is only recommended for use during pregnancy when benefit outweighs risk.
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Terbinafine (Zinclovil OT) is excreted into human milk following oral administration. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The ratio of Terbinafine (Zinclovil OT) in milk to plasma is 7:1.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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