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Bismuth subsalicylate / metronidazole / tetracycline Pregnancy and Breastfeeding Warnings

Bismuth subsalicylate / metronidazole / tetracycline is also known as: Helidac

Bismuth subsalicylate / metronidazole / tetracycline Pregnancy Warnings

Tetracyclines should not be used during pregnancy because they may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long term use of the drugs but has also been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure.

Bismuth subsalicylate/metronidazole/tetracycline has been assigned to pregnancy category D by the FDA. Animal studies have shown that metronidazole and tetracycline cross the placental barrier. Evidence of embryotoxicity early in pregnancy has been reported with tetracycline. There are no controlled data in human pregnancy. Bismuth subsalicylate/metronidazole/tetracycline is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Bismuth subsalicylate / metronidazole / tetracycline Breastfeeding Warnings

Metronidazole and tetracycline are excreted into human milk. Salicylate is absorbed during administration of bismuth subsalicylate. Because of 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.

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