Klacid Use In Pregnancy & Lactation

Film-coated tablet and Granules for oral suspension: Pregnancy: The safety of clarithromycin for use during pregnancy has not been established. Based on variable results obtained from animal studies and experience in humans, the possibility of adverse effects on embryofoetal development cannot be excluded. Some observational studies evaluating exposure to clarithromycin during the first and second trimester have reported an increased risk of miscarriage compared to no antibiotic use or other antibiotic use during the same period. The available epidemiological studies on the risk of major congenital malformations with use of macrolides including clarithromycin during pregnancy provide conflicting results.
Therefore, use during pregnancy is not advised without carefully weighing the benefits against risks (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: The safety of clarithromycin for using during breast-feeding of infants has not been established. Clarithromycin is excreted into human breast milk in small amounts. It has been estimated that an exclusively breastfed infant would receive about 1.7% of the maternal weight-adjusted dose of clarithromycin.
Fertility: In the rat, fertility studies have not shown any evidence of harmful effects (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Modified-release tablet: Pregnancy: Data on clarithromycin use during the first trimester of a limited number of pregnancies showed no clear evidence of teratogenic effects or any other harmful effects on the neonate. At present there are no other relevant epidemiological data available. Results from animal studies showed reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The risk for humans is not shown. Clarithromycin should be used during pregnancy, especially in the first trimester, only when strictly indicated.
Lactation: Clarithromycin and its active metabolite pass into breastmilk. In breast-fed infants, this may cause changes in the intestinal flora with diarrhoea and colonization with yeast-like fungi, so that breast-feeding may need to be interrupted. The possibility of sensitization should also be considered. In breastfeeding women, using the treatment for the mother should be weighed carefully against the potential risk to the child.
Fertility: Fertility studies in rats have not revealed any harmful effects.