Xalacom Use In Pregnancy & Lactation

Pregnancy: Latanoprost: There are no adequate data from the use of latanoprost in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). The potential risk for humans is unknown.
Timolol: There are no adequate data for the use of timolol in pregnant women. Timolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see Dosage & Administration.
Epidemiological studies have not revealed malformative effects but show a risk for intra-uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g., bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If Xalacom is administered until delivery, the neonate should be carefully monitored during the first days of life.
Consequently, Xalacom should not be used during pregnancy (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Breast-feeding: Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see Dosage & Administration. Latanoprost and its metabolites may pass into breast milk.
Xalacom should therefore not be used in women who are breast-feeding.
Fertility: Neither latanoprost nor timolol have been found to have any effect on male or female fertility in animal studies.