DuoTrav

DuoTrav Use In Pregnancy & Lactation

travoprost + timolol

Manufacturer:

Novartis

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Use In Pregnancy & Lactation
Women of childbearing potential/contraception: DuoTrav eye drops must not be used in women of child-bearing age/potential unless adequate contraceptive measures are in place (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-born child.
There are no or limited amount of data from the use of DuoTrav eye drops or the individual components in pregnant women. Timolol should not be used during pregnancy unless clearly necessary.
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 DuoTrav eye drops are administered until delivery, the neonate should be carefully monitored during the first days of life.
DuoTrav eye drops should not be used during pregnancy unless clearly necessary. For information on how to reduce systemic absorption, see Dosage & Administration.
Breastfeeding: It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk and has the potential to cause serious adverse reactions in the breastfed infant. 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. For information on how to reduce systemic absorption, see Dosage & Administration.
The use of DuoTrav eye drops by breast-feeding women is not recommended.
Fertility: There are no data on the effects of DuoTrav eye drops on human fertility. Animal studies showed no effect of travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas no relevant effect of timolol was noted at this dose level.
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