Dolcet Mini Use In Pregnancy & Lactation

Tramadol has been shown to cross the placenta. No appropriate clinical study in pregnant women was conducted, and the safety for fetus is not established. It will be administered only when therapeutic benefits exceed risks in pregnant women or women capable of becoming pregnant.
The use of opioids during childbirth might result in respiratory depression in the newborn infant.
Prolonged use of this drug, or other opioids, during pregnancy may lead to neonatal opioid withdrawal syndrome. This risk is particularly increased during the last trimester (28~40 weeks) of pregnancy.
Do not administer this drug to breast-feeding women. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post dose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1.
Tramadol and its metabolite (M1) are present in human milk. There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The M1 is more potent than tramadol in mu opioid receptor binding. Published studies have reported tramadol and M1 in colostrum with administration of tramadol to nursing mothers in the early post-partum period. Women who are ultra-rapid metabolizers of tramadol may have higher than expected serum levels of M1, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants. In women with normal tramadol metabolism, the amount of tramadol secreted into human milk is low and dose-dependent. Patients should be informed about serious adverse reactions including excess sedation and respiratory depression in a breastfed infant during treatment with this drug.
If infants are exposed to this drug through breast milk, they should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.