Pregnancy & Lactation : הריון/הנקה

4.6 Pregnancy and lactation
Pregnancy
Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Ampicillin and Sulbactam. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response,
AmpiSulVenir should not be used during pregnancy unless clearly necessary. (see PRECAUTIONS- Drug/Laboratory Test Interactions section)

Labor and Delivery:
Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. However, it is not known whether the use of Ampicillin and Sulbactam in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers: Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised when AmpiSulVenir is administered to a nursing woman.

Supplying information for powder for solution for injection-intramuscular administration Ampicillin and sulbactam with lidocaine is contraindicated during pregnancy. Controlled clinical trials and data of pregnant women are not available. Animal data reveal no undesirable effects on reproduction. In animal studies treatment with lidocaine showed some evidence on neurobehavioural changes but no embryotoxic and teratogenic effects were observed. Lidocaine passes into breast-milk in small amounts.
Ampicillin and sulbactam with lidocaine is contraindicated during lactation.

Pediatric Use: The safety and effectiveness of ampicillin and sulbactam have been established for pediatric patients one year of age and older for skin and skin structure infections as approved in adults. Use of ampicillin and sulbactam in pediatric patients is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse events surveillance.

The safety and effectiveness of ampicillin and sulbactam have not been established for pediatric patients for intra-abdominal infections.