Description

It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the drug metabolising cytochrome P450 enzymes. Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers. No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.

Very common (affects more than 1 in 10 people): feeling sick (nausea). Common (affects less than 1 in 10 people): headache, feeling dizzy, hot flushes, being sick (vomiting), fast heartbeat, Low blood pressure. Signs may include feeling dizzy or light-headed, A reaction at the site where the injection was given, high blood sugar. Uncommon (affects less than 1 in 100 people): high temperature (fever), difficulty sleeping (insomnia), itching, rash.

If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban.

When Atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis. There is no experience with Atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of Atosiban is excreted in the urine. In patients with impaired hepatic function, Atosiban should be used with caution There is only limited clinical experience in the use of Atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated. The benefit of Atosiban in these subgroups is therefore uncertain. Re-treatment with Atosiban is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments. In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Atosiban depends on the assessment of fetal maturity. Monitoring of uterine contractions and fetal heart rate during administration of Atosiban and in case of persistent uterine contractions should be considered. As an antagonist of oxytocin, Atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored. However, inadequate uterus contraction postpartum was not observed during the clinical trials. Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta- mimetics are known to be associated with increased risk of pulmonary oedema. Therefore, Atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity

Other preparations

Store in a refrigerator (2°C-8°C). Keep away from light & moisture. Keep out of the reach of children.