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 BRAND NAMES
 MECHANISM OF ACTION
Atosiban is a competitive antagonist of human hormones oxytocin and vasopressin. Atosiban decreases the frequency of contractions and the tone of the uterine musculature, resulting in a suppression of uterine contractions. In animals atosiban did not exhibit cardiovascular effects.
Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with:
- regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes
- a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%
- a gestational age from 24 until 33 completed weeks
- a normal fetal heart rate
Initially 6.75 mg bolus dose via slow IV over 1 min, followed by continuous IV infusion at 18 mg/hour for 3 hours. Thereafter, administer 6 mg/hour via continuous IV infusion up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban.
- Gestational age below 24 or over 33 completed weeks
- Premature rupture of the membranes >30 weeks of gestation
- Abnormal fetal heart rate
- Antepartum uterine hemorrhage requiring immediate delivery
- Eclampsia and severe pre-eclampsia requiring delivery
- Intrauterine fetal death
- Suspected intrauterine infection
- Placenta praevia (an obstetric complication in which the placenta is inserted partially or wholly in lower uterine segment)
- Abruptio placenta (the placenta partially or completely separates from the lining of your uterus)
- Any other conditions of the mother or fetus, in which continuation of pregnancy is hazardous
- Hypersensitivity to the active substance(s) or to any of the excipients
 PREGNANCY AND LACTATION
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation. If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with Atosiban , since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
 SIDE EFFECTS
- Very common (>10%): nausea.
- Common (1-10%): headache, dizziness, hot flushes, vomiting, Hyperglycemia, tachycardia, hypotension, injection site reaction and hyperglycemia.
- Uncommon (0.1%-1%): fever, insomnia, pruritus, rash.
- Rare (<0.1%): incidental cases of uterine hemorrhage/uterine atony and one case of allergic reaction were reported.