Atosiban Hybio: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Atosiban acetate

Indications/Uses

Delay imminent pre-term birth in pregnant adult women w/ regular uterine contractions of at least 30 sec duration at a rate of ≥4 per 30 min, cervical dilation of 1-3 cm (0-3 for nulliparas) & effacement of ≥50%, age ≥18 yr, gestational age from 24-33 completed wk, normal fetal heart rate.

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Dosage/Direction for Use

IV Initially 6.75 mg bolus dose over 1 min, immediately followed by continuous high dose infusion (loading infusion 300 mcg/min) at 24 mL/hr for 3 hr, followed by lower dose (subsequent infusion 100 mcg/min) at 8 mL/hr for up to 45 hr. Max treatment duration: 48 hr. Max total dose: 330.75 mg.

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Overdosage

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Contraindications

Hypersensitivity. Gestational age <24 or >33 completed wk; premature rupture of membranes >30 wk of gestation; abnormal fetal heart rate; antepartum uterine haemorrhage requiring immediate delivery; eclampsia & severe pre-eclampsia requiring delivery; intrauterine fetal death; suspected intrauterine infection; placenta praevia; abruptio placenta; any other conditions of mother or fetus in which continuation of pregnancy is hazardous.

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Special Precautions

Treatment may be repeated only up to 3 re-treatments. Monitor uterine contractions & fetal heart rate during therapy & in case of persistent uterine contractions; blood loss after delivery. Assess fetal maturity in case of intrauterine growth retardation. Resp events eg, dyspnoea & pulmonary oedema (increased risk) w/ multiple pregnancy &/or concomitant use of medicinal products w/ tocolytic activity (eg, Ca antagonists & betamimetics). Patients in whom premature membrane rupture cannot be excluded. Hepatic impairment. Multiple pregnancies or gestational age group between 24 & 27 wk. Should only be used for pre-term labour diagnosed between 24 & 33 completed wk of gestation. Discontinue breastfeeding during treatment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea. Hyperglycaemia; headache, dizziness; tachycardia; hypotension, hot flush; vomiting; inj site reaction.

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Storage

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Description

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Action

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MIMS Class

Drugs Acting on the Uterus

ATC Classification

G02CX01 - atosiban ; Belongs to the class of other gynecologicals. Used to inhibit uncomplicated premature labour between 24 and 33 weeks of gestation.

Thai FDA Category

Presentation/Packing

Form

Atosiban Hybio conc for soln for infusion 37.5 mg/5 mL

Packing/Price

1's

Form

Atosiban Hybio soln for inj 6.75 mg/0.9 mL

Packing/Price

1's

Atosiban Hybio

atosiban

Manufacturer:

Hybio

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare