Tractocile 7.5mg / 1ml Solution for injection, Concentrate for solution for infusion
PDF Leaflet Revision Date: 25 September 2022
Clinical Summary
Quick overview from the medicine insert
Indication
To delay imminent pre-term birth in pregnant women.
Dosage (summary)
Initial bolus: 6.75 mg IV, followed by loading infusion: 300 u00b5g/min for 3 hours, then 100 u00b5g/min for up to 45 hours.
Onset of Action / Duration
Onset: 10 mins, Duration: up to 48 hours
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Use only between 26-33 weeks gestation; discontinue breastfeeding during treatment.
Key Drug Interactions
- Labetalol
- Betamethasone
Contraindications
- Gestational age <26 or >33 weeks
- Premature rupture of membranes >30 weeks
- Antepartum uterine hemorrhage
- Intrauterine growth restriction
- Eclampsia
- Intrauterine fetal death
- Known hypersensitivity
Common side effects
- Nausea
- Headache
- Dizziness
- Tachycardia
- Hypotension
Counselling Points
- Start treatment as soon as pre-term labor is diagnosed.
- Monitor for signs of adverse effects.
- Avoid driving if experiencing dizziness.
Serious warnings
- Risk of chorioamnionitis with premature rupture of membranes
- Use with caution in hepatic impairment
- Monitor uterine contractions and fetal heart rate
Important Disclaimer
The Tractocile 7.5mg / 1ml Solution for injection, Concentrate for solution for infusion professional information leaflet below is the property of Ferring and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
