Cervidil

Cervidil

dinoprostone

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dinoprostone
Indications/Uses
Initiation of cervical ripening in patients, at or near term, who have favourable induction features & in whom there is a medical or obstetrical indication for induction of labour.
Dosage/Direction for Use
Administer 1 vag insert high into the posterior vag fornix. Remove vag insert after 24 hr irrespective of whether cervical ripening has been achieved. Dosing interval: at least 30 min in case of subsequent uterotonic drugs administration following the removal of vag insert.
Contraindications
Hypersensitivity. Start of labour. Patients who have had previous major uterine surgery (eg, caesarean section, myomectomy); previous major uterine cervix surgery (eg, other than biopsies & cervical abrasion) or rupture; w/ cephalopelvic disproportion; fetal malpresentation; suspicion or evidence of fetal distress. Current pelvic inflammatory disease, unless adequate prior treatment has been instituted. Placenta previa or active herpes genitalis or unexplained vag bleeding during current pregnancy. Patient is carrying >1 fetus or fetus is in non-vertex presentation. Abnormal cardiotocography or suspected fetal compromise. Presence of any suggestion of uterine hyperstimulation or hypertonic uterine contractions. Concomitant use of uterotonic drugs &/or other labour induction agents.
Special Precautions
Carefully assess condition of cervix prior to administration & regularly monitor uterine activity & fetal condition after insertion. Remove from the vagina if there is any suggestion of maternal or fetal complications or if adverse effects occur. Do not administer to patients w/ history of previous caesarean section or uterine surgery. Possible uterine hypertonus or rupture; immediately remove vag insert if uterine contractions are prolonged or excessive. 2nd dose is not recommended. Patients w/ ruptured membranes; previous history of uterine hypertonus, glaucoma or asthma. Not recommended in patients w/ lung, liver or renal disease. High risk for developing disseminated intravascular coagulation (DIC) in women ≥35 yr; w/ complications during pregnancy (eg, gestational diabetes, arterial HTN & hypothyroidism); gestational age >40 wk. May rarely develop anaphylactoid syndrome of pregnancy (amniotic fluid embolism). Multiple pregnancy; >3 full term deliveries. Monitor carefully for early signs of DIC development (eg, fibrinolysis) in the immediate post-partum phase. Not indicated for use in pregnancy prior to 37 completed wk of gestation. Lactation. Pregnant women <18 yr.
Adverse Reactions
Fetal heart rate disorder; abnormal labour affecting fetus, abnormal uterine contractions, meconium in amniotic fluid, uterine tachysystole, hyperstimulation or hypertonus.
Drug Interactions
Potentiated uterotonic effect of uterotonic drugs. Discontinue use of NSAIDs including ASA prior to dinoprostone administration.
MIMS Class
Drugs Acting on the Uterus
ATC Classification
G02AD02 - dinoprostone ; Belongs to the class of prostaglandins. Used to induce abortion or augment labour and to minimize blood loss from the placental site.
Presentation/Packing
Form
Cervidil vag insert 10 mg
Packing/Price
1's
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