Usual Adult Dose for Labor Induction

VAGINAL INSERT:

• Single dose: 10 mg intravaginally (designed to be released at approximately 0.3 mg/hour)
• Duration of therapy: Up to a 12-hour period

• Remove the vaginal insert 12 hours after insertion with the onset of active labor, prior to an amniotomy, occurrence of uterine tachysystole, uterine hypersystole, hypertonicity, or fetal distress.
• Should be removed at least 30 minutes prior to administering an oxytocic agent.
• Care should be taken to ensure the vaginal insert remains in place if the patient is ambulatory.

• Initial dose: Syringe applicator with 0.5 mg in 3 mL to be applied endocervical
• Repeat dose: If there is no cervical/uterine response, a recommended repeat dose of 0.5 mg with a dosing interval of 6 hours may be given.
• The need for additional dosing and the interval should be determined by the attending physician based on the course of clinical events.
• Maximum recommended cumulative dose for a 24-hour period: 1.5 mg

• Vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. The 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced.
• This product should be handled carefully to prevent contact with skin. Hands should be washed thoroughly with soap and water after administration.
• The manufacturer product information should be consulted for instructions relating to product preparation and proper insertion.
• Following administration the patient should remain in the supine position for at least 15 to 30 minutes to minimize leakage from the cervical canal.
• If the desired response is obtained, the recommended interval before giving IV oxytocin is 6 to 12 hours.

Usual Adult Dose for Abortion

VAGINAL SUPPOSITORY:

• Dose: 20 mg suppository

• A suppository should be inserted high into the vagina; the patient should remain in the supine position for 10 minutes following insertion.
• Additional intravaginal administration of each subsequent suppository should be at 3 to 5 hour intervals until abortion occurs. Within the recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance.
• Continuous administration for more than 2 days is not recommended.
• The manufacturer product information should be consulted for instructions relating to product preparation and proper administration.

• For the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period
• For evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period
• For the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole)

Usual Adult Dose for Trophoblastic Disease

VAGINAL SUPPOSITORY:

• Dose: 20 mg suppository

• A suppository should be inserted high into the vagina; the patient should remain in the supine position for 10 minutes following insertion.
• Additional intravaginal administration of each subsequent suppository should be at 3 to 5 hour intervals until abortion occurs. Within the recommended intervals administration time should be determined by abortifacient progress, uterine contractility response, and by patient tolerance.
• Continuous administration for more than 2 days is not recommended.
• The manufacturer product information should be consulted for instructions relating to product preparation and proper administration.

• For the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period
• For evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period
• For the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole)

Renal Dose Adjustments

Vaginal insert: Not recommended
Cervical gel: Use with caution
Vaginal suppository: Contraindicated

Liver Dose Adjustments

Vaginal insert: Not recommended
Cervical gel: Use with caution
Vaginal suppository: Contraindicated

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• Hypersensitivity to prostaglandins or any of the ingredients
• Evidence or suspicion of fetal distress where delivery is not imminent
• Unexplained vaginal bleeding during the current pregnancy
• Evidence or suspicion of marked cephalopelvic disproportion
• Conditions for which induction of labor is contraindicated
• Conditions where vaginal delivery is not indicated (e.g. placenta previa or active herpes genitalis)
• Conditions for which oxytocic drugs are contraindicated
• Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy)
• Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety
• Concurrent use with intravenous oxytocic agents
• Six or more previous term pregnancies

Dialysis

Data not available

Other Comments

Administration advice

• The manufacturer product information should be consulted for instructions relating to storage, product preparation and proper insertion.

• The condition of the cervix should be assessed carefully before dinoprostone is used.
• Monitor uterine activity, fetal status, and the progression of cervical dilatation and effacement with the use of this drug.

• This drug should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.