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dinoprostone (Rx)Brand and Other Names:Cervidil, Prepidil, more...Prostaglandin E2, Prostin E2

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal insert

  • 10mg

endocervical gel

  • 0.5mg/3g (3g)

vaginal suppository

  • 20mg
more...

Cervical Ripening

Cervidil: One insert in posterior fornix; remove at the onset of active labor or after 12 hr

Prepidil gel: 2.5 mL (0.5 mg) in cervical canal using syringe and catheter; may repeat after 6 hr, maximum cumulative dose 1.5 mg/24 hr

Pregnancy Termination

Prostin E2: One suppository (20 mg) intravaginal (high in vagina) q3-5hr until abortion occurs; do not exceed more than 2 days of continuous administration

Not applicable

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Interactions

Interaction Checker

dinoprostone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Gel

            • Fever/temperature elevations (1%)
            • GI upset (6%)
            • Abnormal uterine contractions (7%)
            • Warm feeling in vagina (2%)
            • Back pain (3%)

            Insert

            • Hypertonic uterine dysfunction with fetal distress (3%)
            • Hypertonic uterine dysfunction without fetal distress (2-5%)

            <1%

            Gel

            • Amnionitis
            • Premature rupture of membranes
            • Uterine rupture
            • Postpartum disseminated intravascular coagulation

            Insert

            • Hypotention
            • Uterine rupture
            • Postpartum disseminated intravascular coagulation

            Frequency Not Defined

            Suppository

            • Chest pain
            • Arrhythmia
            • Syncope
            • Chest tightness
            • Skin discoloration
            • Endometritis
            • Dehydration
            • Hot flashes
            • Vaginitis
            • Vulvitis
            • Paresthesia
            • Hearing impairment
            • Eye pain
            • Blurred vision
            • Diaphoresis
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            Warnings

            Black Box Warnings

            Should be used only with strict adherence to recommended dosages by medically trained personnel who can provide immediate intensive care in acute surgical facilities

            Contraindications

            Gel

            • Hypersensitivity to the drug or components
            • Patients for whom oxytocic drugs are contraindicated
            • History of cesarea section or major uterine surgery
            • Cephalopelvic disproportion present
            • Cases of fetal distress where delivery not imminent
            • History of difficult labor or traumatic delivery
            • 6 or more previous term pregnancie (grand multiparae)
            • Cases with hyperactive or hypertonic uterine patterns
            • Cases where vaginal delivery not indicated
            • Cases with nonvertex presentation

            Insert

            • Hypersensitivity to prostaglandins
            • Cases of fetal distress where delivery not imminent
            • Unexplained vaginal bleeding during pregnancy
            • Cephalopelvic disproportion present
            • Patients currently receiving IV oxytocic drugs
            • 6 or more  previous term pregnancie (grand multiparae)
            • Patients for whom oxytocic drugs are contraindicated
            • When prolonged contraction of the uterus may negatively affect fetal safety or uterine integrity
            • Uterine rupture or other associated obstetrical complications

            Suppository

            • Hypersensitivity to dinoprostone, acute pelvic inflammatory disease
            • Active pulmonary, cardiac, hepatic, renal disease or acute pelvic inflammatory disease

            Cautions

            Use caution in patients with epilepsy, glaucoma, hepatic/renal impairment, pulmonary disease

            Wait 30 min following removal of insert, or 6-12 hr following gel application, before administering other oxytocic drugs

            Do not administer gel above level of internal os

            Remove insert before amniotomy

            Patients with cervical laceration with resultant retention of placenta and severe hemorrhage may require blood tranfusions

            Closely monitor with acute vaginitis, anemia, cardiovascular disease, cervical stenosis, cervicitis, diabetes mellitus, endocervical lesions, glaucoma, hypertension, hypotension, jaundice, mild pre-eclampsia, multiparity, severe pre-eclampsia, seizures with epilepsy, surgery of uterus or cervix, uterine fibroids

            Increased risk of postpartum disseminated intravascular coagulation in women aged 30 years or older, those with complications during pregnancy, and those with gestational age >40 weeks

            Inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of anaphylactoid syndrome of pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Excretion in milk unknown

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Relaxes cervical smooth muscle; stimulates uterine contractions similar to those observed during labor

            Pharmacokinetics

            Peak plasma time: 0.5-0.75 hr

            Onset: In most first and second trimester pregnancies, slight uterine contractions begin within 10 min

            Duration: Contractions continue for 2-3 hr following vaginal insertion of a dinoprostone suppository

            Metabolism: Rapidly in the maternal lungs, kidneys, spleen, and other tissues, primarily by oxidation of side chains to at least 9 inactive metabolites

            Half-life: 2.5-5 min

            Excretion: Urine (principally); feces (small amount)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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