CERVIDIL Vaginal insert (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Ferring Pharmaceuticals Inc.
Λέξεις κλειδιά
55566-2800
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1. Indications and Usage
CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.
2. Dosage and Administration
2.1 Dosage Instructions Administer one CERVIDIL insert (10 mg) intravaginally for use up to 12 hours (approximately 0.3 mg of dinoprostone is released per hour) <em>[see Dosage and Administration (2.2)] ...
3. Dosage Forms and Strengths
<u>Vaginal Insert:</u> 10 mg of dinoprostone (release rate approximately 0.3 mg/hour up to 12 hours) in a hydrogel polymer. The insert is beige-colored, semi-opaque, thin, flat, and rectangular in shape ...
4. Contraindications
CERVIDIL is contraindicated in patients with: Known hypersensitivity to prostaglandins <em>[see Adverse Reactions (6.2)]</em> Evidence or clinical suspicion of fetal distress where delivery is not imminent ...
5. Warnings and Precautions
5.1 For Hospital Use Only CERVIDIL should be administered in a hospital setting with an obstetrical care facility. 5.2 Disseminated Intravascular Coagulation CERVIDIL should be used with caution in women ...
6. Adverse Reactions
The following adverse reactions are described, or described in greater detail, in other sections: Disseminated Intravascular Coagulation <em>[see Warnings and Precautions (5.2)]</em> Amniotic Fluid Embolism ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of CERVIDIL or other dinoprostone products. Because these reactions are reported voluntarily from a population of uncertain ...
7. Drug Interactions
7.1 Oxytocic Agents CERVIDIL is contraindicated in patients receiving intravenous oxytocic agents because CERVIDIL may augment the activity of oxytocic agents. A dosing interval of at least 30 minutes ...
8.1. Pregnancy
Risk Summary CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of ...
8.2. Lactation
Risk Summary Concomitant administration of CERVIDIL is not indicated in breastfeeding women. There is no information on the effects of maternal CERVIDIL administration on the breastfed child. Insufficient ...
8.4. Pediatric Use
The safety and effectiveness of CERVIDIL have not been established in pregnant girls.
11. Description
CERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer ...
12.1. Mechanism of Action
Dinoprostone is found in low concentrations in most tissues of the body and functions as a local hormone. In pregnancy, dinoprostone is secreted continuously by the fetal membranes and placenta and plays ...
12.2. Pharmacodynamics
No specific pharmacodynamic studies were conducted with CERVIDIL.
12.3. Pharmacokinetics
The delivery rate of dinoprostone from CERVIDIL <em>in vivo</em> is approximately 0.3 mg/per hour over a period of 12 hours. Dinoprostone is metabolized in the tissues of synthesis with the half-life estimated ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity and fertility studies have not been conducted with dinoprostone. No evidence of mutagenicity has been observed with dinoprostone in the Unscheduled DNA Synthesis Assay, the Micronucleus ...
14. Clinical Studies
The effectiveness and safety of CERVIDIL for the induction of cervical ripening was evaluated in 658 pregnant women (320 CERVIDIL-treated women and 338 placebo-treated women) at or near term in three randomized, ...
16.1. How Supplied
CERVIDIL vaginal insert contains 10 mg dinoprostone in a hydrogel polymer (NDC 55566-2800-1). The vaginal insert is beige-colored, semi-opaque, thin, flat, and rectangular in shape with rounded corners, ...
16.2. Storage and Handling
Store in a freezer between -20°C and -10°C (-4°F and 14°F). CERVIDIL, enclosed in its aluminum/polyethylene pack, is stable when stored in a freezer for a period of three years. Vaginal inserts exposed ...
17. Patient Counseling Information
Administration Advise the woman to remain in the recumbent position for 2 hours following CERVIDIL insertion and to inform her health care provider immediately if CERVIDIL does not remain in place <em> ...