PREPIDIL Gel (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
Pharmacia and Upjohn Company LLC
Λέξεις κλειδιά
0009-3359
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1. Description
PREPIDIL Gel contains dinoprostone as the naturally occurring form of prostaglandin E<sub>2</sub> (PGE<sub>2</sub>) and is designated chemically as (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic ...
2. Clinical Pharmacology
PREPIDIL Gel (dinoprostone) administered endocervically may stimulate the myometrium of the gravid uterus to contract in a manner similar to contractions seen in the term uterus during labor. Whether or ...
3. Indications and Usage
PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
4. Contraindications
Endocervically administered PREPIDIL Gel is not recommended for the following: Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered ...
5. Warnings
<b>FOR HOSPITAL USE ONLY</b> Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be administered by physicians in a ...
6. Precautions
Patients With Ruptured Membranes Caution should be exercised in the administration of PREPIDIL Gel in patients with ruptured membranes. The safety of use of PREPIDIL Gel in these patients has not been ...
6.1. General
During use, uterine activity, fetal status, and character of the cervix (dilation and effacement) should be carefully monitored either by auscultation or electronic fetal monitoring to detect possible ...
6.4. Drug Interactions
PREPIDIL Gel may augment the activity of other oxytocic agents and their concomitant use is not recommended. For the sequential use of oxytocin following PREPIDIL Gel administration, a dosing interval ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenic bioassay studies have not been conducted in animals with PREPIDIL Gel due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed ...
6.7. Pregnancy
Teratogenic Effects Prostaglandin E2 produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since PREPIDIL Gel is administered after ...
6.10. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
7. Adverse Reactions
PREPIDIL Gel is generally well-tolerated. In controlled trials, in which 1731 women were entered, the following events were reported at an occurrence of ≥1%: Adverse Reaction PGE<sub>2</sub><br />(N=884) ...
8. Drug Abuse and Dependence
No drug abuse or drug dependence has been seen with the use of PREPIDIL Gel.
9. Overdosage
Overdosage with PREPIDIL Gel may be expressed by uterine hypercontractility and uterine hypertonus. Because of the transient nature of PGE<sub>2</sub>-induced myometrial hyperstimulation, nonspecific, ...
10. Dosage and Administration
NOTE: USE CAUTION IN HANDLING THIS PRODUCT TO PREVENT CONTACT WITH SKIN. WASH HANDS THOROUGHLY WITH SOAP AND WATER AFTER ADMINISTRATION. PREPIDIL Gel should be brought to room temperature (59° to 86°F; ...
11. How Supplied
PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for endocervical application: 0.5 mg PGE<sub>2</sub> per 3.0 g (2.5 mL) in syringe. In addition, each package contains two shielded ...
12. Storage and Handling
PREPIDIL Gel needs to be stored under continuous refrigeration (36° to 46°F; 2° to 8°C).