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Prostin E2 (Dinoprostone Vaginal) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

4. Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenic bioassay studies have not been conducted in animals with PROSTIN E2 due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

5. Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal studies do not indicate that PROSTIN E2 is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk. See WARNINGS section.

CONTRAINDICATIONS

  1. Hypersensitivity to dinoprostone
  2. Acute pelvic inflammatory disease
  3. Patients with active cardiac, pulmonary, renal, or hepatic disease

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