Product Information
Registration Status: ActiveCERVAGEM VAGINAL PESSARY 1mg is approved to be sold in Singapore with effective from 1989-08-03. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN02475P.
This product contains Gemeprost 1mg in the form of SUPPOSITORY. It is approved for VAGINAL use.
This product is manufactured by ONO PHARMACEUTICAL CO LTD in JAPAN.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Gemeprost is a prostaglandin E1 (PGE1) analog and antiprogestogen used for preoperative dilation of the cervix before surgical abortion. It is available as vaginal suppositories and also used in combination with the antiprogestin and mifepristone for termination of 1st- and 2nd-trimester pregnancy [A19726]. It is not FDA-approved but available in Japan marketed as Preglandin.
Indication
Indicated for the softening and dilatation of the cervix uteri prior to transcervical, intrauterine operative procedures in the first trimester of pregnancy or facilitating therapeutic termination of pregnancy in patients in the second trimester of gestation.
Mechanism of Action
As a prostaglandin analog, gemeprost binds to prostaglandin E2 and E3 receptors as an agonist to cause myometrial contractions and progressive cervical dilation via tissue sensitization to oxytocin [A19732].
Pharmacokinetics
- Absorption
- Systemic absorption of gemeprost is limited with about 12-28% of administered dose of gemeprost reaching the systemic circulation [L878]. Following vaginal administration, peak plasma concentration is reached after 2-3 hours [A19726].
- Distribution
- Metabolism
- After intravenous administration, gemeprost is rapidly metabolized via hydrolysis to the free acid with half life of 10-15 minutes. The free acid is then inactivated by β- and ω-oxidation [A19726].
- Elimination
Toxicity
Serious or life-threatening adverse effects include coronary spasms with subsequent myocardial infarctions and uterine rupture following prolonged uterine hypertonia or abnormal uterine pain. More common adverse effects are nausea, vomiting, loose stools, diarrhea, lower abdominal or back pain, headache, mild pyrexia and flushing. Less common side effects include hypotension, chest pain palpitations, tachycardia, muscle weakness, dyspnea, chills and headache. Oral LD50 is 300 mg/kg in mouse, 980 mg/kg in rat and 3200 mg/kg in rabbit [MSDS].
Active Ingredient/Synonyms
16,16-Dimethyl-trans-delta-2-PGE1 methyl ester | 16,16-Dimethyl-trans-delta(sup 2)-prostaglandin E1 methyl ester | SC-37681 | Gemeprost |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.