Product Information
Registration Status: ActiveSIN02520P
PROSTIN E2 VAGINAL TABLET 3mg is approved to be sold in Singapore with effective from 1989-04-17. It is marketed by PFIZER PTE LTD, with the registration number of SIN02520P.
This product contains Dinoprostone 3mg in the form of TABLET. It is approved for VAGINAL use.
This product is manufactured by Sanico NV in BELGIUM.
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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Dinoprostone is a naturally occurring prostaglandin E2 (PGE2). It has important effects in labour. It also stimulates osteoblasts to release factors which stimualtes bone resorption by osteoclasts. As a prescription drug it is used as a vaginal suppository, to prepare the cervix for labour and to induce labour.
Indication
For the termination of pregnancy during the second trimester (from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period), as well as for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Also used in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). Other indications include improving the cervical inducibility (cervical "ripening") in pregnant women at or near term with a medical or obstetrical need for labor induction, and the management of postpartum hemorrhage.
Mechanism of Action
Dinoprostone administered intravaginally stimulates the myometrium of the gravid uterus to contract in a manner that is similar to the contractions seen in the term uterus during labor, resulting in the evacuation of the products of conception from the uterus. It is believed that dinoprostone exerts its uterine effects via direct myometrial stimulation, but the exact mechanism of action is unkown. Other suggested mechanisms include the regulation of cellular membrane calcium transport and of intracellular concentrations of cyclic 3',5'-adenosine monophosphate. Dinoprostone also appears to produce local cervical effects including softening, effacement, and dilation. The exact mechanism of action for this effect is also unknown, but it has been suggested that this effect may be associated with collagen degradation caused by secretion of the enzyme collagenase as a partial response to locally administered dinoprostone.
Pharmacokinetics
- Absorption
- Absorbed at a rate of 0.3 mg per hour over 12 hours while the vaginal system is in place.
- Distribution
- Metabolism
- Rapid metabolism of dinoprostone occurs primarily in the local tissues; any systemic absorption of the medication is cleared mainly in the maternal lungs and, secondarily, at sites such as the liver and kidneys.
- Elimination
Toxicity
Oral, mouse: LD50 = 750 mg/kg; Oral, rat: LD50 = 500 mg/kg.
Active Ingredient/Synonyms
(15S)-Prostaglandin e2 | (5Z,11alpha,13e,15S)-11,15-Dihydroxy-9-oxoprosta-5,13-dien-1-oic acid | (5Z,13e)-(15S)-11alpha,15-Dihydroxy-9-oxoprost-13-enoate | (5Z,13e)-(15S)-11alpha,15-Dihydroxy-9-oxoprosta-5,13-dienoate | (e,Z)-(1R,2R,3R)-7-(3-Hydroxy-2-((3S)-(3-hydroxy-1-octenyl))-5-oxocyclopentyl)-5-heptenoic acid | (Z)-7-((1R,2R,3R)-3-Hydroxy-2-((S,e)-3-hydroxyoct-1-enyl)-5-oxocyclopentyl)hept-5-enoic acid | Dinoproston | Dinoprostona | Dinoprostone | Dinoprostone Prostaglandin E2 | Dinoprostonum | PGE2 | Propess | Prostaglandin E2 | Dinoprostone |
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.