Ospemifene

Drug #2307

OSPHENA is an estrogen agonist/antagonist.The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethano. It is used in the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

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Primary Characteristics

It is of Synthetic origin.

Molecular Weight: 378.5 · Solubility in Water: insoluble · Solubility in Alcohol: soluble · Non-proprietary name: Ospemifene.

Pharmacokinetics

Distribution: Ospemifene has a volume of distribution is 448L. plasma protein binding is more than 99%.

Elimination: it is metabolised via liver, plasma half-life is approx. 26 hrs, renal excretion is 75% by feces & &% by urine.

Indications

Ospemifene is primarily indicated in conditions like dyspareunia.

Contraindications

None recorded.

Dosage

Ospemifene's dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
0 – 60 mg	—	—	PO	for the treatment of moderate to severe Dyspareunia (tablet should be taken with meal.)
Paediatric Dosage (20kg)
No data.
Neonatal Dosage (3kg)
No data.

Drug Interactions

None recorded.

Side Effects

Ospemifene is known to cause more or less tolerable side effects which are usually transient. These include genital discharge, Hot flushes, Hyperhidrosis , muscle spasm, Vaginal discharge.

Warnings / Precautions

Venous Thromboembolism: Risk of DVT and pulmonary embolism, Known, suspected, or history of breast cancer, Severe Hepatic Impairment, cardiovascular disorder like stroke, coronary heart disease, endometrial cancer, caution mst be taken in these disease.

Available Brands

None recorded.

Drug Classification

1.18.4 — Estrogens, their combinations and related preparations