Pricing
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All price changes →Indications & Uses
Ospemifene is an estrogen agonist/antagonist. Doctors use it to treat moderate to severe dyspareunia (pain during sexual intercourse), which is a symptom of vulvar and vaginal atrophy due to menopause.
Pharmacology
Ospemifene is a newer selective estrogen receptor modulator (SERM). It binds to estrogen receptors and, depending on the type of tissue, either stimulates or blocks the action of estrogen. In the endometrium, it has an agonistic effect.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For moderate to severe dyspareunia caused by vulvar and vaginal atrophy after menopause, the dose of Ospemifene is one 60 mg tablet once daily, taken with food. The same dose applies when it is used for moderate to severe vaginal dryness, which is also a symptom of vulvar and vaginal atrophy due to menopause: one 60 mg tablet once daily with food.
Side Effects
Ospemifene has been linked with cardiovascular disorders and malignant neoplasms, which are listed without further detail. Hot flush is the vascular disorder. Vaginal discharge is listed among the reproductive system and breast disorders. Muscle spasms fall under musculoskeletal and connective tissue disorders, and hyperhidrosis under skin and subcutaneous tissue disorders.
Cautions & Contraindications
Warnings & Precautions
Cardiovascular Disorders: Risk factors for cardiovascular disorders should be managed appropriately. These include risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia and obesity) and for venous thromboembolism (VTE) (for example, a personal or family history of VTE, obesity and systemic lupus erythematosus). Stroke: In the clinical trials of Ospemifene (treatment lasting up to 15 months), thromboembolic stroke occurred at 1.13 and hemorrhagic stroke at 3.39 per thousand women years in the 60 mg treatment group. In the placebo group the rates were 3.15 and 0 per thousand women years, respectively. Coronary Heart Disease: Two cases of myocardial infarction (MI) occurred in women taking 60 mg of Ospemifene in the clinical trials. In the WHI estrogen-alone substudy, women receiving estrogen alone showed no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI or CHD death) compared with placebo. Venous Thromboembolism: Two cases of DVT occurred in women taking Ospemifene 60 mg in the clinical trials. If a VTE occurs or is suspected, Ospemifene should be stopped immediately. Where feasible, it should also be stopped at least 4 to 6 weeks before surgery of a type linked with a higher risk of thromboembolism, or before periods of prolonged immobilization. Endometrial Cancer: Ospemifene is an estrogen agonist/antagonist with tissue selective effects, and in the endometrium it has agonistic effects. In the clinical trials (60 mg treatment group), no cases of endometrial cancer were seen with exposure up to 52 weeks. There was a single case of simple hyperplasia without atypia. Endometrial thickening of 5 mm or greater was seen in the treatment groups of up to 52 weeks at a rate of 101.4 per thousand women, against 20.9 per thousand women for placebo. Any type of proliferative (weakly plus active plus disordered) endometrium occurred at 26.3 per thousand women in the treatment groups of up to 52 weeks, against 0 per thousand women for placebo. Uterine polyps occurred at 19.6 per thousand women in those groups, against 8.3 per thousand women for placebo. All women using Ospemifene need clinical surveillance. In postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding, adequate diagnostic measures should be taken to rule out malignancy, including directed or random endometrial sampling when indicated. Breast Cancer: Ospemifene 60 mg has not been adequately studied in women with breast cancer, so it should not be used in women with known or suspected breast cancer. Severe Hepatic Impairment: Ospemifene should not be used in women with severe hepatic impairment. Hypersensitivity Reactions: Tell postmenopausal women who have had hypersensitivity reactions to Ospemifene, such as angioedema, urticaria, rash and pruritus, that they should not take it. Vaginal Bleeding: Tell postmenopausal women to report any unusual vaginal bleeding to their doctors as soon as possible. Hot Flashes or Flushes: Ospemifene may start hot flashes or make them occur more often in some women. Carcinogenesis: In a 2-year carcinogenicity study in female mice, Ospemifene was given orally at 100, 400 or 1500 mg/kg/day. Male mice were not evaluated for carcinogenicity. There was a significant increase in adrenal subcapsular cell adenomas at 4 and 5 times the human exposure based on AUC, and in adrenal cortical tumors at 5 times the human exposure. In the ovary, increases were also seen in sex cord/stromal tumors, tubulostromal tumors, granulosa cell tumors and luteomas. These findings occurred at doses 2 to 5 times the human exposure based on AUC, and they are probably related to the estrogenic/antiestrogenic effect of Ospemifene in mice. Mutagenesis: Ospemifene was not genotoxic in vitro in the Ames test in strains of Salmonella typhimurium, or at the thymidine kinase (tk) locus of mouse lymphoma L5178Y cells, with or without a metabolic activator system. In in vivo testing, it was not genotoxic in a standard mouse bone marrow micronucleus test or in a determination of DNA adducts in the liver of rats. Impairment of Fertility: The effect of Ospemifene on fertility was not directly evaluated. With repeated daily oral doses, female rats and monkeys showed decreased ovarian and uterine weights, fewer corpora lutea, more ovarian cysts, uterine atrophy and disrupted cycles. In male rats, atrophy of the prostate and seminal vesicles was noted. These effects on the reproductive organs in animals are consistent with the estrogen receptor activity of Ospemifene and its potential to impair fertility.
Contraindications
Ospemifene must not be used by women with abnormal genital bleeding that has not been diagnosed, or with a known or suspected estrogen-dependent neoplasia. It is also contraindicated in anyone with active DVT or pulmonary embolism (PE), or a history of these conditions. The same applies to active arterial thromboembolic disease, for example stroke and myocardial infarction, or a history of these conditions. Women who are hypersensitive to the medicine or any of its ingredients (for example, angioedema, urticaria, rash, pruritus) should not take it either. It is contraindicated in women who are pregnant or may become pregnant, because it may cause fetal harm when given to a pregnant woman. In rats, ospemifene was embryo-fetal lethal at doses below clinical exposures, with labor difficulties and more pup deaths. In rabbits it was embryo-fetal lethal at 10 times the clinical exposure, based on mg/m2. If the medicine is used during pregnancy, or if a woman becomes pregnant while taking it, she should be told about the possible hazard to the fetus.
Pregnancy & Breastfeeding
Use in Pregnancy: Ospemifene must not be used by women who are or may become pregnant. If it is used during pregnancy, or if a woman becomes pregnant while taking it, she should be told about the possible harm to the fetus. Based on animal data, Ospemifene is likely to increase the risk of adverse outcomes during pregnancy and labor. At doses that were toxic to the mother, the adverse findings included embryo fetal lethality in rats and rabbits, and neonatal mortality and difficult labor in rats. These reproductive effects fit with the estrogen receptor activity of Ospemifene and are considered to be related to it.
Use in Lactation: It is not known whether Ospemifene passes into human breast milk. There are no data on how it affects the breastfed child or milk production. Do not breastfeed while taking Ospemifene. The medicine was found in rat milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Ospemifene is not indicated in children, and no clinical studies have been done in the pediatric population.
Geriatric Use: Ten phase 2/3 trials of Ospemifene enrolled 2209 treated women, and more than 19 percent of them were 65 years of age or older. The safety and effectiveness seen in these women were not clinically meaningfully different from those in younger women under 65.
Renal Impairment: In women with severe renal impairment (CrCL <30 mL/min), the pharmacokinetics of Ospemifene were similar to those in women with normal kidney function. So no dose adjustment of Ospemifene is needed in women with renal impairment.
Hepatic Impairment: The pharmacokinetics of Ospemifene have not been studied in women with severe hepatic impairment (Child-Pugh Class C). For this reason, don't use Ospemifene in these women.
Storage
Store Ospemifene below 30°C, away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Osmina 60 mg
What is Osmina 60 mg Tablet?
Osmina 60 mg Tablet is a medicine that contains Ospemifene. It is made by Navana Pharmaceuticals Ltd. It belongs to the Drugs used in Vaginal and Vulval condition group of medicines.
What is Osmina used for?
Ospemifene is an estrogen agonist/antagonist. Doctors use it to treat moderate to severe dyspareunia (pain during sexual intercourse), which is a symptom of vulvar and vaginal atrophy due to menopause.
What are the side effects of Osmina?
Ospemifene has been linked with cardiovascular disorders and malignant neoplasms, which are listed without further detail. Hot flush is the vascular disorder.
Can I take Osmina during pregnancy or while breastfeeding?
Use in Pregnancy: Ospemifene must not be used by women who are or may become pregnant. If it is used during pregnancy, or if a woman becomes pregnant while taking it, she should be told about the possible harm to the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Osmina?
Store Ospemifene below 30°C, away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Osmina?
Some medicines can interact with Ospemifene, for example: Fluconazole, Ketoconazole, Rifampicin, Warfarin Sodium. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Osmina is already among the lowest-priced brands of Ospemifene at this strength.
Do I need a prescription for Osmina?
Osmina is a prescription (Rx) medicine. Take it as your doctor advises.