Pricing
Prices are indicative MRP and may vary by pharmacy. Trend compares against the last recorded price.
All price changes →Indications & Uses
Osmina is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause: 60 mg tablet with food once daily. Treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause: 60 mg tablet with food once daily.
Side Effects
Cardiovascular Disorders Malignant Neoplasms Vascular Disorders: Hot flush Reproductive System and Breast Disorders: Vaginal discharge Musculoskeletal and Connective Tissue Disorders: Muscle spasms Skin and Subcutaneous Tissue Disorders: Hyperhidrosis
Cautions & Contraindications
Warnings & Precautions
Cardiovascular Disorders: Risk factors for cardiovascular disorders, arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.Stroke: In the clinical trials for Osmina (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively in Osmina 60 mg treatment group and 3.15 and 0 per thousand women years in placebo.Coronary Heart Disease: In the clinical trials, two cases of myocardial infarction (MI) occurred in women receiving 60 mg of Osmina. In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen-alone compared to placebo.Venous Thromboembolism: In the Osmina clinical trials, two cases of DVT occurred in women receiving Osmina 60 mg. Should a VTE occur or be suspected, Osmina should be discontinued immediately. If feasible, Osmina should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.Endometrial Cancer: Osmina is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, Osmina has agonistic effects. In the Osmina 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 equal to 5 mm or greater was seen in the Osmina up to 52 weeks treatment groups at a rate of 101.4 per thousand women vs. 20.9 per thousand women for placebo. The incidence of any type of proliferative (weakly plus active plus disordered) endometrium was 26.3 per thousand women in the Osmina up to 52 weeks treatment groups vs. 0 per thousand women for placebo. Uterine polyps occurred at an incidence of 19.6 per thousand women in the Osmina up to 52 weeks treatment groups vs. 8.3 per thousand women for placebo. Clinical surveillance of all women using Osmina is important. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Breast Cancer: Osmina 60 mg has not been adequately studied in women with breast cancer; therefore, it should not be used in women with known or suspected breast cancer.Severe Hepatic Impairment: Osmina should not be used in women with severe hepatic impairmentHypersensitivity Reactions: Inform postmenopausal women who have had hypersensitivity reactions to Osmina such as angioedema, urticaria, rash, and pruritus, that they should not take.Vaginal Bleeding: Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare providers as soon as possible.Hot Flashes or Flushes: Osmina may initiate or increase the occurrence of hot flashes in some women.Carcinogenesis: In a 2-year carcinogenicity study in female mice, Osmina was orally administered at 100, 400, or 1500 mg/kg/day. No evaluation for carcinogenicity was conducted in male mice. There was significant increase in adrenal subcapsular cell adenomas at 4 and 5 times the human exposure based on AUC, and adrenal cortical tumors at 5 times the human exposure. In the ovary, an increase in sex cord/stromal tumors, tubulostromal tumors, granulosa cell tumors, and luteomas were also seen. These findings occurred at doses 2 to 5 times the human exposure based on AUC and are probably related to estrogenic/antiestrogenic effect of Osmina in mice.Mutagenesis: Osmina 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 in the absence and in the presence of a metabolic activator system. In in vivo testing, Osmina 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 Osmina on fertility was not directly evaluated. In female rats and monkeys, decreases in ovarian and uterine weights, decreased corpora lutea number, increased ovarian cysts, uterine atrophy, and disrupted cycles were observed when given repeated daily oral doses. In male rats, atrophy of the prostate and seminal vesicles was noted. The effects on reproductive organs observed in animals are consistent with the estrogen receptor activity of Osmina and potential for impairment of fertility.
Contraindications
Undiagnosed abnormal genital bleeding. Known or suspected estrogen-dependent neoplasia. Active DVT, pulmonary embolism (PE), or a history of these conditions. Active arterial thromboembolic disease [for example, stroke and myocardial infarction, or a history of these conditions. Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) or any ingredients. It is contraindicated in women who are or may become pregnant. It may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m2. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.