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Farmgroups: Estrogens, gestagens; their homologues and antagonists

Active substance: Raloxifene

Instructions for use:

• Composition and form of release: 1 coated tablet contains raloxifene hydrochloride 60 mg; in a blister pack 14, 28 or 84 pcs.
• Pharmachologic effect: Pharmacological action – inhibiting bone resorption. Selective estrogen receptor modulator. As an agonist, it affects non-reproductive tissues and as an antagonist, on reproductive ones. Increases the concentration of globulins that bind hormones (sex, thyroxine, corticosteroids) with a simultaneous increase in their total content in the blood without increasing the level of free fraction.
• Pharmacokinetics: Rapidly absorbed after oral administration by approximately 60%. Before entering the systemic circulation, it undergoes intensive formation of glucuronides. Absolute availability is only 2%. The time to reach the mean maximum plasma concentration and bioavailability depend on interconversions in the systemic circulation and transformations of raloxifene and its glucuronide metabolites in the intestine and liver. In patients with hepatic insufficiency, plasma concentrations are approximately 2.5 times higher than in healthy subjects and correlate with the concentration of bilirubin. It has a large volume of distribution (does not depend on the dose). T1 / 2 in plasma is 27.7 hours. Most of the drug and its metabolites are excreted within 5 days and are found mainly in feces (less than 6% is excreted in the urine).
• Pharmacodynamics: Normalizes the processes of bone resorption in the postmenopausal period (increases bone mass), reduces calcium loss through the urinary system. Reduces total cholesterol, cholesterol in the LDL fraction, serum fibrinogen, Lp (a) and increases the concentration of HDL-C2 subfraction. Does not stimulate the proliferation of the endometrium, breast tissue, reduces the risk of developing breast cancer.
• Indications: Prevention of osteoporosis in postmenopausal women.
• Contraindications: Hypersensitivity, thromboembolism (including history), pulmonary embolism and retinal vein thrombosis, deep vein thrombosis, liver failure, osteoporosis in men, childbearing age (in women).
• Use during pregnancy and lactation: Not recommended.
• Side effects: Venous thrombosis, thromboembolism, hot flashes, painful spasms of the calf muscles, peripheral edema.
• Interaction: With simultaneous administration with warfarin or other coumarin derivatives, prothrombin time may decrease. Cholestyramine reduces absorption.
• Dosage and administration: Inside, 1 tab. (60 mg) per day (at any time of the day, regardless of food intake). The course of treatment is long. Women can combine with calcium supplements.
• Storage conditions: List B.: In a dry, dark place, at a temperature not exceeding 30 ° C. Do not freeze or expose to excessive heat or sunlight.
• Best before date: 2 years
• Main release forms tablets: 60 mg, 14 tab. 60 mg, 28 tab. 60 mg, 84 tab.
• Diagnosis: M81.0 – Postmenopausal osteoporosis
• Directions: Gynecology Hirudotherapy Orthopedics Rheumatology Radiology Traumatology Surgery