Aloxif
Raloxifene Hydrochloride 60 mg tablet

Presentation
Aloxif : Each tablet contains Raloxifene Hydrochloride INN 60 mg.

Description
Raloxifene is a selective estrogen receptor modulator (SERM). The biological actions of Raloxifene are largely mediated through binding to estrogen receptor. This binding results in activation of certain estrogenic pathways and blockade of others. Raloxifene reduces resorption of bone and decreases overall bone turnover. These effects on bone are manifested as reductions in the serum and urine levels of bone turnover markers. Clinical trials and data suggest that Raloxifene lacks estrogen like effects on the uterus and breast tissues. Raloxifene is rapidly absorbed after oral administration, metabolized in liver, and primarily excreted in faeces and rest in urine.

Indication
Treatment and prevention of post-menopausal osteoporosis.

Dosage and Administration
One tablet (60 mg) once daily orally. It can be taken without regard to meal. High fat meal increases the absorption of Raloxifene.

Side effects
Raloxifene is generally well tolerated. However, a few side effects like hot flushes, leg cramps, and influenza like symptoms, gastro-intestinal disturbances etc may be seen usually during first 6 months of treatment and were not different from placebo.

Contraindications
Hepatic & renal impairment.
In active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Hypersensitivity to Raloxifene or any other constituents of the tablet.

Precautions
Concurrent Estrogen Therapy: Concomitant use of Raloxifene with systemic estrogens is not recommended.
Lipid Metabolism: Concurrent use of Raloxifene and lipid-lowering agents has not been studied.

Use in Pregnancy and Lactation
Pregnancy: Raloxifene should not be used in women who are or may become pregnant.
Lactation period: It is not known whether Raloxifene is excreted in breast milk. Lactating mother should not use Raloxifne.

Drug interaction
Co-administration with cholestyramin, ampicillin and amoxicillin may reduce the absorption of Raloxifene.

Over dosage
Incidents of overdose in humans have not been reported.

Commercial Pack
Aloxif : Each box contains 3 blister strips of 10 tablets.