Raloxifene Hydrochloride : Uses,Dosage,Side Effects

Generic Name
Raloxifene Hydrochloride
Therapeutic Class: Bone and Joint Disorder/Inhibiting bone resorption

Indications:
Raloxifene is an estrogen agonist/antagonist indicated for:
  • Treatment and prevention of osteoporosis in postmenopausal women
  • Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
  • Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer 
Important Limitations: Raloxifene is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer.

Presentation:
Raloxifene: 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 the estrogen receptor. This binding results in the activation of certain estrogenic pathways and the blockade of others. Raloxifene reduces the 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 the liver, and primarily excreted in faeces and rest in urine.

Dosage & Administration:
One tablet (60 mg) once daily orally. It can be taken without regard to the meal. A 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 the first 6 months of treatment and were not different from placebo.

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 & 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 the mother should not use Raloxifene.

Interaction:
Co-administered with cholestyramine, ampicillin and amoxicillin may reduce the absorption of Raloxifene.

Overdose:
Incidents of overdose in humans have not been reported.
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