Raloxifene Hydrochloride Tablets IP 60 mg – Complete Product Information

Raloxifene Hydrochloride Tablets IP 60 mg are used primarily for the prevention and treatment of osteoporosis in postmenopausal women. Raloxifene acts as an estrogen agonist on bone tissue, helping to maintain bone density, while acting as an estrogen antagonist on breast and uterine tissue, thereby reducing associated risks.

Uses / Indications

Raloxifene Hydrochloride Tablets are indicated for:

• Prevention of osteoporosis in postmenopausal women

• Treatment of osteoporosis in postmenopausal women

• Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk

Mechanism of Action

Raloxifene is a Selective Estrogen Receptor Modulator (SERM) that:

• Mimics estrogen’s beneficial effects on bone density

• Reduces bone resorption and bone turnover

• Does not stimulate breast or endometrial tissue

This selective action helps strengthen bones while minimizing estrogen-related cancer risks.

Dosage & Administration

• Recommended Dose: 60 mg once daily or as directed by the physician

• Can be taken with or without food

• Tablet should be swallowed whole with water

⚠️ Dosage should be decided by a healthcare professional

Side Effects

Common side effects may include:

• Hot flashes

• Leg cramps

• Peripheral edema

• Flu-like symptoms

Rare but serious side effects:

• Deep vein thrombosis (DVT)

• Pulmonary embolism

• Stroke (in high-risk patients)

Precautions & Warnings

• Not recommended for premenopausal women

• Contraindicated in patients with active or past history of thromboembolic disorders

• Use caution in patients with cardiovascular disease

• Adequate calcium and vitamin D intake should be ensured

• Not to be used during pregnancy or lactation

Drug Interactions

• Use cautiously with anticoagulants

• May interact with estrogen-containing therapies

• Inform physician about all ongoing medications

Storage Instructions

• Store below 25°C

• Protect from moisture and light

• Keep out of reach of children

Key Highlights

• Clinically proven therapy for osteoporosis

• Improves bone mineral density

• Reduces fracture risk

• Estrogen-selective action

• Suitable for long-term management under medical supervision