Cleven Injection 6000 Anti-Xa IU/0.6 ml

Indications

Alendon is indicated for the-

- Treatment of Osteoporosis in Postmenopausal Women: Alendon is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendon increases bone mass and reduces the incidence of fractures, including those of the hip and spine.
- Prevention of Osteoporosis in Postmenopausal Women: Alendon is indicated for the prevention of postmenopausal osteoporosis.
- Treatment to Increase Bone Mass in Men with Osteoporosis: Alendon is indicated for treatment to increase bone mass in men with osteoporosis.
- Treatment of Glucocorticoid-Induced Osteoporosis: Alendon is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density.
- Treatment of Paget's Disease of Bone: Alendon is indicated for the treatment of Paget's disease of bone in men and women.

Pharmacology

Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

Dosage & Administration

Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is one 70 mg tablet once weekly or one 10 mg tablet once daily.

Prevention of Osteoporosis in Postmenopausal Women: The recommended dosage is one 35 mg tablet once weekly or one 5 mg tablet once daily.

Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is one 70 mg tablet once weekly or one 10 mg tablet once daily.

Treatment of Glucocorticoid-Induced Osteoporosis: The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Treatment of Paget's Disease of Bone: The recommended treatment regimen is 40 mg once a day for six months.

Side Effects

The commonest symptomatic side effects are constipation, diarrhoea, oesophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angio-oedema.

Precautions & Warnings

- Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur.
- Hypocalcemia can worsen and must be corrected prior to use.
- Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop.
- Osteonecrosis of the Jaw has been reported.
- Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture.

Contraindications

- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
- Hypocalcemia.
- Hypersensitivity to any component of this product.

Pregnancy & Lactation

Alendronic acid should not be given to pregnant women or nursing mother.

Storage Conditions

Store in a well-closed container at room temperature, 15-30°C

Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult your physician or pharmacist before starting any medication.