REVENTA Tablet

- In postmenopausal women for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures).

- In postmenopausal women who are at risk of developing osteoporosis.

- For the treatment of osteoporosis in men to prevent fractures.

- For the treatment and prevention of glucocorticoid-induced osteoporosis in men and women.

- For the treatment of Paget’s disease of bone in men and women.

Dosage and administration

Reventa (Alendronate sodium) must be taken at least 30 minutes before the first food beverage, or medication of the day with plain water only. Food and drinks affect the absorption of REVENTA. Therefore, it is very important that REVENTA must not be used with food or drinks (other than water). The tablets must be swallowed whole, with a full glass of water and not chewed. Patients should not lie down for 30 minutes after taking the tablet. REVENTA should not be taken at bedtime.

Treatment of Osteoporosis in Postmenopausal Women and Men

The recommended dosage is:

- 70mg once weekly OR

- 10mg once daily.

Prevention of Osteoporosis, in Postmenopausal Women

The recommended dosage is 5mg once daily.

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis in Men and Women

The recommended dosage is 5mg once a day except for postmenopausal women not receiving estrogen, for whom the recommended dosage is 10mg once daily.

Paget’s Disease of Bone in Men and Women

The recommended treatment regimen is 40mg once daily for 6 months.

- Hypersensitivity to any component of this product.

- 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.

Body as a Whole:

Common: Hypersensitivity reactions including urticaria, transient symptoms of myalgia and malaise.

Rare: Angioedema, fever, symptomatic hypocalcemia.

Gastrointestinal:

Common: Esophagitis, esophageal erosions, esophageal ulcers.

Rare: Esophageal stricture or perforation and oropharyngeal ulceration.

Gastric or duodenal ulcers, some severe and with complications, have also been reported.

Skin:

Common: Rash (occasionally with photosensitivity), pruritis.

Rare: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Special Senses:

Rare: Uveitis, scleritis.

See the package insert about the details

- Ranitidine

- Prednisone

- Estrogen/Hormone Replacement Therapy (HRT)

- Calcium Supplements/ Antacids

- Aspirin

- NSAIDs

Pregnancy

There are no studies in pregnant women. Alendronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Nursing Mothers

It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when alendronate is administered to nursing women.

General:

- Causes of osteoporosis other than estrogen deficiency, aging and glucocorticoid use should be considered.

- Hypocalcemia must be corrected before initiating therapy with alendronate.

- Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be treated. Patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy.

- Ensuring adequate calcium absorption and vitamin intake is especially important in patients with Paget’s disease of bone and in patients receiving glucocorticoids as small asymptomatic decreases in serum calcium and phosphate may occur with the treatment of alendronate.

Gastrointestinal

- Physicians should be alert to symptoms signaling a possible esophageal reaction including dysphasia, odynophagia, retrostenal pain or new/worsening heartburn. Patients should be instructed to discontinue alendronate.

- Because of possible irritant effects of alendronate on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems.

See the package insert about the details below:

Renal Insufficiency

Glucocorticoid-induced osteoporosis

Pediatric Patients

At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces.