Alendronic acid (as Alendronate sodium).
Each tablet contains: Alendronic acid (as Alendronate sodium) 70 mg.
Pharmacology: Pharmacokinetics: Like other bisphosphonates, alendronate is poorly absorbed after oral doses. Absorption is decreased by food, especially by products containing calcium or other polyvalent cations. Bioavailability is about 0.4% when taken half an hour before food, reduced from 0.7% in the fasting state; absorption is negligible when taken up to 2 hours after a meal. Plasma protein binding is about 78%. Bisphosphonates do not appear to be metabolised. About half of the absorbed portion is excreted in the urine; the remainder is sequestered to bone for a prolonged period.
Used in the management of osteoporosis either alone or with Vitamin D. Used for the treatment of Paget's disease of bone.
The usual dosage for the treatment of osteoporosis in men and women is 10 mg daily. Postmenopausal women may be given 5 mg daily for prophylaxis. It may also be given once weekly to postmenopausal women in a dose of 70 mg for treatment of osteoporosis, or 35 mg for prophylaxis. Men with osteoporosis may be treated with 70 mg once weekly. For the treatment and prevention of corticosteroid-induced osteoporosis a dose of 5 mg daily is given; postmenopausal women who do not take HRT should be given 10 mg daily.
In adults with Paget's disease of bone the usual dose is 40 mg daily for 6 months; treatment may be repeated if necessary after an interval of a further 6 months, or as prescribed by a physician.
Hypersensitivity: Bisphosphonates may rarely cause hypersensitivity reactions such as angioedema, urticaria, and pruritus. A possibly drug-related rash has also been reported in a patient receiving alendronate. Other cutaneous reactions reported with alendronate include urticaria, erythematous papules and petechiae, gyrate erythema, and drug-induced lichen planus; licensed product information states that Stevens-Johnson syndrome has been reported.
Alendronate should not be given to patients with abnormalities of the oesophagus or other factors that might delay oesophageal emptying, or those unable to stand or sit upright for at least 30 minutes. It should be used with caution in patients with upper gastrointestinal abnormalities. To minimise the risk of oesophageal reactions: Patients should be instructed to swallow alendronate tablets whole with plenty of water (not less than 200 mL), in upright position (standing or sitting). Mineral water with high concentration of calcium should be avoided.
Tablets should be taken on rising for the day, on an empty stomach, at least 30 minutes before breakfast and any other oral medication.
Patients should remain upright after taking the tablet, and should not lie down before eating the first meal of the day.
Alendronate should not be taken at bedtime, or before getting up for the day.
Hypocalcaemia should be corrected before starting alendronate therapy, and other disorders affecting mineral metabolism such as Vitamin D deficiency, or hypoparathyroidism should also be treated; serum calcium in these patients should be monitored during therapy.
As for the bisphosphonates in general may cause gastrointestinal disturbances including abdominal pain, nausea and vomiting, and diarrhoea or constipation. Peptic ulceration has been reported. Existing gastrointestinal problems may be exacerbated, and oral bisphosphonates should generally be given with care or avoided if acute upper gastrointestinal inflammation is present. Gastrointestinal symptoms such as abdominal pain, dyspepsia, diarrhoea or constipation are the most frequent adverse effects with alendronate. Severe oesophageal reactions such as oesophagitis, erosions, ulceration, and stricture have occurred; patients should be advised to stop taking the tablets and seek medical attention if they develop symptoms such as dysphagia, new or worsening heartburn, pain on swallowing, or retrosternal pain. Peptic ulceration has also been reported.
The bisphosphonates are not well absorbed from the gastrointestinal tract, and dosage with food further impairs their absorption. Compounds containing aluminum, calcium, iron or magnesium including antacids and mineral supplements are some osmotic laxatives, can also impair the absorption of bisphosphonates given by mouth. It has been suggested that the use of certain bisphosphonates with NSAIDs may result in increased incidence of gastrointestinal or renal adverse effects.
Store at temperatures not exceeding 30°C.
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Sign Out
