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Alendronic Acid information from DrugsUpdate  

See Available Brands of Alendronic Acid in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation

Alendronic acid or alendronate sodium  is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D).

Prophylaxis and treatment of female osteoporosis
Treatment of male osteoporosis
Prevention and treatment of corticosteroid-associated osteoporosis together with supplements of calcium and vitamin D
Paget's disease

Pharmacodynamics

Alendronate inhibits osteoclast-mediated bone-resorption. Like all bisphosphonates it is chemically related to inorganic pyrophosphate, the endogenous regulator of bone turnover. Whereas pyrophosphate and the first bisphosphonate, etidronate, are capable of inhibiting both osteoclastic bone resorption as well as the mineralization of the bone newly formed by osteoblasts, alendronate and the other potent N-containing bisphosphonates such as risedronate and ibandronate and zoledronate specifically inhibit bone resorption without any effect on mineralization at pharmacalogically achievable doses. Its inhibition of bone-resorption is dose-dependent and approximately 1,000 times stronger than the equimolar effect of etidronate. Under therapy normal bone tissue develops, and alendronate is deposited in the bone-matrix in pharmacologically inactive form. For optimal action enough calcium and vitamin D are needed in the body in order to promote normal bone development. Hypocalcemia should therefore be corrected before starting therapy.

Pharmacokinetics

As with all potent bisphosphonates, the systemic bioavailability after oral dosing is low, averaging only 0.6–0.7% in women and in men under fasting conditions. Intake together with meals and beverages other than water further reduces the bioavailability. The absorbed drug rapidly partitions, with approximately 50% binding to the exposed bone surface; the remainder is excreted unchanged by the kidneys. Unlike most drugs, the strong negative charge on the two phosphate moieties limits oral bioavailability, and in turn, the exposure to tissues other than bone is very low. After absorption in the bone, alendronate has an estimated terminal half-life of 10 years.

Alendronic Acid Indications / Alendronic Acid Uses

Information Not Available

Alendronic Acid Adverse Reactions / Alendronic Acid Side Effects

Oesophagitis, oesophageal ulcers, & erosions, dysphagia, heartburn, retrosternal pain, abdominal pain, distension, diarrhoea, constipation, flatulance, headcahe, rash, erthyema, musculoskeletal pain, transient decreases in serum phospate.

Precautions

Acute inflammations of the gastrointestinal tract (esophagitis, gastritis, ulcerations). Clinically manifest osteomalacia. Certain malformations and malfunctions of the esophagus (strictures, achalasia). Inability to stand, walk, or sit for 30 minutes after oral administration, Renal impairment with a creatinine clearance below 30ml/min. Hypersensitivity to alendronate or another ingredient. Hypocalcemia Pregnancy and breastfeeding, Patients below 18 yrs. of age, because no clinical data exists.

Special Precautions

Upper Gi disorders (discontinue if symptoms worsen); history of ulcers, active GI bleeding. Correct Vitamin D & Ca dificiency before starting therapy.

Other Drug Interactions

Highly active vitamin D analogues or fluorides: no data is available. Concomitant treatment should be avoided.
The additional beneficial effect of HRT (hormone replacement therapy) with estrogens/progestins or raloxifene in postmenopausal women remains to be elucidated, but no interactions have been seen. The combination is therefore possible.
Intravenous ranitidine increases the oral bioavailability of alendronate. No clinical consequences are known.
The combination of NSAIDs and alendroate may increase the risk of gastric ulcers. Both these drugs have the potential to irritate the upper gastro-intestinal mucosa.

Other Interactions

Milk, diet and drugs containing high amounts of calcium, magnesium or aluminium (antacids): the resorption of alendronate is decreased.
Food, mineral water, coffee, tea and juice interfere with absorption of alendronate.
At least half an hour should pass after intake of alendronate before taking the supplement or drug.

Dosage

Oral
Osteopetrosis
Adult: 10 mg daily or 70 mg once weekly.
CrCl (ml/min) <35, Dosage not recommended.

Paget's disease of bone
Adult: 40 mg daily for 6 mth; may be repeated if necessary after 6-mth post-treatment evaluation period.

Prevention of postmenopausal osteoporosis
Adult: 5 mg once daily or 35 mg once wkly.
CrCl (ml/min) <35, Dosage not recommended.

Corticosteroid-induced osteoporosis
Adult: Treatment and prevention: 5 mg daily; may increase to 10 mg daily in women who do not receive HRT.

Food(before/after)

Should be taken on an empty stomach. (Take w/ a full glass of plain water at least ½ hr before the 1st food/drink/medication of the day & remain in sitting/upright position for at least ½ hr. Swallow whole, do not chew/crush.)

List of Contraindications

Alendronic Acid and Pregnancy

Contraindicated in pregnancy.


Category C.

Alendronic Acid and Lactation

Contraindicated in lactation

Alendronic Acid and Children

Information Not Available

Alendronic Acid and Geriatic

Information Not Available

Alendronic Acid and Other Contraindications

Information Not Available

Storage

Information Not Available

Lab interference

Information Not Available

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