Alendronic acid (Aldren 70) Tablets contain alendronate sodium which is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P2·3H2O and its molecular weight is 325.12.
Each tablet contains: Alendronic acid (as Alendronate sodium) 70 mg.
Pharmacology: Mechanism of Action: Alendronic acid (Aldren 70) is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate sodium reduces bone resorption with no direct effect on bone formation. Histomorphometry in baboons and rats showed that alendronate sodium treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.
Pharmacokinetics: Relative to an intravenous (IV) reference dose, the mean oral bioavailability of alendronate sodium in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardized breakfast. Bioavailability was decreased (by approximately 40%) when 10 mg alendronate sodium was administered either 0.5 or 1 hour before a standardized breakfast, when compared to dosing 2 hours before eating. Bioavailability was negligible whether alendronate sodium was administered with or up to two hours after a standardized breakfast. Alendronate sodium transiently distributes to soft tissues following 1 mg/kg IV administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 L in humans. Protein binding in human plasma is approximately 78%. There is no evidence that alendronate sodium is metabolized in animals or humans. Following a single IV dose of [14C] alendronate sodium, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the feces. The terminal half-life in humans is estimated to exceed 10 years, probably reflecting release of alendronate sodium from the skeleton.
Treatment and prevention of osteoporosis in postmenopausal women.
Treatment to increase bone mass in men with osteoporosis.
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 in men and women.
Alendronic acid (Aldren 70) Tablets must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium. Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medication will lessen the effect of alendronate sodium by decreasing its absorption into the body. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, alendronate sodium tablets should only be swallowed upon arising for the day with a full glass of water (6-8 oz) and patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium Tablets should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences. Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate. No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium Tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women: The recommended dosage is: one 70 mg tablet once weekly or, one 10 mg tablet once daily.
Treatment to increase bone mass in men with osteoporosis: The recommended dosage is 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 of glucocorticoid-induced osteoporosis in men and women: 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.
Paget's disease of bone in men and women: The recommended treatment regimen is 40 mg once a day for six months.
No specific information is available on the treatment of overdosage with alendronate sodium. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate sodium. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial.
Alendronic acid (Aldren 70) Tablets are contraindicated in the following settings: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
Inability to stand or sit upright for at least 30 minutes.
Hypersensitivity to any component of this product.
Hypocalcemia.
Alendronate sodium, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa. Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture, have been reported in patients receiving treatment with alendronate sodium. Patients should be instructed to discontinue alendronate sodium tablets and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking alendronate sodium and/or who fail to swallow it with a full glass (6-8 oz) of water, and/or who continue to take alendronate sodium after developing symptoms suggestive of esophageal irritation. Because of possible irritant effects of alendronate sodium on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when alendronate sodium tablets are given to patients with active upper gastrointestinal problems (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers). Hypocalcemia must be corrected before initiating therapy with alendronate sodium. Other disturbances of mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Presumably due to the effects of alendronate sodium on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients with Paget's disease, in whom the pretreatment rate of bone turnover may be greatly elevated and in patients receiving glucocorticoids, in whom calcium absorption may be decreased. Ensuring adequate calcium and vitamin D intake is especially important in patients with Paget's disease of bone and in patients receiving glucocorticoids. Alendronate sodium tablets are not recommended for patients with renal insufficiency (creatinine clearance <35 mL/min).
Since there are no studies in pregnant women, alendronate sodium should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. It is not known whether alendronate sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when alendronate sodium is administered to nursing women. Safety and effectiveness of the drug in pediatric patients have not been established.
In clinical studies of up to five years in duration adverse experiences associated with alendronate sodium usually were mild, and generally did not require discontinuation of therapy. The most commonly reported adverse effects reported with alendronate sodium therapy include the following:
Gastrointestinal: abdominal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, acid regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distention, gastritis, gastric ulcer, melena.
Musculoskeletal: musculoskeletal (bone, muscle or joint) pain, muscle cramps.
Nervous System/Psychiatric: headache, dizziness.
Special Senses: taste perversion.
It is likely that calcium supplements, antacids, and some oral medications will interfere with absorption of alendronate sodium. Therefore, patients must wait at least one-half hour after taking alendronate sodium tablets before taking any other oral medications. In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products. Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate sodium tablets. Intravenous ranitidine was shown to double the bioavailability of oral alendronate sodium. The clinical significance of this increased bioavailability and whether similar increases will occur in patients given oral H2-antagonists is unknown. In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in the oral bioavailability of alendronate sodium (a mean increase ranging from 20 to 44%).
Store at temperatures not exceeding 25°C.
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Aldren 70 tab 70 mg
4's (P225/tab)
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