RiteMED Alendronic Acid

White, oval tablets.
Each tablet contains Alendronic Acid (Sodium Alendronate), USP 70 mg (eq. to 91.37 mg Sodium Alendronate).

Bisphosphonate.
Pharmacology: Pharmacodynamics: 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. Osteoporosis in postmenopausal women osteoporosis is characterized by low bone mass that leads to an increased risk of fracture. The diagnosis can be confirmed by the finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis, indicative of vertebral (spinal) fracture. Osteoporosis occurs in both males and females but is most common among women following the menopause, when bone turnover increases and the rate of bone resorption exceeds that of bone formation. These changes result in progressive bone loss and lead to osteoporosis in a significant proportion of women over age 50. Fractures, usually of the spine, hip, and wrist, are the common consequences. From age 50 to age 90, the risk of hip fracture in white women increases 50-fold and the risk of vertebral fracture 15- to 30-fold. It is estimated that approximately 40% of 50-year-old women will sustain one or more osteoporosis-related fractures of the spine, hip, or wrist during their remaining lifetimes. Hip fractures, in particular, are associated with substantial morbidity, disability, and mortality.

Treatment of Osteoporosis in Postmenopausal Women: Alendronic Acid is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronic Acid increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
Prevention of Osteoporosis in Postmenopausal Women: Alendronic Acid is indicated for prevention of postmenopausal osteoporosis.
Treatment to Increase Bone Mass in Men with Osteoporosis: Alendronic Acid is indicated for the treatment to increase bone mass in men with osteoporosis.
Treatment for Glucocorticoid-Induced Osteoporosis: Alendronic Acid is indicated for 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: Alendronic Acid is indicated for the treatment of Paget's disease of bone in men and women. Treatment is indicated in Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
Important Limitations of Use: The optimal duration of use has not been determined. The safety and effectiveness of Alendronic Acid for the treatment of osteoporosis are based on clinical data of four years duration. All the patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk of fracture should be considered for drug continuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Treatment of osteoporosis in postmenopausal women and in men: 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 5 mg tablet once daily.
Treatment and prevention of glucocorticoid-induced osteoporosis in men and women: The recommended dose is 5 mg once a day, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is 10 mg once a day.
Alendronate is not indicated for use in children.
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.

Symptoms: No specific information is available on the treatment of overdosage with Alendronate. Overdosage with bisphosphonates would be likely to result in symptoms of hypocalcemia, paresthesia, hypotension, fever and vomiting and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage.
Treatment: If necessary, parenteral infusion of a calcium salt could be given. Giving milk or antacids, to bind the bisphosphonate and minimize absorption, has been suggested for oral overdosage. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Decontamination: Activated charcoal, gastric lavage.

Hypersensitivity: Bisphosphonates may rarely cause hypersensitivity reactions such as angioedema, urticarial, and pruritus. A possibly drug-related rash has also been reported in a patient receiving Alendronate. Other cutaneous reported with Alendronate include urticarial, erythematous papules and petechiae, gyrate erythema, and drug-induced lichen planus; licensed product information states that Stevens-Johnson syndrome has been reported.

Upper Gastrointestinal Adverse Reactions: Alendronic Acid, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Alendronic Acid is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers). Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including Alendronic Acid. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Alendronic Acid 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 oral bisphosphonates including Alendronic Acid and/or who fail to swallow oral bisphosphonates including Alendronic Acid with the recommended full glass (6-8 ounces) of water, and/or who continue to take oral bisphosphonates including Alendronic Acid after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see Dosage & Administration]. In patients who cannot comply with dosing instructions due to mental disability, therapy with Alendronic Acid should be used under appropriate supervision.
Mineral Metabolism: Hypocalcemia must be corrected before initiating therapy with Alendronic Acid [see Contraindications]. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with Alendronic Acid. Presumably due to the effects of increase in 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.
Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Alendronic Acid. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, bone surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.
Atypical Subtrochanteric and Diaphyseal Femoral: Patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Renal Impairment: Alendronic Acid is not recommended for patients with creatinine clearance less than 35 mL/min.
Glucocorticoid-Induced Osteoporosis: Before initiating treatment, the gonadal hormonal status of both men and women should be ascertained and appropriate replacement considered. A bone mineral density measurement should be made at the initiation of therapy and repeated after 6 to 12 months of combined Alendronic Acid and glucocorticoid treatment.

Pregnancy: There is no data on fetal risk in humans. Alendronate should be used in pregnant women only if the potential benefits justify the potential risk to the mother and fetus.
Lactation: It is not known whether Alendronate is excreted into human breast milk, and the potential for adverse effects in the breastfeeding infant has not been determined. Use caution when administering Alendronate to a nursing woman.

Neurologic: Headache, dizziness, vertigo, dysgeusia.
Gastrointestinal: Abdominal pain, constipation, diarrhea, flatulence, indigestion, vomiting, duodenal ulcer disease, esophageal erosions, esophageal perforation, esophageal stricture, esophagitis, gastric ulcer, ulcerative pharyngitis (acute), ulcer of esophagus.
Immunologic: Hypersensitivity reaction.
Musculoskeletal: Arthralgia, aseptic necrosis of bone of jaw, bone pain, myalgia, joint swelling, low-energy femoral shaft fracture.
Skin: Rash (occasionally with photosensitivity), pruritus, alopecia, rarely severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Senses: Rarely uveitis, scleritis or episcleritis.
Other: Fever, influenza-like symptoms, disturbances in serum electrolytes may occur, most commonly hypocalcemia and hypophosphataemia.
Other rare adverse effects include blood disorders such as anemia, thrombocytopenia, leucopenia and disturbances in liver enzyme values.

Calcium Supplements/Antacids: Co-administration of Alendronic Acid and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of Alendronic Acid. Therefore, instruct patients to wait at least one-half hour after taking Alendronic Acid before taking any other oral medications.
Nonsteroidal Anti-Inflammatory Drugs: Alendronic Acid may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs).

Store at temperatures not exceeding 30°C.

Agents Affecting Bone Metabolism

M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

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