Indications
Alendronate is indicated for:
- The treatment of osteoporosis in postmenopausal women to prevent the hip and spine fractures (vertebral compression fractures).
- The treatment of osteoporosis in men to prevent bone fractures.
- The treatment and prevention of glucocorticoid-induced osteoporosis in men and women.
- The treatment of Paget’s disease of bone in men and women.
Dosage and administration
Administration
- Ostagi 10 mg should be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food and some other medications are likely to reduce the absorption of alendronate.
- Ostagi 10mg should be swallowed with a full glass of water (not less than 200 ml). Patients should not chew or suck on a tablet of Ostagi 10. Patients should sit upright or stand upright for at least 30 minutes after taking the tablet to help the Ostagi tablet reach your stomach quickly and reduce the potential for irritation of the esophagus. Ostagi should not be taken at bedtime.
Dosage
- Treatment of osteoporosis in postmenopausal women: Recommended dose is one 10 mg tablet once daily.
- Prevention of osteoporosis in postmenopausal women: Recommended dose is one half of a 10 mg tablet (5 mg), once daily.
- Treatment and prevention of glucocorticoid-induced osteoporosis in men and women: Recommended dose is one half of a 10 mg tablet (5 mg) once daily, except for postmenopausal women who do not use estrogen, dose of one 10 mg tablet once daily is recommended.
- Paget’s disease of bone in men and women: The recommended treatment regimen is 40 mg once a day for six months.
Contraindications
- Hypersensitivity to any component of this product.
- Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
- Pregnant women
Precautions
- Alendronate can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems (such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers).
- Causes of osteoporosis other than oestrogen deficiency, ageing and glucocorticoid use should be considered.
- Hypocalcaemia must be corrected before initiating therapy with alendronate. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated.
- Patients should be instructed to receive supplemental calcium and vitamin D if dietary intake is inadequate.
- The safety and efficacy of alendronate in pediatric patients have not been
- Osteonecrosis of the jaw, atypical femural fractures have been reported with bisphosphonate therapy.
- Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min
Interactions
- Estrogen: Safety and efficacy of concurrent use of hormone replacement therapy and alendronate for postmenopausal women has not been determined, thus, combined use of alendronate and HRT is not recommended.
- Calcium Supplements/Antacids: Calcium supplements, antacids may reduce the absorption of alendronate. Therefore, before taking any other oral medications patients should be advised to wait at least half an hour after taking Ostagi.
Aspirin: In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving more than 10 mg of alendronate a day concurrently with aspirin-containing products.
- Nonsteroidal anti-inflammatory drugs (NSAIDs): Alendronate may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Tell your doctor and pharmacist about all of your drugs being used to avoid drug-drug interactions.
Pregnancy and lactation
- Pregnancy: Alendronate should not be used during pregnancy because of its potential for causing harmful effects to fetal development or the newborns.
- Lactation: It is not known whether alendronate is excreted into human breast-milk. Therefore, caution should be exercised when giving alendronate to breast-feeding women.
Effects on ability to drive and use machines
Alendronate has no influence on the ability to drive and use machines.
Undesirable effects
Side effects are usually mild, and, in general discontinuation of therapy is not required. Side effects occur primarily in the gastrointestinal tract.
Common, ADR > 1/100
- Central nervous system: Headache (2.6%); pain (4.1%).
- Gastrointestinal: Flatulence (2.6%); acid regurgitation (2%); oesophageal ulcer (1.5%); dysphagia, abdominal distention (1%).
Uncommon, 1/1000 < ADR < 1/100
- Skin: Rash, erythema (rare).
- Gastrointestinal: Gastritis (0.5%).
Inform your doctor about any side effects encountered while taking this medication.
Pharmacodynamic properties
- Alendronate is an aminobisphosphonate which specifically inhibits osteoclastic bone resorption. Preclinical studies have demonstrated that alendronate accumulates selectively at the sites where active resorption takes place and inhibits the the activity of osteoclasts.
- Alendronate can significantly increase bone mineral density at the spine, femoral neck and trochanter.
Pharmacokinetic properties
- Like other bisphosphonates, alendronate is poorly absorpted after oral administration. Absorption is reduced by food, especially by products containing calcium or other multivalent cations.
- Compared with an intravenous reference dose, the mean oral bioavailability of alendronate in women was 0.7% for doses ranging from 5 to 40 mg when administered after an overnight fast and two hours before a standardized breakfast.
- Oral bioavailability was about 0.4% when administered half an hour before meal, decreased 0.7% in the fasted state; absorption was negligible when taken 2 hours after a meal.
- Protein binding in human plasma is approximately 78%.
- There is no evidence showing that alendronate is metabolized in humans.
- About half of the absorbed portion was excreted in the urine, the remainder accumulated in bone for a prolonged period.
- The terminal half-life in humans is estimated to exceed 10 years, probably reflecting release of alendronate from the skeleton.
Overdose and treatment
- No specific information is available on the treatment of overdosage with alendronate. Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage
- Milk or antacids should be given to bind alendronate. Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis is ineffective.
- In case of drug overdose patients shouldbe immediately moved tohealth facilitiesto gettreatmentin time.
