| ALENDRONATE-HAKIM |
| :: Bone resorption inhibitor :: |
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 Tab. 10 mg |
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Pharmacologic category
Bone resorption inhibitors ; Bisphosphonate derivative .
Mechanism of action
A Bisphosphonate which inhibits bone resorption via actions on osteoclasts or on osteoclast precursors ; decreases the rate of bone resorption , leading to an indirect increases in bone mineral density . In Paget's disease , characterized by disordered resorption and formation of bone , inhibition of resorption leads to an indirect decrease in bone formation ; but the newly – formed bone has a more normal architecture .
Indications
Treatment and prevention of osteoporosis in postmenopausal females ; Treatment of osteoporosis in males ; Treatment of Paget's disease in patients with alkaline phosphatase concentration at least two times the upper limit of normal , those who are symptomatic , or those at risk for future complication from the disease ; Treatment of osteoporosis in men and women receiving glucocorticoids in a daily dosage in equivalent to 7.5 milligrams or more prednisone and who have a low bone mineral density .
Side/Adverse effects
Abdominal pain ; Dysphagia ; Heartburn ; Irritation , pain , or ulceration of the esophagus ; Muscle pain ; Skin rash ; Abdominal distention ; Constipation ; Diarrhea ; Flatulence ; Headache ; Nausea ; Hypocalcemia ; Hypophosphatemia ; Angioedema ; Oropharyngeal ulceration ; Photosensitivity ; Uveitis .
Contraindications
Hypersensitivity to alendronate , other bisphosphonates or any component of the formulation ; Hypocalcemia ; Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ; Inability to stand or sit upright for at least 30 minutes ; Renal function impairment when creatine clearance is < 35 ml per minute .
Warnings / Precautions
Use caution in patients with renal impairment . Hypocalcemia must be corrected before therapy initiation ; ensure adequate calcium and vitamin D intake . Use with caution in patients with dysphagia , esophageal disease , gastritis , duodenitis , or ulcers .
Pregnancy
FDA Pregnancy Category C . Safety and efficacy have not been established in pregnant women .
Breast–Feeding
Excretion in breast milk is unknown / use caution .
Drug Interactions
Simultaneous use of dietary supplements ( including calcium ) or food and beverages or oral medications ( including antacids and those containing multivalent cations ) may interfere with the absorption of alendronate at least 30 minutes before taking other medications , food , or beverages . Intravenous ranitidine ( by increasing gastric pH ) was shown to double the bioavailability of oral alendronate . An increased incidence of upper gastrointestinal adverse events was reported in individuals taking more than 10 mg of alendronate a day concurrently with salicylates or salicylate – containing compounds .
Monitoring Parameters
For Paget's disease , serum alkaline phosphatase ( every 3 to 6 months ) , urinary hydroxyproline ( every 6 to 12 months) , serum calcium ( every 3 to 6 months ) and urinary N – telopeptide of type I collagen ( every 3 to 6 months ) determinations are recommended . For postmenopausal osteoporosis , bone mineral density determination is recommended every 1 to 2 years to assess effectiveness of therapy . Also Serum calcium or creatinine determinations is recommended every 6 to 12 months ; serum calcium values should increase with treatment .
Dietary Considerations
Alendronate must be taken with plain water first thing in the morning and at least 30 minutes before the first food or beverage of the day . Patient must be stayed in sitting or standing position for 30 minutes following administration and until after first food of the day to reduce potential for esophageal
irritation .
Administration and dosage
Glucocorticoid – induced osteoporosis ; men and women (treatment) – Oral , 5 mg once a day in the morning .
Osteoporosis , male ( treatment ) – Oral , 10 mg once a day in the morning .
Paget's disease of bone ( treatment ) – Oral , 40 mg once a day in the morning . Re – treatment may be considered for certain patients following a six – month post – treatment evaluation period .
Postmenopausal osteoporosis ( treatment ) – Oral , 10 mg once a day in the morning or 70 mg once a week in the morning .
Postmenopausal osteoporosis ( prophylaxis ) – Oral , 5 mg once a day in the morning or 35 mg once a week in the morning .
How Supplied
Tablet: 10 mg
Storage
Store between 15 an 30°C ( 59 and 86°F ).
References
- USP DI, 2005
- Up To Date, Vol. 13.3 (2005)
- Martindale, The Complete Drug Reference, 34 rd edition 2005
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