Alendronate

Alendronate - Osteofos, Denfos
Use:

Osteoporosis in postmenopausal women; Paget’s disease of the bone; steroid-induced osteoporosis


Pregnancy & Lactation :
Risk Factor - C
Warnings & Precautions:

Use caution in patients with renal impairment; concomitant hormone replacement therapy with alendronate for osteoporosis in postmenopausal women is not recommended; hypocalcemia must be corrected before therapy initiation with alendronate; ensure adequate calcium and vitamin D intake to provide for enhanced needs in patients with Paget’s disease in whom the pretreatment rate of bone turnover may be greatly elevated.

Contraindication:

Hypersensitivity to bisphosphonates or any component of the product; 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

Adverse Reactions :

Incidence of adverse effects increases significantly in patients treated for Paget’s disease at 40 mg/day, mostly GI adverse effects.

1% to 10%: Central nervous system: Headache (2.6%); pain (4.1%) ; Gastrointestinal: Flatulence (2.6%); acid regurgitation (2%); esophagitis ulcer (1.5%); dysphagia, abdominal distention (1%)
<1%: Rash, erythema (rare), gastritis (0.5%)

Interactions :

Ranitidine (by increasing gastric pH) can double the bioavailability of alendronate


Over Dose / Poisoning :

Symptoms of overdose include hypocalcemia,hypophosphatemia; upper GI adverse events (upset stomach, heartburn, esophagitis, gastritis or ulcer) Treat with milk or antacids to bind alendronate; dialysis would not be beneficial


Dosage :

Oral: Alendronate must be taken with plain water first thing in the morning and > or =30 minutes before the first food, beverage, or other medication of the day. Patients should be instructed to take alendronate with a full glass of water (6-8 oz) and not lie down for at least 30 minutes to improve alendronate absorption. Adults: Patients with osteoporosis or Paget’s disease should receive

supplemental calcium and vitamin D if dietary intake is inadequate Osteoporosis in postmenopausal women: Prophylaxis: 5 mg once daily Treatment: 10 mg once daily. Paget’s disease of bone: 40 mg once daily for 6 months Retreatment: Relapses during the 12 months following therapy occurred in 9% of patients who responded to treatment. Specific retreatment data are not available.Retreatment with alendronate may be considered, following a 6-month post-treatment evaluation period, in patients who have relapsed based on increases in serum alkaline phosphatase, which should be measured periodically. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase. Elderly: No dosage adjustment is necessary Dosage adjustment in renal impairment: Clcr 30-60 mL/minute: None necessary Clcr <35 mL/minute: Alendronate is not recommended due to lack of experience. Dosage adjustment in hepatic impairment: None necessary


Patient Information :

Take as directed, with a full glass of water. Stay in sitting or standing position for 30 minutes following administration to reduce potential for esophageal irritation. Avoid aspirin- or aspirin-containing medications. Consult prescriber to determine necessity of lifestyle changes or dietary supplements of calcium or dietary vitamin D.You may experience GI upset (eg, flatulence, bloating, nausea, acid regurgitation); small frequent meals may help.

Report acute headache or gastric pain, unresolved GI upset, or acid stomach. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.





Comments

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ricci, Philippines

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ASHISHMARBADE, India

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