Alendra

Alendra

alendronic acid

Manufacturer:

BIOFEMME, Inc

Distributor:

UNILAB, Inc

Marketer:

BIOFEMME, Inc
Concise Prescribing Info
Contents
Alendronic acid
Indications/Uses
Treatment of osteoporosis in postmenopausal women & in men. Prevention of osteoporosis in postmenopausal women.
Dosage/Direction for Use
Treatment of osteoporosis in postmenopausal women & in men 70 mg once wkly. Prevention of postmenopausal osteoporosis 35 mg once wkly.
Administration
Should be taken on an empty stomach: Take w/ a full glass of plain water only at least 30 min before the 1st food/drink/medication of the day & remain in sitting/upright position for at least 30 min. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to bisphosphonates. Abnormalities of the esophagus which delay esophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min (eg, bedridden & hospitalized patients). Hypocalcemia. Renal impairment (CrCl <35 mL/min). Pregnancy & lactation.
Special Precautions
Discontinue use if symptoms eg, dysphagia, odynophagia, worsening heartburn or retrosternal pain develops or in patients w/ stress fracture. Patients w/ active GI problems eg, dysphagia, esophageal diseases (including Barrett's esophagus), gastritis, duodenitis or ulcers. Consider causes of osteoporosis other than estrogen deficiency, aging & glucocorticoid use. Correct hypocalcemia & other mineral metabolism disturbances eg, vit D deficiency before initiating therapy. Paget's disease or those receiving glucocorticoids. Consider dental exam w/ appropriate preventive dentistry prior to treatment in patients w/ concomitant risk factors for osteonecrosis of the jaw. Evaluate patients w/ suspected stress fractures. Mild & transient decreases in serum Ca & phosphate; increased risk of atrial fibrillation. Increased incidence of vomiting in patients w/ osteogenesis imperfecta. Not indicated for infants & childn. Some older individuals have greater sensitivity to alendronate.
Adverse Reactions
Abdominal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, acid regurgitation, vomiting, dysphagia, abdominal distention, gastritis, gastric ulcer, GERD, melena, esophagitis, esophageal erosions, esophageal ulcers, & taste perversion, anastomic ulcer w/ mild hemorrhage (concomitant use w/ aspirin), esophageal cancer; vertigo, headache, dysgeusia & dizziness.
Drug Interactions
May interfere w/ the absorption w/ Al-, Ca-, Fe-, or Mg-containing compds eg, antacids, mineral supplements & some osmotic laxatives. Doubled bioavailability w/ IV ranitidine. Greater degree of bone turnover suppression w/ hormone replacement therapy eg, estrogen & progestin. May increase the incidence of GI or renal adverse events w/ aspirin & other NSAIDs. May have additive hypocalcemic effect w/ aminoglycosides. May delay absorption w/ herbal products.
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Alendra FC tab 70 mg
Packing/Price
4's (P342.25/box)
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