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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 a wk. Prevention of postmenopausal osteoporosis 35 mg once a wk.
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/suck.
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; if severe & occasionally incapacitating bone, joint &/or muscle pain develop; if ocular inflammatory symptoms are observed. Patients w/ active GI problems eg, dysphagia, esophageal diseases (including Barrett's esophagus), gastritis, duodenitis or ulcers, or w/ recent history (w/in previous yr) of major GI diseases eg, peptic ulcer, or active GI bleeding, or upper GIT surgery other than pyloroplasty. 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. Consider possibility of osteonecrosis of external auditory canal in patients receiving bisphosphonates who present w/ ear symptoms eg, pain or discharge, or chronic ear infections. Atypical subtrochanteric & diaphyseal femoral fractures. Evaluate patients w/ suspected stress fractures. Mild & transient decreases in serum Ca & phosphate; monitor serum Ca during therapy. Increased risk of atrial fibrillation. Refer patients to an ophthalmologist for evaluation in cases of ocular events other than uncomplicated conjunctivitis. May affect ability to drive or operate machinery. 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, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, & nausea.
Drug Interactions
May interfere w/ the absorption w/ Al-, Ca-, Fe-, or Mg-containing compd eg, antacids, mineral supplements & some osmotic laxatives; herbal products. Doubled bioavailability w/ IV ranitidine. Greater degree of bone turnover suppression w/ HRT eg, estrogen & progestin. May increase incidence of GI or renal adverse events w/ aspirin & NSAIDs.
MIMS Class
Agents Affecting Bone Metabolism
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 (P1,665/box)
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