Fosamax Plus

Fosamax Plus

alendronic acid + colecalciferol

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Alendronate Na 70 mg, colecalciferol 5,600 IU (140 mcg)
Indications/Uses
Osteoporosis in postmenopausal women to prevent fractures, including those of hip & spine (vertebral compression fractures) or in men to prevent fractures. Helps ensure vit D adequacy.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take at least 30 min before the 1st food/drink/medication of the day w/ a full glass of plain water & remain in sitting/upright position for at least 30 min. Do not take at bedtime. Swallow whole, do not suck/chew/crush.
Contraindications
Hypersensitivity. Abnormalities of esophagus which delay esophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min. Hypocalcemia.
Special Precautions
Discontinue use if dysphagia, odynophagia, retrosternal pain or new or worsening heartburn; symptoms of esophageal disease eg, difficulty or pain upon swallowing develop. Consider interruption of therapy in patients w/ stress fractures. Local irritation of upper GI mucosa. Esophageal adverse experiences eg, esophagitis, esophageal ulcers & erosions. Patients who lie down after taking the drug &/or who fail to swallow it w/ full glass of water, &/or who continue to take it after developing symptoms suggestive of esophageal irritation; w/ active upper GI problems eg, dysphagia, esophageal diseases (including known Barrett's esophagus), gastritis, duodenitis, or ulcers; requiring invasive dental surgery (eg, tooth extraction, dental implants); w/ malabsorption. Localized osteonecrosis of jaw associated w/ tooth extraction &/or local infection (including osteomyelitis) w/ delayed healing. Bone, joint &/or muscle pain. Low-energy fractures of subtrochanteric & proximal femoral shaft & other bones in long-term (usually >3 yr) bisphosphonate-treated patients. Decreases in serum Ca & phosphate. Consider causes of osteoporosis other than estrogen deficiency, aging & glucocorticoid use. Correct hypocalcemia & other disorders affecting mineral metabolism (eg, vit D deficiency) before initiating therapy & monitor serum Ca & symptoms of hypocalcemia. Monitor urine & serum Ca in patients w/ diseases associated w/ unregulated overproduction of calcitriol (eg, leukemia, lymphoma, sarcoidosis). Not recommended in more severe renal insufficiency (CrCl <35 mL/min). Not to be given during pregnancy & lactation. Not to be given in childn.
Adverse Reactions
Abdominal pain & distension, musculoskeletal (bone, muscle or joint) pain, dyspepsia, acid regurgitation, nausea, constipation, flatulence, muscle cramp, gastritis & gastric ulcer. SJS, TEN.
Drug Interactions
Alendronate Na: Interference in absorption w/ Ca supplements, antacids & other oral medications. Increased bone mass & decreased bone turnover w/ HRT. Concomitant use w/ NSAID. Colecalciferol: Impaired absorption of vit D w/ olestra, mineral oils, orlistat, bile acid sequestrants (eg, cholestyramine & colestipol). Increased vit D catabolism may occur w/ anticonvulsants, cimetidine & thiazides.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BB03 - alendronic acid and colecalciferol ; Belongs to the class bisphosphonates, combinations. Used in the treatment of bone diseases.
Presentation/Packing
Form
Fosamax Plus tab 70 mg/5,600 iu
Packing/Price
4's
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