Fosamax Plus

Fosamax Plus

alendronic acid + colecalciferol

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Per 70 mg/2,800 IU tab Alendronate Na 70 mg, cholecalciferol 2,800 IU. Per 70 mg/5,600 IU tab Alendronate Na 70 mg, cholecalciferol 5,600 IU
Indications/Uses
Osteoporosis in postmenopausal women to increase bone mass, prevent fractures including those of the hip & spine. Osteoporosis in men to prevent fractures.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take at least 30 min before the 1st food/beverage/medication w/ a full glass of water upon arising for the day. Swallow whole, do not chew/suck. Do not lie down for at least 30 min & until after 1st food. Do not take at bedtime.
Contraindications
Hypersensitivity. Esophagus abnormalities (eg, stricture or achalasia), hypocalcemia, inability to stand or sit upright for at least 30 min.
Special Precautions
Discontinue use if dysphagia, odynophagia, retrosternal pain, new or worsening heartburn develops. Local irritation of upper GI mucosa. Active upper GI problems eg, dysphagia, esophageal diseases, gastritis, duodenitis or ulcers. Osteonecrosis of the jaw & external auditory canal; invasive dental surgery; bone, join &/or muscle pain. Evaluate stress fractures, known causes & risk factors eg, vit D deficiency, malabsorption, glucocorticoid use, previous stress fracture, low extremity arthritis or fracture, extreme or increased exercise, DM, chronic alcohol abuse. Correct hypocalcaemia & other disorders affecting mineral absorption (eg, vit D deficiency) prior to therapy. Monitor serum Ca, phosphate & urine. Not recommended in severe renal insufficiency (CrCl <35 mL/min). Not to be given during pregnancy & lactation. Not to be given to childn.
Adverse Reactions
Hypersensitivity, urticaria, myalgia, malaise, asthenia; nausea, vomiting, esophagitis, esophageal erosions & ulcers; bone, joint &/or muscle pain; dizziness, vertigo, dysgeusia; rash, pruritus, alopecia.
Drug Interactions
Interfered absorption by Ca supplements, antacids. Greater increased bone mass w/ hormone replacement therapy. GI irritation w/ NSAIDs. Impaired absorption w/ olestra, mineral oils, orlistat, cholestyramine, colestipol. Increased metabolism w/ anticonvulsants, cimetidine, thiazides.
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 70 mg/2800 IU tab
Packing/Price
4's
Form
Fosamax Plus 70 mg/5600 IU tab
Packing/Price
4's
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