Fosavance

Fosavance

alendronic acid + colecalciferol

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig
Concise Prescribing Info
Contents
Alendronate Na 91.37 mg (equiv to alendronate free acid 70 mg), cholecalciferol 140 mcg (equiv to vit D 5,600 IU)
Indications/Uses
Osteoporosis in postmenopausal women to prevent fractures including those of the hip & spine (vertebral compression fractures) & to help ensure vit D adequacy. Osteoporosis in men to prevent fractures & help ensure vit D adequacy.
Dosage/Direction for Use
1 tab once wkly. Missed dose: 1 tab immediately in the morning after remembered. Do not take 2 tab on the same day but return to taking 1 tab once wkly as original schedule.
Administration
Should be taken on an empty stomach: Take upon arising for the day, at least 30 min before the 1st food, beverage (including mineral water) or medication w/ a full glass of plain water only. Do not lie down for at least 30 min & until after the 1st food of the day. Do not take at bedtime or before arising for the day. Swallow whole, do not suck/chew/crush.
Contraindications
Hypersensitivity. Esophageal abnormalities 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 patient develops dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Patients w/ active upper GI problems eg, dysphagia, esophageal diseases (Barrett's esophagus), gastritis, duodenitis or ulcers. Correct hypocalcemia & other disorders affecting mineral metabolism prior to therapy. Patients w/ diseases associated w/ unregulated overproduction of calcitriol (eg, leukemia, lymphoma, sarcoidosis). Monitor urine & serum Ca. Discontinuation/interruption of bisphosphonate therapy should be considered based on individual benefit/risk assessment in patients requiring invasive dental surgery (eg, tooth extraction, dental implants) due to reported localized osteonecrosis of the jaw, low-energy fractures of subtrochanteric & proximal femoral shaft. Evaluate patients w/ suspected stress fractures. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy reevaluated on a periodic basis. Not recommended in severe renal insufficiency (CrCl <35 mL/min). Not to be used during pregnancy & lactation. Not to be used in childn.
Adverse Reactions
Hypersensitivity reactions including urticaria, myalgia, malaise, asthenia; nausea, vomiting, esophagitis, esophageal erosions & ulcers; localized osteonecrosis of the jaw; bone, joint &/or muscle pain, joint swelling, low-energy femoral shaft fracture; dizziness, vertigo, dysgeusia; pruritus, alopecia.
Drug Interactions
Ca supplements, antacids & other oral medications may interfere in absorption (take after at least 1/2 hr). Impaired absorption of vit D w/ olestra, mineral oil, orlistat, bile sequestrants. Increased catabolism of vit D w/ anticonvulsants, cimetidine & thiazides. Risk of GI irritation w/ NSAIDs.
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
Fosavance tab
Packing/Price
2's (P1,080/pack)
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