Fosamax/Fosamax Plus每週福善美/ 福善美加

Fosamax/Fosamax Plus

alendronic acid

alendronic acid + colecalciferol

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Fosamax Alendronate Na. Fosamax Plus Per 70 mg/2,800 IU Alendronate Na 70 mg, colecalciferol 2,800 IU. Per 70 mg/5,600 IU Alendronate Na 70 mg, colecalciferol 5,600 IU
Indications/Uses
Osteoporosis in postmenopausal women & in men.
Administration
Should be taken on an empty stomach: Take at least 30 min before the 1st food, drink or medication of the day, w/ a full glass of plain water only & remain in sitting/upright position for at least 30 min. Do not take at bedtime or before arising for the day. Swallow whole, do not chew/crush. Failure to follow these instructions may increase the risk of oesophageal adverse experiences. Take Ca & vit D supplements if dietary intake is inadequate.
Contraindications
Hypersensitivity. Abnormalities of the esophagus eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min. Hypocalcemia. Renal insufficiency w/ CrCl <0.58 mL/sec (<35 mL/min).
Special Precautions
Discontinue use in case of symptoms of esophageal disease (eg, difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn). Risk of osteonecrosis of the jaw; osteonecrosis of the external auditory canal; severe & occasionally incapacitating bone, joint, &/or muscle pain; symptomatic hypocalcemia; ocular disturbances including conjunctivitis, uveitis, episcleritis & scleritis. Treatment interruption should be considered in patients w/ stress fractures. Hypocalcemia & other disorders affecting mineral metabolism must be corrected before initiating therapy. May cause local irritation of the upper GI mucosa. Exercise caution in patients w/ active upper GI problems eg, dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers. May affect ability to drive or operate machinery. Pregnancy & lactation. Patients <18 yr. Fosamax Plus Should not be used to treat vit D deficiency.
Adverse Reactions
Abdominal pain, dyspepsia, acid regurgitation, nausea, abdominal distention, constipation, flatulence, gastritis, gastric ulcer; musculoskeletal pain, muscle cramp.
Drug Interactions
Reduced absorption & effectiveness w/ food & beverages; herbal products. Alendronate Na: Interference in absorption w/ Ca supplements, antacid, other multivalent cations & other oral medications. Doubled bioavailability w/ ranitidine IV. Use w/ caution when co-administered w/ NSAIDs. Colecalciferol: Impaired absorption w/ olestra, mineral oils, orlistat, & bile acid sequestrants (eg, cholestyramine, colestipol). Increased catabolism w/ anticonvulsants, cimetidine, & thiazides.
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
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/2,800 IU tab
Packing/Price
4's
Form
Fosamax Plus 70 mg/5,600 IU tab
Packing/Price
4's
Form
Fosamax tab 70 mg
Packing/Price
4's
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