Aldren 70

Aldren 70

alendronic acid

Manufacturer:

Zydus Healthcare

Distributor:

Zydus Healthcare
Concise Prescribing Info
Contents
Alendronate Na
Indications/Uses
Treatment & prevention of osteoporosis in postmenopausal women. Treatment to increase bone mass in men w/ osteoporosis; glucocorticoid-induced osteoporosis in men & women receiving glucocorticoids in a daily dose equiv ≥7.5 mg prednisone & who have low bone mineral density; Paget's disease of bone in men & women.
Dosage/Direction for Use
Treatment of osteoporosis in postmenopausal women 70 mg once wkly or 10 mg once daily. Treatment to increase bone mass in men w/ osteoporosis 10 mg once daily. Prevention of osteoporosis in postmenopausal women 35 mg once wkly or 5 mg once daily. Treatment of glucocorticoid-induced osteoporosis in men & women 5 mg once daily; postmenopausal women not receiving estrogen 10 mg once daily. Paget's disease of bone in men & women 40 mg once daily for 6 mth.
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. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Abnormalities of the esophagus which delay esophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min. Hypocalcemia.
Special Precautions
Not to be taken at bedtime or before arising for the day. May cause local irritation of upper GI mucosa. Reports of esophagitis, esophageal ulcers & erosions, bleeding (occasionally) & esophageal stricture (rarely). Discontinue use if dysphagia, odynophagia, retrosternal pain or new or worsening heartburn develop. Patients w/ active upper GI problems eg, dysphagia, esophageal diseases, gastritis, duodenitis or ulcers. Correct hypocalcemia & treat other disturbances of mineral metabolism (eg, vit D deficiency) prior to initiating therapy. Ensure adequate Ca & vit D intake in patients w/ Paget's disease of bone & those receiving glucocorticoids. Not recommended in patients w/ severe renal insufficiency (CrCl <35 mL/min). No studies in pregnant women; use in pregnancy only if potential benefit justifies potential risk to mother & fetus. Caution to nursing women. Safety & effectiveness in ped patients have not been established.
Adverse Reactions
Abdominal pain & distension, nausea, dyspepsia, constipation, diarrhea, flatulence, acid regurgitation, esophageal & gastric ulcer, vomiting, dysphagia, gastritis, melena; musculoskeletal (bone, muscle or joint) pain, muscle cramps; headache, dizziness; taste perversion.
Drug Interactions
Interfered absorption w/ Ca supplements, antacids, & some oral medications. Increased incidence of upper GI adverse events w/ aspirin-containing products. Caution in concomitant use w/ NSAIDs (associated w/ GI irritation). Doubled bioavailability w/ IV ranitidine.
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
Aldren 70 tab 70 mg
Packing/Price
4's (P225/tab)