Forosa

Forosa

alendronic acid

Manufacturer:

Lek Pharma

Distributor:

Sandoz
Concise Prescribing Info
Contents
Alendronic acid (as alendronate Na trihydrate)
Indications/Uses
Post-menopausal osteoporosis. Reduce risk of vertebral & hip fractures.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take w/ a full glass of plain water at least ½ hr before the 1st food/drink/medication of the day & remain in sitting/upright position for at least ½ hr. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Abnormalities of the oesophagus & other factors w/c delay oesophageal emptying (eg, stricture or achalasia), inability to stand or sit upright for at least 30 min, hypocalcaemia.
Special Precautions
Patients w/ active upper GI problems (eg, dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or w/ recent history (w/in the previous yr) of major GI disease (eg, peptic ulcer, or active GI bleeding, or surgery of upper GIT other than pyloroplasty). May increase risk of oesophageal problems. Osteonecrosis of the jaw associated w/ tooth extraction &/or local infection (including osteomyelitis); consider dental exam w/ preventive dentistry prior to treatment & avoid invasive dental procedures if possible. Severe &/or incapacitating bone, joint, &/or muscle pain. Atypical subtrochanteric & diaphyseal femoral fractures; consider discontinuation of therapy in patient presenting w/ an atypical femur fracture; may present pain in the thigh or groin. Severe skin reactions (including SJS & TEN). Missed dose should be taken the morning after the patient remembers. Correct pre-existing hypocalcemia prior to initiating therapy. Monitor Ca & disorders affecting mineral metabolism (eg, vit D deficiency & hypoparathyroidism). Decreased serum Ca & phosphate may occur especially in patients taking glucocorticoids. May affect the ability to drive & use machine. Not recommended for patients w/ renal impairment (CrCl <35 mL/min). Not to be used during pregnancy & lactation.
Adverse Reactions
Musculoskeletal (bone, muscle or joint) pain. Headache, dizziness; vertigo; abdominal pain/distension, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, acid regurgitation; alopecia, pruritus; joint swelling; asthenia, peripheral oedema.
Drug Interactions
Food & beverages (including mineral water), Ca supplements, antacids, & oral medicinal products may interfere w/ absorption. GI irritation w/ NSAID.
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
Forosa FC tab 70 mg
Packing/Price
2's
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