Aclasta

Aclasta5mg/100ml

Type:100ml bot

Generic Name:Zoledronic Acid 5mg

Manufacturer:Novartis (Bangladesh) Ltd.

Price:38190.00

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Indication

Paget's disease of bone, Postmenopausal osteoporosis, Corticosteroid-induced osteoporosis

Administration

Reconstitute powder with 5 mL SWI; once powder is fully dissolved, dilute further in 100 mL NS or D5W before administering

Adult Dose

Paget's disease of bone Adult: 5 mg as a single infusion over 15 min. Patients should receive elemental Ca 1,500 mg and vit D 800 IU daily particularly w/in 2 wk after admin. Patients who have relapsed: May be given an additional infusion of 5 mg after an interval of at least 1 yr from the initial dose. Osteoporosis in postmenopausal women; Increase bone mass in men with osteoporosis; Corticosteroid-induced osteoporosis Adult: 5 mg as a single infusion over at least 15 min, once yrly, w/ adequate Ca and vit D intake. Patients w/ low-trauma hip fracture: Start 2 or more wk after hip fracture repair w/ a loading dose of vit D 50,000-125,000 IU given orally or by IM route prior to 1st infusion. Prophylaxis of postmenopausal osteoporosis Adult: 5 mg as a single infusion once every 2 yr. Hepatic impairment Safety and efficacy not established

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment CrCl >35 mL/min: No adjustment needed CrCl <35 mL/min: Contraindicated

Contraindication

The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.

Mode of Action

Zoledronic acid, an aminobiphosphonate, is a potent inhibitor of bone resorption. It inhibits osteoclastic activity and skeletal calcium release caused by tumours.

Precaution

Patient w/ aspirin-sensitive asthma. Mild to moderate renal impairment. Pregnancy. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Adequately hydrate patients prior to admin. Ensure adequate Ca and vit D intake. Monitoring Parameters Monitor serum Ca, Mg, phosphate and electrolytes; haematocrit/Hb (oncology use); biochemical markers of bone turnover (non-oncology use). Prior to therapy, perform dental exam and preventive dentistry in patients at risk of osteonecrosis. Lactation: Unknown whether drug crosses into breast milk; avoid using

Side Effect

Arthralgia, fever, flu-like symptoms, myalgia, headache, pain in extremity, nausea, vomiting, diarrhoea, eye inflammation; alopecia, hyperhidrosis, bone/joint/muscle pain, osteonecrosis of the jaw, femoral fracture, hypersensitivity reactions (e.g. urticaria, angioedema), Stevens-Johnson syndrome, toxic epidermal necrolysis, hypotension. Potentially Fatal: Severe hypocalcaemia, severe kidney problems.

Interaction

Increased risk of hypocalcaemia with aminoglycosides and loop diuretics. Increased risk renal dysfunction with nephrotoxic agents.

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