Zoltero Solution For Infusion

Zoledronic Acid 5mg

5mg/100ml

Beximco Pharmaceuticals Ltd.

Pack size
Unite Price	7000 BDT

Indications

Zoltero Solution For Infusion is used for: Paget's disease of bone, Postmenopausal osteoporosis, Corticosteroid-induced osteoporosis

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

Administration

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

Contra Indications

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.

Precautions

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

Pregnancy-Lactation

Pregnancy There are no available data in pregnant women to inform the drug-associated risk Bisphosphonates are incorporated into bone matrix and are gradually released over periods of weeks to years; there may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy; advise pregnant women and females of reproductive potential of the potential risk to a fetus Verify pregnancy status of females of reproductive potential prior to initiation of therapy Therapy can cause fetal harm when administered to a pregnant woman; drug binds to bone long term and may be released over weeks to years; advise females of reproductive potential to use effective contraception during and after therapy Based on animal studies, therapy may impair fertility in females of reproductive potential Animal data Based on findings from animal studies and its mechanism of action, drug can cause fetal harm when administered to a pregnant woman; in animal reproduction studies, administration of drug to pregnant rats during organogenesis resulted in fetal malformations and embryo-fetal lethality at maternal exposures that were greater than or equal to 2.4 times the human clinical exposure based on AUC Lactation Not known whether drug is present in human milk, or whether it affects milk production, or breastfed child; drug binds to bone long term and may be released over weeks to years; because of potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during and after treatment

Interactions

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

Side Effects

Side effects of Zoledronic Acid 5mg : 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.

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.

Note

Zoltero 5mg/100ml Solution For Infusion generic name is Zoledronic Acid 5mg. Zoltero 5mg/100ml Solution For Infusion is manufactured by Beximco Pharmaceuticals Ltd.Zoltero is availble in all over Bangladesh. Mes BD drug index information on Zoltero Solution For Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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