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DESFERAL

DESFERRIOXAMINE MESYLATE · by NOVARTIS

Composition

Inj 250 mg/500 mg: Desferrioxamine Mesylate 250 mg/500 mg; powder in vial Tab 125 mg/250 mg/500 mg: Desferrioxamine Mesylate 125 mg/250 mg/500 mg

Indications & Dosage

Acute iron poisoning, haemochromatosis, Aluminium overload in dialysis patients: Adults & Children: See literature.

Administration

Administration only under the supervision of expert medical practitioners; IM is the preferred route for the treatment of acute iron intoxication, for all patients not in shock. The rate of IV infusion should not exceed 15 mg/kg/h for the first 1 gm administered. Subsequent IV dosing, if needed, must be at a slower rate, not to exceed 125 mg/hr

Stability

Do not store above 25C (77F). Use the product immediately after reconstitution (commencement of treatment within 3 hours) for microbiological safety. When recon-stitution is carried out under validated aseptic conditions (in a sterile laminar flow hood using aseptic technique), the product may be stored at room temperature for a maximum period of 24 hours before use. Do not refrigerate reconstituted solution.

Contraindications

Hypersensitivity to desferrioxamine.

Precautions

Iron overload increases susceptibility to infections with Yersinia enterocolitica and Yersinia pseudotuberculosis. In patients undergoing haemodialysis while receiving Desferal, mucormycosis have been reported. Pregnancy & lactation, elderly, history of liver cirrhosis, not recommended in conditions which may reduce life expectancy such as high-risk myelodysplastic syndromes, platelet count less than 50x109/litre, risk of GI ulceration and haemorrhage, unexplained cytopenia; discontinue treatment, severe renal failure or anuria (in non-dialysed patients). May produce seizures in patients with aluminium-related encephalopathy; pretreat with clonazepam.

Interactions

Prochlorperazine, erythropoietin

Side Effects

Abdominal distension and pain, headache, constipation, diarrhoea, dyspepsia, GI haemorrhage and ulceration, nausea, vomiting, proteinuria, pruritus, raised serum creatinine, raised transaminases, rash, anxiety, cataract, cholelithiasis, disturbances of hearing and vision, dizziness, fatigue, gastritis, glucosuria, hepatitis, laryngeal pain, maculopathy, oedema, pyrexia, renal tubulopathy, skin pigmentation, sleep disorder. Rare: Oesophagitis, optic neuritis