Uromitexan, Oplossing Voor Injectie

Uses

Uromitexan, Oplossing Voor Injectie is a cytoprotective agent used as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Dosage

Uromitexan, Oplossing Voor Injectie dosage

Intravenous-Prophylaxis against urothelial toxicity:

• Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall. Administered either by short (15-30 minutes) or continuous (24 hr) infusion.
• Child: Refer to individual and local protocol. Has been used in children >4 mth.

Oral-Prophylaxis against urothelial toxicity:

• Adult: Refer to individual and local protocol. Dose calculated according to cytotoxic dose. Normally given at a dose ≥cytotoxic dose. Duration of treatment should be as long as cytotoxic treatment; plus the time it takes for concentration of antineoplastic metabolites in urine to fall.
• Child: Refer to individual and local protocol.

Dilute in 50-1000 ml normal saline, 5% dextrose or lactated Ringer's.

Side Effects

Nausea, vomiting, colic, diarrhoea, anorexia, dyspepsia, unpleasant taste, constipation; headache, malaise, fatigue, depression, irritability, somnolence, hyperaesthesia, dizziness, confusion; rash, pruritus, generalised urticaria, alopecia, inj site reactions, flushing; leucopenia, thrombocytopenia, anaemia, granulocytopenia, chest pain, oedema (peripheral, facial and periorbital), hypotension, tachycardia, hypertension, increased heart rate, ST-segment elevation; dyspnoea, coughing, pneumonia, tachypnea; fever; hypocalcaemia; increased sweating; back pain, limb pain, myalgia; increased hepatic enzyme concentrations; pharyngitis; ulceration of mucous membranes. In patients receiving oral and/or IV mesna and were specifically not treated with concurrent cytotoxic therapy: flatulence; rhinitis; rigors; back pain; rash; conjunctivitis; arthralgia. Inhalation: bronchospasm.

Precaution

Protective effect applies only to the urinary tract; pregnancy, lactation. Patients with auto-immune disorders. IV formulation may contain benzyl alcohol as a preservative; avoid in neonates or infants. Instruct patients to seek medical attention if discolouration of urine occurs. During treatment, monitor urine for erythrocytes and haematuria. Maintain adequate hydration in all patients. Patients who vomit within 2 hr of oral dose should repeat dose or receive IV dose.

Uromitexan, Oplossing Voor Injectie Disease Interaction

Major: prematurity, autoimmune disorders

Pregnancy & Breastfeeding use

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Contraindication

Hypersensitivity to thiol-containing compounds.

Storage Condition

Should be stored at 15-30° C.

Innovators Monograph

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