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OMOTIL

PALONOSETRON · by SURGE

ANTIEMETICS & ANTINAUSEANTS 5HT3-Receptor Antagonist SURGE

Composition

Inj per 5 ml: Palonosetron Hydrochloride 0.25 mg

Indications & Dosage

Moderate to severe emetogenic chemotherapy: BY IV INJ: Adult: 250 mcg to be administered over 30 seconds, given as a single dose, 30 minutes prior to chemotherapy. Children 1 month to adolescents: 20mcg/kg/dose IV (max: 1.5mg/dose) infused over 15 minutes as a single dose 30 minutes prior to chemotherapy. Chemotherapy-induced nausea/vomiting (CINV) prophylaxis associated with initial and repeat courses of emetogenic cancer chemotherapy: BY IV INJ: Adult: 250 mcg to be administered over 30 seconds, given as a single dose, 30 minutes prior to chemotherapy. Children 1 month to adolescents: 20mcg/kg/dose IV (max: 1.5mg/dose) infused over 15 minutes as a single dose 30 minutes prior to chemotherapy. For post-operative nausea/vomiting (PONV) prophylaxis for up to 24 hours after surgery: BY IV INJ: Adult: 0.075mg IV single dose administered over 10 seconds immediately before the induction of anesthesia. max. dose ranges that can be administered are given below: Adults: 0.25mg IV or 0.5mg PO as a single dose. Geriatric: 0.25mg IV or 0.5mg PO as a single dose. Adolescents: 20mcg/kg/dose IV (Max: 1.5mg/dose). Children: 20mcg/kg/dose IV (Max: 1.5mg/dose). Infants: 20mcg/kg/dose IV.

Precautions

Hepatic impairment, history of constipation, hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5HT3 receptor antagonists. susceptibility to QT-interval prolongation (including electrolyte disturbances) intestinal obstruction

Interactions

CYP2D6, CYP3A4 and CYP1A2 isoenzymes. Chemotherapeutic agents (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C), CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including metoclopramide, amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine), Corticosteroids, Analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products. Serotonergic Drugs (e.g. SSRIs and SNRIs)

Pregnancy

Avoid

Lactation

Avoid

Side Effects

Anorexia, headache, dizziness, constipation, diarrhea, abdominal pain, amblyopia, anxiety, arrhythmia, arthralgia, asthenia, atrioventricular block, bradycardia, changes in blood pressure, dry mouth, dyspepsia, dyspnea, electrolyte disturbance, euphoria, extrasystoles, flatulence, glycosuria, hyperglycaemia, influenza-like symptoms, insomnia, motion sickness, myalgia, myocardial ischaemia, peripheral neuropathy, serotonin syndrome tachycardia, tinnitus, urinary retention