ONDANSETRON injectable

Prescription under medical supervision


Therapeutic action

– Antiemetic (serotonin 5-HT3 receptor antagonist)

Indications

– Prevention of post-operative nausea and vomiting in children
– Treatment of post-operative nausea and vomiting

Forms and strengths, route of administration

– 4 mg ampoule (2 mg/ml, 2 ml) for slow IV injection (3 to 5 minutes)

Dosage and duration

Prevention of post-operative nausea and vomiting
Child over 1 month: 0.1 mg/kg at the end of surgery (max. 4 mg per injection)

Treatment of nausea and vomiting
• Child over 1 month:
    - no prophylactic dose of ondansetron received: 0.1 mg/kg every 8 hours if necessary
    - prophylactic dose of ondansetron received and late postoperative vomiting (≥ 6 hours after surgery): 0.1 mg/kg every 6 hours if necessary
    Do not exceed 4 mg per injection and 3 injections per 24 hours.
• Adult: 4 mg every 8 hours if necessary (max. 3 injections per 24 hours)

Contra-indications, adverse effects, precautions

– Do not administer to children less than 1 month of age.
– Administer with caution and monitor use in patients with congenital long QT syndrome, cardiac insufficiency and bradycardia.
– Reduce the dose in patients with hepatic failure (max. 8 mg daily).
– May cause: headache, sensation of flushing or warmth, hiccups, constipation, heart rhythm disorders, QT interval prolongation, extrapyramidal reactions, seizures, cutaneous allergic reactions (Lyell’s and Stevens-johnson syndromes).
– Avoid or monitor combination with:
• drugs that prolong the QT interval: amiodarone, bedaquilline, chloroquine, co-artemether, erythromycin, fluconazole, haloperidol, moxifloxacin, mefloquine, pentamidine, quinine, etc.;
• serotonergics: fluoxetine, paroxetine, tricyclic antidepressants, etc.;
• enzyme inducers: rifampicin, rifabutin, nevirapine, ritonavir, phenobarbital, phenytoin, carbamazepine, griseofulvin, etc. (efficacy of ondansetron reduced);
• tramadol (antalgic effect reduced).
Pregnancy: avoid during the first trimester; not recommended for nausea and vomiting of pregnancy
Breast-feeding: not recommended

Remarks

  Storage: below 25 °C -