KROMAFINA 4/MG/5/ML ORAL SOLUTION 50ML

Indications

Approved Uses

Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy; prevention of nausea and vomiting associated with radiotherapy; prevention of postoperative nausea and vomiting.

Off-Label Uses

Nausea/vomiting of pregnancy (including hyperemesis gravidarum), gastroenteritis-associated vomiting, cyclic vomiting syndrome, opioid-induced nausea/vomiting.

Dosage & Administration

Dosing by Condition

Chemotherapy-induced N/V (adults): 8 mg PO 30 minutes before chemotherapy, then 8 mg PO 8 hours later, then 8 mg PO every 12 hours for 1-2 days (some regimens extend longer depending on protocol); Highly emetogenic chemotherapy (adults): 24 mg PO once 30 minutes before chemotherapy (typically with dexamethasone); Radiotherapy-induced N/V (adults): 8 mg PO 1-2 hours before radiotherapy, then 8 mg PO every 8 hours on treatment days; Postoperative N/V prophylaxis (adults): 16 mg PO 1 hour before anesthesia induction.

Initial Dose

8 mg orally 30 minutes before chemotherapy or 1-2 hours before radiotherapy

Maintenance Dose

8 mg every 8-12 hours for up to 5 days following chemotherapy or radiotherapy

Maximum Dose

Oral: up to 24 mg/day for CINV (e.g., 24 mg single dose for highly emetogenic chemotherapy regimens); avoid 32 mg/day dosing (historically used) due to QT risk; severe hepatic impairment: max 8 mg/day.

Children's Dosage

For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron (5 mL of 0.8 mg/mL oral solution) given 3 times a day. For pediatric patients 12 years and older, same as adult dosing.

Dose Adjustment Notes

Renal impairment: no dosage adjustment required; severe hepatic impairment (Child-Pugh ≥10 / Child-Pugh C): total daily dose should not exceed 8 mg.

How to Take

Measure the prescribed dose with an oral syringe or calibrated measuring device (not a household spoon); may be taken with or without food; take at the scheduled time relative to the indication (e.g., before chemotherapy/radiotherapy or prior to anesthesia as directed).

Side Effects

Common Side Effects

Headache, constipation, diarrhea, dizziness, fatigue/malaise.

Safety & Warnings

Age Restriction

Oral ondansetron: generally approved/used in children ≥4 years for chemotherapy-induced nausea/vomiting; younger pediatric use (including infants) is primarily supported/approved for IV formulations (e.g., ≥6 months for CINV) and is off-label for oral in many labels.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Apomorphine (contraindicated); other QT‑prolonging drugs (additive QT risk); serotonergic drugs (serotonin syndrome risk); strong CYP3A4 inducers such as phenytoin, carbamazepine, rifampicin (reduced ondansetron exposure/efficacy).

Food Interaction

No restriction.

Special Populations

Breastfeeding

Caution

Children

For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron (5 mL of 0.8 mg/mL oral solution) given 3 times a day. For pediatric patients 12 years and older, same as adult dosing.

Elderly

Standard adult dosing; however, use with caution due to increased risk of QT prolongation. Monitor ECG in elderly patients with cardiac risk factors

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild-moderate hepatic impairment: no adjustment; severe hepatic impairment (Child‑Pugh ≥10): do not exceed total 8 mg/day.

Pharmacology

Mechanism of Action

Selective 5-HT3 receptor antagonist acting peripherally on vagal afferent nerve terminals in the GI tract and centrally in the chemoreceptor trigger zone to prevent nausea and vomiting.

Half-Life

Approximately 3-6 hours in adults (may be prolonged in elderly and hepatic impairment).

Bioavailability

Approximately 60%.

Metabolism

Extensive hepatic metabolism via CYP3A4, CYP2D6, and CYP1A2 (with subsequent conjugation).

Product Information

Available Dosage Forms

Oral solution, tablet, orally disintegrating tablet, intravenous/intramuscular injection

Composition per Dose

Each 5 ml: 4 mg ondansetron (as ondansetron hydrochloride dihydrate)

Generic Availability

Yes

Gi Condition

Nausea/Vomiting

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