KROMAFINA 4/MG FC TAB 10/FC TAB

Indications

Approved Uses

Prevention and treatment of nausea and vomiting associated with cancer chemotherapy; prevention and treatment of nausea and vomiting associated with radiotherapy; prevention and treatment of postoperative nausea and vomiting (PONV).

Dosage & Administration

Dosing by Condition

Chemotherapy-induced N/V (adults, oral): typically 8 mg 30 minutes before chemotherapy, then 8 mg 8 hours later, then 8 mg every 12 hours for 1-2 days (longer in some regimens per protocol). Highly emetogenic chemotherapy: some guidelines/labels allow a single 24 mg oral dose 30 minutes before chemotherapy (often with dexamethasone). Radiotherapy-induced N/V: 8 mg 1-2 hours before radiotherapy, then 8 mg every 8 hours for 1-2 days. PONV prophylaxis (oral): 16 mg 1 hour before anesthesia.

Initial Dose

8mg orally 30 minutes before chemotherapy or 16mg 1 hour before anesthesia

Maintenance Dose

8 mg every 12 hours for 1-2 days following chemotherapy.

Maximum Dose

Maximum oral daily dose is indication-dependent; for CINV the oral regimen may be up to 24 mg/day (e.g., 24 mg single dose for highly emetogenic chemotherapy). Avoid 32 mg single IV doses (QT risk); do not exceed 8 mg/day in severe hepatic impairment.

Children's Dosage

For moderately emetogenic chemotherapy: 4-11 years: 4 mg 30 min before chemotherapy, then 4 mg at 4 and 8 hours, then 4 mg three times a day for 1-2 days. 12-17 years: adult dosing (8 mg). No pediatric data for PONV.

Dose Adjustment Notes

Severe hepatic impairment (Child‑Pugh ≥10): total daily dose should not exceed 8 mg. No dosage adjustment is generally required in renal impairment.

How to Take

Swallow the 4 mg film‑coated tablet whole with water; may be taken with or without food. If used for prophylaxis, administer prior to the emetogenic trigger (e.g., before chemotherapy/radiotherapy or before anesthesia as directed).

Safety & Warnings

Contraindications

Hypersensitivity to ondansetron or other 5-HT3 antagonists, congenital long QT syndrome, concomitant use with apomorphine

Age Restriction

Oral ondansetron approved for children 4 to 11 years for moderately emetogenic chemotherapy-induced nausea/vomiting; 12-17 years same as adults. No experience in pediatrics for PONV or radiation-induced nausea/vomiting.

Special Populations

Children

For moderately emetogenic chemotherapy: 4-11 years: 4 mg 30 min before chemotherapy, then 4 mg at 4 and 8 hours, then 4 mg three times a day for 1-2 days. 12-17 years: adult dosing (8 mg). No pediatric data for PONV.

Elderly

Standard adult dosing; however, monitor for QT prolongation as elderly patients may have increased cardiac risk

Kidney Impairment

No adjustment needed.

Liver Impairment

Severe hepatic impairment (Child‑Pugh C): maximum total daily dose 8 mg; mild-moderate impairment: no adjustment usually required.

Product Information

Available Dosage Forms

Ondansetron is available (by product line/market) as film‑coated tablets, orally disintegrating tablets, oral solution, and injection (IV/IM).

Composition per Dose

Each film-coated tablet: 4mg ondansetron (as ondansetron hydrochloride dihydrate)

Generic Availability

Yes

Gi Condition

Nausea/Vomiting

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