KROMAFINA 8/MG FC TAB 10/FC TAB

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/or vomiting (PONV).

Dosage & Administration

Dosing by Condition

Chemotherapy-induced N/V (oral): 8 mg 30 minutes before chemotherapy, then 8 mg 8 hours later; thereafter 8 mg every 12 hours for 1-2 days (moderately emetogenic). Highly emetogenic chemotherapy: 24 mg orally 30 minutes before chemotherapy (often with dexamethasone per antiemetic guidelines). Radiotherapy-induced N/V: 8 mg 1-2 hours before radiotherapy, then 8 mg every 8 hours during treatment (and for 1-2 days after completion as needed). PONV prophylaxis (oral): 16 mg 1 hour before induction of anesthesia.

Initial Dose

8 mg orally 30 minutes before moderately emetogenic chemotherapy.

Maintenance Dose

8 mg every 12 hours (twice daily) for 1 to 2 days after completion of chemotherapy or radiotherapy

Maximum Dose

Adults: up to 24 mg as a single oral dose for highly emetogenic chemotherapy; total daily oral dose commonly should not exceed 32 mg (and in severe hepatic impairment max 8 mg/day).

Children's Dosage

4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4 mg dose 4 and 8 hours after the first dose. Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy. 12 to 17 years of age: 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose. Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Dose Adjustment Notes

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

How to Take

Swallow the 8 mg film‑coated tablet whole with water; may be taken with or without food. For chemotherapy-induced nausea/vomiting prophylaxis, administer about 30 minutes before chemotherapy (per standard ondansetron oral regimens).

Safety & Warnings

Age Restriction

Oral ondansetron (film‑coated tablet) is generally used/approved in children ≥4 years for CINV; not recommended for infants <6 months for oral tablet use (IV formulations may be used from ~1 month for specific indications).

Special Populations

Children

4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4 mg dose 4 and 8 hours after the first dose. Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy. 12 to 17 years of age: 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose. Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Elderly

Standard adult dosing; however, monitor for QT prolongation and electrolyte imbalances as elderly patients may be at higher risk

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.

Product Information

Available Dosage Forms

For ondansetron (active ingredient): film‑coated tablet; orally disintegrating tablet (ODT); oral solution; injectable solution (IV).

Composition per Dose

Each film-coated tablet: 8mg ondansetron (as ondansetron hydrochloride dihydrate)

Generic Availability

Yes

Gi Condition

Nausea/Vomiting

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