COMPOSITION :
Ondansetron HCl Dihydrate Syrup 4 mg/5 ml, each 5 ml contains : Ondansetron HCl dihydrate equivalent to Ondansetron 4 mg.
DESCRIPTIONS :
Ondansetron HCl Dihydrate contains Ondansetron HCl dihydrate (equivalent to Ondansetron) available in 4 mg/5 ml syrup.
INDICATIONS :
Management of nausea and vomiting due to chemotherapy and radiotherapy as well as surgery.
DOSAGE AND ADMINISTRATIONS :
- Adult
- Highly emetogenic chemotherapy administration, e.g., Cisplatin : At first give Ondansetron injection 8 mg should be administered as a slow intravenous injection or infusion for 15 minutes immediately before chemotherapy, followed by continuous infusion of Ondansetron 1 mg/hour for less than 24 hours or 2 injection 8 mg by slow intravenous or infusion for 15 minutes with an interval of 4 hours, or may be followed by administration of 8 mg orally every 12 hours for 5 days.
- Less emetogenic chemotherapy administration, e.g., Cyclophosphamide, Doxorubicin, Carboplastin : Administer Ondansetron 8 mg as a intravenous injection slowly or infused for 15 minutes immediately before chemotherapy, or administer Ondansetron 8 mg orally 1 – 2 hours before chemotherapy, followed by 8 mg orally every 12 hours for 5 days.
- Nausea and vomiting due to radiotherapy induction : Administer 8 mg Ondansetron orally for 12 hours. The first dose should be administered 1 – 2 hours before radiotherapy. The duration of treatment depends on the duration of radiotherapy.
- Children : The information is limited, but Ondansetron is effective and well tolerated by children over 4 years old of age when administered intravenously at a dose of 5 mg/m2 for 15 minutes, immediately before chemotherapy, followed by administration of 4 mg orally every 12 hours for 5 days.
- Elderly : Ondansetron is well tolerated in patients over 65 years without change the dosage, frequency or route of administration.
- Patients with impaired renal function : Does not require daily dose adjustment, frequency or route of administration.
- Patients with impaired liver function : Clearance time of Ondansetron is reduced significantly and serum half-life increased significantly in patients with moderate or severe liver function impairment. In some patients, total daily dose should not exceed 8 mg.
OVERDOSAGE :
There is no specific antidote.
Little is present known about overdosage with Ondasetron. However, two patients who received doses of 84 mg and 145 mg intravenously reported only mild side effects and required no active therapy. In cases of suspected overdoses, symptomatic and supportive therapy should be given as appropriate.
CONTRAINDICATIONS :
Hypersensitive to Ondansetron.
WARNINGS AND PRECAUTIONS :
- Pregnancy : Ondansetron is not teratogenic. There is no studies in humans. As with other medicines, Ondansetron should not be used during pregnancy, especially during the 1st trimester, unless the benefit to the patient bigger than any possible risk may occur.
- Lactation woman : Test have shown that Ondansetron is excreted in the breast milk of rats. Therefore, it is recommended that mothers receiving Ondansetron should not breast-feed their babies.
ADVERSE REACTIONS :
- The following side effects may occur : Headache, a sensation of flushing or warmth in the head and epigastrium.
- Rare and temporary side effect is asymptomatic increases in aminotransferases.
- Ondansetron is may increase transit time in colon and may cause constipation in some patients.
- There are some reports of immediate hypersensitivity reactions.
PRESENTATION :
Ondansetron HCl Dihydrate Syrup 4 mg/5 ml Box, bottle @ 60 ml
Reg. No. GKL1902359837A1
STORAGE :
STORE BELOW 30ºC
Ondansetron HCl Dihydrate can only be used for 6 days after the packaging is opened.
ON MEDICAL PRESCRIPTION ONLY
SHAKE WELL BEFORE USE
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
