VOMCERAN - KALBE FARMA

Vomceron is a product of Kalbe Farma Indonesia. 

Composition :

Each film coated tablet contains :

* Ondansetron hydrocloride dihydrate equivalent to Ondansetron --------- 4 mg
* Ondansetron hydrocloride dihydrate equivalent to Ondansetron --------- 8 mg

Each mL of injection contains :

* Ondansetron hydrocloride dihydrate equivalent to Ondansetron --------- 2 mg

Pharmacology :

Ondansetron is a highly selective and competitive 5HT3 receptor antagonist, which inhibits nausea and vomiting caused by cytotoxic agents and radiation.

Indications:

For oral :

The management of nausea and vomiting associated with the treatment of cancer by chemotherapy and radiotherapy and for prevention of post-operative nausea and/or vomiting.

For injection :

The management of nausea and vomiting associated with the treatment of cancer by chemotherapy and radiotherapy and for treatment of post-operative nausea and/or vomiting.

Contraindications :

Ondansetron is contraindicated for patients known to have hypersensitivity to the drug.

Warning and precautions :

Ondansetron should not be used during pregnacy especially during the first trimester, unless the expected benefit to the patient is thought to out weight and possible risk to the fetus. Test have shown that ondansetron is excreted in the breast milk of rats. it is therefore recommended that mothers recieving ondansetron should not breast feed their babies.

Adverse reactions :

Headache, constipation, hot flushing in the head and epigastria, sedation and diarrhea.

Dosage and Administration :

For prevention of post-operative nausea and vomiting :

Initial dose : 8 mg tablet, given 1 hour before anaesthesia, followed by 8 mg tablet every 8 hours for up to 16 hours.

For treatment of post-operative nausea and vomiting :

A single dose of 4 mg intramuscular injection or slow intravenous injection.

For nausea and vomiting of chemotherapy :

Adult :

• For highly emetogenic chemotherapy (ex. cisplatin). Single dose of 8 mg by slow i.v. injection or 15 minutes infusion immediately before chemotherapy, followed by a constant infusion of 1 mg/hour for up to 24 hours or by two further doses of 8 mg slow intravenous injection or 15 minutes infusion four hour apart. Either regimen is then followed by 8 mg orally every 12 hours for up to 5 days.
• For less emetogenic chemotherapy ( ex. cyclophosphamide ). 8 mg slow i.v. injection or 15 minutes infusion immediately before chemotherapy may be given, followed by 8 mg orally every 12 hours for up to 5 days.

Children > 4 years old :

5 mg/mL intravenously over 15 minutes immediately before chemotherapy, followed by 4 mg orally 12-hourly for up to 5 days.

For nausea and vomiting of radiotherapy :

8 mg tablet 8-hourly comencing 1-2 hour prior to the first fraction of radiotherapy. The course of the therapy depend on the duration of radiotherapy.

Elderly :

Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.

Patients with renal impairment :

No alteration of daily dosage or frequency of dosing, or route of administration

Patients with hepatic impairment :

In such patients a total daily dose of 8 mg should no be exceeded.

ON MEDICAL PRESCRIPTION ONLY