Information about Onfran
Composition:

 Each film coated tablet contains:

Ondansetron8 mg (as ondansetron hydrochloride dihydrate )

 Each 5 mL of Oral Solution contains:

Ondansetron

Indications:

Prevention and treatment of nausea and vomiting associated with chemotherapy, including high dose cisplatin, and radiotherapy.

Ondansetron is also indicated for the prevention and treatment of postoperative nausea and vomiting.

Contraindications:

In patients with a history of hyper sensitivity to the drug or any components of its formulations.

Side effect:

 Headache and constipation flushing or warmth.

Central nervoussystem: there have been rare reports of seizures convulsive.

Hypesensitivity:rare cases of immediate hyper sensitivity reactions sometimes severe, including anaphylaxis, chest pain, bradycardia, drop of blood hypertension.

Dermatological: rashhas occurred in approximately 1% of patients receiving ondansetron.

Some cases of occasional asymptomatic increases in liver function tests have been reported.

Overdosage :

For management of a suspected drug overdose you must contact your regional poison control center.

Dosage and administration:

Vomiting associated with Chemotherapy and radio therapy:

Adults:

The recommended adult oral dosage is one (8-mg) Onfran Tablet or 10 mL (2 teaspoonfuls) of OnfranOral Solution taken half an hour to two hours before treatment, followed by one(8-mg) Onfran Tablet or 10 mL (2 teaspoonfuls) of Onfran Oral Solution after 8 hours.

Followed by one (8 mg) Onfran Tablet or 10 mL (2 teaspoonfuls) of Onfran Oral Solution in the morning & the evening for 2 days after treatment.

For the treatment of post-operative nausea and vomiting:

Adults: 16 mg (Two 8 mg Onfran Tablets or 20 mL (4 teaspoonfuls) of Onfran Oral Solution) should begiven 1 hour before anesthesia.

Pediatric Use:

For pediatric patients 12 years of age and older, the dosage is the same as for adults.

For pediatric patients 4 through 11 years of age, the dosage is one 4-mg Onfran Tablet or 5mL (1 teaspoonful) of Onfran Oral Solution given 3 times a day. The first dose should be administered 30 minutes before the start of chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg Onfran Tablet or 5mL (1 teaspoonful) of Onfran Oral Solution should be administered every 8 hours for 1 to 2 days after completion of chemotherapy.

Prevention nausea and vomiting associated with high doses of chemotherapy:

The recommended adult oral dosage of Onfran is a single 24 mg dosage given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2.

Multi day,single dose administration of a 24 mg dosage of Onfran has not been studied.

There is no experience with the use of a 24 mg dosage of Onfran in pediatric patients.

The dosage recommendation for geriatric use is the same as for the general population.

Storage

Tablets : Should be stored between 15 - 30°C, protected from light and moisture.

Oral Solution : Should be stored between 15- 30°C, protected from light .

package :

Packs of 10 tablets.

Glass bottle of 100mL.