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Avona
Ondansetron
 Avona

AVONA 4 Tablet: Each tablet contains Ondansetron Hydrochloride USP equivalent to 4 mg Ondansetron.
AVONA 8 Tablet: Each film coated tablet contains Ondansetron Hydrochloride USP equivalent to 8 mg Ondansetron.
AVONA 4 ml IM/IV Injection: Each 4 ml ampoule contains Ondansetron Hydrochloride USP equivalent to 8 mg Ondansetron.
AVONA Oral Solution : Each 5 ml contains Ondansetron Hydrochloride USP equivalent to 4 mg Ondansetron.

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Pharmacology/Description

Ondansetron is a selective serotonin 5-HT3 receptor antagonist. The antiemetic activity of the drug is brought about through the inhibition of 5-HT3 receptors present both centrally (medullary chemoreceptor zone) and peripherally (GI tract). This inhibition of 5-HT3 receptors in turn inhibits the visceral afferent stimulation of the vomiting center, likely indirectly at the level of the area postrema, as well as through direct inhibition of serotonin activity within the area postrema and the chemoreceptor trigger zone.

Indications

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin >50 mg/m2.
2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single highdose
fraction to the abdomen, or daily fractions to the abdomen.
4. Prevention of postoperative nausea and/or vomiting.

Dosage And Administration

Instructions for Use/Handling AVONA Fast Dissolving Tablets:

Do not attempt to push AVONA tablets through the foil backing. With dry hands, peel back the foil backing of 1 blister and gently remove the tablet. Immediately place the AVONA FT tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

Prevention of Nausea and Vomiting associated with Chemotherapy

Age

category


Parenteral


Oral Tablet


Oral Solution

 

 

 

Adults/ Geriatric

/Child of 12

years or over


Initial and Repeat Courses of Emetogenic Chemotherapy: AVONA injection should be diluted in 50 ml of 5% Dextrose injection or 0.9% Sodium Chloride injection before administration. Single 32 mg dose or three 0.15 mg/kg doses infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of AVONA.


Highly Emetogenic Cancer Chemotherapy:

24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin >50 mg/m2

 

Moderately Emetogenic Cancer Chemotherapy:

8 mg AVONA tablet given twice a day. The first dose should be administered 30 minutes before the emetogenic chemotherapy.


Moderately Emetogenic Cancer Chemotherapy:

10 ml (2 teaspoonfuls equivalent to  8 mg of Ondansetron) of AVONA oral solution given as thrice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours  after the first dose. 10 ml of AVONA oral solution  should  be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

 

 

 

 

 

Pediatrics


Moderately to Highly Emetogenic chemotherapy:

6 months onwards: three 0.15 mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of AVONA. The drug should be infused intravenously over 15 minutes.


Highly Emetogenic Cancer Chemotherapy: There is no experience with the use of     a 24 mg dosage in pediatric patients.

Moderately Emetogenic Cancer Chemotherapy:

4-11 years: one 4 mg AVONA FT tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg AVONA FT tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.


Moderately Emetogenic Cancer Chemotherapy:

4-11 years: 5 ml (1 teaspoonful equivalent to 4 mg of Ondansetron) of AVONA oral solution given 3 times a day. The first dose should be administered 30 minutes

before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. 5 ml of AVONA oral solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.


Prevention of Nausea and Vomiting associated with Radiotherapy


Age

category


Oral Tablet


Oral Solution

 


The recommended oral dosage is one 8 mg AVONA tablet three times a day.


The recommended oral dosage is 10 ml (2 teaspoonfuls equivalent to 8 mg of Ondansetron) oral solution given 3 times a day.

 

Adults/ Geriatric/ Child of 12 years or over


For total body irradiation: One 8 mg AVONA tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

 

For single high-dose fraction radiotherapy to the abdomen: One 8 mg AVONA tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.


 

For total body irradiation: 10 ml (2 teaspoonfuls equivalent to 8 mg of Ondansetron) of AVONA oral solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

 

For single high-dose fraction radiotherapy to the abdomen: 10 ml (2 teaspoonfuls equivalent to 8 mg of Ondansetron) of AVONA oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

 


For daily fractionated radiotherapy to the abdomen: One 8 mg AVONA tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.


 

For daily fractionated radiotherapy to the abdomen: 10 ml (2 teaspoonfuls equivalent to 8 mg of ondansetron) of AVONA oral solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting:


Parenteral

Oral Tablet

Oral Solution

 

&

& Population

&

&         Age

AVONA&

Injection Dosage &

Intravenous Infusion Dosage

& Adults &

> 12 yrs &

4 mg x 1&

Over 2 - 5 min

& Pediatrics (>40 kg)&

1 month-12 yrs &

4 mg x 1&

Over 2 - 5 min

& Pediatrics (<40 kg)

& 1 month-12 yrs &

0.1 mg/kg x 1&

Over 2 - 5 min

 

16 mg given as two 8mg AVONA

tablets 1 hour before induction of anesthesia.

20 ml (4 teaspoonfuls equivalent to 16 mg of ondansetron) of AVONA

oral solution 1 hour before induction of anesthesia.

*For Adults Undiluted 4 mg intravenously or intramuscularly immediately before induction of anesthesia but the administration rate should be over 2-5 minutes.

 

 

Alternatively, the dose can be administered postoperatively if the patient experiences nausea and/or vomiting shortly after surgery.

 

 

* For Pediatrics The dose should be immediately before induction of anesthesia but the administration rate should be over 2-5 minutes.

 

 

Alternatively, the dose can be administered postoperatively if the patient experiences nausea and/or vomiting shortly after surgery.

 

 


Side Effects

Frequently reported adverse events were headache, constipation and diarrhea, but the majority has been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extra pyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence.

Contraindications

AVONA tablets and injections are contraindicated for patients known to have hypersensitivity to the drug.Concomitant use of apomorphine.

Drug Interactions

The following drugs should be used with caution when concomitantly used with Ondensetron: Phenytoin, Carbamazepine, Rifampicin & Tramadol.

Precautions

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

Over Dosage

There is no specific antidote for Ondansetron overdose. In addition to the adverse events, hypotension (and faintness) occurred in a patient that took 48 mg of AVONA tablets. In all instances, the events resolved completely.

Pharmaceutical Precautions

Store in a cool and dry place below 30ºC. Protect from light and moisture. Keep out of reach of children.

Commercial Pack

AVONA 4 Tablet: Each box contains 3X10 tablet in Alu-Alu blister pack.
AVONA 8 Tablet : Each box contains 3X10 tablet in Alu-PVdC blister pack.
AVONA 4 ml IM/IV Injection : Each box contains 1X5 ampoules in Alu-PVC blister pack.
AVONA Oral Solution: Box contains 1 bottle of 50 ml oral solution.