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Avona (Ondansetron)
Avona (Ondansetron)

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.

Indication

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 high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting.

Dosage And Administration

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.

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.