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Indications

Ondansetron is a 5-HT3 receptor antagonist indicated for:
  • Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy.
  • Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
  • Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to abdomen, or daily fractions to the abdomen.
  • Prevention of postoperative nausea and/or vomiting.

Description

Ondansetron oral soluble film is a orally dissolving film designed to be applied on top of the tongue where it will dissolve within 20 seconds and then is swallowed with saliva. Onsaf does not require water to aid dissolution or swallowing. The active ingredient in this preparation is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. The empirical formula is C18H19N3O representing a molecular weight of 293.3.

Pharmacology

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

Dosage

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
  • Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
  • Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
  • Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
  • Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
  • Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

Administration

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Interaction

Apomorphine-profound hypotension and loss of consciousness.

Contraindications

Concomitant use of apomorphine. Hypersensitivity to ondansetron.

Side Effects

The most common adverse drug events (a 5%) in chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting trials were: headache, malaise/fatigue, constipation, and diarrhea. The most common adverse event (&5%) in postoperative nausea and vomiting trials was a headache.

Precautions & Warnings

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting

Use in Special Populations

Pediatrics: The safety and effectiveness in pediatric patients have only been established for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in patients four years of age and older.

Impaired Hepatic Function: In severe hepatic impairment (Child-Pugh score of 10 or greater) 2, a total daily dose of 8 mg should not be exceeded.

Therapeutic Class

Anti-emetic drugs

Storage Conditions

Store at controlled room temperature 20° to 25°C. Store pouches in cartons. Keep product in pouch until ready to use.