Zofra 4 mg/5 ml (Oral Solution)
Medicine Details
| Category | Details |
|---|---|
| Generic | Ondansetron |
| Company | Eskayef pharmaceuticals ltd |
| Also available as |
Indications
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy
- Prevention and treatment of post-operative nausea and vomiting
- Prevention of radiotherapy-induced nausea and vomiting
Description
Zofra 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. Oral soluble film does not require water to aid dissolution or swallowing. The active ingredient in Zofra is Zofra base, the racemic form of Zofra, 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...
Dosage
- Recommended dosages for adults undergoing different types of chemotherapy-induced nausea and vomiting
- Recommended dosages for adults undergoing radiotherapy-induced nausea and vomiting
- Recommended dosages for adults with postoperative nausea and vomiting
- Dosage adjustments for pediatric patients
- Recommended dosages for oral solution and oral soluble film
Administration
Administration of Oral Soluble Film: Tear the pouch carefully along with the edge tear mark. Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds. Do not chew or swallow the film whole. Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid. Wash your hands after taking Onsaf oral soluble film
Interaction
Zofra does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver...
Contraindications
Contraindicated in patients known to have hypersensitivity to the drug or any of its components...
Side Effects
- Frequently reported adverse events such as headache, constipation, and diarrhea
- Rare cases of anaphylaxis, bronchospasm, tachycardia, angina, and hypokalemia
Pregnancy & Lactation
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron...
Precautions & Warnings
- Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists
- Zofra should not be used instead of nasogastric suction
Use in Special Populations
- Dosage Adjustment for Patients With Impaired Renal Function
- Dosage Adjustment for Patients With Impaired Hepatic Function
- Dosage in pediatric patients 4 years of age or younger
- Dosage adjustment in patients over the age of 65
Therapeutic Class
Anti-emetic drugs
Storage Conditions
Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture.