Ofran 8

Indications

Ofran serves as a serotonin subtype 3 (5-HT3) receptor antagonist with the following indications:

• Prevention of nausea and vomiting linked with initial and subsequent rounds of emetogenic cancer chemotherapy.
• Prevention and management of post-operative nausea and vomiting.
• Prevention of nausea and vomiting induced by radiotherapy.

Description

Ofran oral soluble film is formulated for rapid dissolving on the tongue within 20 seconds, eliminating the need for water for swallowing. Its active ingredient, Ofran base, acts as a selective blocker of serotonin 5-HT3 receptors.

Pharmacology

Ondansetron, the active component of Ofran, functions as a potent and highly selective 5HT3 receptor antagonist. Its exact mechanism in controlling nausea and vomiting is not fully understood, but it is believed to inhibit the vomiting reflex triggered by chemotherapy and radiotherapy by blocking serotonin receptors in the peripheral and central nervous systems.

Dosage

Dosage varies depending on the indication:

• For Chemotherapy-Induced Nausea and Vomiting, dosages are specified for adults, pediatric patients, and injection administration.
• For Radiotherapy-Induced Nausea and Vomiting, different dosages are recommended for adults.
• For Postoperative Nausea and Vomiting, dosage recommendations are provided for adults and pediatric patients.

Administration

Detailed steps for administering the oral soluble film are outlined, emphasizing the importance of following medical advice.

Interaction

Ofran’s interaction with the cytochrome P-450 drug-metabolizing enzyme system is explained, along with precautions regarding concurrent use of apomorphine.

Contraindications

Patients with known hypersensitivity to Ofran or its components are advised against its use, as well as those using apomorphine concurrently.

Side Effects

Commonly reported adverse events include headache, constipation, and diarrhea, usually of mild or moderate severity. Rare but serious side effects are also mentioned, along with the absence of evidence for extrapyramidal reactions.

Pregnancy & Lactation

Studies indicate no carcinogenic or mutagenic effects in animals. Caution is advised in pregnant and nursing women due to potential excretion of Ondansetron in breast milk.

Precautions & Warnings

Special precautions regarding hypersensitivity reactions, use post-abdominal surgery, and in patients with chemotherapy-induced nausea and vomiting are highlighted.

Use in Special Populations

Dosage recommendations for patients with impaired renal or hepatic function, pediatric patients, and the elderly are provided.

Therapeutic Class

Ofran falls under the category of anti-emetic drugs.

Storage Conditions

Proper storage conditions are recommended to maintain the drug’s efficacy.