Oncodex 8 mg (Tablet)

Indications

• Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy
• Prevention and treatment of post-operative nausea and vomiting
• Prevention of radiotherapy-induced nausea and vomiting

Dosage

• Dosage varies based on chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting
• Dosage for adults, pediatric patients, geriatric patients, and different cancer chemotherapy levels

Pharmacology

• Mode of action as a potent, highly selective 5HT3 receptor-antagonist
• Mechanisms of action in chemotherapy and radiotherapy-induced nausea and vomiting

Administration

• Oral soluble film designed to dissolve on the tongue within 20 seconds
• Step-by-step administration process

Interaction

• Information about potential interactions with cytochrome P-450 drug-metabolizing enzymes

Contraindications

• Hypersensitivity to the drug or any of its components
• Contraindicated with concomitant use of apomorphine

Side Effects

• Frequently reported adverse events such as headache, constipation, and diarrhea
• Rare cases of anaphylaxis, brochospasm, tachycardia, and hypokalemia

Pregnancy & Lactation

• Carcinogenic and mutagenic effects in animal studies
• Caution advised for use in pregnant and nursing women

Precautions & Warnings

• Hypersensitivity reactions in patients with hypersensitivity to other 5-HT3 receptor antagonists
• Caution in patients following abdominal surgery or with chemotherapy-induced nausea and vomiting

Use in Special Populations

• Dosage adjustments for patients with impaired renal or hepatic function
• Limited information available for pediatric patients 4 years of age or younger

Therapeutic Class

• Belongs to the class of anti-emetic drugs

Storage Conditions

• Storage recommendation at temperature not exceeding 30°C in a dry place
• Protection from light and moisture

Dimensions and Form

• Orally dissolving film designed for application on the tongue

Active Ingredient

• Ondansetron base

Chemical Formula

• C18H19N3O

Molecular Weight

• 293.3

Dissolution Time

• Dissolves within 20 seconds

Water Requirement

• Does not require water for dissolution or swallowing

Usability

• No need for water to aid in swallowing

Targeted Receptor

• Selective blocking agent of the serotonin 5-HT3 receptor type

Dosage Adjustment for Renal Function

• Same dosage recommendation as for the general population

Dosage Adjustment for Hepatic Function

• Recommended single maximal daily dose in severe hepatic impairment

Pediatric Use

• Limited information for dosage in pediatric patients 4 years of age or younger

Efficacy

• Effectiveness in the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy

Half-Life

• Potential change in clearance and half-life with inducers or inhibitors of hepatic cytochrome P-450 enzyme system

Adverse Events

• Majority of adverse events reported as mild or moderate in nature

Route of Administration

• Oral administration for all indicated uses

Maximum Daily Dose

• Maximum daily dosage limits based on indication and patient category

Reproduction Studies

• No evidence of impaired fertility or harm to the fetus in animal studies

Breast Milk Excretion

• Excretion in the breast milk of rats

Age Consideration

• Dosage adjustment not needed in patients over the age of 65

Hepatic Metabolism

• Metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes

Chemotherapy Levels

• Dosage variations based on highly emetogenic and moderately emetogenic cancer chemotherapy

Radiotherapy Dose

• Specific oral dosage recommendations related to radiotherapy-induced nausea and vomiting

Postoperative Dose

• Different dosage recommendations for prevention of postoperative nausea and vomiting

Chemotherapy Medication

• Administered before onset of emetogenic chemotherapy

Radiotherapy Medication

• Administered before each fraction of radiotherapy

Cancer Chemotherapy

• Age-specific dosage information for pediatric and adult patients

Anaphylaxis

• Rare cases of anaphylaxis reported

Brochospasm and Tachycardia

• Reported adverse events

Flushing

• Reported sensation of flushing or warmth

Hiccups

• Reported as an adverse event

Liver Enzyme Abnormalities

• Reported as an adverse event

Related Brands

• Emetus 8 mg/4 ml (IM/IV Injection) - osl-pharma-limited
• Vomistop 4 mg/5 ml (Oral Solution) - naafco-pharma-ltd
• Emetus 4 mg/5 ml (Oral Solution) - osl-pharma-limited
• Emetus 8 mg (Tablet) - osl-pharma-limited
• Emetus 4 mg (Tablet) - osl-pharma-limited