Ofran 8 mg (Tablet)
Unit Price: ৳ 11.00 (3 x 10: ৳ 330.00)
Strip Price: ৳ 110.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Ondansetron |
| Company | Square pharmaceuticals plc |
| 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
Dosage
- Adults, Pediatric patients (6 months to 18 years)
- Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy
- Pediatrics (>40 kg)
- Pediatrics (40 kg)
- Adults/Geriatric/Child of 12 years or over
- Pediatric (4-11 years)
- Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over)
- The recommended oral dosage
- For total body irradiation
- For single high-dose fraction radiotherapy to the abdomen
- For daily fractionated radiotherapy to the abdomen
- Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over)
- Adult oral dose
- Adults and pediatric patients 12 years of age and older
- Pediatric patients 4 through 11 years of age
- Postoperative nausea and vomiting associated with highly emetogenic cancer chemotherapy
- Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy
- Prevention of nausea and vomiting associated with radiotherapy
- Administration of Ondansetron film
- Contraindicated in patients known to have hypersensitivity to the drug or any of its components
- Concomitant use of apomorphine
- Frequently reported adverse events
- Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively
- Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats
- Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively
- Hypersensitivity reactions
- Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists
- Ofran is not a drug that stimulates gastric or intestinal peristalsis
Description
- Ofran 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
- Ondansetron is a potent, highly selective 5HT(3) receptor-antagonist
Pharmacology
- Ondansetron is a potent, highly selective 5HT(3) receptor-antagonist
- Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex
- 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
Administration
- Step 1: Tear the pouch carefully along with the edge tear mark
- Step 2: Put the Ondansetron film on top of your tongue
- Step 3: Do not chew or swallow the film whole
- Step 4: Swallow after the Onsaf oral soluble film dissolves
- Step 5: Wash your hands after taking Onsaf oral soluble film
Interaction
- Ofran does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver
- Because Ofran is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ofran
Contraindications
- Contraindicated in patients known to have hypersensitivity to the drug or any of its components
- Concomitant use of apomorphine
Side Effects
- Frequently reported adverse events were headache, constipation and diarrhea
- In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ofran
- There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities
- Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain)
- Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported
- Except for bronchospasm and anaphylaxis, the relationship to Ofran is unclear
- Rates of these events were not significantly different in the Ofran and placebo groups
Pregnancy & Lactation
- Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively
- Ondansetron was not mutagenic in standard tests for mutagenicity
- Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats
- Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively
- There are, however, no adequate and well-controlled studies in pregnant women
- Ondansetron is excreted in the breast milk of rats
Precautions & Warnings
- Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists
- Ofran is not a drug that stimulates gastric or intestinal peristalsis
Use in Special Populations
- Dosage Adjustment for Patients With Impaired Renal Function
- Dosage Adjustment for Patients With Impaired Hepatic Function
- 4 years of age or younger
- Over the age of 65
Therapeutic Class
- Anti-emetic drugs
Storage Conditions
- Store at temperature not exceeding 30ºC in a dry place
- Protect from light and moisture