Leofran 4 mg/5 ml (Oral Solution)

50 ml bottle: ৳ 45.00

Medicine Details

Category Details
Generic Ondansetron
Company Leon pharmaceuticals ltd
Also available as

Therapeutic Class

  • Anti-emetic drugs

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

  • Leofran is a serotonin subtype 3 (5-HT3) receptor antagonist
  • Oral soluble film designed to be applied on top of the tongue
  • Dissolves within 20 seconds
  • Swallowed with saliva, does not require water

Pharmacology

  • Potent, highly selective 5HT3 receptor antagonist
  • Precise mode of action not known
  • Blocks 5HT3 receptors
  • Antagonizes both peripheral and central nervous system receptors
  • Mechanism of action in post-operative nausea and vomiting not known

Dosage

  • Dosage varies for different types of nausea and vomiting
  • Multiple dosage forms: tablets, orodispersible tablets, injections, oral solution
  • Dosage based on patient's age and weight
  • Different dosages for chemotherapy-induced nausea and vomiting, radiotherapy-induced nausea and vomiting, and postoperative nausea and vomiting

Administration

  • Tear the pouch to access the oral soluble film
  • Place film on top of the tongue
  • Film dissolves within 20 seconds
  • Do not chew or swallow the film whole
  • Swallow after the film dissolves
  • No need for water for administration

Interaction

  • Leofran does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver
  • Metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes
  • Inhibitors or inducers of these enzymes may change clearance and half-life of Leofran

Contraindications

  • Contraindicated in patients with hypersensitivity to the drug or its components
  • Concomitant use of apomorphine

Side Effects

  • Frequently reported adverse events: headache, constipation, diarrhea
  • Mild or moderate in nature
  • Rash occurred in approximately 1% of patients
  • Rare cases of anaphylaxis, brochospasm, tachycardia, angina, hypokalemia, shortness of breath
  • No evidence of extrapyramidal reactions

Pregnancy & Lactation

  • No evidence of carcinogenic effects based on animal studies
  • Not mutagenic in standard tests
  • No effect on fertility or reproduction performance in rats
  • No adequate and well-controlled studies in pregnant women
  • Excreted in breast milk of rats, caution advised for nursing women

Precautions & Warnings

  • Hypersensitivity reactions reported in patients with hypersensitivity to other 5-HT3 receptor antagonists
  • Not a drug that stimulates gastric or intestinal peristalsis
  • Should not be used instead of nasogastric suction
  • Use in patients following abdominal surgery or with chemotherapy-induced nausea and vomiting may mask progressive ileus and/or gastric distension

Use in Special Populations

  • Dosage adjustments not needed for patients with impaired renal function
  • Recommended dosage for severe hepatic impairment
  • Limited information available for pediatric patients under 4 years
  • No dosage adjustment needed for patients over 65

Storage Conditions

  • Store at temperature not exceeding 30°C
  • In a dry place
  • Protect from light and moisture

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