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Danset . (Ampoules)

 


Composition:
The active ingredient in Danset ampoules is ondansetron hydrochloride (HCl), the racemic form of ondansetron

Properties:
The active ingredient in Danset ampoules is ondansetron hydrochloride (HCl), it is a selective blocking agent of the serotonin 5-HT 3 receptor type.
Sterile Injection for intravenous or intramuscular administration : Each 1 mL of aqueous solution in the 2-mL amoule contains 2 mg of ondansetron as the hydrochloride dihydrate


Indications:
Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Prevention of postoperative nausea and/or vomiting. In patients where nausea and/or vomiting must be avoided postoperatively, Danset ampoule is recommended even where the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Danset ampoule and experience nausea and/or vomiting postoperatively, Danset ampoule may be given to prevent further episodes


Dosage Administration:
Prevention of Chemotherapy-Induced Nausea and Vomiting: The recommended I.V. dosage of Danset is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Danset.
Danset ampoules should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Pediatric Use: The dosage in pediatric patients 4 to 18 years of age should be three 0.15-mg/kg doses (see above). Little information is available about dosage in pediatric patients 3 years of age and younger.
Use in the Elderly: The dosage recommendation is the same as for the general population.


Contra Indications:
Danset ampoules are contraindicated for patients known to have hypersensitivity to the drug.



Precautions Warnings:
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.

PRECAUTIONS
Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.



Side Effects:
Cardiovascular: Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and arrhythmias have been reported.
Gastrointestinal: Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.
Hepatic: Transient elevation of liver enzymes have been reported .
Dermal: Rare cases of rash has occurred in 1% of patients receiving ondansetron.
Neurological: There have been rare cases of extrapyramidal reactions and grand mal seizure.
Other: Rare cases of hypokalemia have been reported.
General: Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis, bronchospasm, shortness of breath, hypotension, shock, angioedema, urticaria) have also been reported.
Special Senses: Transient blurred vision, and transient dizziness during or shortly after I.V. infusion.


Packing:
Danset ampoules, 2 mg/mL, supplied as 3 ampoules each of 2ml in a carton box.
- Danset ampoules, 2 mg/mL, supplied as 1 ampoule 2ml in a carton box.
- Danset ampoules, 2 mg/mL, supplied as 1 ampoule 4ml in a carton box.

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