DE-VOMIT (syr)
-
Chemical Name:
Ondansetron -
Therapeutic Category:
Gastro-intestinal drugs -
Pharmacologic Category:
Antiemetic - Selective 5-HT3 Receptor Antagonist -
Pharmaceutical Form:
Syrup -
Composition:
Ondansetron 4mg/5ml
DE – VOMIT
Ondansetron HCl ( Anti - Nausea and Anti – Vomiting )
1-PROPERTIES:
DE-VOMIT is a selective anti-nausea and anti-vomiting blocking agent of the serotonin 5-HT3 receptor type.
2-INDICATIONS:
1.Treatment of mid moderate nausea and vomiting resulting form indigestion of food intoxicetion or after getroenteritis
2.Treatment and prevention of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
3.Treatment and prevention of postoperative nausea and vomiting
3-PRECAUTIONS:
Patients with moderate or severe hepatic impairment, the total daily dose of Ondansetron should not exceed 8 mg.
4-PREGNANCY AND LACTATION:
PREGNANCY CATEGORY B
As directed by the physician.
5-SIDE EFFECTS:
Ondansetron may cause : Constipation , headache, a sensation of flushing or warmth.
Rarely allergic reaction, temporary rise in liver’s enzymes.
6-CONTRA INDICATIONS:
Hypersensitivity to the drug.
7-DRUG INTERACTIONS :
The metabolism of Ondansetron is effected through the metabolic liver enzyme cytochrome P-450 , so , all products metabolised through the enzymes may modify the half-life of Ondansetron .
In humans , Carmustine , etoposide , and cisplatin do not affect the pharmacokinetics
of Ondansetron . The coadministration of Ondansetron had no effect on the Pharmacokinetics and pharmacodynamics of Temazepam .
8-DOSAGE AND ADMINISTRATION:
1-Tablets and Syrup dosage :
a-Chemotherapy and Radiotherapy:
Adults:One tablet (8 mg) taken half-an-hour before treatment, followed by one tablet
(8 mg) after 8 hours. Followed by 1 tablet ( 8 mg ) in the morning and evening for 2 days after the treatment .
Children :4 mg ( one tea spoon ) 3 times daily and the first dose should be given half an hour before the treatment and Ondansetron should be given for 2 days after the end of the treatments
b-For the treatment of post – operative nausea and vomiting :
Adults : 16 mg ( 2 tablets 8 mg ) should be given 1 hour before anesthesia .
2-Ampoules and Liquid Vial dosage:
a-Chemotherapy and Radiotherapy :
Adults:8 mg . as a single dose may be given by slow intravenous injection immediately before treatment, followed by 2 doses of ( 8 mg ) by intravenously after 2 to 4 hours
or a continuous intravenous infusion of 1 mg . per hour for up to 24 hours.
Or a single dose of 32 mg . given by intravenous infusion over 15 minutes given half an hour before chemotherapy.
-The intravenous regimen should be followed by 8 mg. orally twice daily for up to maximum 5 days.
Children :half the dosage of the adults or a dose equivalent to 5 mg / m2 body surface intravenously over 15 minutes immediately before chemotherapy followed by 4 mg. orally every 12 hours for up to maximum 5 days.
b-For the treatment of post – operative nausea and vomiting :
Adults: 4 mg. as a single dose may be given by intramuscular or slow intravenous injection
| Note: DE – VOMIT – 32 contains 5% dextrose |
9-PACKING & COMPOSITION:
DE-VOMIT -Tablets:
Each pack contains 10 or 6 tablets
Each tablet contains : Ondansetron ( HCl ) 8 mg.
DE – VOMIT- Syrup :
Bottle of 100 ml.
Each (5 ml ) Syrup contains : Ondansetron ( HCl ) 4 mg.
DE – VOMIT - 4 Ampoules :
Each pack contains 5 or 25 Ampoules
Each Ampoule ( 2 ml ) contains : Ondansetron ( HCl ) 4 mg.
DE – VOMIT - 8 Ampoules :
Each pack contains 5 or 25 Ampoules
Each Ampoule (4 ml ) contains : Ondansetron ( HCl ) 8 mg.
DE – VOMIT – 32 Singledose Liquid Vial :
Each pack contains 1 Vial
Each Vial (50 ml ) contains : Ondansetron ( HCl ) 32 mg.
DE – VOMIT – 40 Multidose Liquid Vial :
Each pack contains 1 Vial
Each Vial (20 ml ) contains : Ondansetron ( HCl ) 40 mg.
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