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Product
Anti-emetic Products (Granicip)
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Anti-emetic Products (Granicip)
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Granicip
Granicip-1 Tablets
Granicip injections 1 ml
COMPOSITION
Granicip-1 Tablets
Each film-coated tablet contains Granisetron hydrochloride equivalent to
Granisetron 1 mg
Granicip -2 Tablets
Each film-coated tablet contains Granisetron hydrochloride equivalent to
Granisetron 2 mg
Granicip 1 ml Injection
Each 1 ml ampoule contains Granisetron hydrochloride equivalent to
granisetron 1 mg
Granicip 3 ml Injection
Each 3 ml ampoule contains Granisetron hydrochloride equivalent to
granisetron 3 mg
Indications
Granicip (granisetron hydrochloride) is indicated for the prevention or treatment of:
1. Nausea and vomiting associated with the treatment of cancer by chemotherapy
2. Nausea and vomiting associated with the treatment of cancer by radiotherapy
3. Post operative nausea and vomiting
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Dosage and administration
Cancer chemotherapy
Adults
Granicip injection 40 mcg/kg administered intravenously within 30 minutes
before initiation of chemotherapy. Granicip Injection may be administered
intravenously either undiluted over 30 seconds, or diluted with 20-50 ml of
0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes.
One additional dose of 40 mcg/kg body weight (up to 3 mg) may be
administered within a 24-hour period if required. This additional dose should
be administered at least 10 minutes apart from the initial infusion.
Oral Granicip (granisetron hydrochloride) 2 mg once daily or 1 mg twice
daily.
In the 2 mg once-daily regimen, two 1 mg tablets are given up to 1 hour
before chemotherapy.
In the 1 mg twice-daily regimen, the first 1 mg tablet is given up to 1 hour
before chemotherapy, and the second tablet, 12 hours after the first.s
Pediatric Use:
Granicip injection 40 mcg/kg in children 2 to 16 years of age administered
intravenously for over five minutes, diluted to 30 ml infusion fluid.
Administration should be completed prior to the start of cytostatic therapy.
No dosage adjustment is recommended for Granicip tablets.
Children under 2 years of age have not been studied.
Use in the Elderly, in impaired renal function, impaired hepatic function:
No dosage adjustment is recommended.
Cancer Radiotherapy (either total body irradiation or fractionated
abdominal radiation):
Adults
Granicip tablets 2 mg once daily. Two 1 mg tablets are taken within 1 hour
of radiation.
Pediatric Use:
There is no experience with oral Granicip in the prevention of radiation-induced
nausea and vomiting in pediatric patients.
In the Elderly:
No dosage adjustment is recommended.
Post-operative nausea and vomiting
Adults
1 mg diluted to 5ml administered by slow i.v. injection over 30 seconds
prior to induction of anaesthesia.
Pediatric Use:
There is no experience with granisetron injection in the prevention and
treatment of post-operative nausea and vomiting in children under 12 years
of age. Hence granisetron is not recommended in treatment of post operative
nausea and vomiting in pediatric patients.
Use in the Elderly, in impaired renal function, impaired hepatic function:
No dosage adjustment is recommended.
Contraindications
Granicip is contraindicated in patients with known hypersensitivity to the
drug or any of its components.
Presentation
Granicip-1 Strip of 4 Tablets
Granicip injection Ampoules of 1 ml
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