AMERTISAN 1: Each mL contains Granisetron Hydrochloride equivalent to Granisetron 1 mg.
AMERTISAN 3: Each 3 mL contains Granisetron Hydrochloride equivalent to Granisetron 3 mg.
PHARMACOLOGY: The 5-HT3 type serotonin receptor is peripherally located at the terminal of the vagus and central nerve in the chemoreceptor trigger zone of the postrema area. During the chemotherapy process that induces vomiting, enterochromaffin mucous cells release serotonin which stimulates the 5-HT3 receptor. This results in stimulation of the vagus nerve afferent and may induce vomiting. Granisetron is a 5-Hydroxytriptamyne (5-HT3) receptor antagonist that is very selective and potent with antiemetic activity.
Prevention and therapy for: Acute and delayed nausea and vomiting due to chemotherapy and radiotherapy; Post-operative nausea and vomiting.
Nausea and vomiting induced by chemotherapy: Adult: Intravenous: Prevention: A dose of 1-3 mg (10-40 mcg/kg) of Granisetron should be administered either as a slow intravenous injection (more than 30 seconds) or diluted in 20-50 mL of infusion fluid and administered over 5 minutes prior to the start of chemotherapy.
Treatment: A dose of 1-3 mg (10-40 mcg/kg) of Granisetron should be administered either as slow intravenous injection (more than 30 seconds) or diluted in 20-50 mL of infusion fluid and administered over 5 minutes.
If needed, additional doses can be administered over 10 minutes after the last administration. The maximum dose of granisetron to be administered over 24 hours should not exceed 9 mg.
Intramuscular: Prevention and treatment: A dose of 3 mg of Granisetron should be administered by IM, 15 minutes prior to the start of chemotherapy. Two subsequent 3 mg dose of Granisetron may be administered, if required, within a 24 hours period.
Children: Intravenous: A dose of 10-40 mcg/kg body weight (up to 3 mg) should be administered by intravenous infusion, diluted in 10-30 mL of infusion fluid and administered over 5 minutes prior to the start of chemotherapy. One additional dose should be administered within 24 hours if required. This additional dose should be given at least 10 minutes after initial infusion.
Intramuscular: There is insufficient data available for the IM use of Granisetron in children.
Nausea and vomiting induced by radiotherapy: Adult: Intravenous: Prevention: A dose of 1-3 mg (10-40 mcg/kg) of Granisetron should be administered as a slow intravenous injection (more than 30 seconds) or diluted in 20-50 mL of infusion fluid and administered over 5 minutes prior to the start of radiotherapy.
Children: There is insufficient data of Granisetron use for the prevention and treatment of radiotherapy-induced nausea and vomiting in children.
Post-operative nausea and vomiting: Adult: Intravenous: Prevention: A dose of 1 mg (10 mcg/kg) of Granisetron should be administered as a slow intravenous injection (more than 30 seconds) before anesthetic induction.
Treatment: A dose of 1 mg (10 mcg/kg) of Granisetron should be administered by slow intravenous injection (more than 30 seconds). The maximum dose for patients who will undergo surgery for surgery is 3 mg Granisetron IV in 1 day.
Children: There is insufficient data of Granisetron use for the prevention and treatment of postoperative nausea and vomiting in children.
Maximum dose and duration of treatment: 2 doses (2 mg) in 1 day.
Special Dosage Instruction: Geriatric: no dosage adjustment required; Renal Impairment: no dosage adjustment required; Hepatic Impairment: no dosage adjusment required.
There is no specific antidote for Granisetron.
Symptomatic treatment should be given in overdosage case. Symptoms of overdose that have been reported are mild headaches without other accompanying symptoms.
Hypersensitivity to Granisetron.
Granisetron decreases intestinal motility, therefore monitoring is needed for patients with subacute intestinal obstruction.
There are no studies in pregnancy. It is not known whether Granisetron is excreted through breast milk. The use of Granisetron during pregnancy or breastfeeding should be limited where the advantage is greater risk to the fetus or breastfeeding baby.
In general, Granisetron has been well tolerated. Just like other drugs in this class, headaches and constipation have been reported. The case of hypersensitivity reactions are rare, including rashes and anaphylaxis have been, also reported. In getting an increase in liver transaminases and the same frequency in patients who received comparative therapy.
In human, hepatic enzymes induction by phenobarbital can increase the total clearance of intravenous Granisetron plasma by about a quarter. Granisetron is safe to use with Benzodiazepines, neuroleptics and anti-ulcer drugs which are commonly prescribed along with antiemetics. In addition, Granisetron does not show any drug interaction with emetogenic cancer chemotherapy. Granisetron is safely administered with commonly used anesthetics and analgesics.
INSTRUCTIONS FOR USE: Infusion preparations: Adults: The appropriate dosage is diluted with intravenous fluids, up to 20-50 mL of total volume.
Children: The appropriate dosage is diluted with intravenous fluids, up to 10-30 mL of total volume.
Compatible infusion solution: 0.9% NaCl; 5% Dextrose; and Mannitol.
Store below 30°C, protected from light.
After dilution the solution is stable for 24 hours at temperature below 30°C.
A04AA02 - granisetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Amertisan inj 1 mg/mL
5 × 1's (Rp275,000/boks)
Amertisan inj 3 mg/3 mL
5 × 1's (Rp550,000/boks)
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