GratronTM 3 mg (Ampoule)
(Granisetron)
GratronTM 3 mg (Ampoule)
COMPOSITION:
Pharmaceutical Form
Intravenous: Each GratronTM 3 mg ampoule contains a sterile, clear solution equivalent to 1 mg granisetron free base per 1 mL isotonic solution. The content allows withdrawal of 3 mL.
PHARMACOLOGICAL CLASSIFICATION:
Anti-emetics and anti-vertigo preparations.
PHARMACOLOGICAL ACTION:
GratronTM is a selective antagonist of 5-hydroxytryptamine (5-HT)3-receptors. Radioligand binding studies have demonstrated that GratronTM has negligible affinity for other receptor types including 5-HT and dopamine D2 binding sites.
Indications
5-HT3 receptor antagonists are the primary drugs used to treat and prevent chemotherapy-induced nausea and vomiting. Many times they are given intravenously about 30 minutes before beginning therapy.
- Post-operative and post-radiation nausea and vomiting (PONV)
- Used in radiation induced nausea and vomiting (RINV)
CONTRA-INDICATIONS:
Sensitivity to any of the ingredients.
WARNINGS:
A dose related increase in background hepatocellular carcinoma and/or adenoma in rats and mice of both sexes receiving in excess of 25 times the intended dose for 2 years have been reported. None of these findings were present after one year at any of the doses. The clinical relevance of this finding is unclear.
As GratronTM may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of GratronTM.
The maximum dose of GratronTM to be administered over 24 hours should not exceed 9 mg (120 µg/kg).
DOSAGE:
Adults:
GratronTM should be administered within one hour before the start of cytostatic therapy.
Intravenous: The dose of GratronTM is 3 mg (corresponding to a dose of plus minus 40 µg/kg) which should be diluted as directed in 20 to 50 mL infusion fluid and administered over 5 minutes by slow intravenous injection or infusion.
Maximum Daily Dose:
Up to two additional 5-minute administrations of 3 mg GratronTM may be administered within a 24 hour period.
Additional administration should be administered at least 10 minutes apart. The maximum dose of GratronTM infusion to be administered over 24 hours should not exceed 9 mg (120 µg/kg).
The experience of the use of granisetron beyond 7 cycles of chemotherapy is limited.
Special Groups:
Although present experience indicates that no dosage adjustment is required, care should be exercised when administering GratronTM to elderly patients and patients with renal or hepatic impairment.
Children:
Insufficient data is available at present to enable a dosage recommendation to be made in children.
DIRECTIONS FOR USE:
Preparing the Injection:
To prepare the dose of GratronTM 3 mg the contents of one ampoule (3 mg) or 40 µg/kg is withdrawn from the ampoule and diluted with infusion fluid, to a total volume of 20 to 50 mL in any of the following solutions: 0,9% m/v sodium chloride, 0,18% m/v sodium chloride and 4% m/v dextrose, 5% m/v dextrose, Hartmann’s solution, sodium lactate and 10% m/v mannitol.
Stability:
Ideally intravenous injections of GratronTM 3 mg should be prepared at the time of administration.
However, the recommended solutions of GratronTM 3 mg have been shown to be stable for at least 24 hours in the following solutions when stored at room temperature: 0,9% m/v sodium chloride, 0,18% m/v sodium chloride and 4% m/v dextrose, 5% m/v dextrose, Hartmann’s solution, sodium lactate and 10% m/v mannitol.
Compatibility:
As a general precaution, GratronTM 3 mg should not be mixed in solution with other medicines. Prophylactic administration of GratronTM 3 mg should be completed prior to the start of cytostatic therapy. No interactions with GratronTM 3 mg have been recorded with multiple chemotherapy regimens including cisplatin up to 120 mg/m2.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Headache and constipation have been the most frequently noted adverse events. A rise in hepatic transaminases may occur. Minor skin rashes have been noted less frequently.
Interactions:
In humans, hepatic enzyme induction with phenol barbital resulted in an increase in total plasma clearance of intravenous GratronTM of approximately one-quarter.
GratronTM has been administered in humans with benzodiazepines, narcoleptics and antiulcer medications, commonly prescribed with anti-emetic treatments. Additionally, GratronTM has shown no apparent drug interaction with emetogenic cancer chemotherapies.
Use in pregnancy and lactating mothers:
Safety in pregnancy and lactation has not been established.
Effects on ability to drive and use machines:
There have been reports of somnolence in clinical studies and this should be taken into account
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Headache may occur. There is no specific antidote for GratronTM 3 mg. In the case of over dosage, symptomatic treatment should be given.
IDENTIFICATION:
GratronTM 3 mg: Each GratronTM 3 mg ampoule contains a clear, color less or slightly straw-colored sterile solution.
PRESENTATION:.
GratronTM 3 mg is supplied in cartons containing 5 or 10 ampoules.
STORAGE INSTRUCTIONS:
Store below 30°C.
Ampoules removed from the pack should be stored protected from direct sunlight.
Do not freeze.
KEEP OUT OF REACH OF CHILDREN.
Available at all leading pharmacies in Pakistan
on prescription only.
For further queries.
Tel: +92 21 34123535, 34123636 |
