Gratril ODT (Granisetron Hydrochloride)

Adult dose

1. Adults 1) Chemotherapy During chemotherapy (up to one week after chemotherapy), place 1 tablet on the tongue twice daily and take without water after it dissolves, or place 2 tablets on the tongue once daily and take without water after they dissolve. Administer the initial dose within 1 hour before starting chemotherapy, and do not exceed a maximum daily dose of 9mg. 2) Radiotherapy During radiotherapy, place 2 tablets on the tongue once daily and take without water after they dissolve. Administer the initial dose within 1 hour before starting radiotherapy, and do not exceed a maximum daily dose of 9mg. 2. Older adults: No special dosage adjustment is necessary. 3. Patients with renal or hepatic impairment: No special dosage adjustment is necessary.

This medicine contains aspartame, an artificial sweetener, which is converted to phenylalanine in the body; therefore, it should not be used by patients with phenylketonuria, a genetic disorder. This medication contains lactose and should not be given to patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It may suppress lower gastrointestinal motility, so special caution should be exercised when used in patients with signs of bowel obstruction. Because it can affect cardiac electrical activity, it should be administered cautiously in patients with arrhythmias, ECG abnormalities, heart diseases, or those receiving cardiotoxic chemotherapy. Common side effects may include headache and constipation, and liver function test values may temporarily increase. Hypersensitivity reactions such as rashes or anaphylaxis may occur, so caution is advised. When taken with other serotoninergic medications, serotonin syndrome may develop, characterized by changes in mental state, autonomic dysfunction, and neuromuscular abnormalities; hence, patients should be closely monitored when using in combination. While there is no clear data on the effects of this medication on driving or operating machinery, drowsiness has been reported in clinical trials so caution is necessary. This medicine may mask bowel obstruction or gastric distention caused by underlying conditions, thus it should be used cautiously in patients suspected of having such conditions. Generally, interactions with other medications are minimal; however, the effects may change when used with some drugs, so consulting with healthcare professionals is important. It is advisable not to use this medication during pregnancy unless in special circumstances, and breastfeeding should be discontinued during the treatment period. Safety and proper usage data for children under 12 years is lacking, so caution is advised in such cases. Elderly patients should be administered cautiously due to the potential for adverse reactions. There is no specific antidote for overdose, so symptomatic treatment should be administered as necessary. This medication should be kept out of reach of children, and transferring it to another container should be avoided as it may not maintain quality and safety.

• Allergic reactions
• anaphylaxis
• urticaria
• headache
• serotonin syndrome
• QT prolongation
• constipation
• increase in liver aminotransferases
• rash

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius.

Appearance

White square oral dissolving tablet

Package unit

10 tablets (10 tablets/PTP×1)