What happens if I overdose Bili?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Bili tablets:
Store Bili tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bili tablets out of the reach of children and away from pets.
Overdose of Bili in details
There is no specific antidote for Bili (Bili hydrochloride) overdosage. In case of overdosage, symptomatic treatment should be given. One patient had received 10 times the recommended oral dose of Bili. The patient reported a slight headache but no other sequelae were observed.
Overdosage of up to 38.5 mg of Bili hydrochloride injection has been reported without symptoms or only the occurrence of slight headache.
What should I avoid while taking Bili?
While you are wearing the skin patch, avoid exposing it to sunlight or tanning beds. Natural or artificial sunlight can cause a skin reaction where the Bili skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch.
Bili warnings
Serotonin Syndrome
The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.
Symptoms associated with serotonin syndrome may include the following conbination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of Bili and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Bili and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Bili is used concomitantly with other serotonergic drugs.
What should I discuss with my healthcare provider before taking Bili?
Some medical conditions may interact with Bili tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to other 5-HT receptor antagonists (eg, ondansetron)
- if you have heart problems (eg, irregular heartbeat, conduction problems), blood electrolyte problems (eg, low calcium, potassium, or magnesium), an abnormal electrocardiogram (ECG), or you are receiving chemotherapy that may cause heart problems
- if you have stomach or bowel problems (eg, pain, swelling) or if you have recently had stomach surgery
Some MEDICINES MAY INTERACT with Bili tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Apomorphine because the risk of side effects, such as severely low blood pressure or loss of consciousness, may occur
- Medicines that may affect your heartbeat such as antiarrhythmics (eg, flecainide, sotalol), azole antifungals (eg, ketoconazole) or quinolones (eg, ciprofloxacin) because heart rhythm problems may occur. Ask your doctor if you are unsure if any medicines that you take may affect your heartbeat
This may not be a complete list of all interactions that may occur. Ask your health care provider if Bili tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Bili precautions
Bili (Bili) is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Bili (Bili) in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.
An adequate QT assessment has not been conducted, but QT prolongation has been reported with Bili (Bili). Therefore, Bili (Bili) should be used with caution in patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month carcinogenicity study, rats were treated orally with Bili 1, 5 or 50 mg/kg/day (6, 30 or 300 mg/m²/day). The 50 mg/kg/day dose was reduced to 25 mg/kg/day (150 mg/m²/day) during week 59 due to toxicity. For a 50 kg person of average height (1.46 m² body surface area), these doses represent 4, 20, and 101 times the recommended clinical dose (1.48 mg/m², oral) on a body surface area basis. There was a statistically significant increase in the incidence of hepatocellular carcinomas and adenomas in males treated with 5 mg/kg/day (30 mg/m²/day, 20 times the recommended human dose based on body surface area) and above, and in females treated with 25 mg/kg/day (150 mg/m²/day, 101 times the recommended human dose based on body surface area). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6 mg/m²/day, 4 times the recommended human dose based on body surface area) in males and 5 mg/kg/day (30 mg/m²/day, 20 times the recommended human dose based on body surface area) in females. In a 12-month oral toxicity study, treatment with Bili 100 mg/kg/day (600 mg/m²/day, 405 times the recommended human dose based on body surface area) produced hepatocellular adenomas in male and female rats while no such tumors were found in the control rats. A 24-month mouse carcinogenicity study of Bili did not show a statistically significant increase in tumor incidence, but the study was not conclusive.
Because of the tumor findings in rat studies, Bili (Bili hydrochloride) should be prescribed only at the dose and for the indication recommended.
Bili was not mutagenic in in vitro Ames test and mouse lymphoma cell forward mutation assay, and in vivo mouse micronucleus test and in vitro and ex vivo rat hepatocyte UDS assays. It, however, produced a significant increase in UDS in HeLa cells in vitro and a significant increased incidence of cells with polyploidy in an in vitro human lymphocyte chromosomal aberration test.
Bili at oral doses up to 100 mg/kg/day (600 mg/m²/day, 405 times the recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
Pregnancy
Teratogenic Effects
Pregnancy Category B.
Reproduction studies have been performed in pregnant rats at oral doses up to 125 mg/kg/day (750 mg/m²/day, 507 times the recommended human dose based on body surface area) and pregnant rabbits at oral doses up to 32 mg/kg/day (378 mg/m²/day, 255 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to Bili. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether Bili is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bili (Bili) is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
During clinical trials, 325 patients 65 years of age or older received Bili (Bili) Tablets; 298 were 65 to 74 years of age, and 27 were 75 years of age or older. Efficacy and safety were maintained with increasing age.
What happens if I miss a dose of Bili?
Call your doctor for instructions if you forget to apply a Bili skin patch at least 24 hours before your chemotherapy is scheduled to start. Do not use extra patches to make up the missed dose.
References
- DailyMed. "GRANISETRON: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "granisetron". http://www.drugbank.ca/drugs/DB00889 (accessed September 17, 2018).
- MeSH. "Serotonin Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
