What happens if I overdose Biomebal?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Biomebal suspension:
Store Biomebal suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 58 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after 7 days. Keep Biomebal suspension out of the reach of children and away from pets.
Overdose of Biomebal in details
Limited information on Biomebal overdosage is available. Single oral doses of up to 4000 mg Biomebal have been administered to healthy adult volunteers without significant adverse effects. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with Biomebal. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.
What should I avoid while taking Biomebal?
There are no restrictions on food, beverages, or activity during treatment with Biomebal unless otherwise directed by your doctor.
Biomebal warnings
Biomebal should be taken with food. Diabetic patients should be aware that the oral suspension contains 1.48 g of sucrose/5 ml.
What should I discuss with my healthcare provider before taking Biomebal?
Some medical conditions may interact with Biomebal suspension. 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 have liver or gallbladder problems, kidney problems, immune system problems, or HIV infection
Some MEDICINES MAY INTERACT with Biomebal suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Warfarin because its actions and side effects may be increased by Biomebal suspension
This may not be a complete list of all interactions that may occur. Ask your health care provider if Biomebal suspension 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.
Biomebal precautions
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenesis
Long-term carcinogenicity studies have not been conducted.
Mutagenesis
Biomebal was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. Biomebal was genotoxic in one tester strain (TA 100) in the Ames bacterial mutation assay.
Impairment Of Fertility
Biomebal did not adversely affect male or female fertility in the rat at 2400 mg/kg/day (approximately 20 times the clinical adult dose adjusted for body surface area).
Use In Specific Populations
Pregnancy
Risk Summary
There are no data with Biomebal in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of Biomebal to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
Biomebal was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Biomebal produced no evidence of systemic maternal toxicity when administered once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis.
In rabbits, Biomebal administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20.
Oral treatment of pregnant rabbits with Biomebal during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies.
Lactation
Risk Summary
No information regarding the presence of Biomebal in human milk, the effects on the breastfed infant, or the effects on milk production is available. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Biomebal and any potential adverse effects on the breastfed infant from Biomebal or from the underlying maternal condition.
Pediatric Use
The safety and efficacy of Biomebal for
Oral Suspension for the treatment of diarrhea caused by
G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with Biomebal forOral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of Biomebal for
Oral Suspension for the treatment of diarrhea caused by
G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with Biomebal forOral Suspension 100 mg/5 mL.
The safety and efficacy of Biomebal Tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with Biomebal Tablets 500 mg.
A single Biomebal Tablet contains a greater amount of Biomebal than is recommended for use in pediatric patients 11 years or younger..
Safety and efficacy of Biomebal for
Oral Suspension in pediatric patients less than one year of age has not been studied.
Geriatric Use
Clinical studies of Biomebal Tablets and Biomebal for
Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Biomebal Tablets and Biomebal for
Oral Suspension.
Renal And Hepatic Impairment
The pharmacokinetics of Biomebal in patients with compromised renal or hepatic function has not been studied.
HIV-Infected Or Immunodeficient Patients
Biomebal Tablets and Biomebal for
Oral Suspension have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. Biomebal Tablets and Biomebal for
Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients.
What happens if I miss a dose of Biomebal?
Take the missed dose as soon as you remember. If you do not remember until it is time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of the medication.
References
- DailyMed. "NITAZOXANIDE: 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. "NITAZOXANIDE". http://www.drugbank.ca/drugs/DB00507 (accessed September 17, 2018).
- MeSH. "Antiparasitic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
