What are the possible side effects of Givotan?
Stop taking Givotan and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take the medication and talk to your doctor if you experience
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abdominal pain;
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nausea;
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diarrhea;
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vomiting; or
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headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Givotan in details
Givotan Tablets: In controlled and uncontrolled clinical studies of 1,657 HIV-uninfected patients age 12 years and older who received various dosage regimens of Givotan Tablets, the most common adverse events reported regardless of causality assessment were: abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo. In placebo-controlled trials of HIV-uninfected patients age 12 years and older who received Givotan Tablets for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum, less than 1% of patients discontinued therapy because of an adverse event.
Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Givotan Tablets are listed below:
Body as a Whole: asthenia, fever, pain, allergic reaction, pelvic pain, back pain, chills, chills and fever, flu syndrome.
Nervous System: dizziness, somnolence, insomnia, tremor, hypesthesia.
Digestive System: vomiting, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst.
Urogenital System: discolored urine, dysuria, amenorrhea, metrorrhagia, kidney pain, edema labia.
Metabolic & Nutrition: increased SGPT.
Hemic & Lymphatic Systems: anemia, leukocytosis.
Skin: rash, pruritus.
Special Senses: eye discoloration, ear ache.
Respiratory System: epistaxis, lung disease, pharyngitis.
Cardiovascular System: tachycardia, syncope, hypertension.
Muscular System: myalgia, leg cramps, spontaneous bone fracture.
Givotan for
Oral Suspension: In controlled and uncontrolled clinical studies of 613 HIV-uninfected pediatric patients who received Givotan for
Oral Suspension, the most frequent adverse events reported regardless of causality assessment were: abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials, the rates of occurrence of these events did not differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of adverse events.
Adverse events occurring in less than 1% of the pediatric patients participating in clinical trials of Givotan for
Oral Suspension are listed below:
Digestive System: nausea, anorexia, flatulence, appetite increase, enlarged salivary glands.
Body as a Whole: fever, infection, malaise.
Metabolic & Nutrition: increased creatinine, increased SGPT.
Skin: pruritus, sweat.
Special Senses: eye discoloration (pale yellow).
Respiratory System: rhinitis.
Nervous System: dizziness.
Urogenital System: discolored urine.
The adverse events seen in adult patients treated with Givotan for
Oral Suspension were similar to those observed in adult patients treated with Givotan Tablets.
OVERDOSAGE
Information on Givotan overdosage is not available. In acute studies in rodents and dogs, the oral LD 50 was higher than 10,000 mg/kg. Single oral doses of up to 4,000 mg Givotan 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 carefully observed and given symptomatic and supportive treatment.
What is the most important information I should know about Givotan?
- Givotan suspension may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Givotan suspension. Using Givotan suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Diabetes patients - Givotan suspension contains sucrose.
- Use Givotan suspension with extreme caution in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Givotan suspension, discuss with your doctor the benefits and risks of using Givotan suspension during pregnancy. It is not known if Givotan suspension is excreted in breast milk. If you are or will be breast-feeding, check with your doctor or pharmacist to discuss the risk to your baby.
Givotan contraindications
Hypersensitivity
Givotan Tablets and Givotan for
Oral Suspension are contraindicated in patients with a prior hypersensitivity to Givotan or any other ingredient in the formulations.
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).
- DTP/NCI. "NITAZOXANIDE: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "o-[N-(5-nitrothiazol-2-yl)carbamoyl]phenyl acetate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Givotan are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Givotan. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
