Tinidazole+Diloxanide+Simethicone
Nitroimidazole Antimicrobial [EPC]
What it is used for
for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.5) . 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies ( 14.1 )]. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia ) in both adults and pediatric patients older than three years of age [see Clinical Studies ( 14.2 )]. 1.3 Amebiasis Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage [see Clinical Studies ( 14.3 , 14.4 )]. 1.4 Bacterial Vaginosis Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in adult women [see Use in Specific Populations ( 8.1 ) and Clinical Studies ( 14.5 )] . Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis , Chlamydia trachomatis , Neisseria gonorrhoeae , Candida albicans and Herpes simplex virus should be ruled out. 1.5 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemology and susceptibility patterns may contribute to the empiric selection of therapy.
Warnings
5 WARNINGS AND PRECAUTIONS Seizures and neuropathy have been reported. Discontinue Tinidazole Tablets if abnormal neurologic signs develop ( 5.1 ) Vaginal candidiasis may develop with Tinidazole Tablets and require treatment with an antifungal agent ( 5.2 ) Use Tinidazole Tablets with caution in patients with blood dyscrasias. Tinidazole Tablets may produce transient leukopenia and neutropenia ( 5.3, 7.3 ) 5.1 Potential for Genotoxicity and Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole [see Nonclinical Toxicology ( 13.1 )] . Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. However, it is unclear if the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of Tinidazole Tablet. Use should be limited to approved indications only. Avoid chronic use. 5.2 Neurological Adverse Reactions Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with tinidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of tinidazole therapy. 5.3 Vaginal Candidiasis The use of tinidazole may result in Candida vaginitis. In a clinical study of 235 women who received tinidazole for bacterial vaginosis, a vaginal fungal infection developed in 11 (4.7%) of all study subjects [see Clinical Studies ( 14.5 )]. 5.4 Blood Dyscrasia Tinidazole should be used with caution in patients with evidence of or history of blood dyscrasia [see Drug Interactions ( 7.3 )]. 5.5 Development of Drug-Resistant Bacteria Prescribing Tinidazole Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Possible side effects
6 ADVERSE REACTIONS Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Among 3669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.) Other adverse reactions reported with tinidazole include: Central Nervous System: Two serious adverse reactions reported include convulsions and transient peripheral neuropathy including numbness and paresthesia [see Warnings and Precautions ( 5.1 )]. Other CNS reports include vertigo, ataxia, giddiness, insomnia, drowsiness. Gastrointestinal: tongue discoloration, stomatitis, diarrhea Hypersensitivity: urticaria, pruritis, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema Renal: darkened urine Cardiovascular: palpitations Hematopoietic: transient neutropenia, transient leukopenia Other: Candida overgrowth, increased vaginal discharge, oral candidiasis, hepatic abnormalities including raised transaminase level, arthralgias, myalgias, and arthritis. Table 1. Adverse Reactions Summary of Published Reports 2 g single dose Multi-day dose GI: Metallic/bitter taste 3.7% 6.3% Nausea 3.2% 4.5% Anorexia 1.5% 2.5% Dyspepsia/cramps/epigastric discomfort 1.8% 1.4% Vomiting 1.5% 0.9% Constipation 0.4% 1.4% CNS: Weakness/fatigue/malaise 2.1% 1.1% Dizziness 1.1% 0.5% Other: Headache 1.3% 0.7% Total patients with adverse reactions 11.0% (403/3669) 13.8% (244/1765) Rare reported adverse reactions include bronchospasm, dyspnea, coma, confusion, depression, furry tongue, pharyngitis and reversible thrombocytopenia. Adverse Reactions in Pediatric Patients: In pooled pediatric studies, adverse reactions reported in pediatric patients taking tinidazole were similar in nature and frequency to adult findings including nausea, vomiting, diarrhea, taste change, anorexia, and abdominal pain. Bacterial vaginosis: The most common adverse reactions in treated patients (incidence >2%), which were not identified in the trichomoniasis, giardiasis and amebiasis studies, are gastrointestinal: decreased appetite, and flatulence; renal: urinary tract infection, painful urination, and urine abnormality; and other reactions including pelvic pain, vulvo-vaginal discomfort, vaginal odor, menorrhagia, and upper respiratory tract infection [See Clinical Studies ( 14.5 )]. 6.2 Postmarketing Experience The following adverse reactions have been identified and reported during post-approval use of Tinidazole Tablets. Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure. Tinidazole: Severe acute hypersensitivity reactions have been reported on initial or subsequent exposure to tinidazole. Hypersensitivity reactions may include urticaria, pruritis, angioedema, Stevens-Johnson syndrome and erythema multiforme. Metronidazole, Another Nitroimidazole Product, Structurally Related to Tinidazole: Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after intiation of systemic use of metronidazole, another nitroimidazole agent structurally related to tinidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days) [see Contraindications ( 4 )].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Tinidazole Tablets USP 250 mg are pink color, circular shaped film coated scored tablets with "250" debossed on one side and " T│P" on the other side, supplied in bottles with child-resistant caps as: NDC 64980-426-02 Bottle of 20 Tinidazole Tablets USP 500 mg are pink color, capsule shaped film coated scored tablets with "500" debossed on one side and " T│P" on the other side, supplied in bottles with child-resistant caps as: NDC 64980-427-12 Bottle of 12 Storage: Store at controlled room temperature 20-25° C (68-77° F); excursions permitted to 15-30° C (59-86° F) [see USP]. Protect contents from light.
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