Drugs Details

Drugs Info of Tindamax
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Jun 2015 05:37 am
  • Brand Name : Tindamax
  • Generic Name :  tinidazole (Pronunciation: tye NYE da zole)
Descriptions

Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:

Tindamax  (tinidazole) structural formula illustration

Tindamax pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include croscarmellose sodium, FD&C Red 40 lake, FD&C Yellow 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized corn starch, titanium dioxide, and triacetin.

What are the possible side effects of tinidazole (Tindamax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • numbness, burning pain, or tingly feeling; or
  • seizure (convulsions).

Less serious side effects may include:

  • vaginal itching or discharge;
  • nausea, vomiting, loss of appetite, indigestion;
  • constipation, diarrhea, stomach cramps;
  • feeling weak or...

Read All Potential Side Effects and See Pictures of Tindamax »

What are the precautions when taking tinidazole (Tindamax)?

Before taking tinidazole, tell your doctor or pharmacist if you are allergic to it; or to metronidazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., low white blood cells), brain or nervous system disorders (e.g., neuropathy, seizures), untreated fungal/yeast infection, kidney dialysis, liver disease.

While taking this medication and for at least 3 days after your last dose, do not drink alcoholic beverages or take products that contain alcohol/propylene glycol. Doing so may cause severe stomach upset, nausea, vomiting,...

Read All Potential Precautions of Tindamax »

Indications

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].

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].

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].

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 non-pregnant women [see Use in Specific Populations and CLINICAL STUDIES].

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tindamax (tinidazole) and other antibacterial drugs, Tindamax (tinidazole) 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 epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosage Administration

Dosing Instructions

It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole [see CLINICAL PHARMACOLOGY].

Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [see DRUG INTERACTIONS].

Compounding of the Oral Suspension

For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup to be taken with food.

Procedure for Extemporaneous Pharmacy Compounding of the Oral Suspension: Pulverize four 500 mg oral tablets with a mortar and pestle. Add approximately 10 mL of cherry syrup to the powder and mix until smooth. Transfer the suspension to a graduated amber container. Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a final volume of 30 mL. The suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature. When this suspension is used, it should be shaken well before each administration.

Trichomoniasis

The recommended dose in both females and males is a single 2 g oral dose taken with food. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time.

Giardiasis

The recommended dose in adults is a single 2 g dose taken with food. In pediatric patients older than three years of age, the recommended dose is a single dose of 50 mg/kg (up to 2 g) with food.

Amebiasis

Intestinal: The recommended dose in adults is a 2 g dose per day for 3 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 days with food.

Amebic Liver Abscess: The recommended dose in adults is a 2 g dose per day for 3-5 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without additional reported adverse reactions. Children should be closely monitored when treatment durations exceed 3 days.

Bacterial Vaginosis

The recommended dose in non-pregnant females is a 2 g oral dose once daily for 2 days taken with food or a 1 g oral dose once daily for 5 days taken with food. The use of tinidazole in pregnant patients has not been studied for bacterial vaginosis.

Dosage Forms And Strengths

  • 250 mg tablets are pink, round, scored tablets, with TM debossed on one side and 250 on the other
  • 500 mg tablets are pink, oval, scored tablets, with TM debossed on one side and 500 on the other

How Supplied

Storage And Handling

Tindamax (tinidazole) 250 mg tablets are pink, round, scored tablets, with TM debossed on one side and 250 on the other, supplied in bottles with child-resistant caps as:

NDC 0178-8250-40 Bottle of 40

Tindamax (tinidazole) 500 mg tablets are pink, oval, scored tablets, with TM debossed on one side and 500 on the other, supplied in bottles with child-resistant caps as:

NDC 0178-8500-60 Bottle of 60

NDC 0178-8500-20 Bottle of 20

Professional Samples:

NDC 0178-8500-04 Bottle of 4

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.

Side Effects

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]. 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].

Postmarketing Experience

The following adverse reactions have been identified and reported during post-approval use of Tindamax (tinidazole) . 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.

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.

Read the Tindamax (tinidazole) Side Effects Center for a complete guide to possible side effects

Interactions

Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole.

Potential Effects of Tinidazole on Other Drugs

Warfarin and Other Oral Coumarin Anticoagulants: As with metronidazole, tinidazole may enhance the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The dosage of oral anticoagulants may need to be adjusted during tinidazole co-administration and up to 8 days after discontinuation.

Alcohols, Disulfiram: Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during tinidazole therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients using metronidazole and disulfiram concurrently. Though no similar reactions have been reported with tinidazole, tinidazole should not be given to patients who have taken disulfiram within the last two weeks.

Lithium: Metronidazole has been reported to elevate serum lithium levels. It is not known if tinidazole shares this property with metronidazole, but consideration should be given to measuring serum lithium and creatinine levels after several days of simultaneous lithium and tinidazole treatment to detect potential lithium intoxication.

Phenytoin, Fosphenytoin: Concomitant administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin. Metronidazole did not significantly affect the pharmacokinetics of orally-administered phenytoin.

Cyclosporine, Tacrolimus: There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During tinidazole co-administration with either of these drugs, the patient should be monitored for signs of calcineurin-inhibitor associated toxicities.

Fluorouracil: Metronidazole was shown to decrease the clearance of fluorouracil, resulting in an increase in side-effects without an increase in therapeutic benefits. If the concomitant use of tinidazole and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities.

Potential Effects of Other Drugs on Tinidazole

CYP3A4 Inducers and Inhibitors: Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole, decreasing the plasma level of tinidazole. Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole.

Cholestyramine: Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and tinidazole to minimize any potential effect on the oral bioavailability of tinidazole.

Oxytetracycline: Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole.

Laboratory Test Interactions

Tinidazole, like metronidazole, may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD + ↔ NADH). Potential interference is due to the similarity of absorbance peaks of NADH and tinidazole.

Tinidazole, like metronidazole, may produce transient leukopenia and neutropenia; however, no persistent hematological abnormalities attributable to tinidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended if re-treatment is necessary.

Read the Tindamax Drug Interactions Center for a complete guide to possible interactions

Warnings

Included as part of the PRECAUTIONS section.

Precautions

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.

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].

Blood Dyscrasia

Tinidazole should be used with caution in patients with evidence of or history of blood dyscrasia [see DRUG INTERACTIONS].

Drug Resistance

Prescribing Tindamax (tinidazole) 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Metronidazole, a chemically-related nitroimidazole, has been reported to be carcinogenic in mice and rats but not hamsters. In several studies metronidazole showed evidence of pulmonary, hepatic, and lymphatic tumorigenesis in mice and mammary and hepatic tumors in female rats. Tinidazole carcinogenicity studies in rats, mice or hamsters have not been reported.

Tinidazole was mutagenic in the TA 100, S. typhimurium tester strain both with and without the metabolic activation system and was negative for mutagenicity in the TA 98 strain. Mutagenicity results were mixed (positive and negative) in the TA 1535, 1537, and 1538 strains. Tinidazole was also mutagenic in a tester strain of Klebsiella pneumonia. Tinidazole was negative for mutagenicity in a mammalian cell culture system utilizing Chinese hamster lung V79 cells (HGPRT test system) and negative for genotoxicity in the Chinese hamster ovary (CHO) sister chromatid exchange assay. Tinidazole was positive for in vivo genotoxicity in the mouse micronucleus assay.

In a 60-day fertility study, tinidazole reduced fertility and produced testicular histopathology in male rats at a 600 mg/kg/day dose level (approximately 3-fold the highest human therapeutic dose based upon body surface area conversions). Spermatogenic effects resulted from 300 and 600 mg/kg/day dose levels. The no observed adverse reaction level for testicular and spermatogenic effects was 100 mg/kg/day (approximately 0.5-fold the highest human therapeutic dose based upon body surface area conversions). This effect is characteristic of agents in the 5-nitroimidazole class.

Use In Specific Populations

Pregnancy
Teratogenic effects: Pregnancy Category C

The use of tinidazole in pregnant patients has not been studied. Since tinidazole crosses the placental barrier and enters fetal circulation it should not be administered to pregnant patients in the first trimester.

Embryo-fetal developmental toxicity studies in pregnant mice indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in rat neonates following maternal doses as high as 600 mg/kg (3-fold the highest human therapeutic dose based upon body surface area conversions). Although there is some evidence of mutagenic potential and animal reproduction studies are not always predictive of human response, the use of tinidazole after the first trimester of pregnancy requires that the potential benefits of the drug be weighed against the possible risks to both the mother and the fetus.

Nursing Mothers

Tinidazole is excreted in breast milk in concentrations similar to those seen in serum. Tinidazole can be detected in breast milk for up to 72 hours following administration. Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.

Pediatric Use

Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established.

Pediatric Administration: For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup, to be taken with food [see DOSAGE AND ADMINISTRATION].

Geriatric Use

Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment

Because the pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from those in healthy subjects, no dose adjustments are necessary in these patients. Patients undergoing hemodialysis: If tinidazole is administered on the same day as and prior to hemodialysis, it is recommended that an additional dose of tinidazole equivalent to one-half of the recommended dose be administered after the end of the hemodialysis [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function. Reduced elimination of metronidazole, a chemically-related nitroimidazole, has been reported in this population. Usual recommended doses of tinidazole should be administered cautiously in patients with hepatic dysfunction [see CLINICAL PHARMACOLOGY].

OverDose

There are no reported overdoses with tinidazole in humans.

Treatment of Overdosage: There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.

ContrainDications

The use of tinidazole is contraindicated:

  • In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [see ADVERSE REACTIONS].
  • During first trimester of pregnancy [see Use in Specific Populations].
  • In nursing mothers: Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose [see Use in Specific Populations].

Clinical Pharamacology

Mechanism of Action

Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology].

Pharmacokinetics

Absorption: After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tindamax (tinidazole) tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of Tindamax (tinidazole) following an overnight fast. Oral administration of four 500 mg tablets of Tindamax (tinidazole) under fasted conditions produced a mean peak plasma concentration (Cmax) of 47.7 (±7.5) µg/mL with a mean time to peak concentration (Tmax) of 1.6 (±0.7) hours, and a mean area under the plasma concentration-time curve (AUC, 0-∞) of 901.6 (± 126.5) µg/hr/mL at 72 hours. The elimination half-life (T½) was 13.2 (±1.4) hours. Mean plasma levels decreased to 14.3 µg/mL at 24 hours, 3.8 µg/mL at 48 hours and 0.8 µg/mL at 72 hours following administration. Steady-state conditions are reached in 2½ - 3 days of multi-day dosing.

Administration of Tindamax (tinidazole) tablets with food resulted in a delay in Tmax of approximately 2 hours and a decline in Cmax of approximately 10%, compared to fasted conditions. However, administration of Tindamax (tinidazole) with food did not affect AUC or T½ in this study.

In healthy volunteers, administration of crushed Tindamax (tinidazole) tablets in artificial cherry syrup, [prepared as described in DOSAGE AND ADMINISTRATION] after an overnight fast had no effect on any pharmacokinetic parameter as compared to tablets swallowed whole under fasted conditions.

Distribution: Tinidazole is distributed into virtually all tissues and body fluids and also crosses the blood-brain barrier. The apparent volume of distribution is about 50 liters. Plasma protein binding of tinidazole is 12%. Tinidazole crosses the placental barrier and is secreted in breast milk.

Metabolism: Tinidazole is significantly metabolized in humans prior to excretion. Tinidazole is partly metabolized by oxidation, hydroxylation, and conjugation. Tinidazole is the major drug-related constituent in plasma after human treatment, along with a small amount of the 2-hydroxymethyl metabolite.

Tinidazole is biotransformed mainly by CYP3A4. In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 µg/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4.

The potential of tinidazole to induce the metabolism of other drugs has not been evaluated.

Elimination: The plasma half-life of tinidazole is approximately 12-14 hours. Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.

Patients with impaired renal function: The pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from the pharmacokinetics seen in healthy subjects.

However, during hemodialysis, clearance of tinidazole is significantly increased; the half-life is reduced from 12.0 hours to 4.9 hours. Approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session [See Use in Specific Populations]. The pharmacokinetics of tinidazole in patients undergoing routine continuous peritoneal dialysis have not been investigated.

Patients with impaired hepatic function: There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function. Reduction of metabolic elimination of metronidazole, a chemically-related nitroimidazole, in patients with hepatic dysfunction has been reported in several studies [See Use in Specific Populations].

Microbiology

Mechanism of Action: Tinidazole is an antiprotozoal, antibacterial agent. The nitro- group of tinidazole is reduced by cell extracts of Trichomonas. The free nitro- radical generated as a result of this reduction may be responsible for the antiprotozoal activity. Chemically reduced tinidazole was shown to release nitrites and cause damage to purified bacterial DNA in vitro. Additionally, the drug caused DNA base changes in bacterial cells and DNA strand breakage in mammalian cells. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known.

Antibacterial: Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see INDICATIONS AND USAGE]; standard methodology for the susceptibility testing of potential bacterial pathogens, Gardnerella vaginalis, Mobiluncus spp. or Mycoplasma hominis, has not been defined. The following in vitro data are available, but their clinical significance is unknown. Tinidazole is active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

Bacteroides spp.

Gardnerella vaginalis

Prevotella spp.

Tinidazole does not appear to have activity against most strains of vaginal lactobacilli.

Antiprotozoal: Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa: Trichomonas vaginalis; Giardia duodenalis (also termed G. lamblia); and Entamoeba histolytica.

For protozoal parasites, standardized susceptibility tests do not exist for use in clinical microbiology laboratories.

Drug Resistance: The development of resistance to tinidazole by G. duodenalis, E. histolytica, or bacteria associated with bacterial vaginosis has not been examined.

Cross-resistance: Approximately 38% of T. vaginalis isolates exhibiting reduced susceptibility to metronidazole also show reduced susceptibility to tinidazole in vitro. The clinical significance of such an effect is not known.

Animal Toxicology and/or Pharmacology

In acute studies with mice and rats, the LD50 for mice was generally > 3,600 mg/kg for oral administration and was > 2,300 mg/kg for intraperitoneal administration. In rats, the LD50 was > 2,000 mg/kg for both oral and intraperitoneal administration.

A repeated-dose toxicology study has been performed in beagle dogs using oral dosing of tinidazole at 100 mg/kg/day, 300 mg/kg/day, and 1000 mg/kg/day for 28-days. On Day 18 of the study, the highest dose was lowered to 600/mg/kg/day due to severe clinical symptoms. The two compound-related effects observed in the dogs treated with tinidazole were increased atrophy of the thymus in both sexes at the middle and high doses, and atrophy of the prostate at all doses in the males. A no-adverse-effect level (NOAEL) of 100 mg/kg/day for females was determined. There was no NOAEL identified for males because of minimal atrophy of the prostate at 100/mg/kg/day (approximately 0.9-fold the highest human dose based upon plasma AUC comparisons).

Clinical Studies

Trichomoniasis

Tinidazole (2 g single oral dose) use in trichomoniasis has been well documented in 34 published reports from the world literature involving over 2,800 patients treated with tinidazole. In four published, blinded, randomized, comparative studies of the 2 g tinidazole single oral dose where efficacy was assessed by culture at time points post-treatment ranging from one week to one month, reported cure rates ranged from 92% (37/40) to 100% (65/65) (n=172 total subjects). In four published, blinded, randomized, comparative studies where efficacy was assessed by wet mount between 7-14 days post-treatment, reported cure rates ranged from 80% (8/10) to 100% (16/16) (n=116 total subjects). In these studies, tinidazole was superior to placebo and comparable to other anti-trichomonal drugs. The single oral 2 g tinidazole dose was also assessed in four open-label trials in men (one comparative to metronidazole and 3 single-arm studies). Parasitological evaluation of the urine was performed both pre- and post-treatment and reported cure rates ranged from 83% (25/30) to 100% (80/80) (n=142 total subjects).

Giardiasis

Tinidazole (2 g single dose) use in giardiasis has been documented in 19 published reports from the world literature involving over 1,600 patients (adults and pediatric patients). In eight controlled studies involving a total of 619 subjects of whom 299 were given the 2 g x 1 day (50 mg/kg x 1 day in pediatric patients) oral dose of tinidazole, reported cure rates ranged from 80% (40/50) to 100% (15/15). In three of these trials where the comparator was 2 to 3 days of various doses of metronidazole, reported cure rates for metronidazole were 76% (19/25) to 93% (14/15). Data comparing a single 2 g dose of tinidazole to usually recommended 5-7 days of metronidazole are limited.

Intestinal Amebiasis

Tinidazole use in intestinal amebiasis has been documented in 26 published reports from the world literature involving over 1,400 patients. Most reports utilized tinidazole 2 g/day x 3 days. In four published, randomized, controlled studies (1 investigator single-blind, 3 open-label) of the 2 g/day x 3 days oral dose of tinidazole, reported cure rates after 3 days of therapy among a total of 220 subjects ranged from 86% (25/29) to 93% (25/27).

Amebic Liver Abscess

Tinidazole use in amebic liver abscess has been documented in 18 published reports from the world literature involving over 470 patients. Most reports utilized tinidazole 2 g/day x 2-5 days. In seven published, randomized, controlled studies (1 double-blind, 1 single-blind, 5 open-label) of the 2 g/day x 2-5 days oral dose of tinidazole accompanied by aspiration of the liver abscess when clinically necessary, reported cure rates among 133 subjects ranged from 81% (17/21) to 100% (16/16). Four of these studies utilized at least 3 days of tinidazole.

Bacterial Vaginosis

A randomized, double-blind, placebo-controlled clinical trial in 235 non-pregnant women was conducted to evaluate the efficacy of tinidazole for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was based on Amsel's criteria and defined by the presence of an abnormal homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains ≥20% clue cells on microscopic examination. Clinical cure required a return to normal vaginal discharge and resolution of all Amsel's criteria. A microbiologic diagnosis of bacterial vaginosis was based on Gram stain of the vaginal smear demonstrating (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells, with quantification of these bacterial morphotypes to determine the Nugent score, where a score ≥4 was required for study inclusion and a score of 0-3 considered a microbiologic cure. Therapeutic cure was a composite endpoint, consisting of both a clinical cure and microbiologic cure. In patients with all four Amsel's criteria and with a baseline Nugent score ≥4, tinidazole oral tablets given as either 2 g once daily for 2 days or 1 g once daily for 5 days demonstrated superior efficacy over placebo tablets as measured by therapeutic cure, clinical cure, and a microbiologic cure.

Table 2. Efficacy of Tindamax (tinidazole) in the Treatment of Bacterial Vaginosis in a Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial: Modified Intent-to-Treat Population1 (n=227)

 

Outcome Tindamax (tinidazole)
1 g x 5 days
(n=76)
Tindamax (tinidazole)
2 g x 2 days
(n=73)
Placebo
(n=78)
  % Cure % Cure % Cure
Therapeutic Cure 36.8 27.4 5.1
  Difference2
  97.5% CI3
31.7
(16.8, 46.6)
22.3
(8.0, 36.6)
 
Clinical Cure 51.3 35.6 11.5
  Difference2
  97.5% CI3
39.8
(23.3, 56.3)
24.1
(7.8, 40.3)
 
Nugent Score Cure 38.2 27.4 5.1
  Difference2
  97.5% CI3
33.1
(18.1, 48.0)
22.3
(8.0, 36.6)
 
1Modified Intent-to-Treat defined as all patients randomized with a baselineNugent score of at least 4
2Difference in cure rates (Tindamax (tinidazole) -placebo)
3CI: confidence interval
p-values for both Tindamax (tinidazole) regimens vs. placebo for therapeutic, clinical andNugent score cure rates for both 2 and 5 days <0.001

The therapeutic cure rates reported in this clinical study conducted with Tindamax (tinidazole) were based on resolution of 4 out of 4 Amsel's criteria and a Nugent score of <4. The cure rates for previous clinical studies with other products approved for bacterial vaginosis were based on resolution of either 2 or 3 out of 4 Amsel's criteria. At the time of approval for other products for bacterial vaginosis, there was no requirement for a Nugent score on Gram stain, resulting in higher reported rates of cure for bacterial vaginosis for those products than for those reported here for tinidazole.

Patient Information

Administration of Drug

Patients should be told to take Tindamax (tinidazole) with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.

Alcohol Avoidance

Patients should be told to avoid alcoholic beverages and preparations containing ethanol or propylene glycol during Tindamax (tinidazole) therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.

Drug Resistance

Patients should be counseled that antibacterial drugs including Tindamax (tinidazole) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tindamax (tinidazole) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tindamax (tinidazole) or other antibacterial drugs in the future.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

TINIDAZOLE - ORAL

 

(tye-NI-da-zole)

 

COMMON BRAND NAME(S): Tindamax

 

USES: Tinidazole is used to treat certain types of vaginal infections (bacterial vaginosis, trichomoniasis). It is also used to treat certain types of parasite infections (giardiasis, amebiasis). It belongs to a class of antibiotics known as nitroimidazoles. It works by stopping the growth of bacteria and protozoa.

This medication only treats bacterial and protozoal infections. It will not work for virus infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

 

HOW TO USE: To prevent stomach upset, take this medication with food as directed by your doctor. Your doctor may direct you to take a single dose or take it once daily for 2 to 5 days. Dosage is based on your medical condition, the type of infection being treated, and your response to treatment. In children, the dose is also based on weight. Most adults will need to take more than 1 tablet for each dose. Follow the doctor's directions closely.

If you have trouble swallowing tablets, the tablets may be crushed and mixed in food, or your pharmacist can make a suspension in syrup. If your pharmacist has prepared a suspension, shake the bottle well before each dose.

Tinidazole works best when the amount of medicine in your body is kept at a constant level. If you are taking this drug for more than one day, take it at the same time each day.

Certain medications may decrease the absorption of tinidazole. If you are taking cholestyramine or colestipol, wait at least 2 hours after your tinidazole dose before taking either of these products.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Consumer Overview Side Effect

SIDE EFFECTS: Bitter/metallic taste in the mouth, nausea, vomiting, upset stomach, stomach cramps/pain, loss of appetite, constipation, diarrhea, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This drug may cause your tongue or urine to darken. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness/feeling of spinning (vertigo), unsteadiness.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/irregular/pounding heartbeat, numbness/tingling in arms/legs, signs of a new infection (e.g., fever, persistent sore throat), seizures.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Tindamax (tinidazole) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking tinidazole, tell your doctor or pharmacist if you are allergic to it; or to metronidazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., low white blood cells), brain or nervous system disorders (e.g., neuropathy, seizures), untreated fungal/yeast infection, kidney dialysis, liver disease.

While taking this medication and for at least 3 days after your last dose, do not drink alcoholic beverages or take products that contain alcohol/propylene glycol. Doing so may cause severe stomach upset, nausea, vomiting, headaches, and flushing. Consult your pharmacist for further information.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug and for at least 3 days after finishing this medicine. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

The following medication should not be used while taking this drug or for 2 weeks after your last dose because a very serious interaction may occur: disulfiram.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting tinidazole.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), cyclosporine, fluorouracil, lithium, oxytetracycline, tacrolimus, drugs affecting liver enzymes that remove tinidazole from your body (e.g., cimetidine, certain anti-seizure medicines such as carbamazepine, fosphenytoin, phenytoin, phenobarbital, azole antifungals such as ketoconazole, macrolide antibiotic such as erythromycin, rifamycins such as rifampin, St. John's wort).

This drug may affect the results of certain laboratory tests (e.g., liver enzymes, triglycerides). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

If you are being treated for a certain infection (trichomoniasis), all sexual partners may also need treatment to avoid re-infection. During treatment, avoid sexual intercourse, or always use latex or polyurethane condoms.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be needed in that case.

Laboratory and/or medical tests (e.g., liver function tests, blood counts) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature at 68-77 degrees F (20-25 degrees C) away from heat, light, and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Discard any unused liquid suspension after 7 days.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Patient Detailed Side Effect

Brand Names: Tindamax

Generic Name: tinidazole (Pronunciation: tye NYE da zole)

  • What is tinidazole (Tindamax)?
  • What are the possible side effects of tinidazole (Tindamax)?
  • What is the most important information I should know about tinidazole (Tindamax)?
  • What should I discuss with my healthcare provider before taking tinidazole (Tindamax)?
  • How should I take tinidazole (Tindamax)?
  • What happens if I miss a dose (Tindamax)?
  • What happens if I overdose (Tindamax)?
  • What should I avoid while taking tinidazole (Tindamax)?
  • What other drugs will affect tinidazole (Tindamax)?
  • Where can I get more information?

What is tinidazole (Tindamax)?

Tinidazole is an antibiotic that fights bacteria in the body.

Tinidazole is used to treat certain infections caused by bacteria, such as infection of the intestines or vagina. It is also used to treat certain sexually transmitted infections.

Tinidazole may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of tinidazole (Tindamax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • numbness, burning pain, or tingly feeling; or
  • seizure (convulsions).

Less serious side effects may include:

  • vaginal itching or discharge;
  • nausea, vomiting, loss of appetite, indigestion;
  • constipation, diarrhea, stomach cramps;
  • feeling weak or tired;
  • headache, dizziness; or
  • a metallic or bitter taste in your mouth;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Tindamax (tinidazole) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about tinidazole (Tindamax)?

You should not use this medication if you are allergic to tinidazole or metronidazole (Flagyl), or if you are in the first 3 months of pregnancy.

You should not breast-feed a baby while you are taking tinidazole. However, you may begin nursing again 3 days after you take the last dose. Do not keep any milk you collect with a breast pump while you are taking tinidazole.

Before you take tinidazole, tell your doctor if you have kidney disease (or if you are on dialysis), epilepsy or other seizure disorder, a blood cell disorder such as anemia or low platelets, or a weak immune system.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Tinidazole will not treat a viral infection such as the common cold or flu.

Do not drink alcohol while taking tinidazole and for at least 3 days after your treatment ends.

A medicine similar to tinidazole has caused cancer in laboratory animals. It is not known if tinidazole would have the same effect in animals, or in humans. Talk with your doctor about your individual risk.

Side Effects Centers
  • Tindamax

Patient Detailed How Take

What should I discuss with my healthcare provider before taking tinidazole (Tindamax)?

You should not use this medication if you are allergic to tinidazole or metronidazole (Flagyl), or if you are in the first 3 months of pregnancy.

Tinidazole can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are taking tinidazole and for at least 3 days after your last dose.

You may begin nursing again 3 days after your last dose or tinidazole. If you use a breast pump during treatment, throw out any milk you collect while taking tinidazole. Do not feed it to your baby.

To make sure you can safely take tinidazole, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis);
  • epilepsy or other seizure disorder;
  • a blood cell disorder such as anemia or low platelets; or
  • a weak immune system.

FDA pregnancy category C. Do not take tinidazole during the first 3 months of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

A medicine similar to tinidazole has caused cancer in laboratory animals. It is not known if tinidazole would have the same effect in animals, or in humans. Talk with your doctor about your individual risk.

How should I take tinidazole (Tindamax)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take tinidazole with food.

Some infections are treated with only one dose. Follow your doctor's instructions.

Do not share this medication with another person, even if they have the same symptoms you have.

If you are treating a sexually transmitted infection, make sure your sexual partner seeks medical attention to be treated also.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Tinidazole will not treat a viral infection such as the common cold or flu.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Tindamax

Patient Detailed Avoid Taking

What happens if I miss a dose (Tindamax)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Tindamax)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tinidazole (Tindamax)?

Do not drink alcohol while taking tinidazole and for at least 3 days after your treatment ends. You may have unpleasant side effects such as fast heartbeats, severe nausea, vomiting, sweating, and warmth or tingling under your skin.

Check the label of the products and other medicines you use, such as mouthwash or cough and cold medicines. Alcohol in these products can also cause a reaction if you use them while taking tinidazole.

What other drugs will affect tinidazole (Tindamax)?

Tell your doctor about all other medicines you use, especially:

  • any other antibiotic;
  • a blood thinner such as warfarin (Coumadin);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • fluorouracil (Adrucil, Efudex, Carac, Flurorplex);
  • isoniazid (for treating tuberculosis);
  • lithium (Lithobid, Eskalith);
  • St. John's wort;
  • tacrolimus (Prograf);
  • an antidepressant such as nefazodone;
  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);
  • a barbiturate such as phenobarbital (Solfoton) and others;
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir); or
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Solfoton), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with tinidazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about tinidazole.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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