Tindamax (tinidazole)

What is Tindamax, and how does it work?

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.

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. Sections or subsections omitted from the full prescribing information are not listed.

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.

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.

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 and other antibacterial drugs, Tindamax 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.

What are the side effects of Tindamax?

WARNING

POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic 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. 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

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.

Postmarketing Experience

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

What is the dosage for Tindamax?

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.
• Alcoholic beverages should be avoided when taking tinidazole and for 3
  days afterwards

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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

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  What drugs interact with Tindamax?

  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

  Is Tindamax safe to use while pregnant or breastfeeding?

  • 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.
  • 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.