Tindamax

Name: Tindamax

Adverse Effects

1-10%

Anorexia (2-3%)

Constipation (<1%)

Dizziness (<1%)

Dysgeusia (4-6%)

Dyspepsia (1-2%)

Headache (<1%)

Nausea (3-5%)

Vomiting (1-2%)

Weakness/fatigue/malaise (1-2%)

Frequency Not Defined

Ataxia

Candida overgrowth

Convulsions & transient peripheral neuropathy

Numbness & paresthesia

Diarrhea

Darkened urine

Tongue discoloration

Transient leukopenia/neutropenia

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to tinidazole. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking tinidazole.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the tinidazole, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

What Is Tinidazole?

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.

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.

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.

Clinical pharmacology

Mechanism Of Action

Tinidazole is an antiprotozoal, antibacterial agent. [See Microbiology].

Pharmacokinetics

Absorption

After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tindamax tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of Tindamax following an overnight fast. Oral administration of four 500 mg tablets of Tindamax 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 (T1/2) 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 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 with food did not affect AUC or T1/2 in this study.

In healthy volunteers, administration of crushed Tindamax tablets in artificial cherry syrup, [prepared as described in Dosage and Administration (2.2)] 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 × 1 day (50 mg/kg × 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 × 3 days. In four published, randomized, controlled studies (1 investigator single-blind, 3 open-label) of the 2 g/day × 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 × 2-5 days. In seven published, randomized, controlled studies (1 double-blind, 1 single-blind, 5 open-label) of the 2 g/day × 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 in the Treatment of Bacterial Vaginos is in a Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial: Modified Intent-to-Treat Population1 (n=227)

Outcome Tindamax 1 g x 5 days
(n=76)
Tindamax 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 Difference2
97.5% CI3
38.2 33.1
(18.1, 48.0)
27.4 22.3
(8.0, 36.6)
5.1
1Modified Intent-to-Treat defined as all patients randomized with a baseline Nugent score of at least 4
2Difference in cure rates (Tindamax-placebo)
3CI: confidence interval
p-values for both Tindamax regimens vs. placebo for therapeutic, clinical and Nugent score cure rates for both 2 and 5 days < 0.001

The therapeutic cure rates reported in this clinical study conducted with Tindamax 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.

Tindamax Overview

Tindamax is a prescription medication used to treat trichomoniasis (an STD), giardiasis (an infection of the intestine), and amebiasis (an infection of the intestine). It is also used to treat bacterial vaginosis. This is a a condition where the normal balance of bacteria in the vagina is disrupted. Tindamax belongs to a group of drugs called antiprotozoal agents. These work by killing the organisms that can cause infection.

This medication comes in tablet form and is typically taken once daily with food.

Common side effects of Tindamax include a metallic or bitter taste, nausea, weakness, upset stomach, and headache. Tindamax can also cause dizziness. Do not drive or operate heavy machinery until you know how Tindamax affects you.

Uses of Tindamax

Tindamax is a prescription medication used to treat trichomoniasis (an STD), giardiasis (an infection of the intestine), and amebiasis (an infection of the intestine). It is also used to treat bacterial vaginosis.

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

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.

What should I avoid while taking tinidazole?

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.

Interactions for Tindamax

Metabolized principally by CYP3A4.1

Does not inhibit CYP1A2, 2B6, 2C9, 2D6, 2E1, or 3A4 in vitro.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma tinidazole concentrations).1

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma tinidazole concentrations).1

Specific Drugs and Laboratory Tests

No formal drug interaction studies performed with tinidazole to date; interactions reported with metronidazole (a chemically similar nitroimidazole) may occur with tinidazole.1

Drug or Test

Interaction

Comments

Alcohol

Alcoholic beverages or preparations containing alcohol or propylene glycol may cause abdominal cramps, nausea, vomiting, headaches, and flushing 1

Avoid alcoholic beverages and preparations containing alcohol or propylene glycol during or for 3 days following completion of tinidazole therapy1

Anticoagulants, oral (warfarin)

Possible increased PT and enhanced anticoagulant effects1

Monitor PT and warfarin dosage carefully during concomitant use and for up to 8 days after the last tinidazole dose1 32

Antifungal agents (ketoconazole)

Possible prolonged half-life, decreased clearance, and increased plasma concentrations of tinidazole1

Cholestyramine

Studies using metronidazole indicate cholestyramine decreases oral bioavailability of the nitroimidazole by 21%1

Give tinidazole and cholestyramine doses at separate times1

Cimetidine

Possible prolonged half-life, decreased clearance, and increased plasma concentrations of tinidazole1

Disulfiram

Experience with metronidazole and disulfiram indicates psychotic reactions can occur; such reactions not reported to date with tinidazole 1 31

Do not use concomitantly; do not initiate tinidazole until 2 weeks after disulfiram is discontinued1

Fluorouracil

Experience with metronidazole and fluorouracil indicates decreased fluorouracil clearance, increased fluorouracil-associated adverse effects, no increased therapeutic benefit1

If concomitant use of tinidazole and fluorouracil is unavoidable, monitor for fluorouracil toxicity1

Immunosuppressive agents (cyclosporine, tacrolimus)

Experience with metronidazole indicates increased plasma concentrations of cyclosporine or tacrolimus1

Monitor for cyclosporine or tacrolimus toxicity if tinidazole used concomitantly with one of these drugs1

Lithium

Experience with metronidazole and lithium indicates increased lithium concentrations;1 not reported to date with tinidazole1

Measure serum lithium and creatinine concentrations after several days of concomitant lithium and tinidazole therapy to detect potential lithium intoxication1

Phenobarbital

Possible increased elimination and decreased plasma concentrations of tinidazole1

Phenytoin or fosphenytoin

Experience with oral metronidazole and IV phenytoin indicates prolonged phenytoin half-life and reduced phenytoin clearance;1 not reported with oral phenytoin and oral metronidazole1

Possible increased elimination and decreased plasma concentrations of tinidazole1

Rifampin

Possible increased elimination and decreased plasma concentrations of tinidazole1

Tests based on ultraviolet (UV) absorbance

Falsely decreased serum concentrations (including undetectable concentrations) of AST, ALT, LDH, triglycerides, or hexokinase glucose may be reported during tinidazole therapy if results are based on decreases in UV absorbance that occur during oxidation-reduction of NADH/NAD1

UV absorbance peaks of NADH and tinidazole are similar1

Use caution when interpreting test results based on UV absorbance during tinidazole therapy1

Tetracyclines

Experience with metronidazole indicates oxytetracycline (no longer commercially available in the US) may inhibit therapeutic effects of the nitroimidazole1

Advice to Patients

  • Importance of taking with food to reduce the incidence of adverse GI effects (e.g., epigastric discomfort).1

  • Advise patients to avoid alcoholic beverages and preparations containing alcohol or propylene glycol during and for at least 3 days after receiving tinidazole.1

  • Advise patients to promptly discontinue tinidazole and contact clinician if abnormal neurologic signs occur.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Before Using Tindamax

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tinidazole in children below 3 years of age. Safety and efficacy have not been established. It is only used in children three years of age and older for the treatment of giardiasis and amebiasis .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of tinidazole in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require adjustment of dosage in patients receiving tinidazole .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Capecitabine
  • Disulfiram
  • Doxifluridine
  • Fluorouracil
  • Tegafur

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood disease or a history of blood disease—Tinidazole may make this condition worse.
  • Central nervous system (CNS) disease, including epilepsy—Tinidazole may increase the chance of seizures (convulsions) or other CNS side effects.
  • Liver disease, severe—Patients with severe liver disease may have an increase in side effects.
  • Oral thrush or vaginal yeast infection—Tinidazole may make yeast infections worse.

Tindamax Dosage and 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 ( 12.3)].

Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [see Drug Interactions ( 7.1)].

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.

Overdosage

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.

How should I take Tindamax?

Take Tindamax 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 Tindamax with food.

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

Do not share Tindamax 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. Tindamax will not treat a viral infection such as the common cold or flu. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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 should I avoid?

Do not drink alcohol while taking Tindamax 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 Tindamax.

Tindamax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tindamax: 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 Tindamax 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.

Administrative Information

LactMed Record Number

441

Last Revision Date

20150908

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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