What is Tindamax, and how does it work?
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.
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.
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.
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.
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?
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
|2 g single dose||Multi-day dose|
|GI: Metallic/bitter taste||3.7%||6.3%|
|Total patients with adverse reactions||11.0% (403/3669)||13.8% (244/1765)|
Rare reported adverse reactions include
- 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
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
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
What is the dosage for Tindamax?
- 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
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.
- 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.
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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 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.
Tindamax (tinidazole) is an antibiotic used to treat trichomoniasis, giardiasis, intestinal amebiasis, and bacterial vaginosis. Tindamax has a potential risk for carcinogenicity, which has been seen has in mice and rats treated chronically with metronidazole, another nitroimidazole agent.
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Related Disease Conditions
Trichinosis Worm Infection
Trichinosis is a food-borne disease caused by ingesting parasites (roundworms) in undercooked pork or wild-game meat. Symptoms of trichinosis include diarrhea, nausea, muscle aches, itching, fever, chills, and joint pains.Trichinosis usually resolves without treatment, but more severe cases are treated with thiabendazole (Mintezol), albendazole (Abenza), or mebendazole (Vermox).
Sporotrichosis is a skin infection caused by a fungus called Sporothrix schenckii. The fungus, which may be present in sphagnum moss, thorny plants, or baled hay, enters the skin through punctures and small cuts. Symptoms include painless bumps on the skin near the site of infection. The nodules may open and look like boils. The infection is treated with potassium iodide or itraconazole (Sporanox).
Bacterial vaginosis is an abnormal vaginal condition with signs and symptoms of vaginal discharge, vaginal odor, and vaginal pain. Bacterial vaginosis results from an overgrowth of normal bacteria in the vagina. Although it may cause some disturbing symptoms (discharge and odor), it is not dangerous and cannot be passed by sex. Diagnosis becomes important to exclude serious infections like gonorrhea and Chlamydia. Many treatment options are available such as oral antibiotics and vaginal gels.
Trichomoniasis is a sexually transmitted disease (STD) caused by a parasite passed from person to person. Trichomoniasis can be picked up from contact with damp, moist objects like towels, wet clothing, or toilet seat. Symptoms include yellow, green, or gray vaginal discharge with a strong odor, painful intercourse or urination, genital irritation and itching, and lower abdominal pain. Antibiotics are the only treatment to cure trichomoniasis.
Amebiasis (Entamoeba Histolytica Infection)
Amebiasis is an infection caused by an amoeba. Signs and symptoms include bloody stools, abdominal pain, weight loss, fever, and gas. Treatment may involve taking luminal agents or antibiotics. Surgery may be indicated for various reasons.
Yeast Infection vs. Bacterial Vaginosis (BV)
Yeast infections and bacterial vaginosis (BV) both cause vaginal discharge. Yeast infection discharge is thick, white, and had a cottage cheese consistency. BV discharge is whitish-gray and is thinner. Vaginal odor, irritation, and pain may also be present. Treatment of yeast infections includes over-the-counter and prescription antifungals. BV treatment involves antibiotics.
Can a Man Give a Woman Trichomoniasis?
Trichomoniasis or trich is caused by a tiny one-celled parasite called Trichomonas vaginalis. It lives in the genitals. It is transmitted usually during unprotected sexual activity. Yes, a man can infect a woman with trich.
Can You Get Trichomoniasis Without Being Sexually Active?
Trichomoniasis is passed from an infected person to another primarily during sexual activity. In very rare cases, it can be transferred from an infected mother to her unborn child. Any sexual activity during vaginal, oral or anal sex can cause the infection to spread. Even if your partner has no symptoms, they can spread the infection.
What Are the Symptoms of Trichomoniasis in Females?
Trichomoniasis or Trich is a type of sexually transmitted disease (STD) caused by a parasite, Trichomonas vaginalis. It is the commonest curable STD. The parasite can infect both men and women, however, the infection is more common in women than in men. Trichomoniasis is more common in older women.
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