Tinidazole: Potent Antimicrobial Therapy for Anaerobic and Protozoal Infections
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Synonyms
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Tinidazole is a second-generation nitroimidazole antimicrobial agent renowned for its potent and broad-spectrum activity against a variety of anaerobic bacteria and protozoa. It functions as a prodrug, undergoing intracellular reduction to form reactive intermediates that cause strand breaks in microbial DNA, leading to cell death. With an extended plasma half-life permitting less frequent dosing compared to older agents, it offers a convenient and effective treatment option for clinicians managing specific infectious diseases. Its efficacy, tolerability, and pharmacokinetic profile make it a valuable tool in both hospital and outpatient settings.
Features
- Active pharmaceutical ingredient: Tinidazole
- Drug class: Nitroimidazole antimicrobial
- Mechanism of Action: Prodrug activated intracellularly in anaerobic microbes, forming cytotoxic compounds that cause DNA strand breakage and inhibition of nucleic acid synthesis.
- Spectrum of Activity: Effective against obligate anaerobes (e.g., Bacteroides fragilis, Clostridium difficile, Gardnerella vaginalis), and protozoa (e.g., Giardia lamblia, Entamoeba histolytica, Trichomonas vaginalis).
- Pharmacokinetics: High oral bioavailability (>90%); widely distributed into body tissues and fluids, including the central nervous system; plasma half-life of approximately 12-14 hours; primarily metabolized by the liver and excreted via bile and urine.
Benefits
- Superior Pharmacokinetics: The extended half-life allows for once- or twice-daily dosing, which can significantly improve patient compliance and convenience compared to shorter-acting alternatives like metronidazole.
- High Clinical Efficacy: Demonstrates excellent cure rates in the treatment of bacterial vaginosis, giardiasis, amebiasis, and trichomoniasis, often with shorter treatment courses.
- Excellent Tissue Penetration: Achieves therapeutic concentrations in target tissues, including the genitourinary tract, liver (for amoebic liver abscesses), and central nervous system, ensuring effective eradication of pathogens at the site of infection.
- Generally Well-Tolerated Profile: While side effects exist, many patients experience fewer gastrointestinal disturbances and a lower incidence of a metallic taste compared to other drugs in its class.
- Single-Dose Potential: For certain indications like trichomoniasis and giardiasis, a single, high dose can be as effective as a multi-day regimen, offering a simple and discreet treatment solution.
Common use
Tinidazole is clinically indicated for the treatment of specific infections caused by susceptible anaerobic microorganisms and protozoa. Its primary uses include:
- Bacterial Vaginosis: In non-pregnant women, for the eradication of the anaerobic bacterial overgrowth associated with this condition.
- Trichomoniasis: For the treatment of urogenital trichomoniasis caused by Trichomonas vaginalis in both female and male patients. Treatment of sexual partners is recommended to prevent reinfection.
- Giardiasis: For the treatment of diarrhea caused by the protozoan Giardia lamblia.
- Amebiasis: For the treatment of intestinal amebiasis (amebic dysentery) and extraintestinal amebiasis, notably amebic liver abscesses, caused by Entamoeba histolytica.
- Anaerobic Bacterial Infections: Used as part of a therapeutic regimen for the treatment of a wide range of infections caused by susceptible anaerobic bacteria, including intra-abdominal infections, skin and soft tissue infections, and bacterial septicemia.
Dosage and direction
Dosage is contingent upon the specific infection being treated, patient weight (for pediatric patients), and renal/hepatic function. All doses are for oral administration. Tablets should be taken with food to minimize gastrointestinal upset.
- Bacterial Vaginosis: 2 g orally once daily for 2 days, OR 1 g orally once daily for 5 days.
- Trichomoniasis: A single 2 g dose. Sexual partners should be treated concurrently.
- Giardiasis: A single 2 g dose. In pediatric patients older than 3 years, 50 mg/kg (up to 2 g) as a single dose.
- Intestinal Amebiasis: 2 g once daily for 3 days. In pediatric patients older than 3 years, 50 mg/kg (up to 2 g) once daily for 3 days.
- Amebic Liver Abscess: 2 g once daily for 3-5 days. In pediatric patients older than 3 years, 50 mg/kg (up to 2 g) once daily for 3-5 days.
- Anaerobic Bacterial Infections: The usual adult dosage is 2 g initially on the first day, followed by 1 g daily thereafter. The duration of therapy is typically 5 to 7 days, based on clinical response.
Dosage adjustment is necessary in patients with severe hepatic impairment (Child-Pugh C). No adjustment is typically required for renal impairment, including patients on hemodialysis, though caution is advised.
Precautions
- Neurological Effects: Convulsive seizures and peripheral neuropathy have been reported with nitroimidazole agents. Use with caution in patients with central nervous system diseases. Discontinue therapy if abnormal neurologic signs appear.
- Candidiasis: Tinidazole may predispose patients to vulvovaginal candidiasis.
- Hematologic Effects: Mild, transient leukopenia and neutropenia have been observed. Monitor total and differential leukocyte counts if therapy is repeated.
- Hepatic Impairment: Use with caution and at a reduced dosage in patients with severe hepatic impairment, as metabolism and clearance may be decreased.
- Disulfiram-like Reaction: A reaction characterized by flushing, vomiting, and tachycardia can occur if alcohol is consumed during therapy or for at least 3 days after the last dose. Patients must be warned to avoid alcohol-containing products.
- Laboratory Test Interference: Tinidazole may interfere with certain chemical analyses of AST, ALT, LDH, triglycerides, and hexokinase glucose, yielding falsely low values.
Contraindications
Tinidazole is contraindicated in the following patient populations:
- Patients with a known hypersensitivity to tinidazole, other nitroimidazole derivatives, or any component of the formulation.
- During the first trimester of pregnancy.
- In nursing mothers, as tinidazole is secreted in breast milk. Interruption of breastfeeding is recommended during therapy and for 3 days after the last dose.
Possible side effect
The most common side effects are gastrointestinal and neurologic in nature. Most are mild to moderate in intensity.
- Very Common (>10%): Metallic/bitter taste, nausea.
- Common (1-10%): Anorexia, vomiting, diarrhea, epigastric discomfort, dizziness, headache, fatigue.
- Uncommon (0.1-1%): Constipation, tongue discoloration, furred tongue, pruritus, rash, urticaria.
- Rare (<0.1%): Seizures, peripheral neuropathy, transient leukopenia, ataxia, drowsiness, insomnia, vertigo. Allergic reactions, including angioedema, have been reported.
Drug interaction
Tinidazole can potentiate the effects of several drugs and should be used cautiously with the following:
- Alcohol: Contraindicated due to the risk of a disulfiram-like reaction (flushing, nausea, vomiting, tachycardia).
- Warfarin and other Coumarin Anticoagulants: Tinidazole may potentiate the anticoagulant effect, increasing the risk of bleeding. Prothrombin time (INR) should be closely monitored.
- Cyclosporine: Tinidazole may increase cyclosporine levels, potentiating its nephrotoxic and neurotoxic effects. Monitor cyclosporine levels and renal function.
- Phenytoin, Phenobarbital: Concomitant use may accelerate the metabolism of tinidazole, potentially reducing its plasma concentration and efficacy.
- Fluorouracil (5-FU): Tinidazole may reduce the clearance of 5-FU, leading to increased toxicity. Monitor for signs of 5-FU toxicity.
- Cholestyramine: May decrease the oral bioavailability of tinidazole if taken simultaneously.
- Lithium: Potential to increase lithium serum levels and risk of toxicity. Monitor lithium levels.
Missed dose
If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed one. Maintaining the regular dosing schedule is critical for maintaining effective antimicrobial concentrations.
Overdose
Experience with tinidazole overdose is limited. Symptoms may be an exaggeration of known adverse effects, including severe nausea, vomiting, dizziness, and ataxia. There is no specific antidote. Management consists of gastric lavage (if ingestion was recent) and supportive and symptomatic therapy. Hemodialysis may accelerate elimination, though this has not been extensively studied.
Storage
- Store at room temperature between 15°C and 30°C (59°F to 86°F).
- Protect from light and moisture.
- Keep in the original container, tightly closed.
- Keep out of reach of children and pets.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on standard prescribing guidelines and may not be applicable to every individual.
Reviews
- “As an infectious disease specialist, the pharmacokinetic profile of tinidazole is a significant advantage in outpatient management. The single-dose regimen for trichomoniasis dramatically improves compliance and outcomes in a difficult-to-treat population.” – Dr. E. Lawson, MD
- “We’ve incorporated it into our protocols for giardiasis outbreaks. The high efficacy and simple dosing schedule make it far easier to manage from a public health perspective compared to multi-day metronidazole courses.” – Public Health Official
- “From a patient perspective, the shorter course and reduced metallic taste were a welcome change. Completing a 3-day course for BV was much less disruptive than previous 7-day therapies.” – Clinical Trial Participant
- “Its role in treating anaerobic intra-abdominal infections is well-established. The once-daily dosing simplifies IV-to-oral switch protocols, facilitating earlier discharge for stable patients.” – Clinical Pharmacist