Tindamax 500mg Tablets
WARNING: A drug like this one has been shown to cause cancer in mice and rats. It is not known if this drug may cause this effect in humans. If you have questions, talk with the doctor.The doctor has given you this drug for a certain health problem. Do not use this drug for other health problems.Do not take this drug for longer than you were told by your doctor. @ COMMON USES: It is used to treat infections.
Drug Class
Antiprotozoal, Antibacterial
Pharmacologic Class
Nitroimidazole Antimicrobial
Pregnancy Category
Category C
FDA Approved
May 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tinidazole is an antibiotic that treats certain types of infections caused by parasites (like those causing giardiasis or trichomoniasis) and some bacterial infections (like bacterial vaginosis). It works by stopping the growth of these harmful organisms.
How to Use This Medicine
Taking Your Medication
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication with food to help prevent stomach upset. If you have trouble swallowing pills, you can ask your doctor or pharmacist about creating a liquid suspension.
If a liquid suspension is prepared, make sure to shake it well before each use. When measuring the liquid dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from light and in a dry place. Avoid storing it in a bathroom. If a liquid suspension is made from the tablets, discard any unused portion after 7 days. Keep all medications in a safe location, out of the reach of children and pets.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses. For certain infections, you may be prescribed a single dose, so be sure to follow your doctor's specific instructions.
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication with food to help prevent stomach upset. If you have trouble swallowing pills, you can ask your doctor or pharmacist about creating a liquid suspension.
If a liquid suspension is prepared, make sure to shake it well before each use. When measuring the liquid dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from light and in a dry place. Avoid storing it in a bathroom. If a liquid suspension is made from the tablets, discard any unused portion after 7 days. Keep all medications in a safe location, out of the reach of children and pets.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses. For certain infections, you may be prescribed a single dose, so be sure to follow your doctor's specific instructions.
Lifestyle & Tips
- DO NOT drink alcohol or use alcohol-containing products (e.g., cough syrups, mouthwash) during treatment with tinidazole and for at least 3 days after stopping the medication. Combining them can cause severe nausea, vomiting, flushing, and headache (disulfiram-like reaction).
- Take tinidazole with food to help reduce stomach upset.
- Complete the entire course of medication as prescribed, even if you start feeling better, to prevent the infection from returning.
- If treating a sexually transmitted infection like trichomoniasis, ensure your sexual partner(s) are also treated to prevent re-infection.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. Examples: Trichomoniasis/Giardiasis: 2 g single oral dose. Bacterial Vaginosis: 2 g single oral dose OR 1 g once daily for 5 days. Intestinal Amebiasis: 2 g once daily for 3 days. Amebic Liver Abscess: 2 g once daily for 3-5 days.
Dose Range:
1000 - 2000 mg
Condition-Specific Dosing:
Trichomoniasis:
2 g single oral dose
Giardiasis:
2 g single oral dose
Bacterial Vaginosis:
2 g single oral dose OR 1 g once daily for 5 days
Intestinal Amebiasis:
2 g once daily for 3 days
Amebic Liver Abscess:
2 g once daily for 3-5 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Giardiasis/Amebiasis (children >3 years): 50 mg/kg single oral dose (max 2 g).
Adolescent:
Giardiasis/Amebiasis: 50 mg/kg single oral dose (max 2 g). For other indications, adult dosing may apply based on weight/age.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No specific dose adjustment recommended, but caution is advised due to potential for accumulation of metabolites. Monitor for adverse effects.
Dialysis:
Tinidazole is removed by hemodialysis. Administer dose after completion of hemodialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment needed.
Moderate:
No specific dose adjustment needed.
Severe:
Use with caution. Consider reduced dosage or extended dosing interval, and monitor for adverse effects. Data are limited.
Pharmacology
Mechanism of Action
Tinidazole is a nitroimidazole antimicrobial. It enters the cell of anaerobic bacteria and protozoa, where its nitro group is reduced by ferredoxin-linked electron transport systems. This reduction forms reactive nitro radical anions and other cytotoxic reduced products that damage DNA and other macromolecules, leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Nearly 100%
Tmax:
1.6 hours (range 0.5-2 hours)
FoodEffect:
Food delays the rate of absorption (Tmax increased by approximately 2 hours) but does not affect the extent of absorption (AUC). Taking with food helps minimize GI upset.
Distribution:
Vd:
50 L
ProteinBinding:
Approximately 16%
CnssPenetration:
Yes, readily penetrates the cerebrospinal fluid (CSF) achieving concentrations similar to plasma.
Elimination:
HalfLife:
12-14 hours
Clearance:
Not available (variable)
ExcretionRoute:
Renal (approximately 25% unchanged drug), and fecal (approximately 12% unchanged drug).
Unchanged:
Approximately 25% (renal), 12% (fecal)
Pharmacodynamics
OnsetOfAction:
Rapid, typically within hours of administration.
PeakEffect:
Peak plasma concentrations reached within 1-2 hours.
DurationOfAction:
Due to its long half-life, a single dose provides sustained therapeutic concentrations for 24-72 hours depending on the pathogen and dose.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
A burning, numbness, or tingling feeling that is not normal
Seizures
Vaginal itching or discharge
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Bad taste in your mouth
Upset stomach
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
A burning, numbness, or tingling feeling that is not normal
Seizures
Vaginal itching or discharge
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Bad taste in your mouth
Upset stomach
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
- Signs of nerve problems (numbness, tingling, pain, or weakness in hands or feet)
- Seizures
- Severe or persistent diarrhea (may indicate a new infection)
- Unusual bleeding or bruising
- Signs of liver problems (yellowing eyes/skin, dark urine, severe stomach pain, persistent nausea/vomiting)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have Cockayne syndrome, as individuals with this condition may be at risk for liver problems when taking this medication. In some cases, these liver issues have been severe, persistent, or even fatal.
If you have taken disulfiram in the past 2 weeks, as this may interact with the medication.
If you are breastfeeding, as you should not breastfeed for at least 72 hours after receiving this medication.
Additionally, this is not an exhaustive list of potential interactions. It is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have Cockayne syndrome, as individuals with this condition may be at risk for liver problems when taking this medication. In some cases, these liver issues have been severe, persistent, or even fatal.
If you have taken disulfiram in the past 2 weeks, as this may interact with the medication.
If you are breastfeeding, as you should not breastfeed for at least 72 hours after receiving this medication.
Additionally, this is not an exhaustive list of potential interactions. It is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because this drug may interfere with certain laboratory tests. Therefore, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication.
To minimize potential interactions, you may need to avoid consuming alcohol and products containing alcohol or propylene glycol during treatment with this drug and for at least 72 hours after your last dose. This is because combining alcohol or products with alcohol or propylene glycol (such as some cough syrups) with this medication can cause adverse effects like stomach cramps, nausea, vomiting, headaches, and flushing. Consult your doctor to determine if you need to avoid alcohol and products containing alcohol or propylene glycol.
Do not take this medication for a longer duration than prescribed, as this may increase the risk of a second infection. If you are taking cholestyramine, you may need to take it at a different time than this drug; consult your pharmacist for guidance.
If you are being treated for a sexually transmitted disease, your partner may also require treatment. Discuss this with your doctor to ensure appropriate management.
This medication may affect fertility in males. If you have concerns about fathering a child, discuss this with your doctor.
If you are pregnant or planning to become pregnant, inform your doctor. You will need to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
To minimize potential interactions, you may need to avoid consuming alcohol and products containing alcohol or propylene glycol during treatment with this drug and for at least 72 hours after your last dose. This is because combining alcohol or products with alcohol or propylene glycol (such as some cough syrups) with this medication can cause adverse effects like stomach cramps, nausea, vomiting, headaches, and flushing. Consult your doctor to determine if you need to avoid alcohol and products containing alcohol or propylene glycol.
Do not take this medication for a longer duration than prescribed, as this may increase the risk of a second infection. If you are taking cholestyramine, you may need to take it at a different time than this drug; consult your pharmacist for guidance.
If you are being treated for a sexually transmitted disease, your partner may also require treatment. Discuss this with your doctor to ensure appropriate management.
This medication may affect fertility in males. If you have concerns about fathering a child, discuss this with your doctor.
If you are pregnant or planning to become pregnant, inform your doctor. You will need to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Ataxia (loss of coordination)
- Peripheral neuropathy (numbness, tingling)
- Seizures
What to Do:
There is no specific antidote for tinidazole overdose. Treatment is symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can remove tinidazole from the body. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Contraindicated Interactions
- Alcohol (including alcohol-containing medications)
Major Interactions
- Warfarin (and other oral anticoagulants)
- Lithium
Moderate Interactions
- Phenytoin
- Phenobarbital
- Cimetidine
- Cyclosporine
- Tacrolimus
- Fluorouracil
Minor Interactions
- Not specifically documented as minor, but caution with drugs metabolized by CYP3A4.
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with known or suspected hepatic impairment, as tinidazole is metabolized in the liver.
Timing: Prior to initiation of therapy in patients with severe hepatic impairment.
History of blood dyscrasias
Rationale: Tinidazole, like other nitroimidazoles, has been associated with transient leukopenia and neutropenia. Assess patient history.
Timing: Prior to initiation of therapy.
Routine Monitoring
Neurological symptoms (e.g., numbness, tingling, paresthesia, weakness, dizziness, seizures)
Frequency: Daily during therapy, and post-therapy if symptoms persist.
Target: Absence of new or worsening symptoms.
Action Threshold: Discontinue tinidazole and evaluate if neurological symptoms develop or worsen.
Complete Blood Count (CBC) with differential
Frequency: Periodically, especially with prolonged therapy (e.g., >10 days) or in patients with a history of blood dyscrasias.
Target: Within normal limits.
Action Threshold: Discontinue tinidazole if significant leukopenia or neutropenia occurs.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Metallic taste in mouth
- Headache
- Dizziness
- Peripheral neuropathy (numbness, tingling, weakness in extremities)
- Rash
- Pruritus
- Darkening of urine (harmless)
Special Patient Groups
Pregnancy
Tinidazole is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of fetotoxicity at high doses.
Trimester-Specific Risks:
First Trimester:
Avoid use if possible, especially during the first trimester, due to potential for teratogenicity observed in some animal studies with related compounds.
Second Trimester:
Use with caution; consider if clearly needed.
Third Trimester:
Use with caution; consider if clearly needed.
Lactation
Tinidazole is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. For a single 2g dose, breastfeeding should be interrupted for 72 hours (3 days) after administration.
Infant Risk:
L3 (Moderately Safe) - Potential for gastrointestinal upset (diarrhea, candidiasis), and theoretical risk of carcinogenicity based on animal data with related compounds. Monitor infant for adverse effects.
Pediatric Use
Approved for use in children aged >3 years for giardiasis and amebiasis. Safety and efficacy for other indications in younger children or infants have not been established. Dosing is weight-based.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced renal or hepatic function, which could necessitate dose adjustment or closer monitoring for adverse effects, particularly neurological symptoms.
Clinical Information
Clinical Pearls
- Patients should be warned about the severe disulfiram-like reaction with alcohol; this includes alcohol in foods, beverages, and non-prescription medications (e.g., cough syrups, mouthwash).
- A metallic taste in the mouth is a common and expected side effect.
- Take tinidazole with food to minimize gastrointestinal upset.
- Tinidazole has a long half-life, allowing for convenient single-dose or short-course regimens for many indications.
- Monitor for signs of peripheral neuropathy (numbness, tingling, weakness) and discontinue the drug if these symptoms occur.
Alternative Therapies
- Metronidazole (for trichomoniasis, giardiasis, amebiasis, bacterial vaginosis)
- Secnidazole (for bacterial vaginosis, trichomoniasis)
- Clindamycin (for bacterial vaginosis)
- Nitazoxanide (for giardiasis, cryptosporidiosis)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 tablets (500mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.