Tindamax 250mg 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
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 bacteria and parasites. It works by stopping the growth of these 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 your medication with food to help prevent stomach upset. If you have trouble swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension.
When taking the liquid suspension, make sure to shake it well before each use. Measure your liquid doses carefully using the measuring device that comes with the medication. If you don't have one, ask your pharmacist for a suitable device to measure your medication accurately.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and in a dry place. Avoid storing it in a bathroom. If you prepare a liquid suspension from the tablets, discard any unused portion after 7 days. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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. Avoid taking two doses at the same time or taking extra doses. For certain infections, you may be prescribed a single dose, so be sure to follow your doctor's instructions carefully.
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with food to help prevent stomach upset. If you have trouble swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension.
When taking the liquid suspension, make sure to shake it well before each use. Measure your liquid doses carefully using the measuring device that comes with the medication. If you don't have one, ask your pharmacist for a suitable device to measure your medication accurately.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and in a dry place. Avoid storing it in a bathroom. If you prepare a liquid suspension from the tablets, discard any unused portion after 7 days. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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. Avoid taking two doses at the same time or taking extra doses. For certain infections, you may be prescribed a single dose, so be sure to follow your doctor's instructions carefully.
Lifestyle & Tips
- Avoid alcohol or alcohol-containing products (e.g., cough syrups, mouthwashes) during treatment and for at least 3 days after the last dose, as it can cause severe nausea, vomiting, abdominal cramps, and headache (disulfiram-like reaction).
- Take with food to minimize stomach upset.
- Complete the full course of medication as prescribed, even if symptoms improve, to prevent recurrence and resistance.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. E.g., Trichomoniasis/Bacterial Vaginosis: 2 g as a single oral dose with food.
Dose Range:
500 - 2000 mg
Condition-Specific Dosing:
Trichomoniasis:
2 g orally once with food.
Bacterial Vaginosis:
2 g orally once with food OR 1 g orally once daily for 5 days with food.
Giardiasis:
2 g orally once with food.
Intestinal Amebiasis:
2 g orally once daily for 3 days with food.
Amebic Liver Abscess:
2 g orally once daily for 3-5 days with food.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Giardiasis/Amebiasis (âĨ3 years): 50 mg/kg orally once daily (max 2 g/day) for 3 days (giardiasis) or 3-5 days (amebiasis).
Adolescent:
Same as adult dosing for specific indications.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Tinidazole is removed by hemodialysis; administer after completion of hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Use with caution; monitor for adverse effects. Data are limited.
Pharmacology
Mechanism of Action
Tinidazole is a nitroimidazole antimicrobial. Its mechanism of action involves the uptake of tinidazole by anaerobic and microaerophilic organisms, followed by its reduction to active metabolites. These reduced metabolites are believed to damage DNA and other macromolecules, leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Nearly 100%
Tmax:
1.6 hours (fasted), 2.1 hours (fed)
FoodEffect:
Food delays Tmax but does not significantly affect AUC or Cmax.
Distribution:
Vd:
50 L
ProteinBinding:
Approximately 16%
CnssPenetration:
Yes
Elimination:
HalfLife:
12-14 hours
Clearance:
Not available
ExcretionRoute:
Renal (approximately 20-25% as unchanged drug), fecal (approximately 12%)
Unchanged:
20-25%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for single dose regimens)
PeakEffect:
Not applicable (bactericidal/protozoacidal effect)
DurationOfAction:
Sustained activity due to long half-life, allowing for single-dose or short-course regimens.
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Bad taste in your mouth
Upset stomach
Note: This is not a comprehensive 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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Bad taste in your mouth
Upset stomach
Note: This is not a comprehensive 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 or persistent nausea, vomiting, or diarrhea
- Numbness, tingling, pain, or weakness in hands or feet (signs of peripheral neuropathy)
- Severe allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual bleeding or bruising
- Signs of liver problems (yellowing of skin/eyes, dark urine, severe stomach pain)
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, including any symptoms that occurred.
If you have Cockayne syndrome, as some individuals with this condition have developed liver problems when taking similar medications. In some cases, these liver problems have been severe, persistent, or even fatal.
If you have taken disulfiram within the past 14 days.
If you are breastfeeding, as you should not breastfeed for at least 72 hours after receiving this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in combination with your other medications and health conditions. Do not start, stop, or change the dosage of any medication without first consulting 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, including any symptoms that occurred.
If you have Cockayne syndrome, as some individuals with this condition have developed liver problems when taking similar medications. In some cases, these liver problems have been severe, persistent, or even fatal.
If you have taken disulfiram within the past 14 days.
If you are breastfeeding, as you should not breastfeed for at least 72 hours after receiving this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in combination with your other medications and health conditions. Do not start, stop, or change the dosage of any medication without first consulting your doctor.
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 it may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.
To minimize potential interactions, you may need to avoid consuming alcohol and products containing alcohol or propylene glycol during treatment with this medication and for at least 72 hours after your last dose. This is because combining alcohol or propylene glycol with this drug can cause adverse effects such as stomach cramps, nausea, vomiting, headaches, and flushing. Some products, like certain cough syrups, contain alcohol or propylene glycol, so it is vital to discuss with your doctor whether you need to avoid these substances.
Do not take this medication for a longer duration than prescribed, as this may increase the risk of developing a second infection. If you are taking cholestyramine, you may need to take it at a different time than this medication; consult with 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, so it is essential to talk to your doctor about this potential issue. If you are pregnant or planning to become pregnant, inform your doctor, as you will need to discuss the benefits and risks of using this medication during pregnancy.
To minimize potential interactions, you may need to avoid consuming alcohol and products containing alcohol or propylene glycol during treatment with this medication and for at least 72 hours after your last dose. This is because combining alcohol or propylene glycol with this drug can cause adverse effects such as stomach cramps, nausea, vomiting, headaches, and flushing. Some products, like certain cough syrups, contain alcohol or propylene glycol, so it is vital to discuss with your doctor whether you need to avoid these substances.
Do not take this medication for a longer duration than prescribed, as this may increase the risk of developing a second infection. If you are taking cholestyramine, you may need to take it at a different time than this medication; consult with 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, so it is essential to talk to your doctor about this potential issue. If you are pregnant or planning to become pregnant, inform your doctor, as you will need to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Ataxia (loss of coordination)
- Peripheral neuropathy
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage may be helpful. Tinidazole is dialyzable. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Contraindicated Interactions
- Alcohol (including alcohol-containing medications) due to disulfiram-like reaction.
Major Interactions
- Warfarin (increased anticoagulant effect, monitor INR)
- Disulfiram (psychotic reactions, avoid concomitant use)
Moderate Interactions
- Lithium (increased lithium levels, monitor)
- Phenytoin (increased phenytoin levels, monitor)
- Cyclosporine (increased cyclosporine levels, monitor)
- Tacrolimus (increased tacrolimus levels, monitor)
- Fluorouracil (increased fluorouracil toxicity)
Minor Interactions
- Cimetidine (may increase tinidazole levels)
- Phenobarbital (may decrease tinidazole levels)
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function, especially in patients with known or suspected hepatic impairment.
Timing: Prior to initiation, if clinically indicated.
Complete Blood Count (CBC)
Rationale: For patients on prolonged therapy or with a history of blood dyscrasias, as nitroimidazoles can cause transient leukopenia or neutropenia.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Clinical response to therapy
Frequency: Throughout treatment and post-treatment
Target: Resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance.
Adverse effects (e.g., GI upset, metallic taste, headache, dizziness, peripheral neuropathy)
Frequency: Daily during treatment
Target: Absence or mild, tolerable symptoms
Action Threshold: Severe or persistent adverse effects may require dose reduction or discontinuation.
INR (for patients on warfarin)
Frequency: Frequently during and after tinidazole therapy
Target: Therapeutic range for indication
Action Threshold: Elevated INR requires warfarin dose adjustment.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Metallic taste
- Headache
- Dizziness
- Fatigue
- Peripheral neuropathy (numbness, tingling, weakness)
- Rash
- Pruritus
- Darkened urine
Special Patient Groups
Pregnancy
Category C. Use only if clearly needed and potential benefits outweigh potential risks. Avoid during the first trimester.
Trimester-Specific Risks:
First Trimester:
Avoid use due to potential for teratogenicity observed with related nitroimidazoles in animal studies.
Second Trimester:
Use with caution; limited human data.
Third Trimester:
Use with caution; limited human data.
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. Advise mothers to pump and discard breast milk for 72 hours after the last dose.
Infant Risk:
Moderate risk (L3). Potential for gastrointestinal upset, candidiasis, and theoretical risk of carcinogenicity (based on animal data for related compounds).
Pediatric Use
Approved for use in children âĨ3 years for giardiasis and amebiasis. Dosing is weight-based. Safety and efficacy in children <3 years have not been established.
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may have reduced renal or hepatic function, and may be more susceptible to adverse effects, so monitor closely.
Clinical Information
Clinical Pearls
- Tinidazole offers a shorter course of therapy (often single dose or 3-5 days) compared to metronidazole for many indications, which may improve patient adherence.
- Always emphasize the strict avoidance of alcohol during and for at least 3 days after treatment due to the severe disulfiram-like reaction.
- Taking the medication with food helps to reduce gastrointestinal side effects like nausea and metallic taste.
- While generally well-tolerated, monitor for neurological side effects, especially peripheral neuropathy, which can be irreversible if not caught early.
Alternative Therapies
- Metronidazole (Flagyl)
- Nitazoxanide (Alinia)
- Paromomycin (for amebiasis)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 30 tablets (250mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic, Tier 3 or higher for brand
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.