Tinidazole 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, Antibiotic
Pharmacologic Class
Nitroimidazole
Pregnancy Category
Category B
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 trichomoniasis, giardiasis, and amebiasis) and some bacterial infections (like bacterial vaginosis). It works by stopping the growth of the infection-causing 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, your doctor or pharmacist can help you prepare a liquid suspension.
When taking the liquid suspension, be sure to shake it well before each use. Measure the liquid dose carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for one to ensure accurate measurement.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. If a liquid suspension is prepared 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 have questions about disposal, consult your pharmacist. You may also want to check if there are 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 dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. For certain infections, you may be prescribed a single dose.
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, your doctor or pharmacist can help you prepare a liquid suspension.
When taking the liquid suspension, be sure to shake it well before each use. Measure the liquid dose carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for one to ensure accurate measurement.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. If a liquid suspension is prepared 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 have questions about disposal, consult your pharmacist. You may also want to check if there are 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 dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. For certain infections, you may be prescribed a single dose.
Lifestyle & Tips
- Avoid alcohol completely during treatment and for at least 3 days (72 hours) after the last dose, as it can cause severe nausea, vomiting, flushing, and headache.
- Take with food to minimize stomach upset, although it can be taken without food.
- Complete the full course of medication, even if symptoms improve, to prevent recurrence and resistance.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. E.g., Trichomoniasis/Giardiasis: 2 g as a single oral dose. Bacterial Vaginosis: 2 g as a single oral dose or 1 g once daily for 5 days. Intestinal Amebiasis: 2 g once daily for 3 days. Hepatic Amebiasis: 1.5 g once daily for 3-5 days.
Dose Range:
250 - 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
Hepatic Amebiasis:
1.5 g once daily for 3-5 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Giardiasis/Amebiasis (âĨ3 years): 50 mg/kg (max 2 g) as a single oral dose.
Adolescent:
Same as adult dosing for relevant indications.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
Tinidazole is readily removed by hemodialysis. Administer after completion of hemodialysis.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
Reduced clearance and increased plasma concentrations. Monitor for adverse reactions. Dosage reduction may be necessary, but specific recommendations are not well-defined. Use with caution.
Pharmacology
Mechanism of Action
Tinidazole is a nitroimidazole antimicrobial. It is a prodrug that is reduced by susceptible anaerobic organisms and protozoa. The reduction process forms reactive nitro radical anions that are believed to damage DNA and inhibit nucleic acid synthesis, leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Nearly 100%
Tmax:
1-2 hours
FoodEffect:
Food delays Tmax and decreases Cmax, but does not significantly affect AUC. Can be taken with or without food.
Distribution:
Vd:
Approximately 50 L
ProteinBinding:
Approximately 16%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 12-14 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily) and fecal
Unchanged:
Approximately 20-25% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for single dose regimens)
PeakEffect:
Not applicable for antimicrobial effect, related to concentration
DurationOfAction:
Sufficient for single-dose or short-course regimens due to long half-life
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Bad taste in your mouth
Upset stomach
Note: This is not an exhaustive list of 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Bad taste in your mouth
Upset stomach
Note: This is not an exhaustive list of 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)
- New or worsening numbness, tingling, pain, or weakness in hands or feet (signs of peripheral neuropathy)
- Seizures
- Severe diarrhea (especially if watery or bloody)
- Unusual bruising or bleeding
- Signs of liver problems (yellowing eyes/skin, dark urine, severe stomach pain, persistent nausea/vomiting)
- Signs of a new infection (e.g., oral thrush, vaginal yeast infection)
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 symptoms you experienced.
If you have Cockayne syndrome, as some individuals with this condition have developed liver problems after taking similar medications, which in some cases have been severe or even fatal.
If you have taken disulfiram in the past 2 weeks.
If you are breastfeeding, as you should not breastfeed for at least 72 hours after receiving this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 symptoms you experienced.
If you have Cockayne syndrome, as some individuals with this condition have developed liver problems after taking similar medications, which in some cases have been severe or even fatal.
If you have taken disulfiram in the past 2 weeks.
If you are breastfeeding, as you should not breastfeed for at least 72 hours after receiving this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and lab personnel that you are taking it.
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. Examples of products that may contain alcohol or propylene glycol include some cough syrups. Using these products while taking this medication can cause adverse effects such as 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 developing a second infection. If you are taking cholestyramine, you may need to take it at a different time than this medication; 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, so it is crucial to discuss this potential risk with your doctor. If you are pregnant or planning to become pregnant, inform your doctor, as you will need to weigh 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 drug and for at least 72 hours after your last dose. Examples of products that may contain alcohol or propylene glycol include some cough syrups. Using these products while taking this medication can cause adverse effects such as 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 developing a second infection. If you are taking cholestyramine, you may need to take it at a different time than this medication; 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, so it is crucial to discuss this potential risk with your doctor. If you are pregnant or planning to become pregnant, inform your doctor, as you will need to weigh the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Ataxia (loss of coordination)
- Peripheral neuropathy
- Seizures
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis is effective in removing tinidazole. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Alcohol (including alcohol-containing medications) - Disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, flushing)
Major Interactions
- Warfarin (increased anticoagulant effect, monitor INR)
- Lithium (increased lithium levels, monitor levels)
Moderate Interactions
- Phenytoin (may decrease tinidazole levels)
- Phenobarbital (may decrease tinidazole levels)
- Rifampin (may decrease tinidazole levels)
- Cimetidine (may increase tinidazole levels)
- Cyclosporine (potential for increased cyclosporine levels)
Minor Interactions
- Not well-documented for minor interactions
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 of therapy, particularly for patients with severe hepatic impairment.
Complete Blood Count (CBC)
Rationale: To establish baseline hematologic parameters, especially if prolonged therapy is anticipated, due to potential for transient leukopenia or neutropenia.
Timing: Prior to initiation of therapy for prolonged courses.
Routine Monitoring
Neurological symptoms (e.g., paresthesia, numbness, weakness, dizziness, seizures)
Frequency: Daily during therapy and post-therapy
Target: Absence of new or worsening symptoms
Action Threshold: Discontinue tinidazole if abnormal neurological signs or symptoms appear.
Signs of candidiasis (e.g., oral thrush, vaginal yeast infection)
Frequency: Daily during therapy
Target: Absence of signs of superinfection
Action Threshold: Treat appropriately if superinfection occurs.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Metallic taste
- Headache
- Dizziness
- Peripheral neuropathy (numbness, tingling, weakness)
- Seizures
- Rash
- Pruritus
- Darkened urine
Special Patient Groups
Pregnancy
Category B. Avoid use during the first trimester of pregnancy. Use during the second and third trimesters only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Avoid due to potential for teratogenicity observed with related compounds in animal studies, though human data is limited.
Second Trimester:
Considered safer than first trimester, but use only if clearly indicated.
Third Trimester:
Considered safer than first trimester, but use only if clearly indicated.
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 discontinue breastfeeding for 72 hours (3 days) after the last dose.
Infant Risk:
L3 (Moderately safe; advise temporary discontinuation of breastfeeding due to potential for gastrointestinal upset, candidiasis, and theoretical risk of carcinogenicity based on animal data).
Pediatric Use
Approved for use in children âĨ3 years of age for giardiasis and amebiasis. Safety and efficacy in children <3 years have not been established. Dosing is weight-based.
Geriatric Use
No specific dosage adjustment is necessary based solely on age. However, elderly patients may have reduced renal or hepatic function, which should be considered. Monitor for adverse effects, particularly neurological symptoms.
Clinical Information
Clinical Pearls
- Metallic taste is a very common side effect and is usually transient.
- Strict alcohol avoidance is crucial to prevent a disulfiram-like reaction.
- Tinidazole has a longer half-life than metronidazole, allowing for less frequent dosing (often single-dose or short courses).
- Patients should be advised about the potential for peripheral neuropathy and to report any numbness, tingling, or weakness immediately.
- Can cause darkening of urine, which is a harmless effect.
Alternative Therapies
- Metronidazole (for trichomoniasis, giardiasis, amebiasis, bacterial vaginosis)
- Secnidazole (for bacterial vaginosis, trichomoniasis, giardiasis)
- Nitazoxanide (for giardiasis, cryptosporidiosis)
Cost & Coverage
Average Cost:
Varies, typically $20-$100 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.