Metronidazole 250mg Tablets

Manufacturer UNICHEM PHARMACEUTICALS Active Ingredient Metronidazole Tablets and Capsules(met roe NYE da zole) Pronunciation met roe NYE da zole
WARNING: Metronidazole has been shown to cause cancer in mice and rats with long-term use. 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. @ COMMON USES: It is used to treat infections.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic; Antiprotozoal
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Pharmacologic Class
Nitroimidazole
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Pregnancy Category
Category B
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FDA Approved
Sep 1963
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metronidazole is an antibiotic that treats certain types of bacterial and parasitic infections. It works by stopping the growth of the bacteria or parasites. It's commonly used for infections in the stomach, intestines, skin, joints, and for certain sexually transmitted infections.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food.

It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. Don't stop taking the medication without consulting your doctor first.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.

When disposing of unused or expired medication, don't flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs in your area.

What to Do If You Miss 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 resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses to make up for a missed one.
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Lifestyle & Tips

  • Avoid all alcohol and alcohol-containing products (e.g., cough syrups, mouthwash, aftershave) during treatment and for at least 3 days after stopping metronidazole, due to a severe reaction (nausea, vomiting, flushing, headache, abdominal cramps).
  • Take with food or milk if stomach upset occurs.
  • Complete the full course of medication, even if symptoms improve, to prevent recurrence and antibiotic resistance.
  • Maintain good hydration.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. Examples: Trichomoniasis: 2g single dose OR 500mg orally twice daily for 7 days. Bacterial Vaginosis: 500mg orally twice daily for 7 days. Clostridioides difficile infection (mild-moderate): 500mg orally three times daily for 10-14 days. Anaerobic bacterial infections: 500mg orally three times daily.
Dose Range: 250 - 2000 mg

Condition-Specific Dosing:

Trichomoniasis: 2g single dose OR 500mg BID x 7 days
Bacterial Vaginosis: 500mg BID x 7 days
Clostridioides difficile infection (mild-moderate): 500mg TID x 10-14 days
Anaerobic bacterial infections: 500mg TID
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Pediatric Dosing

Neonatal: Not established for routine use; consult infectious disease specialist for specific indications (e.g., necrotizing enterocolitis, sepsis). Dosing typically 7.5-15 mg/kg/dose every 12-24 hours depending on gestational/postnatal age.
Infant: 7.5-15 mg/kg/dose every 8-12 hours depending on indication (e.g., amebiasis, giardiasis, anaerobic infections). Max 500mg/dose.
Child: 7.5-15 mg/kg/dose every 8-12 hours depending on indication (e.g., amebiasis, giardiasis, anaerobic infections). Max 500mg/dose or 2g/day.
Adolescent: Dosing generally similar to adult dosing, adjusted for weight/BSA if necessary, depending on indication.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: For CrCl <10 mL/min, consider reducing dose by 50% or extending dosing interval. Monitor for adverse effects.
Dialysis: Hemodialysis removes metronidazole. Administer dose after hemodialysis on dialysis days. No adjustment needed for peritoneal dialysis.

Hepatic Impairment:

Mild: No specific adjustment, monitor for adverse effects.
Moderate: Reduce dose by 25-50% in patients with severe hepatic impairment (Child-Pugh C).
Severe: Reduce dose by 50-75% in patients with severe hepatic impairment (Child-Pugh C). Monitor plasma concentrations if available.

Pharmacology

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Mechanism of Action

Metronidazole is a nitroimidazole antimicrobial. It acts as a prodrug that is activated by reduction of its nitro group by anaerobic organisms and certain protozoa. This reduction forms reactive cytotoxic compounds that bind to and damage DNA, leading to inhibition of nucleic acid synthesis and cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80% (oral)
Tmax: 1-2 hours (oral)
FoodEffect: Food delays Tmax but does not significantly affect the extent of absorption (AUC). Taking with food may reduce GI upset.

Distribution:

Vd: 0.51-1.1 L/kg
ProteinBinding: <20%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF, brain abscesses)

Elimination:

HalfLife: Approximately 8 hours (range 6-12 hours)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (60-80%), Fecal (6-15%)
Unchanged: Approximately 20% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for susceptible organisms)
PeakEffect: Not directly applicable for antimicrobial effect, but peak plasma concentrations reached within 1-2 hours.
DurationOfAction: Dependent on dosing interval and organism susceptibility; typically maintains therapeutic levels for 6-8 hours after a dose.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek 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
Redness or white patches in the mouth or throat
Vaginal itching or discharge
Fast or abnormal heartbeat
Pain when passing urine or blood in urine
Passing urine more often
Pelvic pain
Ringing in the ears, hearing loss, or other changes in hearing

Nervous System Problems

This medication can cause nervous system problems, which may be long-lasting. If you experience any of the following symptoms, contact your doctor right away:

Burning, numbness, or tingling sensations that are not normal
Changes in balance or eyesight
Dizziness or fainting
Headache
Insomnia
Seizures
Trouble speaking
Confusion
Depression
Irritability
Fatigue
Weakness

Aseptic Meningitis

This medication may increase the risk of a severe brain problem called aseptic meningitis. If you experience any of the following symptoms, contact your doctor right away:

Headache
Fever
Chills
Severe nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Drowsiness
Confusion

Low White Blood Cell Counts

This medication can cause low white blood cell counts, which may increase the risk of infection. If you experience any of the following symptoms, contact your doctor right away:

Fever
Chills
Sore throat

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. If you experience any of the following symptoms, seek medical help right away:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects

Most people do not experience serious side effects, but some may occur. If you experience any of the following symptoms, contact your doctor if they bother you or do not go away:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Stomach cramps
Metallic taste
Headache
Joint pain
* Decreased libido

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
  • Signs of liver problems (yellowing eyes/skin, dark urine, severe stomach pain, persistent nausea/vomiting)
  • New or worsening numbness, tingling, pain, or weakness in hands or feet (signs of peripheral neuropathy)
  • Seizures
  • Severe headache, stiff neck, confusion, fever (signs of aseptic meningitis)
  • Vision changes (e.g., double vision)
  • Severe or persistent diarrhea (may indicate C. difficile infection)
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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 while taking this medication. In some cases, these liver issues have been severe, persistent, or even fatal.
If you have taken disulfiram within the past 14 days.
If you are less than 12 weeks pregnant, as this medication is not intended for use in certain patients during this stage of pregnancy.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

As this medication may interfere with certain laboratory tests, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are undergoing dialysis, consult with your doctor to discuss any necessary precautions.

To minimize potential interactions, you may need to avoid consuming alcohol or products containing alcohol or propylene glycol during treatment with this medication and for at least 72 hours after your last dose. Examples of products that may contain alcohol or propylene glycol include some cough syrups. Consuming these substances may cause adverse effects such as stomach cramps, nausea, vomiting, headaches, and flushing. Consult with your doctor to determine if you need to avoid alcohol or products containing alcohol or propylene glycol.

Do not exceed the recommended treatment duration, as this may increase the risk of a secondary infection. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Ataxia (loss of coordination)
  • Disorientation
  • Seizures
  • Peripheral neuropathy

What to Do:

Call 911 or your local poison control center immediately (e.g., 1-800-222-1222 in the US). Treatment is supportive and symptomatic; there is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Alcohol (including alcohol-containing products like cough syrups, mouthwash) - disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, flushing)
  • Disulfiram - psychotic reactions
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Major Interactions

  • Warfarin (and other oral anticoagulants) - increased anticoagulant effect (monitor INR/PT)
  • Lithium - increased lithium levels (monitor lithium levels)
  • Busulfan - increased busulfan levels (increased toxicity)
  • Phenytoin - increased phenytoin levels, decreased metronidazole levels
  • Phenobarbital - decreased metronidazole levels
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Moderate Interactions

  • Cimetidine - decreased metronidazole clearance (increased metronidazole levels)
  • Fluorouracil - increased fluorouracil toxicity
  • Cyclosporine - increased cyclosporine levels (monitor cyclosporine levels)
  • Tacrolimus - increased tacrolimus levels (monitor tacrolimus levels)
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Minor Interactions

  • Oral contraceptives - theoretical reduction in efficacy (use alternative contraception)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To establish baseline and monitor for leukopenia or neutropenia, which can occur with prolonged therapy.

Timing: Prior to initiation of therapy, especially for prolonged courses.

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with known liver disease, as metronidazole is metabolized by the liver.

Timing: Prior to initiation of therapy in patients with hepatic impairment.

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Routine Monitoring

Complete Blood Count (CBC) with differential

Frequency: Periodically (e.g., weekly to bi-weekly) for prolonged therapy (>10 days) or high doses.

Target: Within normal limits

Action Threshold: Discontinue if significant leukopenia or neutropenia develops.

Neurological assessment (e.g., signs of peripheral neuropathy, seizures)

Frequency: Regularly throughout therapy, especially with prolonged use.

Target: Absence of new or worsening neurological symptoms.

Action Threshold: Discontinue if signs of peripheral neuropathy (numbness, tingling, weakness) or seizures occur.

INR/PT (if on warfarin)

Frequency: More frequently (e.g., daily to every few days) upon initiation and dose changes.

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose to maintain target INR.

Lithium levels (if on lithium)

Frequency: More frequently upon initiation and dose changes.

Target: Therapeutic range for indication

Action Threshold: Adjust lithium dose to maintain target levels.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Metallic taste
  • Headache
  • Dizziness
  • Peripheral neuropathy (numbness, tingling, weakness in extremities)
  • Seizures
  • Rash
  • Darkening of urine
  • Signs of candidiasis (oral thrush, vaginal yeast infection)

Special Patient Groups

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Pregnancy

Metronidazole is generally considered safe for use during the second and third trimesters of pregnancy when clearly needed. Use in the first trimester is generally avoided unless the benefits outweigh the potential risks, due to some conflicting data regarding teratogenicity, though most studies do not show an increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: Conflicting data; some studies suggest a possible, but unconfirmed, increased risk of cleft lip with or without cleft palate. Generally avoided unless no safer alternative.
Second Trimester: Considered generally safe; widely used for appropriate indications.
Third Trimester: Considered generally safe; widely used for appropriate indications.
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Lactation

Metronidazole is excreted into breast milk in concentrations similar to maternal plasma. The American Academy of Pediatrics considers it compatible with breastfeeding. For single high doses (e.g., 2g for trichomoniasis), some experts recommend pumping and discarding breast milk for 12-24 hours after the dose to minimize infant exposure. For multi-dose regimens, monitor the infant for gastrointestinal upset (diarrhea, candidiasis) or metallic taste aversion.

Infant Risk: Low to moderate risk. Potential for GI upset (diarrhea, candidiasis), metallic taste, or theoretical risk of carcinogenicity (unproven in humans). Benefits of breastfeeding generally outweigh risks for multi-dose regimens.
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Pediatric Use

Dosing is weight-based. Use with caution in neonates due to immature hepatic function and prolonged half-life. Monitor for adverse effects, especially neurological. Safety and efficacy for some indications (e.g., C. difficile) are well-established.

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Geriatric Use

No specific dose adjustment is typically needed based on age alone, but elderly patients may have reduced hepatic or renal function, requiring dose adjustments based on impairment. They may also be more susceptible to neurological adverse effects (e.g., peripheral neuropathy). Monitor closely for adverse reactions.

Clinical Information

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Clinical Pearls

  • Metronidazole is effective against anaerobic bacteria and certain protozoa (e.g., Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica).
  • The metallic taste is a common and often bothersome side effect.
  • Warn patients explicitly about the disulfiram-like reaction with alcohol; this is a critical patient education point.
  • Darkening of urine (reddish-brown) is a harmless side effect due to metabolites.
  • For C. difficile infection, metronidazole is typically used for mild-to-moderate cases or as an alternative to vancomycin.
  • Prolonged use (especially >10-14 days) or high doses increase the risk of peripheral neuropathy; monitor for symptoms.
  • Can cause a false-negative result in the Treponema pallidum immobilization test for syphilis.
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Alternative Therapies

  • Clindamycin (for anaerobic infections, bacterial vaginosis)
  • Tinidazole (for trichomoniasis, giardiasis, amebiasis - similar class, longer half-life)
  • Vancomycin (oral, for C. difficile infection)
  • Doxycycline (for bacterial vaginosis, some anaerobic infections)
  • Secnidazole (for bacterial vaginosis, trichomoniasis - single dose)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (250mg or 500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure 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 taken, the amount, and the time it happened.