Rifampin 300mg Capsules

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Rifampin Capsules(rif AM pin) Pronunciation rif-AM-pin
It is used to treat TB (tuberculosis). It is used to stop the spread of meningitis in people who carry the bacteria but are not sick with the disease.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antimycobacterial; Antibiotic
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Pharmacologic Class
Rifamycin; RNA Polymerase Inhibitor
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Pregnancy Category
Category C
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FDA Approved
Aug 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Rifampin is an antibiotic used to treat serious bacterial infections, most commonly tuberculosis (TB). It works by stopping the growth of bacteria. It is often used in combination with other medicines.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.

Take this medication on an empty stomach, either at least 1 hour before or at least 2 hours after a meal.
Swallow the medication with a full glass of water.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel well.

If you are taking an antacid, be sure to take this medication at least 1 hour before taking the antacid.

Special Instructions for Liquid Formulation

If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid (suspension) form of this medication. If a liquid formulation is prepared, shake it well before use.

Measure liquid doses carefully using the measuring device provided with the medication. If no device is provided, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, away from the bathroom.
Protect the medication from heat and light.
If a liquid formulation is prepared, store it at room temperature or in the refrigerator.
Discard any unused portion of the liquid formulation after 4 weeks.

What to Do if You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take on an empty stomach (1 hour before or 2 hours after meals) for best absorption.
  • Do not miss doses; take exactly as prescribed to prevent drug resistance.
  • Expect orange-red discoloration of urine, sweat, tears, saliva, and contact lenses. This is harmless but can permanently stain soft contact lenses.
  • Avoid alcohol, as it can increase the risk of liver problems.
  • Rifampin can make birth control pills less effective; use an alternative non-hormonal method of contraception.
  • Inform your doctor about all other medications, including over-the-counter drugs, herbal supplements, and vitamins, as Rifampin interacts with many drugs.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg once daily or 10 mg/kg (max 600 mg) once daily for tuberculosis (TB)
Dose Range: 10 - 10 mg

Condition-Specific Dosing:

Tuberculosis (TB): 10 mg/kg (max 600 mg) orally or IV once daily or 2-3 times weekly, depending on regimen.
Leprosy: 600 mg orally once monthly (multibacillary) or once every 2-4 weeks (paucibacillary) in combination with other agents.
Meningococcal Carrier State: 600 mg orally every 12 hours for 2 days.
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Pediatric Dosing

Neonatal: 10-20 mg/kg/day orally or IV once daily (for TB, in combination with other agents).
Infant: 10-20 mg/kg/day orally or IV once daily (for TB, in combination with other agents).
Child: 10-20 mg/kg/day orally or IV once daily (max 600 mg/day) for TB, in combination with other agents. For meningococcal prophylaxis: <1 month: 10 mg/kg/day for 2 days; â‰Ĩ1 month: 20 mg/kg/day for 2 days.
Adolescent: 10 mg/kg/day orally or IV once daily (max 600 mg/day) for TB, in combination with other agents.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed for intermittent dosing (2-3 times weekly). For daily dosing, consider 10 mg/kg 3 times weekly if CrCl <30 mL/min, but generally well tolerated.
Dialysis: No supplemental dose needed after dialysis. Rifampin is not significantly removed by hemodialysis or peritoneal dialysis.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; dose reduction may be necessary, monitor liver function closely.
Severe: Contraindicated or use with extreme caution; significant dose reduction and close monitoring required. Consider alternative agents.

Pharmacology

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Mechanism of Action

Rifampin inhibits bacterial DNA-dependent RNA polymerase activity by binding to the beta subunit of the enzyme. This binding prevents the initiation of transcription, thereby inhibiting bacterial RNA synthesis and ultimately protein synthesis. It is bactericidal against susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 90-95%
Tmax: 2-4 hours (oral)
FoodEffect: Food decreases and delays absorption. Should be taken on an empty stomach (1 hour before or 2 hours after meals).

Distribution:

Vd: 0.9-1.2 L/kg
ProteinBinding: 75-90%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF, especially with inflamed meninges)

Elimination:

HalfLife: 3-5 hours (decreases with repeated dosing due to autoinduction)
Clearance: Not available (highly variable)
ExcretionRoute: Primarily biliary/fecal (60-65%), with a smaller portion (6-15%) excreted in urine (unchanged drug and metabolites).
Unchanged: Approximately 6-15% in urine, 60-65% in feces.
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 2-4 hours (antibacterial effect)
DurationOfAction: 24 hours (allows for once-daily dosing)

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 emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Dizziness or fainting.
Flu-like symptoms.
Fever, chills, or sore throat.
Unexplained bruising or bleeding, or feeling extremely tired or weak.
Joint pain or swelling.
Muscle pain or weakness.
Chest pain.
Excessive sweating.
Abnormal heartbeat.
Swelling in the arms or legs.
Purple spots or redness on the skin.
Changes in balance or coordination.
Confusion, difficulty focusing, or changes in behavior.
Menstrual changes.
Changes in vision, eye pain, or severe eye irritation.
Changes in tooth color (which may be long-lasting).

New or Worsening Symptoms: Contact Your Doctor

If you experience any new or worsening symptoms, such as cough, fever, fatigue, weakness, shortness of breath, headache, pain, night sweats, swollen glands, decreased appetite, weight loss, or skin sores, contact your doctor right away.

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. These reactions can be life-threatening and may affect other organs. 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; or swollen glands.

Blood Problems

In rare cases, this medication can cause severe and potentially life-threatening blood problems, such as thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). If you experience any of the following symptoms, contact your doctor immediately: extreme fatigue or weakness, bruising or bleeding, dark urine or yellow skin and eyes, pale skin, changes in urine output, changes in vision, weakness or numbness on one side of the body, difficulty speaking or thinking, or changes in balance.

Other Side Effects

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

Drowsiness.
Gas.
Diarrhea, stomach upset, or vomiting.
Heartburn.
Stomach cramps.
* Changes in the color of body fluids to orange or red.

Reporting Side Effects

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

  • Signs of liver problems: unusual tiredness, weakness, loss of appetite, nausea, vomiting, dark urine, yellowing of skin or eyes (jaundice), light-colored stools.
  • Flu-like symptoms: fever, chills, headache, muscle aches, dizziness.
  • Unusual bleeding or bruising.
  • Severe skin rash or itching.
  • Swelling of the face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction).
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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 symptoms you experienced.
If you have previously taken this medication and it caused liver problems.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some of these may interact with this medication. Specifically, certain medications used to treat HIV, infections, depression, and other conditions should not be taken with this drug. Your doctor or pharmacist can advise you on which medications are safe to take together.

Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect your use of this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose 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. Your doctor will likely recommend regular blood tests and other laboratory assessments to monitor your condition. Be aware that this drug may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.

To minimize potential risks, avoid consuming alcohol while taking this drug. If you have diabetes, it is vital to closely monitor your blood sugar levels, as this medication may affect them. Be aware of the signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, and report them to your doctor promptly.

Additionally, this medication may cause discoloration of contact lenses. Do not use this drug for longer than prescribed, as this may increase the risk of a second infection.

Rifampin has been associated with liver problems, which can be severe and potentially life-threatening, especially in individuals with pre-existing liver disease or those taking other medications that may increase the risk of liver damage. If you have concerns, discuss them with your doctor.

This medication has also been linked to certain lung problems, which can be fatal. If you have questions or concerns, consult your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

It is essential to note that birth control pills and other hormone-based contraceptives may be less effective while taking this drug. To prevent pregnancy, use an additional form of birth control, such as a condom.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea, vomiting, abdominal pain
  • Lethargy, drowsiness
  • Headache, dizziness
  • Generalized pruritus
  • Orange-red discoloration of skin, urine, sweat, tears, and feces (often referred to as 'red man syndrome' or 'orange man syndrome')
  • Hepatomegaly, jaundice, elevated liver enzymes
  • In severe cases: loss of consciousness, convulsions, cardiac arrhythmias, respiratory arrest.

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately. Seek emergency medical attention. Treatment is supportive and symptomatic; there is no specific antidote. Gastric lavage may be considered if performed early after ingestion. Activated charcoal may be administered. Hemodialysis is generally not effective.

Drug Interactions

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Contraindicated Interactions

  • Protease Inhibitors (e.g., Atazanavir, Darunavir, Fosamprenavir, Lopinavir/Ritonavir, Saquinavir, Tipranavir) - significant decrease in PI concentrations.
  • Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., Delavirdine, Rilpivirine) - significant decrease in NNRTI concentrations.
  • Daclatasvir, Ledipasvir/Sofosbuvir, Ombitasvir/Paritaprevir/Ritonavir, Sofosbuvir/Velpatasvir, Voxilaprevir/Sofosbuvir/Velpatasvir (HCV antivirals) - significant decrease in antiviral concentrations.
  • Praziquantel - significant decrease in praziquantel concentrations.
  • Voriconazole - significant decrease in voriconazole concentrations.
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Major Interactions

  • Oral Contraceptives - decreased efficacy, leading to contraceptive failure.
  • Warfarin - decreased anticoagulant effect.
  • Corticosteroids (e.g., Prednisone, Dexamethasone) - decreased corticosteroid effect.
  • Cyclosporine, Tacrolimus, Sirolimus (Immunosuppressants) - decreased immunosuppressant levels, leading to transplant rejection.
  • Digoxin - decreased digoxin levels.
  • Phenytoin, Carbamazepine (Anticonvulsants) - decreased anticonvulsant levels, leading to loss of seizure control.
  • Sulfonylureas (e.g., Glyburide, Glipizide) - decreased hypoglycemic effect.
  • Methadone - decreased methadone levels, leading to withdrawal symptoms.
  • Clarithromycin, Erythromycin - decreased macrolide levels.
  • Fluconazole, Itraconazole, Ketoconazole, Posaconazole - decreased azole antifungal levels.
  • Calcium Channel Blockers (e.g., Verapamil, Diltiazem, Nifedipine) - decreased antihypertensive effect.
  • Beta-blockers (e.g., Metoprolol, Propranolol) - decreased beta-blocker effect.
  • Amiodarone - decreased amiodarone levels.
  • Statins (e.g., Simvastatin, Atorvastatin) - decreased statin levels, potentially leading to hyperlipidemia.
  • Theophylline - decreased theophylline levels.
  • Quinine - decreased quinine levels.
  • Oral Hypoglycemics - decreased hypoglycemic effect.
  • Dapsone - decreased dapsone levels.
  • Chloramphenicol - decreased chloramphenicol levels.
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Moderate Interactions

  • Acetaminophen - increased risk of hepatotoxicity with chronic use.
  • Oral Anticoagulants (other than warfarin) - decreased anticoagulant effect.
  • Propafenone - decreased propafenone levels.
  • Quinidine - decreased quinidine levels.
  • Tramadol - decreased tramadol levels.
  • Zolpidem - decreased zolpidem levels.
  • Buspirone - decreased buspirone levels.
  • Clozapine - decreased clozapine levels.
  • Haloperidol - decreased haloperidol levels.
  • Olanzapine - decreased olanzapine levels.
  • Risperidone - decreased risperidone levels.
  • Sertraline - decreased sertraline levels.
  • Tricyclic Antidepressants (e.g., Amitriptyline) - decreased antidepressant levels.
  • Bupropion - decreased bupropion levels.
  • Fentanyl - decreased fentanyl levels.
  • Gabapentin - decreased gabapentin levels.
  • Levothyroxine - decreased levothyroxine levels.
  • Metformin - decreased metformin levels.
  • Phenobarbital - decreased phenobarbital levels.
  • Topiramate - decreased topiramate levels.
  • Valproic Acid - decreased valproic acid levels.
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Minor Interactions

  • Not available (most interactions are significant due to strong enzyme induction).

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs) including AST, ALT, bilirubin

Rationale: Rifampin can cause hepatotoxicity, especially in combination with other antitubercular drugs.

Timing: Before initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: To establish baseline and monitor for hematologic abnormalities (e.g., thrombocytopenia, leukopenia) which are rare but possible.

Timing: Before initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, although dose adjustment is generally not needed for renal impairment.

Timing: Before initiation of therapy.

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Routine Monitoring

Liver Function Tests (LFTs)

Frequency: Monthly or more frequently if clinically indicated (e.g., symptoms of hepatotoxicity, pre-existing liver disease, concomitant hepatotoxic drugs).

Target: Within normal limits or stable from baseline.

Action Threshold: Discontinue if AST/ALT >5x ULN (without symptoms) or >3x ULN (with symptoms of liver injury).

Complete Blood Count (CBC)

Frequency: Periodically, especially if patient develops fever, purpura, or other signs of hematologic dysfunction.

Target: Within normal limits.

Action Threshold: Discontinue if significant thrombocytopenia or other severe hematologic abnormalities occur.

Clinical Symptoms (e.g., fever, rash, jaundice, fatigue, nausea, vomiting, dark urine, light stools)

Frequency: Daily patient self-monitoring and regular clinical assessment.

Target: Absence of symptoms.

Action Threshold: Prompt evaluation and potential discontinuation if symptoms of hepatotoxicity, hypersensitivity, or flu-like syndrome develop.

Therapeutic Drug Monitoring (TDM)

Frequency: Not routinely recommended for all patients, but may be considered in specific populations (e.g., HIV co-infection, malabsorption, treatment failure, severe disease, non-adherence concerns).

Target: Peak serum concentrations typically 8-24 mcg/mL (2-4 hours post-dose).

Action Threshold: Adjust dose based on levels and clinical response.

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Symptom Monitoring

  • Flu-like syndrome (fever, chills, headache, dizziness, bone pain)
  • Hepatotoxicity (fatigue, weakness, malaise, anorexia, nausea, vomiting, dark urine, jaundice, light-colored stools)
  • Hypersensitivity reactions (rash, pruritus, urticaria, fever, eosinophilia)
  • Thrombocytopenia (easy bruising, petechiae, purpura, bleeding)
  • Hemolytic anemia
  • Renal insufficiency (rare, acute tubular necrosis)
  • Gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea)
  • Orange-red discoloration of urine, sweat, tears, saliva, and contact lenses

Special Patient Groups

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Pregnancy

Rifampin is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a theoretical risk of hemorrhagic disease in the newborn due to vitamin K deficiency if Rifampin is used in the last few weeks of pregnancy; vitamin K supplementation for the mother and/or newborn may be considered.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies (e.g., spina bifida, cleft palate in rodents at high doses). Human data are limited but generally do not show a consistent pattern of major malformations.
Second Trimester: Generally considered safer than the first trimester, but continued monitoring for maternal hepatotoxicity is crucial.
Third Trimester: Risk of hemorrhagic disease in the newborn due to interference with vitamin K metabolism. Vitamin K supplementation (10 mg orally daily for mother for 2-4 weeks before delivery, or 1 mg IM for newborn at birth) may be considered.
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Lactation

Rifampin is excreted into breast milk. The amount is generally considered small and unlikely to cause adverse effects in a breastfed infant. The American Academy of Pediatrics considers Rifampin compatible with breastfeeding. However, monitor the infant for potential side effects such as gastrointestinal upset (diarrhea, vomiting) or orange discoloration of urine/stools (though rare in infants).

Infant Risk: L3 (Moderately Safe) - There is some evidence of risk, but the benefits of use in pregnant women may outweigh the risks. Monitor infant for adverse effects.
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Pediatric Use

Rifampin is commonly used in pediatric patients for the treatment of tuberculosis and other susceptible infections. Dosing is weight-based. Children are generally more tolerant of Rifampin than adults, but monitoring for hepatotoxicity is still important. The orange discoloration of body fluids should be explained to parents/guardians.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, geriatric patients may have age-related decreases in hepatic or renal function, or multiple comorbidities and polypharmacy, which may increase the risk of adverse effects (especially hepatotoxicity) and drug interactions. Close monitoring of liver function and drug interactions is essential.

Clinical Information

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Clinical Pearls

  • Always take Rifampin on an empty stomach (1 hour before or 2 hours after meals) for optimal absorption.
  • Warn patients about the harmless but striking orange-red discoloration of urine, sweat, tears, saliva, and contact lenses. This can permanently stain soft contact lenses.
  • Rifampin is a potent inducer of many CYP450 enzymes and P-glycoprotein, leading to numerous significant drug interactions. Always review the patient's full medication list.
  • Counsel female patients on the decreased efficacy of hormonal contraceptives and advise using alternative non-hormonal birth control methods.
  • Monitor liver function tests (LFTs) regularly, especially in patients with pre-existing liver disease, alcohol use, or those receiving other hepatotoxic drugs (e.g., isoniazid, pyrazinamide).
  • Rifampin is almost always used in combination with other antitubercular drugs to prevent the development of resistance.
  • Patients should be educated on the importance of adherence to the full course of therapy to prevent treatment failure and drug resistance.
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Alternative Therapies

  • Isoniazid (INH)
  • Pyrazinamide (PZA)
  • Ethambutol (EMB)
  • Streptomycin
  • Other fluoroquinolones (e.g., Moxifloxacin, Levofloxacin) for drug-resistant TB
  • Bedaquiline
  • Delamanid
  • Linezolid
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Cost & Coverage

Average Cost: $20 - $100 per 30 capsules (300mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.