Rifampin 150mg 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; Antitubercular
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Pharmacologic Class
Rifamycin
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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 like tuberculosis (TB) and leprosy. It works by stopping the growth of bacteria. It's also used to prevent certain types of meningitis in people who have been exposed to it.
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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 your medication on an empty stomach, either at least 1 hour before or at least 2 hours after a meal.
Swallow your medication with a full glass of water.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

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

Special Instructions for Liquid (Suspension) Form

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

Measure your liquid doses carefully using the measuring device provided with your medication. If you don't have one, ask your pharmacist for a device to measure your medication accurately.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
If you have a liquid (suspension) form, you can store it at room temperature or in the refrigerator. However, discard any unused portion 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's close to the time for your next dose, skip the missed dose and return to your regular schedule.
Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take rifampin on an empty stomach, either 1 hour before or 2 hours after a meal, with a full glass of water.
  • Take all doses exactly as prescribed, even if you start to feel better. Stopping early can lead to drug-resistant infections.
  • Rifampin can cause your urine, sweat, tears, saliva, and other body fluids to turn a harmless red-orange color. This can permanently stain soft contact lenses.
  • Avoid alcohol while taking rifampin, as it can increase the risk of liver problems.
  • If you use hormonal birth control (pills, patches, rings, implants, injections), rifampin can make them less effective. Use a non-hormonal backup method (like condoms) while taking rifampin and for at least one month after stopping it.
  • Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking, 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 once daily or 2-3 times weekly, depending on regimen.
Leprosy: 600 mg orally once monthly, typically in combination with other agents.
Meningococcal Prophylaxis: 600 mg orally every 12 hours for 2 days (total 4 doses).
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Pediatric Dosing

Neonatal: 10-20 mg/kg orally once daily (for TB, consult specialist).
Infant: 10-20 mg/kg orally once daily (for TB, max 600 mg/day).
Child: 10-20 mg/kg orally once daily (for TB, max 600 mg/day).
Adolescent: 10-20 mg/kg orally once daily (for TB, max 600 mg/day).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed, but monitor for adverse effects.
Dialysis: No supplemental dose needed after hemodialysis or peritoneal dialysis.

Hepatic Impairment:

Mild: Use with caution; monitor liver function closely.
Moderate: Dose reduction may be necessary; monitor liver function closely.
Severe: Contraindicated in severe hepatic disease or active hepatitis unless absolutely necessary and under strict supervision.

Pharmacology

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Mechanism of Action

Rifampin inhibits bacterial DNA-dependent RNA polymerase activity by binding to its beta subunit. This binding prevents the initiation of RNA synthesis, leading to bactericidal activity against susceptible organisms, particularly Mycobacterium tuberculosis.
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Pharmacokinetics

Absorption:

Bioavailability: 90-95%
Tmax: 2-4 hours
FoodEffect: Food decreases the rate and extent of absorption; administer on an empty stomach (1 hour before or 2 hours after meals).

Distribution:

Vd: 1.6 L/kg
ProteinBinding: 75-90%
CnssPenetration: Yes (especially with inflamed meninges)

Elimination:

HalfLife: 2-5 hours (decreases with autoinduction upon repeated dosing)
Clearance: Not available
ExcretionRoute: Primarily biliary/fecal (60-65%), with a smaller portion (6-15%) excreted renally.
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 2-4 hours (plasma concentration)
DurationOfAction: Not directly applicable for effect, but bactericidal activity persists as long as concentrations are above MIC.

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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant 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 or excessive sweating
Abnormal heartbeat or 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: Seek Medical Help Right Away

If you experience any new or worsening symptoms, such as:

Cough
Fever
Fatigue or weakness
Shortness of breath
Headache
Pain
Night sweats
Swollen glands
Decreased appetite
Weight loss
Skin sores

contact your doctor immediately.

Diarrhea and Antibiotic Use

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 a life-threatening bowel problem. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor right away. Do not treat diarrhea without consulting your doctor first.

Severe Skin Reactions: Seek Medical Help Right Away

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 notice any of the following symptoms, seek medical help immediately:

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

Blood Problems: Seek Medical Help Right Away

In rare cases, this medication can cause severe blood problems, including 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
Changes in strength or coordination
Trouble speaking or thinking
Changes in balance
Fever

Other Side Effects

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

Drowsiness
Gas
Diarrhea, upset stomach, 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:

  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Unusual tiredness or weakness
  • Loss of appetite, nausea, or vomiting
  • Fever, chills, or body aches (flu-like symptoms)
  • Unexplained rash or itching
  • Easy bruising or bleeding
  • Severe diarrhea or abdominal pain
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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 previously experienced liver problems while taking this medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, depression, and other conditions, should not be taken with this medication. Your doctor or pharmacist can advise you on potential interactions.
Please note that this is not an exhaustive list of all medications or health conditions that may interact with this medication.

To ensure your safety, it is vital to discuss all of your medications (prescription and OTC), natural products, vitamins, and health conditions with your doctor and pharmacist. This will help determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change 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 work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.

This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.

To minimize potential risks, avoid consuming alcohol while taking this medication. If you have diabetes (high blood sugar), closely monitor your blood sugar levels, as this medication may affect them. Be aware of 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 staining of contact lenses. Do not use this medication for an extended period beyond the recommended duration, as this may increase the risk of a second infection.

Rifampin, the active ingredient in this medication, 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 problems. 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 medication. 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
  • Enlargement of the liver (hepatomegaly)
  • Jaundice
  • Increased liver enzymes
  • Brownish-red or orange discoloration of skin, urine, sweat, saliva, tears, and feces
  • Lethargy
  • Headache
  • Dizziness
  • In severe cases: loss of consciousness, convulsions, cardiac arrhythmias

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and may include gastric lavage, activated charcoal, and monitoring of vital signs and liver function.

Drug Interactions

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Contraindicated Interactions

  • Protease inhibitors (e.g., atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir) - due to significant reduction in antiretroviral concentrations.
  • Non-nucleoside reverse transcriptase inhibitors (e.g., rilpivirine, doravirine) - due to significant reduction in antiretroviral concentrations.
  • Praziquantel - due to significant reduction in praziquantel concentrations.
  • Daclatasvir, Ledipasvir/Sofosbuvir, Velpatasvir/Sofosbuvir - due to significant reduction in antiviral concentrations.
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Major Interactions

  • Oral contraceptives (decreased efficacy, leading to contraceptive failure)
  • Warfarin (decreased anticoagulant effect)
  • Corticosteroids (decreased corticosteroid effect)
  • Oral hypoglycemics (e.g., sulfonylureas) (decreased hypoglycemic effect)
  • Digoxin (decreased digoxin levels)
  • Phenytoin (decreased phenytoin levels)
  • Theophylline (decreased theophylline levels)
  • Cyclosporine, Tacrolimus (decreased immunosuppressant levels)
  • Methadone (withdrawal symptoms due to decreased methadone levels)
  • Statins (e.g., simvastatin, atorvastatin) (decreased statin levels)
  • Azole antifungals (e.g., ketoconazole, fluconazole, itraconazole, voriconazole) (decreased 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)
  • Clopidogrel (decreased antiplatelet effect)
  • Dabigatran (decreased dabigatran levels)
  • Quinine (decreased quinine levels)
  • Selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline, paroxetine) (decreased SSRI levels)
  • Tricyclic antidepressants (TCAs) (e.g., imipramine, amitriptyline) (decreased TCA levels)
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Moderate Interactions

  • Acetaminophen (increased risk of hepatotoxicity with chronic use)
  • Oral iron supplements (decreased rifampin absorption if taken concurrently)
  • Antacids (decreased rifampin absorption if taken concurrently)
  • Atovaquone (decreased atovaquone levels, increased rifampin levels)
  • Chloramphenicol (decreased chloramphenicol levels)
  • Dapsone (decreased dapsone levels)
  • Erythromycin (decreased erythromycin levels)
  • Linezolid (potential for serotonin syndrome if co-administered with serotonergic agents)
  • Propafenone (decreased propafenone levels)
  • Zidovudine (decreased zidovudine levels)
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Minor Interactions

  • Food (decreased absorption of rifampin)

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: To establish baseline hepatic function and detect pre-existing liver disease, as rifampin can cause hepatotoxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC)

Rationale: To establish baseline hematologic parameters and monitor for potential hematologic abnormalities (e.g., thrombocytopenia, leukopenia).

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline renal function, although dose adjustment is generally not needed, it's important for overall patient assessment.

Timing: Prior to initiation of therapy.

Ophthalmologic Exam

Rationale: If co-administered with ethambutol, to establish baseline visual acuity and color discrimination.

Timing: Prior to 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).

Target: Within normal limits or stable from baseline.

Action Threshold: Discontinue if transaminases are >3-5 times upper limit of normal (ULN) with symptoms, or >5 times ULN without symptoms.

Complete Blood Count (CBC)

Frequency: Monthly or as clinically indicated.

Target: Within normal limits.

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

Renal Function (BUN, Creatinine)

Frequency: Periodically, as clinically indicated.

Target: Within normal limits.

Action Threshold: Not available

Drug Interaction Monitoring

Frequency: Continuously, especially when new medications are added or existing medications are adjusted.

Target: Therapeutic levels of co-administered drugs.

Action Threshold: Adjust doses of interacting drugs or switch to alternatives as needed.

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Symptom Monitoring

  • Signs and symptoms of hepatotoxicity (e.g., fatigue, weakness, malaise, anorexia, nausea, vomiting, dark urine, jaundice, light-colored stools).
  • Flu-like syndrome (fever, chills, headache, dizziness, bone pain) - more common with intermittent dosing.
  • Skin rash, pruritus, or other hypersensitivity reactions.
  • Gastrointestinal upset (e.g., abdominal pain, diarrhea).
  • Unusual bleeding or bruising (due to thrombocytopenia).
  • Red-orange discoloration of urine, sweat, tears, saliva, and contact lenses.

Special Patient Groups

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Pregnancy

Rifampin is generally considered acceptable for use during pregnancy for the treatment of active tuberculosis, especially when the benefits outweigh the risks. It is a Category C drug, meaning animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. However, untreated TB poses a greater risk to both mother and fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though human data are largely reassuring for TB treatment.
Second Trimester: Generally considered safer than first trimester, continued monitoring for maternal adverse effects.
Third Trimester: May cause postnatal hemorrhage in mother and infant due to vitamin K deficiency; vitamin K supplementation is often recommended for the mother in the last month of pregnancy and for the neonate at birth.
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Lactation

Rifampin is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding, but the infant should be monitored for potential adverse effects such as gastrointestinal upset, rash, or orange discoloration of urine. The amount transferred is usually too low to be therapeutic for the infant.

Infant Risk: Low risk (L3 - Moderately safe). Monitor for GI upset, rash, or orange discoloration of body fluids. No significant adverse effects have been reported in breastfed infants.
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Pediatric Use

Rifampin is used in pediatric patients for the treatment of tuberculosis and other susceptible infections. Dosing is weight-based (10-20 mg/kg/day, max 600 mg/day). Close monitoring for adverse effects, particularly hepatotoxicity, is crucial.

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Geriatric Use

No specific dose adjustment is typically required based on age alone, but geriatric patients may have age-related decreases in hepatic or renal function, which could necessitate closer monitoring for adverse effects, especially hepatotoxicity. Polypharmacy in this population increases the risk of drug interactions due to rifampin's potent enzyme-inducing properties.

Clinical Information

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Clinical Pearls

  • Rifampin is a potent inducer of multiple cytochrome P450 enzymes (especially CYP3A4) and P-glycoprotein, leading to numerous significant drug interactions. Always review a patient's full medication list.
  • Causes a harmless red-orange discoloration of urine, sweat, tears, saliva, and contact lenses. Patients should be counselled about this to prevent alarm.
  • Administer on an empty stomach for optimal absorption.
  • Crucial component of most first-line tuberculosis treatment regimens.
  • Monitor liver function tests (LFTs) regularly due to the risk of hepatotoxicity, especially when used in combination with other antitubercular drugs like isoniazid and pyrazinamide.
  • Intermittent dosing (e.g., twice or thrice weekly) is associated with a higher incidence of flu-like syndrome and hypersensitivity reactions compared to daily dosing.
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Alternative Therapies

  • Isoniazid (for TB)
  • Pyrazinamide (for TB)
  • Ethambutol (for TB)
  • Streptomycin (for TB)
  • Other rifamycins (e.g., rifabutin, rifapentine) for specific indications or drug interactions considerations.
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Cost & Coverage

Average Cost: $50 - $150 per 30 capsules (150mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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, including the amount taken and the time it happened, to ensure you receive the best possible care.