Rifampin 600mg Inj, 1 Vial

Manufacturer FRESENIUS KABI USA Active Ingredient Rifampin Injection(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 antibiotic
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Pregnancy Category
Category C
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FDA Approved
Mar 1988
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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 is also sometimes 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

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication is administered as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
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Lifestyle & Tips

  • Avoid alcohol consumption while taking rifampin, as it can increase the risk of liver problems.
  • Rifampin can cause a harmless reddish-orange discoloration of body fluids, including urine, sweat, tears, saliva, and stools. This is normal and not a cause for concern, but it can permanently stain soft contact lenses, clothing, and other items. Consider wearing glasses instead of contact lenses.
  • If you are taking oral contraceptives (birth control pills), rifampin can make them less effective. You should use an alternative, non-hormonal method of birth control (e.g., condoms, diaphragm) while taking rifampin and for at least one month after stopping it.
  • Take rifampin exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better, as this can lead to drug resistance and treatment failure.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg IV daily or 2-3 times weekly (for Tuberculosis)
Dose Range: 10 - 600 mg

Condition-Specific Dosing:

Tuberculosis: 600 mg IV daily or 2-3 times weekly (as part of a multi-drug regimen)
Meningococcal Prophylaxis: 600 mg IV every 12 hours for 2 days
Leprosy: 600 mg IV once monthly (often combined with other agents)
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Pediatric Dosing

Neonatal: Not established (used off-label, typically 10-20 mg/kg/day)
Infant: 10-20 mg/kg/day IV, maximum 600 mg/day
Child: 10-20 mg/kg/day IV, maximum 600 mg/day
Adolescent: 10-20 mg/kg/day IV, maximum 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 dose adjustment needed after dialysis

Hepatic Impairment:

Mild: Monitor closely, consider dose reduction
Moderate: Dose reduction recommended, monitor LFTs closely
Severe: Dose reduction recommended, monitor LFTs closely

Pharmacology

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Mechanism of Action

Rifampin inhibits bacterial DNA-dependent RNA polymerase, thereby suppressing RNA synthesis and protein synthesis. It is bactericidal against both intracellular and extracellular Mycobacterium tuberculosis organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 0.9-1.2 L/kg
ProteinBinding: 80-90%
CnssPenetration: Yes (good, especially with inflamed meninges)

Elimination:

HalfLife: 1.5-5 hours (decreases with repeated dosing due to autoinduction)
Clearance: Not available (highly variable due to autoinduction)
ExcretionRoute: Primarily biliary/fecal (60-65%), some renal (6-15% unchanged)
Unchanged: 6-15% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (IV)
PeakEffect: Not applicable (continuous effect with IV infusion)
DurationOfAction: 24 hours (for 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 or seek medical attention immediately:

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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Dizziness or fainting
Flu-like symptoms
Fever, chills, or sore throat
Unexplained bruising or bleeding
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 of the skin
Changes in balance
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)

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

Important Warnings

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur. These reactions can be life-threatening and may affect other organs. Seek medical help right away if you notice:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Rare but potentially life-threatening blood problems, such as thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), may occur. Contact your doctor immediately if you experience:
+ Extreme tiredness or weakness
+ Bruising or bleeding
+ Dark urine or yellow skin or eyes
+ Pale skin
+ Changes in urine output
+ Changes in vision
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ Fever
This medication may cause vein irritation. If you notice redness, burning, pain, swelling, or fluid leakage at the injection site, inform your nurse.

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:

Drowsiness
Gas
Diarrhea
Upset stomach or vomiting
Heartburn
Stomach cramps
* Changes in body fluid color to orange or red

If you experience any of these side effects or others that bother you or do not go away, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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
  • Persistent nausea, vomiting, or loss of appetite
  • Unusual fatigue or weakness
  • Severe skin rash, itching, or hives
  • Easy bruising or bleeding
  • Fever, chills, or flu-like symptoms that are new or worsening
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Sudden decrease in urine output
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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 to take this medication with 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. 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, closely monitor your blood sugar levels, as this medication can 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 discoloration 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 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 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 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
  • Headache
  • Increasing liver enlargement (hepatomegaly)
  • Jaundice
  • Reddish-orange discoloration of skin, urine, sweat, and tears (more intense than usual therapeutic effect)
  • In severe cases: loss of consciousness, convulsions, cardiac arrhythmias

What to Do:

In case of suspected overdose, seek immediate medical attention. Call your local poison control center (e.g., 1-800-222-1222 in the US) or emergency services. Treatment is supportive and symptomatic. Gastric lavage may be considered if oral ingestion. Activated charcoal may be administered. Maintain airway, breathing, and circulation. Monitor liver function and provide supportive care for hepatic dysfunction.

Drug Interactions

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Contraindicated Interactions

  • Protease inhibitors (e.g., tipranavir/ritonavir, saquinavir/ritonavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, telaprevir) due to significant reduction in PI concentrations and loss of antiviral effect.
  • Delamanid (concurrent use not recommended due to potential for QT prolongation)
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Major Interactions

  • Oral contraceptives (decreased efficacy, leading to contraceptive failure)
  • Warfarin (decreased anticoagulant effect)
  • Cyclosporine, Tacrolimus, Sirolimus (decreased immunosuppressant levels)
  • Corticosteroids (decreased corticosteroid levels)
  • Oral hypoglycemics (e.g., sulfonylureas, glinides - decreased efficacy)
  • Phenytoin (decreased anticonvulsant levels)
  • Digoxin (decreased digoxin levels)
  • Antiarrhythmics (e.g., quinidine, disopyramide, mexiletine, propafenone - decreased levels)
  • Azole antifungals (e.g., fluconazole, itraconazole, voriconazole - decreased antifungal levels)
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., efavirenz, nevirapine - altered levels)
  • Certain calcium channel blockers (e.g., verapamil, diltiazem, nifedipine - decreased levels)
  • Methadone (decreased methadone levels, leading to withdrawal symptoms)
  • Clopidogrel (decreased antiplatelet effect)
  • Dapsone (altered dapsone levels)
  • Theophylline (decreased theophylline levels)
  • Statins (e.g., simvastatin, atorvastatin - decreased statin levels)
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Moderate Interactions

  • Beta-blockers (decreased beta-blocker levels)
  • Clozapine (decreased clozapine levels)
  • Tricyclic antidepressants (decreased antidepressant levels)
  • Selective serotonin reuptake inhibitors (SSRIs) (altered SSRI levels)
  • Benzodiazepines (e.g., midazolam, triazolam - decreased levels)
  • Buspirone (decreased buspirone levels)
  • Chloramphenicol (decreased chloramphenicol levels)
  • Cimetidine (decreased cimetidine levels)
  • Erythromycin (decreased erythromycin levels)
  • Haloperidol (decreased haloperidol levels)
  • Ketoconazole (decreased ketoconazole levels)
  • Levothyroxine (decreased thyroid hormone levels)
  • Losartan (decreased losartan levels)
  • Metoprolol (decreased metoprolol levels)
  • Nortriptyline (decreased nortriptyline levels)
  • Ondansetron (decreased ondansetron levels)
  • Propranolol (decreased propranolol levels)
  • Quinine (decreased quinine levels)
  • Sildenafil (decreased sildenafil levels)
  • Tramadol (decreased tramadol levels)
  • Zolpidem (decreased zolpidem levels)
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Minor Interactions

  • Not typically categorized as minor due to potent enzyme induction effects on most interacting drugs.

Monitoring

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Baseline Monitoring

Liver Function Tests (AST, ALT, Bilirubin)

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

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with Platelets

Rationale: To establish baseline hematologic status 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, monitoring is prudent.

Timing: Prior to initiation of therapy

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Routine Monitoring

Liver Function Tests (AST, ALT, Bilirubin)

Frequency: Monthly or as clinically indicated (e.g., if symptoms of hepatotoxicity develop)

Target: Within normal limits or stable from baseline

Action Threshold: Discontinue if AST/ALT > 3-5x ULN with symptoms, or > 5x ULN without symptoms; or if bilirubin > 2x ULN.

Complete Blood Count (CBC) with Platelets

Frequency: Periodically (e.g., monthly for first few months, then less frequently if stable)

Target: Within normal limits

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

Renal Function (BUN, Creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or risk factors

Target: Within normal limits or stable from baseline

Action Threshold: Not a primary concern for dose adjustment, but monitor for acute kidney injury in rare cases.

Therapeutic Drug Monitoring (TDM)

Frequency: Considered in specific situations (e.g., treatment failure, drug interactions, malabsorption, severe disease, HIV co-infection)

Target: Peak plasma concentration (Cmax) 8-24 mcg/mL (for TB)

Action Threshold: Adjust dose based on levels to optimize efficacy and minimize toxicity.

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Symptom Monitoring

  • Jaundice (yellowing of skin or eyes)
  • Dark urine
  • Pale stools
  • Persistent nausea or vomiting
  • Unusual fatigue or weakness
  • Abdominal pain (especially right upper quadrant)
  • Fever
  • Rash or itching
  • Flu-like symptoms (fever, chills, headache, muscle aches)
  • Easy bruising or bleeding
  • Changes in vision

Special Patient Groups

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Pregnancy

Category C. Rifampin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a risk of postnatal hemorrhage in the mother and infant when rifampin is given during the last few weeks of pregnancy, possibly due to vitamin K deficiency. Vitamin K supplementation may be considered for the mother during the last month of pregnancy and for the neonate.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies show teratogenicity at high doses. Use only if clearly needed.
Second Trimester: Generally considered safer than first trimester, but still Category C. Monitor for maternal hepatotoxicity.
Third Trimester: Risk of postnatal hemorrhage in mother and infant. Vitamin K supplementation may be considered.
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Lactation

Rifampin is excreted into breast milk. The American Academy of Pediatrics considers rifampin compatible with breastfeeding. However, due to the potential for adverse effects in the infant (e.g., jaundice, poor feeding, theoretical risk of liver toxicity), caution is advised. The benefits of breastfeeding for the infant and the mother's need for treatment should be weighed against the potential risks.

Infant Risk: L3 (Moderate risk). Monitor infant for signs of adverse effects (e.g., jaundice, poor feeding, rash).
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Pediatric Use

Rifampin is generally safe and effective for pediatric patients for appropriate indications (e.g., tuberculosis). Dosing is weight-based (10-20 mg/kg/day, max 600 mg/day). Close monitoring for adverse effects, particularly hepatotoxicity, is important.

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Geriatric Use

No specific dose adjustment is generally needed for elderly patients based on age alone. However, geriatric patients may have age-related decreases in hepatic and/or renal function, and may be more susceptible to adverse effects. Close monitoring of liver function and overall tolerance is recommended.

Clinical Information

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Clinical Pearls

  • Rifampin is a potent inducer of numerous CYP450 enzymes (e.g., CYP3A4, CYP2C9, CYP2C19) and P-glycoprotein, leading to a high potential for significant drug-drug interactions. Always review concomitant medications carefully.
  • Causes a harmless reddish-orange discoloration of body fluids (urine, sweat, tears, saliva), which can permanently stain soft contact lenses and clothing.
  • Resistance to rifampin can develop rapidly if used as monotherapy; it should always be used in combination with other antitubercular drugs for the treatment of tuberculosis.
  • Administer intravenous infusion over 3 hours. Rapid infusion can lead to 'red man syndrome' (flushing, rash, itching).
  • Monitor liver function tests (AST, ALT, bilirubin) closely, especially in patients with pre-existing liver disease, alcoholism, or those receiving other hepatotoxic medications (e.g., isoniazid, pyrazinamide).
  • For meningococcal prophylaxis, rifampin is effective but should be reserved for situations where other agents are contraindicated or not feasible, due to its broad-spectrum activity and potential for resistance development.
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Alternative Therapies

  • Other antitubercular drugs (e.g., Isoniazid, Pyrazinamide, Ethambutol, Streptomycin, Bedaquiline, Linezolid, Moxifloxacin, Pretomanid)
  • For meningococcal prophylaxis: Ceftriaxone, Ciprofloxacin
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Cost & Coverage

Average Cost: Variable, check current pricing per 600mg vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities have drug take-back programs in place.

Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the medication, including the amount taken and the time it was ingested, to ensure prompt and effective treatment.