Rifadin 600mg Inj, 1 Vial

Manufacturer SANOFI-AVENTIS 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
Antitubercular, 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 a powerful antibiotic used to treat serious bacterial infections, especially tuberculosis (TB) and certain staphylococcal infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully review all accompanying information and follow the instructions provided. This medication is administered as an intravenous infusion, which means it is given slowly into a vein over a specified period of time.

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 the next steps to take.
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Lifestyle & Tips

  • Avoid alcohol consumption during treatment, as it can increase the risk of liver problems.
  • Rifampin can cause body fluids (urine, tears, sweat, saliva, stool) to turn a harmless orange-red color. This is normal and expected.
  • Soft contact lenses may be permanently stained; consider wearing glasses during treatment.
  • If you are taking oral contraceptives, rifampin can make them less effective. Use an alternative or additional method of birth control (e.g., condoms) while on rifampin and for at least one month after stopping it.
  • Take rifampin on an empty stomach (1 hour before or 2 hours after a meal) for best absorption, unless directed otherwise by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For Tuberculosis (TB): 10 mg/kg (max 600 mg) intravenously or orally once daily or 2-3 times weekly. For Meningococcal prophylaxis: 600 mg intravenously or orally every 12 hours for 2 days.
Dose Range: 300 - 600 mg

Condition-Specific Dosing:

Tuberculosis (TB): 10 mg/kg (max 600 mg) IV/PO daily or 2-3 times weekly
Meningococcal prophylaxis: 600 mg IV/PO every 12 hours for 2 days
Staphylococcal infections (e.g., prosthetic valve endocarditis): 300-600 mg IV/PO daily or BID, usually in combination with other agents
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Pediatric Dosing

Neonatal: Not established for routine use; consult specialist. For TB: 10-20 mg/kg/day (max 600 mg/day). For Meningococcal prophylaxis: 10 mg/kg/dose every 12 hours for 2 days (max 600 mg/dose).
Infant: For TB: 10-20 mg/kg/day (max 600 mg/day). For Meningococcal prophylaxis: 10 mg/kg/dose every 12 hours for 2 days (max 600 mg/dose).
Child: For TB: 10-20 mg/kg/day (max 600 mg/day). For Meningococcal prophylaxis: 10 mg/kg/dose every 12 hours for 2 days (max 600 mg/dose).
Adolescent: For TB: 10-20 mg/kg/day (max 600 mg/day). For Meningococcal prophylaxis: 10 mg/kg/dose every 12 hours for 2 days (max 600 mg/dose).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: For CrCl < 10 mL/min, consider 10 mg/kg three times weekly for TB. Monitor closely.
Dialysis: No supplemental dose needed after hemodialysis or peritoneal dialysis.

Hepatic Impairment:

Mild: Use with caution, monitor LFTs closely.
Moderate: Dose reduction may be necessary. Monitor LFTs closely.
Severe: Contraindicated or significantly reduced dose. Monitor LFTs closely. Consider alternative agents.

Pharmacology

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Mechanism of Action

Rifampin inhibits bacterial DNA-dependent RNA polymerase by binding to its beta-subunit, thereby suppressing RNA synthesis and bacterial growth. It is bactericidal against susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV); ~90-95% (oral)
Tmax: Not applicable for IV; 2-4 hours (oral)
FoodEffect: Not applicable for IV; food decreases oral absorption.

Distribution:

Vd: 0.9 L/kg
ProteinBinding: 75-90%
CnssPenetration: Yes (especially with inflamed meninges)

Elimination:

HalfLife: 2-5 hours (decreases with repeated dosing due to autoinduction)
Clearance: Not available (highly variable due to autoinduction)
ExcretionRoute: Primarily biliary (60-65%), some renal (30%)
Unchanged: 15-30% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Not precisely defined for clinical effect; peak plasma concentrations reached within hours.
DurationOfAction: Concentration-dependent killing; effects persist 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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of kidney problems: inability to pass urine, change 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
Excessive sweating
Abnormal heartbeat
Swelling in the arms or legs
Purple spots or redness of the skin
Balance problems
Confusion, difficulty focusing, or changes in behavior
Changes in menstrual periods
Vision changes, 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 loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor.
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 immediately if you experience 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; or 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, vision changes, weakness on one side of the body, trouble speaking or thinking, or balance problems.

Vein Irritation

If the medication leaks from the vein, it may cause irritation around the injection site. Inform your nurse if you experience redness, burning, pain, swelling, or fluid leakage at the injection site.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience 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 body fluid color to orange or red

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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)
  • Unusually dark urine or pale stools
  • Severe fatigue or weakness
  • Persistent nausea, vomiting, or abdominal pain
  • Fever, chills, or flu-like symptoms that don't go away
  • Unexplained rash or itching
  • Unusual bleeding or bruising
  • Swelling of the face, lips, tongue, or throat (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 experienced 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 provide guidance on potential interactions.
Please note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.

To ensure your safety, it is crucial 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 in conjunction 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. Your doctor will likely recommend regular blood tests and other laboratory evaluations 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
  • Increased liver enzymes
  • Orange-red discoloration of skin, urine, sweat, and feces (more intense than therapeutic effect)
  • In severe cases: liver enlargement, jaundice, loss of consciousness

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, including gastric lavage and activated charcoal if ingestion was recent.

Drug Interactions

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Contraindicated Interactions

  • Protease inhibitors (e.g., ritonavir-boosted saquinavir, atazanavir, darunavir)
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., rilpivirine, delavirdine)
  • Praziquantel
  • Voriconazole
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Major Interactions

  • Oral contraceptives (decreased efficacy, leading to pregnancy)
  • Warfarin (decreased anticoagulant effect)
  • Corticosteroids (decreased effect)
  • Cyclosporine, Tacrolimus, Sirolimus (decreased immunosuppressant effect)
  • Digoxin (decreased effect)
  • Phenytoin (decreased anticonvulsant effect)
  • Sulfonylureas (decreased hypoglycemic effect)
  • Methadone (withdrawal symptoms)
  • Many antiretrovirals (e.g., efavirenz, nevirapine, dolutegravir, raltegravir, bictegravir)
  • Azole antifungals (e.g., ketoconazole, itraconazole, fluconazole)
  • Antiarrhythmics (e.g., amiodarone, quinidine, disopyramide)
  • Calcium channel blockers (e.g., verapamil, diltiazem, nifedipine)
  • Statins (e.g., simvastatin, atorvastatin - increased risk of myopathy with some)
  • Clopidogrel (decreased antiplatelet effect)
  • Dapsone (decreased effect)
  • Theophylline (decreased effect)
  • Oral anticoagulants (DOACs like rivaroxaban, apixaban - decreased effect)
  • Tyrosine kinase inhibitors (e.g., imatinib, nilotinib, dasatinib)
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Moderate Interactions

  • Acetaminophen (increased risk of hepatotoxicity with chronic use)
  • Beta-blockers (decreased effect)
  • Benzodiazepines (decreased effect)
  • Tricyclic antidepressants (decreased effect)
  • Opioids (decreased effect)
  • Quinine (decreased effect)
  • Selective serotonin reuptake inhibitors (SSRIs) (decreased effect)
  • Buspirone (decreased effect)
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Minor Interactions

  • Not typically categorized as minor due to potent enzyme induction.

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline liver function due to risk of hepatotoxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with platelets

Rationale: To establish baseline hematologic parameters and monitor for thrombocytopenia or other dyscrasias.

Timing: Prior to initiation of therapy.

Renal Function (BUN, creatinine)

Rationale: To assess baseline kidney function.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Liver Function Tests (LFTs)

Frequency: Monthly or as clinically indicated, especially in patients with pre-existing liver disease or those receiving other hepatotoxic drugs.

Target: Within normal limits or stable baseline.

Action Threshold: Discontinue if AST/ALT > 3-5 times ULN with symptoms, or > 5 times ULN without symptoms. Re-evaluate if bilirubin increases.

Complete Blood Count (CBC) with platelets

Frequency: Periodically, or if signs of bleeding/bruising occur.

Target: Within normal limits.

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

Clinical signs and symptoms of adverse effects

Frequency: Regularly throughout therapy.

Target: Absence of significant adverse effects.

Action Threshold: Report flu-like syndrome, rash, fever, jaundice, dark urine, unusual fatigue, or bleeding/bruising immediately.

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Symptom Monitoring

  • Jaundice (yellowing of skin or eyes)
  • Dark urine
  • Unusual fatigue or weakness
  • Nausea, vomiting, abdominal pain (especially right upper quadrant)
  • Fever, chills, flu-like symptoms
  • Rash, itching
  • Unusual bleeding or bruising
  • Headache
  • Dizziness

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rifampin crosses the placenta. There is a theoretical risk of postnatal hemorrhage in the mother and infant due to vitamin K deficiency; prophylactic vitamin K administration to the mother during the last few weeks of pregnancy and to the infant at birth is often recommended.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of teratogenicity in humans. Animal studies show some teratogenic effects at high doses.
Second Trimester: Generally considered safer than first trimester, but still Category C.
Third Trimester: Risk of postnatal hemorrhage in mother and infant due to vitamin K deficiency. Prophylactic vitamin K recommended.
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Lactation

L3 (Moderately Safe). Rifampin is excreted into breast milk. While the amount is generally considered too low to be harmful to the infant, monitor the infant for potential adverse effects such as gastrointestinal upset (diarrhea, poor feeding) or signs of hepatotoxicity (though rare). The benefits of breastfeeding should be weighed against the potential risks.

Infant Risk: Low risk of adverse effects; monitor for GI upset or rare hepatotoxicity.
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Pediatric Use

Dosing is weight-based. Generally well-tolerated in children, but monitoring for adverse effects (especially hepatotoxicity) is important. Specific formulations and concentrations may be preferred for ease of administration in younger children.

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Geriatric Use

Increased risk of hepatotoxicity, especially in patients with pre-existing liver disease or those taking other hepatotoxic medications. Monitor liver function tests closely. No specific dose adjustment based solely on age, but consider overall health status and comorbidities.

Clinical Information

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Clinical Pearls

  • Rifampin is a potent inducer of numerous CYP450 enzymes and drug transporters, leading to significant drug-drug interactions. Always review concomitant medications carefully.
  • Causes harmless orange-red discoloration of urine, tears, sweat, saliva, and contact lenses. Patients should be counselled about this to prevent alarm.
  • Never use rifampin as monotherapy for active tuberculosis due to rapid development of resistance; it must always be used in combination with other antitubercular agents.
  • Intermittent dosing (e.g., twice or thrice weekly) may increase the risk of flu-like syndrome, thrombocytopenia, and hemolytic anemia compared to daily dosing.
  • Patients should be advised to report any signs of liver problems (e.g., jaundice, dark urine, persistent fatigue) immediately.
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Alternative Therapies

  • Isoniazid (for TB)
  • Pyrazinamide (for TB)
  • Ethambutol (for TB)
  • Streptomycin (for TB)
  • Other antibiotics depending on the specific bacterial infection and susceptibility.
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Cost & Coverage

Average Cost: Price varies significantly by pharmacy and formulation (IV vs. oral). per 600mg vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure timely and effective treatment.