Rifadin 300mg Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Take your medication on an empty stomach, either 1 hour before or 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 to feel 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) Formulation
If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid (suspension) form of your medication. If a liquid formulation is prepared, shake it well before use. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with your medication. If no device is provided, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from heat and light. Do not store your medication in a bathroom. If a liquid (suspension) formulation is prepared, you can 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. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take on an empty stomach (1 hour before or 2 hours after meals) for best absorption.
- Do not stop taking this medication without consulting your doctor, even if you feel better, as this can lead to drug resistance.
- Rifampin can cause your urine, sweat, tears, and other body fluids to turn orange-red. This is harmless but can permanently stain soft contact lenses. Consider wearing glasses during treatment.
- Avoid alcohol while taking rifampin due to increased risk of liver problems.
- Rifampin can make birth control pills less effective. Use an alternative, non-hormonal method of birth control (e.g., condoms) while taking rifampin and for at least 1 month after stopping it.
- Inform all healthcare providers that you are taking rifampin, as it interacts with many other medications.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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, 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.
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, weakness, 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, in rare cases, a severe form called C. difficile-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. Do not treat diarrhea without consulting your doctor first.
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, changes in vision, changes in strength on one side of the body, trouble speaking or thinking, or changes in balance, or fever.
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following:
Drowsiness.
Gas.
Diarrhea, upset stomach, or vomiting.
Heartburn.
Stomach cramps.
* Changes in the color of body fluids to orange or red.
If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 tiredness or weakness
- Abdominal pain, especially in the upper right side
- Flu-like symptoms (fever, chills, headache, muscle/joint aches) that are severe or persistent
- Skin rash, itching, or hives
- Unusual bleeding or bruising
- Swelling of the face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction)
Before Using This Medicine
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 problems 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.
Precautions & Cautions
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 drug may cause discoloration of contact lenses. Do not use this medication 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 you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea, vomiting, abdominal pain
- Lethargy, drowsiness
- Increased liver enzymes (transaminases)
- Jaundice (yellowing of skin/eyes)
- Orange-red discoloration of skin, urine, sweat, tears, and feces (more intense than usual therapeutic effect)
- Hepatomegaly (enlarged liver)
- In severe cases: loss of consciousness, convulsions, cardiac arrhythmias, cardiac arrest.
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be performed if ingestion is recent. Activated charcoal may be administered. Hemodialysis is generally not effective.
Drug Interactions
Contraindicated Interactions
- Protease inhibitors (e.g., atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir) - due to significant decrease in antiretroviral concentrations.
- Non-nucleoside reverse transcriptase inhibitors (e.g., delavirdine, rilpivirine) - due to significant decrease in antiretroviral concentrations.
- Praziquantel - significantly reduces praziquantel levels.
- Voriconazole - significantly reduces voriconazole levels.
- Oral contraceptives - significant reduction in efficacy leading to contraceptive failure.
Major Interactions
- Warfarin (decreased anticoagulant effect)
- Oral hypoglycemics (decreased effect)
- Corticosteroids (decreased effect)
- Digoxin (decreased effect)
- Phenytoin (decreased effect)
- Theophylline (decreased effect)
- Cyclosporine, tacrolimus, sirolimus (decreased immunosuppressant effect)
- Calcium channel blockers (e.g., verapamil, diltiazem, nifedipine) (decreased effect)
- Beta-blockers (e.g., metoprolol, propranolol) (decreased effect)
- Statins (e.g., simvastatin, atorvastatin) (decreased effect)
- Antifungals (e.g., fluconazole, itraconazole, ketoconazole) (decreased effect)
- Methadone (withdrawal symptoms due to decreased levels)
- Clopidogrel (decreased antiplatelet effect)
- Dabigatran (decreased anticoagulant effect)
- Quinine (decreased effect)
- Selective serotonin reuptake inhibitors (SSRIs) (decreased effect)
- Tricyclic antidepressants (TCAs) (decreased effect)
- Buspirone (decreased effect)
- Zolpidem (decreased effect)
- Propafenone (decreased effect)
- Mexiletine (decreased effect)
- Amiodarone (decreased effect)
- Lidocaine (decreased effect)
- Quinidine (decreased effect)
- Dapsone (decreased effect)
- Chloramphenicol (decreased effect)
- Clarithromycin (decreased effect)
- Erythromycin (decreased effect)
- Telithromycin (decreased effect)
- Linezolid (decreased effect)
- Atovaquone (decreased effect)
- Sulfonylureas (decreased effect)
- Thiazolidinediones (decreased effect)
- Repaglinide (decreased effect)
- Nateglinide (decreased effect)
- Pioglitazone (decreased effect)
- Rosiglitazone (decreased effect)
- Ethosuximide (decreased effect)
- Valproic acid (decreased effect)
- Lamotrigine (decreased effect)
- Tiagabine (decreased effect)
- Topiramate (decreased effect)
- Zonisamide (decreased effect)
- Carbamazepine (decreased effect)
- Phenobarbital (decreased effect)
- Fentanyl (decreased effect)
- Alfentanil (decreased effect)
- Sufentanil (decreased effect)
- Tramadol (decreased effect)
- Oxycodone (decreased effect)
- Hydrocodone (decreased effect)
- Codeine (decreased effect)
- Morphine (decreased effect)
- Buprenorphine (decreased effect)
- Naloxone (decreased effect)
- Naltrexone (decreased effect)
- Benzodiazepines (e.g., midazolam, triazolam) (decreased effect)
- Buspirone (decreased effect)
- Zaleplon (decreased effect)
- Zopiclone (decreased effect)
- Eplerenone (decreased effect)
- Spironolactone (decreased effect)
- Furosemide (decreased effect)
- Hydrochlorothiazide (decreased effect)
- Amiloride (decreased effect)
- Triamterene (decreased effect)
- Sildenafil (decreased effect)
- Tadalafil (decreased effect)
- Vardenafil (decreased effect)
- Ranolazine (decreased effect)
- Ivabradine (decreased effect)
- Ticagrelor (decreased effect)
- Rivaroxaban (decreased effect)
- Apixaban (decreased effect)
- Edoxaban (decreased effect)
- Dronedarone (decreased effect)
- Rifabutin (increased rifabutin levels, potential for toxicity)
- Isoniazid (increased risk of hepatotoxicity)
Moderate Interactions
- Acetaminophen (increased risk of hepatotoxicity with chronic use)
- Alcohol (increased risk of hepatotoxicity)
- Grapefruit juice (may affect absorption, but less significant than other interactions)
- Food (decreased absorption if taken with food)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: Rifampin can cause hepatotoxicity, especially in patients with pre-existing liver disease or when co-administered with other hepatotoxic drugs.
Timing: Before initiation of therapy.
Rationale: Rarely, rifampin can cause hematologic abnormalities (e.g., thrombocytopenia, leukopenia, hemolytic anemia).
Timing: Before initiation of therapy.
Rationale: Although primarily eliminated hepatically, renal impairment can influence drug accumulation in severe cases.
Timing: Before initiation of therapy.
Routine Monitoring
Frequency: Monthly or every 2-4 weeks during initial intensive phase of TB treatment, then as clinically indicated.
Target: Within normal limits or stable from baseline.
Action Threshold: Discontinue if ALT/AST >3-5 times ULN with symptoms, or >5 times ULN without symptoms. Re-evaluate if significant increases occur.
Frequency: Daily patient education and inquiry.
Target: Absence of symptoms.
Action Threshold: Prompt evaluation and discontinuation if symptoms appear.
Frequency: Periodically, especially if patient develops fever, rash, or other signs of bone marrow suppression.
Target: Within normal limits.
Action Threshold: Discontinue if significant thrombocytopenia, leukopenia, or hemolytic anemia develops.
Frequency: Not routinely recommended for all patients, but may be considered in specific populations (e.g., HIV co-infection, malabsorption, treatment failure, severe disease, or suspected non-adherence).
Target: Peak (2-4 hours post-dose) 8-24 mcg/mL.
Action Threshold: Adjust dose if levels are subtherapeutic or supratherapeutic.
Symptom Monitoring
- Signs of hepatotoxicity (yellowing of skin/eyes, dark urine, pale stools, persistent nausea/vomiting, unusual fatigue, abdominal pain)
- Flu-like syndrome (fever, chills, headache, muscle/joint pain)
- Skin rash, itching, hives
- Unusual bleeding or bruising (signs of thrombocytopenia)
- Shortness of breath, unusual weakness (signs of hemolytic anemia)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Changes in vision or hearing (rare)
Special Patient Groups
Pregnancy
Rifampin is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. 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. It is generally considered part of standard TB treatment regimens during pregnancy due to the risks of untreated TB.
Trimester-Specific Risks:
Lactation
Rifampin is excreted in breast milk. The amount transferred to the infant is small and generally not considered harmful. The American Academy of Pediatrics considers rifampin compatible with breastfeeding. Monitor breastfed infants for signs of adverse effects (e.g., poor feeding, jaundice, unusual lethargy).
Pediatric Use
Rifampin is widely used in pediatric populations for TB and prophylaxis. Dosing is weight-based. Children are generally more susceptible to drug-induced hepatitis than adults, but rifampin is usually well-tolerated. Close monitoring of liver function is important.
Geriatric Use
No specific dose adjustment is required based solely on age. However, elderly patients may have age-related decreases in hepatic or renal function, or may be on multiple medications, increasing the risk of adverse effects and drug interactions. Monitor liver function and for adverse effects closely.
Clinical Information
Clinical Pearls
- Rifampin is a potent inducer of many CYP450 enzymes and P-glycoprotein, leading to numerous significant drug interactions. Always review concomitant medications carefully.
- Counsel patients about the harmless but noticeable orange-red discoloration of body fluids (urine, sweat, tears, saliva, feces). Advise against wearing soft contact lenses.
- Emphasize the importance of adherence to the full course of therapy, especially for TB, to prevent drug resistance.
- Always use rifampin as part of a multi-drug regimen for active TB to prevent resistance.
- Monitor liver function tests regularly, especially in patients with pre-existing liver disease, alcohol use, or those taking other hepatotoxic drugs.
- Advise women of childbearing potential about the reduced efficacy of hormonal contraceptives and recommend alternative birth control methods.
Alternative Therapies
- For Tuberculosis: Isoniazid, Pyrazinamide, Ethambutol, Streptomycin, Bedaquiline, Delamanid, Pretomanid, Linezolid, Moxifloxacin, Levofloxacin, Amikacin, Kanamycin, Capreomycin.
- For Meningococcal/Hib prophylaxis: Ciprofloxacin (adults), Ceftriaxone (children/pregnant women).