Rimactane

Name: Rimactane

Adverse Effects

1-10%

Elevated liver function test (LFT) results (up to 14%)

Rash (1-5%)

Epigastric distress (1-2%)

Anorexia (1-2%)

Nausea (1-2%)

Vomiting (1-2%)

Diarrhea (1-2%)

Cramps (1-2%)

Pseudomembranous colitis (1-2%)

Pancreatitis (1-2%)

Frequency Not Defined

Muscular weakness

Edema

Flushing

Ataxia

Impaired concentration

Fever

Fatigue

Headache

Numbness

Behavioral changes

Dizziness

Warnings

Contraindications

Hypersensitivity to rifamycins

Concomitant administration of live bacterial vaccines

Contraindicated in patients receiving ritonavir-boosted saquinavir, because of increased risk of severe hepatocellular toxicity

Contraindicated in patients receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir, because rifampin may cause substantial decreases in plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy or development of viral resistance

Cautions

May decrease the effectiveness of oral contraceptive pills (OCPs)

Do not administer parenteral preparation IM or SC

Patients on regimens of >600 mg once or twice weekly may experience adverse reactions, including flulike syndrome

History of diabetes mellitus (rifampin may make diabetes management more difficult)

Regimens of >600 mg once or twice weekly may cause leukemia, anemia, or thrombocytopenia

Discontinue therapy if patient develops any signs of hepatocellular damage, including hyperbilirubinemia

Prolonged use may result in bacterial or fungal superinfection

Use with caution in patients with liver impairment and porphyria

Not for use in meningococcal disease; may be suitable for short-term use in asymptomatic carriers

Use with caution in patients with history of alcoholism and patients receiving additional medications that may cause hepatotoxicity

Rifampin is not recommended for intermittent therapy; caution patient against intentional or accidental interruption of daily dosage regimen; rare renal hypersensitivity reactions have been reported when therapy was resumed in such cases

Rifampin has enzyme-inducing properties that can enhance metabolism of endogenous substrates, including adrenal hormones, thyroid hormones, and vitamin D

Systemic hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, may occur; signs and symptoms may include fever, rash, urticaria, angioedema, hypotension, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia, elevated liver transaminases or flu-like syndrome (weakness, fatigue, muscle pain, nausea, vomiting, headache, chills, aches, itching, sweats, dizziness, shortness of breath, chest pain, cough, syncope, palpitations;. reactions may be severe and fatal; monitor for signs and/or symptoms of hypersensitivity reactions; discontinue therapy and administer supportive measures if symptoms occur

Pregnancy & Lactation

Pregnancy category: C

Effects unknown; reported to cross placental barrier and appear in cord blood; increased congenital malformations, primarily spina bifida and cleft palate reported in offspring of rodents given oral doses of 150-250 mg/kg/day during pregnancy; case reports of postnatal hemorrhage in mother and infant when administered during last few weeks of pregnancy

Lactation: Drug enters breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Patient Handout

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Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifampin in the elderly.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Artemether
  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Daclatasvir
  • Darunavir
  • Dasabuvir
  • Delamanid
  • Elbasvir
  • Elvitegravir
  • Fosamprenavir
  • Grazoprevir
  • Isavuconazonium
  • Lopinavir
  • Lurasidone
  • Maraviroc
  • Nelfinavir
  • Ombitasvir
  • Paritaprevir
  • Praziquantel
  • Ranolazine
  • Rilpivirine
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir
  • Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Afatinib
  • Amiodarone
  • Amprenavir
  • Apixaban
  • Apremilast
  • Aprepitant
  • Aripiprazole
  • Atovaquone
  • Axitinib
  • Bedaquiline
  • Bosutinib
  • Brexpiprazole
  • Brivaracetam
  • Cabozantinib
  • Cariprazine
  • Ceritinib
  • Cholera Vaccine, Live
  • Clozapine
  • Cobimetinib
  • Crizotinib
  • Cyclosporine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dasatinib
  • Deferasirox
  • Delavirdine
  • Digoxin
  • Dolutegravir
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Edoxaban
  • Efavirenz
  • Eliglustat
  • Eluxadoline
  • Enzalutamide
  • Erlotinib
  • Ethionamide
  • Etravirine
  • Everolimus
  • Exemestane
  • Fentanyl
  • Fosaprepitant
  • Fosphenytoin
  • Gefitinib
  • Hydrocodone
  • Ibrutinib
  • Idelalisib
  • Ifosfamide
  • Imatinib
  • Indinavir
  • Irinotecan
  • Irinotecan Liposome
  • Isoniazid
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ixabepilone
  • Ixazomib
  • Ketoconazole
  • Lamotrigine
  • Lapatinib
  • Ledipasvir
  • Linagliptin
  • Lorcainide
  • Macitentan
  • Manidipine
  • Mifepristone
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Naloxegol
  • Netupitant
  • Nevirapine
  • Nifedipine
  • Nilotinib
  • Nimodipine
  • Nintedanib
  • Olaparib
  • Osimertinib
  • Palbociclib
  • Panobinostat
  • Pazopanib
  • Perampanel
  • Phenytoin
  • Piperaquine
  • Pitavastatin
  • Pixantrone
  • Ponatinib
  • Posaconazole
  • Pyrazinamide
  • Quetiapine
  • Quinine
  • Regorafenib
  • Rivaroxaban
  • Roflumilast
  • Rolapitant
  • Romidepsin
  • Simeprevir
  • Sirolimus
  • Sofosbuvir
  • Sonidegib
  • Sorafenib
  • Sunitinib
  • Tacrolimus
  • Tasimelteon
  • Telithromycin
  • Temsirolimus
  • Tenofovir Alafenamide
  • Ticagrelor
  • Tofacitinib
  • Tolvaptan
  • Trabectedin
  • Ulipristal
  • Vandetanib
  • Velpatasvir
  • Vemurafenib
  • Venetoclax
  • Vilazodone
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Vorapaxar
  • Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetyldigoxin
  • Aliskiren
  • Anisindione
  • Atorvastatin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Buspirone
  • Carbamazepine
  • Carvedilol
  • Caspofungin
  • Chloramphenicol
  • Chlorpropamide
  • Citalopram
  • Clarithromycin
  • Clofibrate
  • Cortisone
  • Desogestrel
  • Dexamethasone
  • Dicumarol
  • Dienogest
  • Diltiazem
  • Disopyramide
  • Doxycycline
  • Drospirenone
  • Eltrombopag
  • Enalaprilat
  • Enalapril Maleate
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Etoricoxib
  • Fesoterodine
  • Fluconazole
  • Fludrocortisone
  • Gliclazide
  • Glyburide
  • Haloperidol
  • Isradipine
  • Levomethadyl
  • Levonorgestrel
  • Levothyroxine
  • Linezolid
  • Losartan
  • Mefloquine
  • Mestranol
  • Metformin
  • Methadone
  • Methylprednisolone
  • Metoprolol
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nisoldipine
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Ospemifene
  • Oxycodone
  • Phenprocoumon
  • Pioglitazone
  • Pirmenol
  • Prednisolone
  • Prednisone
  • Propafenone
  • Raltegravir
  • Repaglinide
  • Rofecoxib
  • Rosiglitazone
  • Sertraline
  • Simvastatin
  • Tadalafil
  • Tamoxifen
  • Theophylline
  • Tocainide
  • Triazolam
  • Trimetrexate
  • Valproic Acid
  • Warfarin
  • Zaleplon
  • Zidovudine

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The specially prepared liquid form may be kept at room temperature or in a refrigerator for 4 weeks. Do not use the liquid after the expiration date on the label.

Before Using Rimactane

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rifampin in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifampin in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Artemether
  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Daclatasvir
  • Darunavir
  • Dasabuvir
  • Delamanid
  • Elbasvir
  • Elvitegravir
  • Fosamprenavir
  • Grazoprevir
  • Isavuconazonium
  • Lopinavir
  • Lurasidone
  • Maraviroc
  • Nelfinavir
  • Ombitasvir
  • Paritaprevir
  • Praziquantel
  • Ranolazine
  • Rilpivirine
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir
  • Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Afatinib
  • Amiodarone
  • Amprenavir
  • Apixaban
  • Apremilast
  • Aprepitant
  • Aripiprazole
  • Atovaquone
  • Axitinib
  • Bedaquiline
  • Bosutinib
  • Brexpiprazole
  • Brigatinib
  • Brivaracetam
  • Cabozantinib
  • Cariprazine
  • Ceritinib
  • Cholera Vaccine, Live
  • Clozapine
  • Cobimetinib
  • Crizotinib
  • Cyclosporine
  • Dabigatran Etexilate
  • Dasatinib
  • Deferasirox
  • Deflazacort
  • Delavirdine
  • Desogestrel
  • Dienogest
  • Digoxin
  • Dolutegravir
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Drospirenone
  • Edoxaban
  • Efavirenz
  • Eliglustat
  • Eluxadoline
  • Enzalutamide
  • Erlotinib
  • Estradiol
  • Ethinyl Estradiol
  • Ethionamide
  • Ethynodiol
  • Etonogestrel
  • Etravirine
  • Everolimus
  • Exemestane
  • Fentanyl
  • Fosaprepitant
  • Fosphenytoin
  • Gefitinib
  • Gestodene
  • Ibrutinib
  • Idelalisib
  • Ifosfamide
  • Imatinib
  • Indinavir
  • Irinotecan
  • Irinotecan Liposome
  • Isoniazid
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ixabepilone
  • Ixazomib
  • Ketoconazole
  • Lamotrigine
  • Lapatinib
  • Ledipasvir
  • Levonorgestrel
  • Linagliptin
  • Lorcainide
  • Macitentan
  • Manidipine
  • Mestranol
  • Methadone
  • Midostaurin
  • Mifepristone
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Naloxegol
  • Netupitant
  • Nevirapine
  • Nifedipine
  • Nilotinib
  • Nimodipine
  • Nintedanib
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Olaparib
  • Osimertinib
  • Palbociclib
  • Panobinostat
  • Pazopanib
  • Perampanel
  • Phenytoin
  • Piperaquine
  • Pitavastatin
  • Pixantrone
  • Ponatinib
  • Posaconazole
  • Pyrazinamide
  • Quetiapine
  • Quinine
  • Regorafenib
  • Ribociclib
  • Rivaroxaban
  • Roflumilast
  • Rolapitant
  • Romidepsin
  • Simeprevir
  • Sirolimus
  • Sofosbuvir
  • Sonidegib
  • Sorafenib
  • Sunitinib
  • Tacrolimus
  • Tasimelteon
  • Telithromycin
  • Temsirolimus
  • Tenofovir Alafenamide
  • Thiotepa
  • Ticagrelor
  • Tofacitinib
  • Tolvaptan
  • Trabectedin
  • Ulipristal
  • Valbenazine
  • Vandetanib
  • Velpatasvir
  • Vemurafenib
  • Venetoclax
  • Vilazodone
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Vorapaxar
  • Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetyldigoxin
  • Aliskiren
  • Anisindione
  • Aripiprazole Lauroxil
  • Atorvastatin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Buspirone
  • Carbamazepine
  • Carvedilol
  • Caspofungin
  • Chloramphenicol
  • Chlorpropamide
  • Citalopram
  • Clarithromycin
  • Clofibrate
  • Cortisone
  • Dexamethasone
  • Dicumarol
  • Diltiazem
  • Disopyramide
  • Doxycycline
  • Eltrombopag
  • Enalaprilat
  • Enalapril Maleate
  • Etoricoxib
  • Fesoterodine
  • Fluconazole
  • Fludrocortisone
  • Gliclazide
  • Glyburide
  • Haloperidol
  • Isradipine
  • Levomethadyl
  • Levothyroxine
  • Linezolid
  • Losartan
  • Mefloquine
  • Metformin
  • Methylprednisolone
  • Metoprolol
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nisoldipine
  • Ospemifene
  • Oxcarbazepine
  • Oxycodone
  • Phenprocoumon
  • Pioglitazone
  • Pirmenol
  • Prednisolone
  • Prednisone
  • Propafenone
  • Raltegravir
  • Repaglinide
  • Rofecoxib
  • Rosiglitazone
  • Sertraline
  • Simvastatin
  • Tadalafil
  • Tamoxifen
  • Theophylline
  • Tocainide
  • Triazolam
  • Trimetrexate
  • Valproic Acid
  • Warfarin
  • Zaleplon
  • Zidovudine
  • Zolpidem

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of—Use with caution. May cause side effects to become worse.
  • Diabetes, history of or
  • Liver disease or
  • Porphyria (an enzyme problem)—Use with caution. May make these conditions worse.

Precautions While Using Rimactane

It is very important that your doctor check the progress of you or your child at regular visits. Blood and urine tests may be needed to check for unwanted effects.

You should not use this medicine if you are also receiving certain medicines to treat HIV infection (eg, atazanavir, darunavir, fosamprenavir, ritonavir, saquinavir, tipranavir, Aptivus®, Fortovase®, Invirase®, Lexiva®, Norvir®, Prezista®, or Reyataz®).

Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Also, the regular use of alcohol may keep this medicine from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are taking this medicine.

Check with your doctor right away if you have fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Rifampin will cause urine, stool, saliva, sputum, sweat, and tears to turn a reddish-orange to reddish-brown color. This is to be expected while you are using this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. Therefore, it is best not to wear soft contact lenses while taking this medicine. Hard contact lenses are not discolored by this medicine. This condition will return to normal once you stop taking this medicine. If you have any questions about this, check with your doctor.

If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

Birth control pills may not work properly while you are taking this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

Before you have any medical tests, tell the doctor in charge that you or your child are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For the Consumer

Applies to rifampin: oral capsule, oral syrup, oral tablet

Other dosage forms:

  • intravenous powder for solution

Along with its needed effects, rifampin (the active ingredient contained in Rimactane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rifampin:

Rare
  • Agitation
  • bleeding gums
  • blood in the urine or stools
  • bruising
  • confusion
  • cough or hoarseness
  • coughing or vomiting blood
  • dark urine
  • darkening of the skin
  • decreased frequency or amount of urine
  • difficulty in breathing and swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • headache
  • hives
  • hostility
  • increased blood pressure
  • increased thirst
  • irritability
  • lethargy
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • mental depression
  • nausea and vomiting
  • painful or difficult urination
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin itching, rash, or redness
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • swelling of the face, ankles, fingers, hands, or lower legs
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating
  • bloody, severe, or watery diarrhea
  • bone pain
  • chest pain
  • chills
  • cold, clammy skin
  • difficulty with speaking
  • double vision
  • fast heartbeat
  • fast, weak pulse
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • joint or muscle pain
  • lightheadedness
  • pale skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • slow speech
  • sores, welting, blisters
  • sweating
  • swollen glands
  • unpleasant breath odor
  • unusual weight loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking rifampin:

Symptoms of overdose
  • Blurred vision
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • full feeling in the upper abdomen or stomach
  • low blood pressure or slow pulse
  • pain in the upper abdomen or stomach
  • reddish-orange to reddish-brown color of the urine, stool, saliva, sputum, sweat, and tears
  • seizures
  • swelling around the eyes or face
  • unconsciousness
  • yellow eyes or skin

Some side effects of rifampin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • muscle pain, tenderness, wasting, or weakness
  • severe mood or mental changes
  • unusual behavior
Incidence not known
  • Belching
  • bloated or full feeling
  • drowsiness
  • excess air or gas in the stomach or intestines
  • indigestion
  • not able to concentrate
  • pain or discomfort in the chest, upper stomach, or throat

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