Rifamate (Rifampin and Isoniazid)
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Rifamate (Rifampin and Isoniazid)

RIFAMATE®
(rifampin and isoniazid) Capsules USP

WARNING

Severe and sometimes fatal hepatitis associated with isoniazid therapy may occur and may develop even after many months of treatment. The risk of developing hepatitis is age related. Approximate case rates by age are: 0 per 1,000 for persons under 20 years of age, 3 per 1,000 for persons in the 20-34 year age group, 12 per 1,000 for persons in the 35-49 year age group, 23 per 1,000 for persons in the 50-64 year age group, and 8 per 1,000 for persons over 65 years of age. The risk of hepatitis is increased with daily consumption of alcohol. Precise data to provide a fatality rate for isoniazid-related hepatitis is not available; however, in a U.S. Public Health Service Surveillance Study of 13,838 persons taking isoniazid, there were 8 deaths among 174 cases of hepatitis.

Therefore, patients given isoniazid should be carefully monitored and interviewed at monthly intervals. Serum transaminase concentration becomes elevated in about 10-20 percent of patients, usually during the first few months of therapy, but it can occur at any time. Usually enzyme levels return to normal despite continuance of drug, but in some cases progressive liver dysfunction occurs. Patients should be instructed to report immediately any of the prodromal symptoms of hepatitis, such as fatigue, weakness, malaise, anorexia, nausea, or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage.

Patients with tuberculosis should be given appropriate treatment with alternative drugs. If isoniazid must be reinstituted, it should be reinstituted only after symptoms and laboratory abnormalities have cleared. The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent liver involvement. Treatment should be deferred in persons with acute hepatic diseases.

DRUG DESCRIPTION

RIFAMATE (rifampin and isoniazid) is a combination capsule containing 300 mg rifampin and 150 mg isoniazid. The capsules also contain as inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, sodium starch glycolate, and titanium dioxide.

Rifampin is a semisynthetic antibiotic derivative of rifamycin B. The chemical name for rifampin is 3-(4-methyl-1-piperazinyliminomethyl) rifamycin SV.

Isoniazid is the hydrazide of isonicotinic acid. It exists as colorless or white crystals or as a white, crystalline powder that is water soluble, odorless, and slowly affected by exposure to air and light.

What are the possible side effects of isoniazid and rifampin (Rifamate)?

If you experience any of the following serious side effects, stop taking isoniazid and rifampin and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • excessive tiredness or weakness;
  • nausea, vomiting, diarrhea, or loss of appetite;
  • yellow skin or eyes;
  • unusual bruising or bleeding;
  • dark urine;
  • little or no urine;
  • numbness or tingling in your hands or feet;
  • muscle or bone...

Read All Potential Side Effects and See Pictures of Rifamate »

What are the precautions when taking rifampin and isoniazid (Rifamate)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to rifampin or isoniazid; or to other rifamycins (such as rifabutin, rifapentine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe reaction from isoniazid (such as liver disease), liver disease, kidney disease, alcohol use, HIV infection, diabetes, numbness/tingling of arms/legs (peripheral neuropathy), recent childbirth, a certain blood disorder (porphyria).

Before having surgery, tell your doctor or dentist about all the...

Read All Potential Precautions of Rifamate »

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

For pulmonary tuberculosis in which organisms are susceptible, and when the patient has been titrated on the individual components and it has therefore been established that this fixed dosage is therapeutically effective.

This fixed-dosage combination drug is not recommended for initial therapy of tuberculosis or for preventive therapy.

In the treatment of tuberculosis, small numbers of resistant cells, present within large populations of susceptible cells, can rapidly become the predominating type. Since rapid emergence of resistance can occur, culture and susceptibility tests should be performed in the event of persistent positive cultures.

This drug is not indicated for the treatment of meningococcal infections or asymptomatic carriers of N. meningitidis to eliminate meningococci from the nasopharynx.

DOSAGE AND ADMINISTRATION

In general, therapy should be continued until bacterial conversion and maximal improvement have occurred.

Adults: Two RIFAMATE (rifampin and isoniazid capsules USP) capsules (600 mg rifampin, 300 mg isoniazid) once daily, administered one hour before or two hours after a meal.

Concomitant administration of pyridoxine (B6) is recommended in the malnourished, in those predisposed to neuropathy (e.g., diabetic), and in adolescents.

Susceptibility Testing

Rifampin

Rifampin susceptibility powders are available for both direct and indirect methods of determining the susceptibility of strains of mycobacteria. The MIC's of susceptible clinical isolates when determined in 7H10 or other non-egg-containing media have ranged from 0.1 to 2 mcg/mL.

Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with discs for testing susceptibility to rifampin. Interpretations correlate zone diameters from the disc test with MIC (minimal inhibitory concentration) values for rifampin.

HOW SUPPLIED

Capsules (opaque red), imprinted “RIFAMATE (rifampin and isoniazid) ” on both ends of the capsule, containing 300 mg rifampin and 150 mg isoniazid; bottles of 60 (NDC 0068-0509-60).

Storage

Keep tightly closed. Store in a dry place. Avoid excessive heat.

Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Rev. March 2007.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Rifampin

Nervous system reactions: headache, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, visual disturbances, muscular weakness, pain in extremities, and generalized numbness

Gastrointestinal disturbances: in some patients heartburn, epigastric distress, anorexia, nausea, vomiting, gas, cramps, and diarrhea

Hepatic reactions: transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, BSP, alkaline phosphatase, serum transaminases) have been observed. Rarely, hepatitis or a shocklike syndrome with hepatic involvement and abnormal liver function tests.

Renal reactions: elevations in BUN and serum uric acid have been reported. Rarely, hemolysis, hemoglobinuria, hematuria, interstitial nephritis, renal insufficiency, and acute renal failure have been noted. These are generally considered to be hypersensitivity reactions. They usually occur during intermittent therapy or when treatment is resumed following intentional or accidental interruption of a daily dosage regimen, and are reversible when rifampin is discontinued and appropriate therapy instituted.

Hematologic reactions: thrombocytopenia, leukopenia, hemolytic anemia, eosinophilia, and decreased hemoglobin have been observed. Thrombocytopenia has occurred when rifampin and ethambutol were administered concomitantly according to an intermittent dose schedule twice weekly and in high doses. Agranulocytosis has been reported very rarely.

Allergic and immunological reactions:occasionally pruritus, urticaria, rash, pemphigoid reaction, eosinophilia, sore mouth, sore tongue, and exudative conjunctivitis. Rarely, hemolysis, hemoglobinuria, hematuria, renal insufficiency or acute renal failure have been reported which are generally considered to be hypersensitivity reactions. These have usually occurred during intermittent therapy or when treatment was resumed following intentional or accidental interruption of a daily dosage regimen and were reversible when rifampin was discontinued and appropriate therapy instituted.

Although rifampin has been reported to have an immunosuppressive effect in some animal experiments, available human data indicate that this has no clinical significance.

Metabolic reactions: elevations in BUN and serum uric acid have occurred.

Miscellaneous reactions: fever and menstrual disturbances have been noted.

Isoniazid

The most frequent reactions are those affecting the nervous system and the liver.

Nervous system reactions:peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics), and is usually preceded by paresthesias of the feet and hands. The incidence is higher in “slow inactivators.”

Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment, and toxic psychosis.

Gastrointestinal reactions: nausea, vomiting, and epigastric distress

Hepatic reactions:elevated serum transaminases (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice, and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms are anorexia, nausea, vomiting, fatigue, malaise, and weakness. Mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of persons taking isoniazid. The abnormality usually occurs in the first 4 to 6 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal with no necessity to discontinue medication. In occasional instances, progressive liver damage occurs, with accompanying symptoms. In these cases, the drug should be discontinued immediately. The frequency of progressive liver damage increases with age. It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age.

Hematologic reactions:agranulocytosis, hemolytic sideroblastic or aplastic anemia, thrombocytopenia, and eosinophilia

Hypersensitivity reactions:fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, and vasculitis

Metabolic and endocrine reactions: pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, and gynecomastia

Miscellaneous reactions: rheumatic syndrome and systemic lupus erythematosus-like syndrome

Read the Rifamate (rifampin and isoniazid) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

RIFAMATE (rifampin and isoniazid capsules USP) is a combination of two drugs, each of which has been associated with liver dysfunction. Liver function tests should be performed prior to therapy with RIFAMATE (rifampin and isoniazid) and periodically during treatment.

Rifampin

Rifampin has been shown to produce liver dysfunction. There have been fatalities associated with jaundice in patients with liver disease or receiving rifampin concomitantly with other hepatotoxic agents. Since an increased risk may exist for individuals with liver disease, benefits must be weighed carefully against the risk of further liver damage.

Several studies of tumorigenicity potential have been done in rodents. In one strain of mice known to be particularly susceptible to the spontaneous development of hepatomas, rifampin given at a level 2-10 times the maximum dosage used clinically resulted in a significant increase in the occurrence of hepatomas in female mice of this strain after one year of administration.

There was no evidence of tumorigenicity in the males of this strain, in males or females of another mouse strain, or in rats.

Isoniazid

See the BOXED WARNING.

PRECAUTIONS

Rifampin

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

Rifampin has been observed to increase the requirements for anticoagulant drugs of the coumarin type. The cause of the phenomenon is unknown. In patients receiving anticoagulants and rifampin concurrently, it is recommended that the prothrombin time be performed daily or as frequently as necessary to establish and maintain the required dose of anticoagulant.

Urine, feces, saliva, sputum, sweat, and tears may be colored red-orange by rifampin and its metabolites. Soft contact lenses may be permanently stained. Individuals to be treated should be made aware of these possibilities.

It has been reported that the reliability of oral contraceptives may be affected in some patients being treated for tuberculosis with rifampin in combination with at least one other antituberculosis drug. In such cases, alternative contraceptive measures may need to be considered.

It has also been reported that rifampin given in combination with other antituberculosis drugs may decrease the pharmacologic activity of methadone, oral hypoglycemics, digitoxin, quinidine, disopyramide, dapsone, and corticosteroids. In these cases, dosage adjustment of the interacting drugs is recommended.

Therapeutic levels of rifampin have been shown to inhibit standard microbiological assays for serum folate and vitamin B12. Alternative methods must be considered when determining folate and vitamin B12 concentrations in the presence of rifampin.

Since rifampin has been reported to cross the placental barrier and appear in cord blood and in maternal milk, neonates and newborns of rifampin-treated mothers should be carefully observed for any evidence of untoward effects.

Isoniazid

All drugs should be stopped and an evaluation of the patient should be made at the first sign of a hypersensitivity reaction.

Use of isoniazid should be carefully monitored in the following:

  1. Patients who are receiving phenytoin (diphenylhydantoin) concurrently. Isoniazid may decrease the excretion of phenytoin or may enhance its effects. To avoid phenytoin intoxication, appropriate adjustment of the anticonvulsant dose should be made.
  2. Daily users of alcohol. Daily ingestion of alcohol may be associated with a higher incidence of isoniazid hepatitis.
  3. Patients with current chronic liver disease or severe renal dysfunction. Periodic ophthalmoscopic examination during isoniazid therapy is recommended when visual symptoms occur.

Usage in Pregnancy and Lactation

Rifampin

Although rifampin has been reported to cross the placental barrier and appear in cord blood, the effect of rifampin, alone or in combination with other antituberculosis drugs, on the human fetus is not known. An increase in congenital malformations, primarily spina bifida and cleft palate, has been reported in the offspring of rodents given oral doses of 150-250 mg/kg/day of rifampin during pregnancy.

The possible teratogenic potential in women capable of bearing children should be carefully weighed against the benefits of therapy.

Isoniazid

It has been reported that in both rats and rabbits, isoniazid may exert an embryocidal effect when administered orally during pregnancy, although no isoniazid-related congenital anomalies have been found in reproduction studies in mammalian species (mice, rats, and rabbits). Isoniazid should be prescribed during pregnancy only when therapeutically necessary. The benefit of preventive therapy should be weighed against a possible risk to the fetus. Preventive treatment generally should be started after delivery because of the increased risk of tuberculosis for new mothers.

Since isoniazid is known to cross the placental barrier and to pass into maternal breast milk, neonates and breast-fed infants of isoniazid-treated mothers should be carefully observed for any evidence of adverse effects.

Carcinogenesis

Isoniazid has been reported to induce pulmonary tumors in a number of strains of mice.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Rifampin

Signs and Symptoms

Nausea, vomiting, and increasing lethargy will probably occur within a short time after ingestion; actual unconsciousness may occur with severe hepatic involvement. Brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces is proportional to amount ingested.

Liver enlargement, possibly with tenderness, can develop within a few hours after severe overdosage, and jaundice may develop rapidly. Hepatic involvement may be more marked in patients with prior impairment of hepatic function. Other physical findings remain essentially normal.

Direct and total bilirubin levels may increase rapidly with severe overdosage; hepatic enzyme levels may be affected, especially with prior impairment of hepatic function. A direct effect upon hemopoietic system, electrolyte levels, or acid-base balance is unlikely.

Isoniazid

Signs and Symptoms

Isoniazid overdosage produces signs and symptoms within 30 minutes to 3 hours. Nausea, vomiting, dizziness, slurring of speech, blurring of vision, visual hallucinations (including bright colors and strange designs), are among the early manifestations. With marked overdosage, respiratory distress and CNS depression, progressing rapidly from stupor to profound coma, are to be expected, along with severe, intractable seizures. Severe metabolic acidosis, acetonuria, and hyperglycemia are typical laboratory findings.

RIFAMATE (rifampin and isoniazid capsules USP)

Treatment

The airway should be secured and adequate respiratory exchange established. Only then should gastric emptying (lavage-aspiration) be attempted; this may be difficult because of seizures. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis.

Activated charcoal slurry instilled into the stomach following evacuation of gastric contents can help absorb any remaining drug in the GI tract. Antiemetic medication may be required to control severe nausea and vomiting.

Blood samples should be obtained for immediate determination of gases, electrolytes, BUN, glucose, etc. Blood should be typed and crossmatched in preparation for possible hemodialysis.

Rapid control of metabolic acidosis is fundamental to management. Intravenous sodium bicarbonate should be given at once and repeated as needed, adjusting subsequent dosage on the basis of laboratory findings (i.e., serum sodium, pH, etc.). At the same time, anticonvulsants should be given intravenously (i.e., barbiturates, diphenylhydantoin, diazepam) as required, and large doses of intravenous pyridoxine.

Forced osmotic diuresis must be started early and should be continued for some hours after clinical improvement to hasten renal clearance of drug and help prevent relapse. Fluid intake and output should be monitored.

Bile drainage may be indicated in presence of serious impairment of hepatic function lasting more than 24-48 hours. Under these circumstances and for severe cases, extracorporeal hemodialysis may be required; if this is not available, peritoneal dialysis can be used along with forced diuresis.

Along with measures based on initial and repeated determination of blood gases and other laboratory tests as needed, meticulous respiratory and other intensive care should be utilized to protect against hypoxia, hypotension, aspiration, pneumonitis, etc.

In patients with previously adequate hepatic function, reversal of liver enlargement and impaired hepatic excretory function probably will be noted within 72 hours, with rapid return toward normal thereafter.

Untreated or inadequately treated cases of gross isoniazid overdosage can terminate fatally, but good response has been reported in most patients brought under adequate treatment within the first few hours after drug ingestion.

CONTRAINDICATIONS

Previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid, such as drug fever, chills, and arthritis; acute liver disease of any etiology. A history of previous hypersensitivity reaction to any of the rifamycins or to isoniazid, including drug-induced hepatitis.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Rifampin

Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. This is the mechanism of action by which rifampin exerts its therapeutic effect. Rifampin cross-resistance has only been shown with other rifamycins.

In a study of 14 normal human adult males, peak blood levels of rifampin occurred 1 1/2 to 3 hours following oral administration of two RIFAMATE (rifampin and isoniazid) capsules. The peaks ranged from 6.9 to 14 mcg/mL with an average of 10 mcg/mL.

In normal subjects the T1/2 (biological half-life) of rifampin in blood is approximately 3 hours. Elimination occurs mainly through the bile and, to a much lesser extent, the urine.

Isoniazid

Isoniazid acts against actively growing tubercle bacilli.

After oral administration isoniazid produces peak blood levels within 1 to 2 hours which decline to 50% or less within 6 hours. It diffuses readily into all body fluids (cerebrospinal, pleural, and ascitic fluids), tissues, organs, and excreta (saliva, sputum, and feces). The drug also passes through the placental barrier and into milk in concentrations comparable to those in the plasma. From 50 to 70% of a dose of isoniazid is excreted in the urine in 24 hours.

Isoniazid is metabolized primarily by acetylation and dehydrazination. The rate of acetylation is genetically determined. Approximately 50% of Blacks and Caucasians are “slow inactivators”; the majority of Eskimos and Orientals are “rapid inactivators.”

The rate of acetylation does not significantly alter the effectiveness of isoniazid. However, slow acetylation may lead to higher blood levels of the drug, and thus an increase in toxic reactions.

Pyridoxine deficiency (B6) is sometimes observed in adults with high doses of isoniazid and is considered probably due to its competition with pyridoxal phosphate for the enzyme apotryptophanase.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Rifamate Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RIFAMPIN/ISONIAZID - ORAL

(riff-AM-pin/eye-so-NYE-uh-zid)

COMMON BRAND NAME(S): Rifamate

WARNING: Isoniazid has rarely caused very serious (possibly fatal) liver disease. The risk of liver disease is increased in people who are 35 years and older, who use alcohol or illegal injection drugs, or who currently have long-term liver problems. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea/vomiting, severe stomach/abdominal pain, unusual weakness/tiredness, dark urine, yellowing eyes/skin.

Your doctor should order liver function tests while you are taking this medication. Keep all medical and laboratory appointments.

USES: This product is used to treat tuberculosis (TB). It contains 2 medications: rifampin and isoniazid. Both medications are antibiotics. Rifampin is known as a rifamycin antibiotic. This product works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: Take this product by mouth 1 hour before or 2 hours after a meal, usually once daily or as directed by your doctor.

If you also take antacids, take this medication at least 1 hour before the antacid.

The dosage is based on your age, weight, medical condition, and response to treatment.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).

Your doctor may also direct you to take vitamin B6 (pyridoxine) to help prevent certain side effects (such as nerve problems) from isoniazid. Follow your doctor's instructions carefully.

Isoniazid may interact with foods containing tyramine/histamine (such as cheese, red wine, certain types of fish). This interaction may cause increased blood pressure, flushing of the skin, headache, dizziness, or fast/pounding heartbeat. Tell your doctor immediately if any of these symptoms occur. Your doctor may recommend that you follow a special diet while taking this medication. Consult your doctor for more details.

Tell your doctor if your condition persists or worsens.

Disclaimer

Rifamate Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, upset stomach, heartburn, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn reddish. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may become permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, painful/swollen joints.

Tell your doctor immediately if any of these rare but serious side effects occur: change in the amount of urine, increased thirst/urination, bloody urine, vision changes, easy bruising/bleeding, signs of a new infection (such as fever, persistent sore throat), mental/mood changes (such as confusion, psychosis), seizures.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Rifamate (rifampin and isoniazid) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to rifampin or isoniazid; or to other rifamycins (such as rifabutin, rifapentine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe reaction from isoniazid (such as liver disease), liver disease, kidney disease, alcohol use, HIV infection, diabetes, numbness/tingling of arms/legs (peripheral neuropathy), recent childbirth, a certain blood disorder (porphyria).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

This product may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

During pregnancy, this product should be used only when clearly needed. When rifampin is taken during the last few weeks of pregnancy, the risk of bleeding in both mother and infant may be increased. Tell your doctor immediately if you notice any bleeding in your newborn. Discuss the risks and benefits with your doctor.

This product passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Rifamate Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: acetaminophen, carbamazepine, disulfiram, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), SSRI antidepressants (such as fluoxetine, sertraline), valproic acid.

Rifampin can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, digoxin, nimodipine, phenytoin, ranolazine, tacrolimus, theophylline, certain anti-infectives (e.g., chloramphenicol, clarithromycin, dapsone, doxycycline, linezolid, telithromycin, zidovudine, quinolones such as ciprofloxacin) azole antifungals (such as itraconazole, ketoconazole), "blood thinners" (such as warfarin), calcium channel blockers (such as diltiazem, verapamil), HIV NNRTIs (such as delavirdine, etravirine, nevirapine), HIV protease inhibitors (such as atazanavir, ritonavir, saquinavir), certain diabetes drugs (sulfonylureas such as tolbutamide), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (including folate/vitamin B12 levels, urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach/abdominal pain, unusual tiredness/weakness, yellowing eyes/skin, vision changes, slow/shallow breathing, severe drowsiness.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as sputum test, kidney/liver function, bilirubin levels, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to take each scheduled dose of this medication as directed. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Check the product package for the exact temperature range, or ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.

Rifamate Patient Information Including Side Effects

Brand Names: Rifamate

Generic Name: isoniazid and rifampin (Pronunciation: eye so NYE a zid and RIF am pin)

What is isoniazid and rifampin (Rifamate)?

Isoniazid and rifampin are antibiotics. They prevent tuberculous bacteria from multiplying in your body.

Isoniazid and rifampin are used together to treat tuberculosis (TB).

Isoniazid and rifampin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of isoniazid and rifampin (Rifamate)?

If you experience any of the following serious side effects, stop taking isoniazid and rifampin and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • excessive tiredness or weakness;
  • nausea, vomiting, diarrhea, or loss of appetite;
  • yellow skin or eyes;
  • unusual bruising or bleeding;
  • dark urine;
  • little or no urine;
  • numbness or tingling in your hands or feet;
  • muscle or bone pain;
  • seizures;
  • blurred vision;
  • fever, chills, or a sore throat;
  • a headache;
  • a rash or itching; or
  • confusion or abnormal behavior.

Other, less serious side effects may be more likely to occur. Continue to take isoniazid and rifampin and talk to your doctor if you experience

  • red-orange coloration of tears, sweat, saliva, urine, or feces; or
  • mild tiredness or weakness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Rifamate (rifampin and isoniazid) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about isoniazid and rifampin (Rifamate)?

Take all of the isoniazid and rifampin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Avoid alcohol while taking isoniazid and rifampin. Alcohol will increase the risk of damage to your liver during treatment with this medication.

Call your doctor immediately if you experience a fever, chills, a sore throat, muscle and bone pain, a headache, excessive tiredness or weakness, numbness or tingling in your hands or feet, loss of appetite, nausea and vomiting, yellowing of your skin or eyes, darkening of your urine, unusual bleeding or bruising, a rash, or itching.

Take isoniazid and rifampin on an empty stomach 1 hour before or 2 hours after a meal.

This medication may decrease the effectiveness of birth control pills. Talk to your doctor about using another form of birth control during treatment.

Side Effects Centers

Rifamate Patient Information including How Should I Take

Who should not take isoniazid and rifampin (Rifamate)?

Before taking this medication, tell your doctor if you have

  • ever had an allergic reaction to isoniazid or rifampin;
  • disease;
  • liver disease; or
  • porphyria.

You may not be able to take isoniazid and rifampin, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether isoniazid and rifampin will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

It is also not known whether isoniazid and rifampin will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take isoniazid and rifampin (Rifamate)?

Take isoniazid and rifampin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water.

Take isoniazid and rifampin on an empty stomach one hour before or two hours after meals.

If nausea occurs, ask your doctor if you can take isoniazid and rifampin with food.

Take all of the isoniazid and rifampin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Your doctor may also want you to take a supplemental vitamin B6 (pyridoxine) tablet daily during treatment to prevent numbness and tingling caused by low levels of this vitamin.

Store this medication at room temperature away from moisture and heat.

Side Effects Centers

Rifamate Patient Information including If I Miss a Dose

What happens if I miss a dose (Rifamate)?

Take the missed dose as soon as you remember. If it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose (Rifamate)?

Seek emergency medical attention.

Symptoms of an isoniazid and rifampin overdose include nausea, vomiting, abdominal pain, tiredness, dizziness, slurring of speech, yellow skin or eyes, blurred vision, visual hallucinations, seizures, coma, and death.

What should I avoid while taking isoniazid and rifampin (Rifamate)?

Do not wear contact lenses while taking isoniazid and rifampin. Rifampin may turn your tears, sweat, saliva, urine, feces, and contact lenses a red-orange color. This effect may be permanent on contact lenses.

This medication may decrease the effectiveness of birth control pills. Talk to your doctor about using another form of birth control during treatment.

Avoid alcohol while taking isoniazid and rifampin. Alcohol will increase the risk of damage to your liver during treatment with this medication.

Use caution with the foods listed below. They can interact with isoniazid and rifampin and cause a reaction that includes a severe headache, large pupils, neck stiffness, nausea, vomiting, diarrhea, flushing, sweating, itching, irregular heartbeats, and chest. A reaction will not necessarily occur, but eat these foods with caution until you know if you will react to them. Call your doctor immediately if you experience any of these symptoms.

Eat the following foods with caution:

  • cheeses, including american, blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, mozzarella, parmesan, romano, roquefort, stilton, and swiss;
  • sour cream and yogurt;
  • beef or chicken liver, fish, meats prepared with tenderizer, bologna, pepperoni, salami, summer sausage, game meat, meat extracts, caviar, dried fish, herring, shrimp paste, and tuna;
  • avocados, bananas, figs, raisins, and sauerkraut;
  • soy sauce, miso soup, bean curd, and fava beans;
  • yeast extracts;
  • ginseng;
  • chocolate;
  • caffeine (coffee, tea, cola, etc.); and
  • beer (alcoholic and nonalcoholic), red wine (especially Chianti), sherry, vermouth, and other distilled spirits.

What other drugs will affect isoniazid and rifampin (Rifamate)?

Before taking isoniazid and rifampin, tell your doctor if you are taking any of the following drugs:

  • antacids;
  • ketoconazole (Nizoral), fluconazole (Diflucan), or itraconazole (Sporanox);
  • disulfiram (Antabuse);
  • warfarin (Coumadin);
  • carbamazepine (Tegretol);
  • cycloserine (Seromycin);
  • phenytoin (Dilantin), ethotoin (Peganone), and mephenytoin (Mesantoin);
  • meperidine (Demerol);
  • benzodiazepines such as alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), and temazepam (Restoril).
  • acetaminophen (Tylenol, others);
  • blood thinners such as warfarin (Coumadin);
  • barbiturates such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), secobarbital (Seconal), and butabarbital (Butisol);
  • beta-blockers such as atenolol (Tenormin), propranolol (Inderal), and metoprolol (Lopressor);
  • heart medicines such as digoxin (Lanoxin), disopyramide (Norpace), quinidine (Quinora, Quinidex, Cardioquin, others), mexiletine (Mexitil), tocainide (Tonocard), verapamil (Calan, Verelan, Isoptin), and enalapril (Vasotec);
  • corticosteroids such as prednisone (Deltasone, Orasone, Meticorten), prednisolone (Delta Cortef, Prelone, others), methylprednisolone (Medrol), and betamethasone (Celestone);
  • sulfonylureas such as glipizide (Glucotrol), glyburide (Micronase, Diabeta, Glynase), chlorpropamide (Diabinese), tolbutamide (Orinase), and tolazamide (Tolinase);
  • sulfa medicines such as sulfamethoxazole (Bactrim, Septra, Gantanol, Azo-Gantanol), and sulfisoxazole (Gantrisin, Azo-Gantrisin);
  • the HIV and AIDS medicines delavirdine (Rescriptor), saquinavir (Invirase), ritonavir (Norvir), indinavir (Crixivan), nelfinavir (Viracept), and zidovudine (Retrovir);
  • estrogens such as Premarin, Ogen, Estrace, Menest, Estratab, Ortho-Est, and others;
  • oral birth control pills such as Triphasil, Ortho-Novum, Ortho-Cyclen, Ortho-Tri-Cyclen, Ovral, Lo/Ovral, Desogen, Nordette, Levora, Levlen, Tri-Levlen, Nelova, Norinyl, Brevicon, Ovcon, Loestrin, Demulen, and others;
  • phenytoin (Dilantin), ethotoin (Peganone), and mephenytoin (Mesantoin);
  • theophylline (Theolair, Theo-Dur, Theochron, Theo-Bid, others);
  • methadone (Dolophine);
  • clofibrate (Atromid-S); or
  • cyclosporine (Sandimmune, Neoral).

You may not be able to take isoniazid and rifampin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with isoniazid and rifampin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about isoniazid and rifampin written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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