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Rifampin
Overview
What is Rifampin?
Rifampin capsules, USP contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, and titanium dioxide.
The printing ink contains ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze, propylene glycol, simethicone, and titanium dioxide
Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is CHNO. The chemical name for rifampin is either 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piper-azinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is:
What does Rifampin look like?
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What are the available doses of Rifampin?
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What should I talk to my health care provider before I take Rifampin?
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How should I use Rifampin?
In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.
Rifampin can be administered by the oral route or by IV infusion (see ). IV doses are the same as those for oral. See for dosing information in patients with renal failure.
What interacts with Rifampin?
Rifampin is contraindicated in patients with a history of hypersensitivity to any of the rifamycins. (See .)
What are the warnings of Rifampin?
Patients should avoid alcoholic beverages while taking the drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. Do not give to children under 12 years of age unless directed by a doctor.
Rifampin has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with liver disease and in patients taking rifampin with other hepatotoxic agents. Patients with impaired liver function should be given rifampin only in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function, especially SGPT/ALT and SGOT/AST should be carried out prior to therapy and then every 2 to 4 weeks during therapy. If signs of hepatocellular damage occur, rifampin should be withdrawn.
In some cases, hyperbilirubinemia resulting from competition between rifampin and bilirubin for excretory pathways of the liver at the cell level can occur in the early days of treatment. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather, the decision should be made after repeating the tests, noting trends in the levels, and considering them in conjunction with the patient's clinical condition.
Rifampin has enzyme-inducing properties, including induction of delta amino levulinic acid synthetase. Isolated reports have associated porphyria exacerbation with rifampin administration.
The possibility of rapid emergence of resistant meningococci restricts the use of rifampin to short-term treatment of the asymptomatic carrier state.
Rifampin is not to be used for the treatment of meningococcal disease.
What are the precautions of Rifampin?
General
Prescribing rifampin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
For the treatment of tuberculosis, rifampin is usually administered on a daily basis. Doses of rifampin greater than 600 mg given once or twice weekly have resulted in a higher incidence of adverse reactions, including the “flu syndrome” (fever, chills and malaise), hematopoietic reactions (leukopenia, thrombocytopenia, or acute hemolytic anemia), cutaneous, gastrointestinal and hepatic reactions, shortness of breath, shock, anaphylaxis and renal failure. Recent studies indicate that regimens using twice weekly doses of rifampin 600 mg plus isoniazid 15 mg/kg are much better tolerated.
Intermittent therapy may be used if the patient cannot (or will not) self-administer drugs on a daily basis. Patients on intermittent therapy should be closely monitored for compliance and cautioned against intentional or accidental interruption of prescribed therapy, because of the increased risk of serious adverse reactions.
Rifampin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones, and vitamin D. Rifampin and isoniazid have been reported to alter vitamin D metabolism. In some cases, reduced levels of circulating 25-hydroxy vitamin D and 1,25-dihydroxy vitamin D have been accompanied by reduced serum calcium and phosphate, and elevated parathyroid hormone.
Information for Patients
Patients should be counseled that antibacterial drugs including rifampin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When rifampin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full courses of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by rifampin or other antibacterial drugs in the future.
The patient should be told that rifampin may produce a reddish coloration of the urine, sweat, sputum, and tears, and the patient should be forewarned of this. Soft contact lenses may be permanently stained.
The patient should be advised that the reliability of oral or other systemic hormonal contraceptives may be affected; consideration should be given to using alternative contraceptive measures.
Patients should be instructed to take rifampin either 1 hour before or 2 hours after a meal with a full glass of water.
Patients should be instructed to notify their physicians promptly if they experience any of the following: fever, loss of appetite, malaise, nausea and vomiting, darkened urine, yellowish discoloration of the skin and eyes, and pain or swelling of the joints.
Compliance with the full course of therapy must be emphasized, and the importance of not missing any doses must be stressed.
Laboratory Tests
Adults treated for tuberculosis with rifampin should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count, and a platelet count (or estimate). Baseline tests are unnecessary in pediatric patients unless a complicating condition is known or clinically suspected.
Patients should be seen at least monthly during therapy and should be specifically questioned concerning symptoms associated with adverse reactions. All patients with abnormalities should have follow-up, including laboratory testing, if necessary. Routine laboratory monitoring for toxicity in people with normal baseline measurements is generally not necessary.
Drug Interactions
Enzyme Induction:
Rifampin has been reported to accelerate the metabolism of the following drugs: anticonvulsants (e.g., phenytoin), antiarrhythmics (e.g., disopyramide, mexiletine, quinidine, tocainide), oral anticoagulants, antifungals (e.g., fluconazole, itraconazole, ketoconazole), barbiturates, beta-blockers, calcium channel blockers (e.g., diltiazem, nifedipine, verapamil), chloramphenicol, clarithromycin, corticosteroids, cyclosporine, cardiac glycoside preparations, clofibrate, oral or other systemic hormonal contraceptives, dapsone, diazepam, doxycycline, fluoroquinolones (e.g., ciprofloxacin), haloperidol, oral hypoglycemic agents (sulfonylureas), levothyroxine, methadone, narcotic analgesics, nortriptyline, progestins, quinine, tacrolimus, theophylline, tricyclic antidepressants (e.g., amitriptyline, nortripty-line), and zidovudine. It may be necessary to adjust the dosages of these drugs if they are given concurrently with Rifampin.
Patients using oral or other systemic hormonal contraceptives should be advised to change to non-hormonal methods of birth control during Rifampin therapy.
Rifampin has been observed to increase the requirements for anticoagulant drugs of the coumarin type. 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.
Diabetes may become more difficult to control.
Other Interactions:
Concurrent use of ketoconazole and rifampin has resulted in decreased serum concentrations of both drugs. Concurrent use of rifampin and enalapril has resulted in decreased concentrations of enalaprilat, the active metabolite of enalapril. Dosage adjustments should be made if indicated by the patient's clinical condition.
Concomitant antacid administration may reduce the absorption of rifampin. Daily doses of rifampin should be given at least 1 hour before the ingestion of antacids.
Probenecid and cotrimoxazole have been reported to increase the blood level of rifampin.
When rifampin is given concomitantly with either halothane or isoniazid, the potential of hepatotoxicity is increased. The concomitant use of rifampin and halothane should be avoided. Patients receiving both rifampin and isoniazid should be monitored closely for hepatotoxicity.
Plasma concentrations of sulfapyridine may be reduced following the concomitant administration of sulfasalazine and rifampin. This finding may be the result of alteration in the colonic bacteria responsible for the reduction of sulfasalazine to sulfapyridine and mesalamine.
Drug/Laboratory Interactions
Cross-reactivity and false-positive urine screening tests for opiates have been reported in patients receiving rifampin when using the KIMS (Kinetic Interaction of Microparticles in Solution) method (e.g., Abuscreen OnLine opiates assay; Roche Diagnostic Systems). Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish rifampin from opiates.
Therapeutic levels of rifampin have been shown to inhibit standard microbiological assays for serum folate and vitamin B. Thus, alternate assay methods should be considered. Transient abnormalities in liver function tests (e.g., elevation in serum bilirubin, alkaline phosphatase, and serum trans-aminases) and reduced biliary excretion of contrast media used for visualization of the gallbladder have also been observed. Therefore, these tests should be performed before the morning dose of rifampin.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. A few cases of accelerated growth of lung carcinoma have been reported in man, but a causal relationship with the drug has not been established. An increase in the incidence of hepatomas in female mice (of a strain known to be particularly susceptible to the spontaneous development of hepatomas) was observed when rifampin was administered in doses 2 to 10 times the average daily human dose for 60 weeks, followed by an observation period of 46 weeks. No evidence of carcinogenicity was found in male mice of the same strain, mice of a different strain or rats under similar experimental conditions.
Rifampin has been reported to possess immuno-suppressive potential in rabbits, mice, rats, guinea pigs, human lymphocytes , and humans. Antitumor activity has also been shown with rifampin.
There was no evidence of mutagenicity in bacteria, or mice. An increase in chromotid breaks was noted when whole blood cell cultures were treated with rifampin. Increased frequency of chromosomal aberrations was observed in lymphocytes obtained from patients treated with combinations of rifampin, isoniazid, and pyrazinamide and combinations of streptomycin, rifampin, isoniazid, and pyrazinamide.
Pregnancy-Teratogenic Effects
Category C. Rifampin has been shown to be teratogenic in rodents given oral doses of rifampin 15 to 25 times the human dose. 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. Neonates of rifampin-treated mothers should be carefully observed for any evidence of adverse effects. Isolated cases of fetal malformations have been reported; however, there are no adequate and well-controlled studies in pregnant women. Rifampin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rifampin in oral doses of 150 to 250 mg/kg produced teratogenic effects in mice and rats. Malformations were primarily cleft palate in the mouse and spina bifida in the rat. The incidence of these anomalies was dose-dependent. When rifampin was given to pregnant rabbits in doses up to 20 times the usual daily human dose, imperfect osteogenesis and embryotoxicity were reported.
Pregnancy-Non-Teratogenic Effects
When administered during the last few weeks of pregnancy, rifampin can cause post-natal hemorrhages in the mother and infant for which treatment with vitamin K may be indicated.
Nursing Mothers
Because of the potential for tumorigenicity shown for rifampin in animal studies, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
See see also .
Geriatric Use
Clinical studies of rifampin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution should therefore be observed in using rifampin in elderly patients. (See .)
What are the side effects of Rifampin?
Gastrointestinal
Heartburn, epigastric distress, anorexia, nausea, vomiting, jaundice, flatulence, cramps, and diarrhea have been noted in some patients. Although has been shown to be sensitive to rifampin, pseudomembranous colitis has been reported with the use of rifampin (and other broad spectrum antibiotics). Therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with antibiotic use. Rarely, hepatitis or a shock-like syndrome with hepatic involvement and abnormal liver function tests has been reported.
Hematologic
Thrombocytopenia has occurred primarily with high dose intermittent therapy, but has also been noted after resumption of interrupted treatment. It rarely occurs during well supervised daily therapy. This effect is reversible if the drug is discontinued as soon as purpura occurs. Cerebral hemorrhage and fatalities have been reported when rifampin administration has been continued or resumed after the appearance of purpura.
Rare reports of disseminated intravascular coagulation have been observed.
Transient leukopenia, hemolytic anemia, and decreased hemoglobin have been observed.
Central Nervous System
Headache, fever, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, behavioral changes, pains in extremities, and generalized numbness have been observed. Psychoses have been rarely reported.
Ocular
Visual disturbances have been observed.
Endocrine
Menstrual disturbances have been observed.
Rare reports of adrenal insufficiency in patients with compromised adrenal function have been observed.
Renal
Elevations in BUN and serum uric acid have been reported. Rarely, hemolysis, hemoglobinuria, hematuria, interstitial nephritis, acute tubular necrosis, 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.
Dermatologic
Cutaneous reactions are mild and self-limiting and do not appear to be hypersensitivity reactions. Typically, they consist of flushing and itching with or without a rash. More serious cutaneous reactions which may be due to hypersensitivity occur but are uncommon.
Hypersensitivity Reactions
Occasionally, pruritis, urticaria, rash, pemphigoid reaction, erythema multiforme including Stevens-Johnson Syndrome, toxic epidermal necrolysis, vasculitis, eosinophilia, sore mouth, sore tongue, and conjunctivitis have been observed. Anaphylaxis has been reported rarely.
Miscellaneous
Rare reports of myopathy and muscular weakness have also been observed.
Edema of the face and extremities has been reported. Other reactions reported to have occurred with intermittent dosage regimens include “flu syndrome” (such as episodes of fever, chills, headache, dizziness, and bone pain), shortness of breath, wheezing, decrease in blood pressure and shock. The “flu syndrome” may also appear if rifampin is taken irregularly by the patient or if daily administration is resumed after a drug free interval.
What should I look out for while using Rifampin?
Rifampin is contraindicated in patients with a history of hypersensitivity to any of the rifamycins. (See .)
Rifampin has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with liver disease and in patients taking rifampin with other hepatotoxic agents. Patients with impaired liver function should be given rifampin only in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function, especially SGPT/ALT and SGOT/AST should be carried out prior to therapy and then every 2 to 4 weeks during therapy. If signs of hepatocellular damage occur, rifampin should be withdrawn.
In some cases, hyperbilirubinemia resulting from competition between rifampin and bilirubin for excretory pathways of the liver at the cell level can occur in the early days of treatment. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather, the decision should be made after repeating the tests, noting trends in the levels, and considering them in conjunction with the patient's clinical condition.
Rifampin has enzyme-inducing properties, including induction of delta amino levulinic acid synthetase. Isolated reports have associated porphyria exacerbation with rifampin administration.
The possibility of rapid emergence of resistant meningococci restricts the use of rifampin to short-term treatment of the asymptomatic carrier state.
Rifampin is not to be used for the treatment of meningococcal disease.
What might happen if I take too much Rifampin?
How should I store and handle Rifampin?
Store below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyStore below 30° C (86° F) [see USP].Dispense in a tight, light-resistant container as defined in USP/NF.BIBLIOGRAPHYAvailable on request.Manufactured by:Patheon Pharmaceuticals Inc.Cincinnati, OH 45215 USAFor: Corona, CA 92880This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyRifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”They are supplied by as follows:Storage: Store at 20-25°C (68-77°F) [See usp Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Dispense in tight, light resistant container.References:Manufactured for VersaPharm IncorporatedMarietta, GA 30062by West-ward Pharmaceutical Corp.Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central Pharmacy
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Rifampin is readily absorbed from the gastrointestinal tract. Peak serum concentrations in healthy adults and pediatric populations vary widely from individual to individual. Following a single 600 mg oral dose of rifampin in healthy adults, the peak serum concentration averages 7 mcg/mL but may vary from 4 to 32 mcg/mL. Absorption of rifampin is reduced by about 30% when the drug is ingested with food.
Rifampin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid. Rifampin is about 80% protein bound. Most of the unbound fraction is not ionized and, therefore, diffuses freely into tissues.
In healthy adults, the mean biological half-life of rifampin in serum averages 3.35 ± 0.66 hours after a 600 mg oral dose, with increases up to 5.08 ± 2.45 hours reported after a 900 mg dose. With repeated administration, the half-life decreases and reaches average values of approximately 2 to 3 hours. The half-life does not differ in patients with renal failure at doses not exceeding 600 mg daily, and consequently, no dosage adjustment is required. Following a single 900 mg oral dose of rifampin in patients with varying degrees of renal insufficiency, the mean half-life increased from 3.6 hours in healthy adults to 5.0, 7.3, and 11.0 hours in patients with glomerular filtration rates of 30 to 50 mL/min, less than 30 mL/min, and in anuric patients, respectively. Refer to the section for information regarding patients with hepatic insufficiency.
Rifampin is rapidly eliminated in the bile, and an enterohepatic circulation ensues. During this process, rifampin undergoes progressive deacetylation so that nearly all the drug in the bile is in this form in about 6 hours. This metabolite is microbiologically active. Intestinal reabsorption is reduced by deacetylation, and elimination is facilitated. Up to 30% of a dose is excreted in the urine, with about half of this being unchanged drug.
Non-Clinical Toxicology
Rifampin is contraindicated in patients with a history of hypersensitivity to any of the rifamycins. (See .)Rifampin has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with liver disease and in patients taking rifampin with other hepatotoxic agents. Patients with impaired liver function should be given rifampin only in cases of necessity and then with caution and under strict medical supervision. In these patients, careful monitoring of liver function, especially SGPT/ALT and SGOT/AST should be carried out prior to therapy and then every 2 to 4 weeks during therapy. If signs of hepatocellular damage occur, rifampin should be withdrawn.
In some cases, hyperbilirubinemia resulting from competition between rifampin and bilirubin for excretory pathways of the liver at the cell level can occur in the early days of treatment. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather, the decision should be made after repeating the tests, noting trends in the levels, and considering them in conjunction with the patient's clinical condition.
Rifampin has enzyme-inducing properties, including induction of delta amino levulinic acid synthetase. Isolated reports have associated porphyria exacerbation with rifampin administration.
The possibility of rapid emergence of resistant meningococci restricts the use of rifampin to short-term treatment of the asymptomatic carrier state.
Rifampin is not to be used for the treatment of meningococcal disease.
Prescribing rifampin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
For the treatment of tuberculosis, rifampin is usually administered on a daily basis. Doses of rifampin greater than 600 mg given once or twice weekly have resulted in a higher incidence of adverse reactions, including the “flu syndrome” (fever, chills and malaise), hematopoietic reactions (leukopenia, thrombocytopenia, or acute hemolytic anemia), cutaneous, gastrointestinal and hepatic reactions, shortness of breath, shock, anaphylaxis and renal failure. Recent studies indicate that regimens using twice weekly doses of rifampin 600 mg plus isoniazid 15 mg/kg are much better tolerated.
Intermittent therapy may be used if the patient cannot (or will not) self-administer drugs on a daily basis. Patients on intermittent therapy should be closely monitored for compliance and cautioned against intentional or accidental interruption of prescribed therapy, because of the increased risk of serious adverse reactions.
Rifampin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones, and vitamin D. Rifampin and isoniazid have been reported to alter vitamin D metabolism. In some cases, reduced levels of circulating 25-hydroxy vitamin D and 1,25-dihydroxy vitamin D have been accompanied by reduced serum calcium and phosphate, and elevated parathyroid hormone.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).