Isonarif
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Questions & Answers
Side Effects & Adverse Reactions
Rifampin and isoniazid capsules are a combination of two drugs, each of which has been associated with liverdysfunction. Liver function tests should be performed prior to therapy with rifampin/isoniazid and periodicallyduring treatment.
Rifampin
Rifampin has been shown to produce liver dysfunction. There have been fatalities associated with jaundice inpatients with liver disease or receiving rifampin concomitantly with other hepatoxic agents. Since an increased riskmay 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 particularlysusceptible to the spontaneous development of hepatomas, rifampin given at a level 2-10 times the maximumdosage used clinically resulted in a significant increase in the occurrence of hepatomas in female mice of this strainafter one year of administration.
There was no evidence of tumorigenicity in the males of this strain, in males or females of another mouse strain, orin rats.
Isoniazid
See the boxed warning.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For pulmonary tuberculosis in which organisms are susceptible, and when the patient has been titrated on theindividual 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 susceptiblecells, can rapidly become the predominating type. Since rapid emergence of resistance can occur, culture andsusceptibility 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. meningitides to eliminate meningococci from the nasopharynx.
History
There is currently no drug history available for this drug.
Other Information
Rifampin/Isoniazid is a combination capsule containing 300 mg rifampin and 150 mg isoniazid. Each capsule for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate,magnesium stearate, and pregelatinized starch.
Capsule shell contains: FD&C blue #1, FD&C red #40, gelatin 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 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 powderthat is water soluble, odorless and slowly affected by exposure to air and light.
Sources
Isonarif Manufacturers
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Versapharm Incorporated
![Isonarif (Rifampin And Isoniazid) Capsule [Versapharm Incorporated]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isonarif | Versapharm Incorporated
In general, therapy should be continued until bacterial conversion and maximal improvement have occurred.
Adults: Two Rifampin and Isoniazid Capsules, USP (600 mg rifampin, 300 mg isoniazid) once daily, administeredone hour before or two hours after a meal.
Concomitant administration of pyridoxine (B6) is recommended in the malnourished, in those predisposed toneuropathy (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-eggcontainingmedia have ranged from 0.1 to 2 mcg/mL. Quantitative methods that require measurement of zonediameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommendedfor use with discs for testing susceptibility to rifampin. Interpretations correlate zone diameters from the disc testwith MIC (minimal inhibitory concentration) values for rifampin.
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