Rifabutin (Capsules) Instructions for Use
ATC Code
J04AB04 (Rifabutin)
Active Substance
Rifabutin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antibiotic of the rifamycin group. Antituberculosis drug
Pharmacotherapeutic Group
Antibiotic-rifamycin
Pharmacological Action
A semisynthetic antibiotic of the rifamycin group. It has a broad spectrum of action. The mechanism of action is probably associated with the inhibition of amino acid synthesis due to the inhibition of DNA-dependent RNA polymerase.
Rifabutin is active against Mycobacterium tuberculosis (both strains sensitive and resistant to rifampicin), Mycobacterium leprae (both strains sensitive and resistant to rifampicin), and against the Mycobacterium avium complex.
Rifabutin is also active against gram-positive bacteria: Staphylococcus spp. (including polyresistant strains), some strains of Clostridium spp.; gram-negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Legionella spp., Chlamydia trachomatis; intracellular parasites; some viruses (including HIV-1).
Resistance of pathogen strains to rifabutin develops rapidly.
Pharmacokinetics
It is rapidly absorbed from the gastrointestinal tract. Bioavailability is 20%. Cmax in blood plasma is reached in 2-4 hours. Plasma protein binding is 85%. It penetrates the blood-brain barrier. T1/2 is 45 hours. 30% of rifabutin is excreted in feces, 5% is excreted unchanged in bile, 5% is excreted unchanged in urine, 53% is excreted in urine as metabolites.
Indications
Treatment of infections caused by susceptible microorganisms (Mycobacterium tuberculosis, MAC complex, other atypical mycobacteria such as Mycobacterium xenopi), including in patients with immunodeficiency. Prevention of infections caused by the MAC complex in patients with immunosuppression, with a CD4 cell count <200 per µl. Treatment of disseminated Mycobacterium avium infection in patients with HIV infection. Tuberculosis (as part of combination therapy).
ICD codes
| ICD-10 code | Indication |
| A15 | Respiratory tuberculosis, bacteriologically and histologically confirmed |
| A17 | Tuberculosis of nervous system |
| A18 | Tuberculosis of other organs |
| A31 | Infections due to other mycobacteria |
| B20.0 | HIV disease resulting in mycobacterial infection |
| ICD-11 code | Indication |
| 1B10.0 | Respiratory tuberculosis, bacteriologically or histologically confirmed |
| 1B11.Z | Tuberculosis of nervous system, unspecified |
| 1B12 | Tuberculosis of other systems and organs |
| 1B21.Z | Nontuberculous mycobacterial infection of unspecified site |
| 1C62.Z | Human immunodeficiency virus [HIV] disease without mention of associated disease or condition, clinical stage unspecified |
| 1H0Z | Unspecified infection |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Capsules
Orally, once a day, regardless of meals.
Prevention of infection in patients with immunosuppression – 300 mg/day.
In combination with other drugs: for nontuberculous mycobacterial infection – 450-600 mg/day, up to 6 months from the time of obtaining a negative culture.
For chronic polyresistant pulmonary tuberculosis – 300-450 mg/day, up to 6 months from the time of obtaining a negative culture.
For newly diagnosed pulmonary tuberculosis – 150-300 mg/day, for 6 months.
In case of creatinine clearance below 30 ml/min, the dose is reduced by 50%.
In case of moderate impairment of liver and/or kidney function, no dose adjustment is required.
Adverse Reactions
From the digestive system: nausea, vomiting, taste alteration, dyspepsia, belching, flatulence, diarrhea, abdominal pain, increased activity of liver transaminases, alkaline phosphatase, jaundice, hepatitis, pseudomembranous colitis.
From the hematopoietic organs: leukopenia, including neutropenia, thrombocytopenia, anemia, hemolysis.
From the musculoskeletal system: arthralgia, myalgia, myositis.
From the nervous system: insomnia.
From the respiratory system: dyspnea.
From the immune system: fever, rash, eosinophilia, bronchospasm, anaphylactic shock, uveitis.
Other: asthenia, chest pain, fever, flu-like syndrome, orange discoloration of urine, skin discoloration.
Contraindications
Hypersensitivity to rifabutin and other rifamycins; pregnancy, breastfeeding period; children and adolescents under 18 years of age.
With caution severe renal failure, hepatic failure, viral hepatitis, severe atherosclerosis.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Hepatic Impairment
Contraindicated for use in hepatic failure, viral hepatitis.
Use in Renal Impairment
Contraindicated for use in severe renal failure. If creatinine clearance is less than 30 ml/min, a 50% dose reduction is indicated.
Pediatric Use
Use in children and adolescents under 18 years of age is contraindicated.
Special Precautions
To prevent the rapid development of resistance, Rifabutin is used simultaneously with macrolides; in AIDS patients with associated MAC infection – with clarithromycin; for the prevention of candidiasis – with antifungal agents. In these cases, the dose of rifabutin should be reduced.
During treatment with rifabutin, liver function and peripheral blood picture should be monitored.
Taking folic acid is effective for the prevention of anemia.
Rifabutin may impart a reddish-orange color to urine, skin, and secreted fluids. Patients taking Rifabutin should not wear contact lenses due to the possibility of them turning orange.
The use of rifabutin as monotherapy for the prevention of disease caused by Mycobacterium avium in tuberculosis patients may lead to the development of cross-resistance to rifabutin and rifampicin.
It is advisable to combine Rifabutin with antituberculosis drugs that do not belong to the rifamycin group.
When used concomitantly with rifabutin, oral contraceptives may be ineffective; other means of contraception should be used.
Effect on ability to drive vehicles and mechanisms
During the use of rifabutin, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Drug Interactions
Rifabutin is an inducer of liver microsomal enzymes, therefore it accelerates the metabolism and reduces the activity of glucocorticosteroids, oral hypoglycemic agents, indirect anticoagulants, oral contraceptives, digitalis preparations, beta-blockers, class I antiarrhythmic agents, calcium channel blockers.
With simultaneous use of rifabutin with zidovudine, a slight decrease in the concentration of the latter in the blood plasma was noted, which has no clinical significance.
With simultaneous use of fluconazole and clarithromycin, the concentration of rifabutin in plasma increases.
With simultaneous use of rifabutin and zidovudine, the concentration of the latter in plasma decreases.
Combined use of Rifabutin with pyrazinamide, protionamide and isoniazid is indicated due to pronounced synergy at the microbiological level.
Simultaneous use of fluoroquinolones is not recommended.
Storage Conditions
Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 150 mg: 10, 30, or 100 pcs.
Marketing Authorization Holder
Lok-Beta Pharmaceuticals (India), Private Limited (India)
Manufactured By
Lok-Beta Pharmaceuticals (India), Private Limited (India)
Packaging and Quality Control Release
LOK-BETA PHARMACEUTICALS (India), Private Limited (India)
Or
RAFARMA, JSC (Russia)
Dosage Form
 |
Rifabutin | Capsules 150 mg: 10, 30, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Rifabutin | 150 mg |
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
Capsules 150 mg: 30 pcs.
Marketing Authorization Holder
Lupin, Ltd. (India)
Manufactured By
Lupin, Ltd. (India)
Labeled By
MAKIZ-PHARMA, LLC (Russia)
Dosage Form
|
Rifabutin | Capsules 150 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Rifabutin | 150 mg |
10 pcs. – contour cell packs (3) – cardboard packs.
Capsules 150 mg: 30 pcs.
Marketing Authorization Holder
Lupin, Ltd. (India)
Manufactured By
Lupin, Ltd. (India)
Labeled By
PHARMASINTEZ, JSC (Russia)
Dosage Form
|
Rifabutin | Capsules 150 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Rifabutin | 150 mg |
30 pcs. – polyethylene bags – high-density polyethylene containers.
Capsules 150 mg: 30, 100, 500, or 1500 pcs.
Marketing Authorization Holder
Lupin, Ltd. (India)
Dosage Form
|
Rifabutin | Capsules 150 mg: 30, 100, 500, or 1500 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Rifabutin | 150 mg |
10 pcs. – contour cell packs (3) – cardboard boxes.
30 pcs. – polyethylene bags – high-density polyethylene containers.
100 pcs. – polyethylene bags – high-density polyethylene containers.
500 pcs. – polyethylene bags – high-density polyethylene containers.
10 pcs. – contour cell packs (50) – cardboard boxes.
10 pcs. – contour cell packs (150) – cardboard boxes.
Capsules 150 mg: 10, 20, or 30 pcs.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
|
Rifabutin | Capsules 150 mg: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size No. 0, red color; capsule contents – a powder heterogeneous in dispersion, from dark purple to purple-brown in color, with light inclusions.
| 1 caps. | |
| Rifabutin | 150 mg |
Excipients: sodium lauryl sulfate, povidone (low molecular weight medical polyvinylpyrrolidone (12600± 2700)), colloidal silicon dioxide (aerosil), magnesium stearate, talc, pregelatinized starch, titanium dioxide, azorubine (acid red 2C), quinoline yellow, brilliant black, patent blue, ponceau 4R, gelatin.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
Capsules 150 mg: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 80, 90, 100, 200, 300, 400, 500, or 1000 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Dosage Form
|
Rifabutin | Capsules 150 mg: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 80, 90, 100, 200, 300, 400, 500, or 1000 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Rifabutin | 150 mg |
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (7) – cardboard packs.
5 pcs. – contour cell packs (8) – cardboard packs.
5 pcs. – contour cell packs (9) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
5 pcs. – contour cell packs (20) – cardboard packs.
5 pcs. – contour cell packs (40) – cardboard packs.
5 pcs. – contour cell packs (60) – cardboard packs.
5 pcs. – contour cell packs (80) – cardboard packs.
5 pcs. – contour cell packs (100) – cardboard packs.
10 pcs. – contour cell packs (100) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (20) – cardboard packs.
10 pcs. – contour cell packs (40) – cardboard packs.
10 pcs. – contour cell packs (60) – cardboard packs.
10 pcs. – polymer containers (1) – cardboard packs.
10 pcs. – polymer containers (5) – cardboard boxes.
10 pcs. – polymer containers (10) – cardboard boxes.
10 pcs. – polymer containers (20) – cardboard boxes.
20 pcs. – polymer containers (20) – cardboard boxes.
20 pcs. – polymer containers (10) – cardboard boxes.
20 pcs. – polymer containers (1) – cardboard boxes.
20 pcs. – polymer containers (5) – cardboard boxes.
30 pcs. – polymer containers (5) – cardboard boxes.
30 pcs. – polymer containers (1) – cardboard boxes.
30 pcs. – polymer containers (10) – cardboard boxes.
30 pcs. – polymer containers (20) – cardboard boxes.
40 pcs. – polymer containers (20) – cardboard boxes.
40 pcs. – polymer containers (10) – cardboard boxes.
40 pcs. – polymer containers (5) – cardboard boxes.
40 pcs. – polymer containers (1) – cardboard boxes.
50 pcs. – polymer containers (1) – cardboard boxes.
50 pcs. – polymer containers (5) – cardboard boxes.
50 pcs. – polymer containers (10) – cardboard boxes.
50 pcs. – polymer containers (20) – cardboard boxes.
60 pcs. – polymer containers (20) – cardboard boxes.
60 pcs. – polymer containers (10) – cardboard boxes.
60 pcs. – polymer containers (5) – cardboard boxes.
60 pcs. – polymer containers (1) – cardboard boxes.
100 pcs. – polymer containers (1) – cardboard boxes.
100 pcs. – polymer containers (10) – cardboard boxes.
100 pcs. – polymer containers (20) – cardboard boxes.
Capsules 150 mg: 10, 30, 100, 500, 540, or 600 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Dosage Form
|
Rifabutin | Capsules 150 mg: 10, 30, 100, 500, 540, or 600 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Rifabutin | 150 mg |
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (50) – cardboard boxes.
10 pcs. – blister packs (54) – cardboard boxes.
10 pcs. – blister packs (60) – cardboard boxes.
10 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars.
Capsules 150 mg: 10, 20, 30, 50, or 100 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Rifabutin-Ferein® | Capsules 150 mg: 10, 20, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size No. 0, body and cap dark brown in color; capsule contents – purple powder with white specks.
| 1 caps. | |
| Rifabutin | 150 mg |
Excipients : colloidal silicon dioxide – 1.2 mg, sodium lauryl sulfate – 12 mg, magnesium stearate – 4.8 mg, microcrystalline cellulose – 72 mg.
Capsule body composition titanium dioxide (E171) – 0.5%, colorants (iron oxide red (E172) – 1%, Ponceau 4R (E124) – 1.5967%, Patent Blue V (E131) – 0.0073%, Brilliant Black BN (E151) – 0.0415%, water – 14.5%, gelatin – 82.35%).
Capsule cap composition titanium dioxide (E171) – 0.5%, colorants (iron oxide red (E172) – 1%, Ponceau 4R (E124) – 1.5967%, Patent Blue V (E131) – 0.0073%, Brilliant Black BN (E151) – 0.0415%, water – 14.5%, gelatin – 82.35%).
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
![Rifabutin [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Rifabutin [Capsules] 2")