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Rifabutin
Mycobutin, Talicia (rifabutin) is a small molecule pharmaceutical. Rifabutin was first approved as Mycobutin on 1992-12-23. It is used to treat mycobacterium avium-intracellulare infection, mycobacterium infections, and pulmonary tuberculosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Mycobutin (generic drugs available since 2014-02-24)
Combinations
Talicia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Omeprazole magnesium
+
Rifabutin
Tradename
Company
Number
Date
Products
TALICIARedHill BiopharmaN-213004 RX2019-11-01
1 products, RLD, RS
Rifabutin
Tradename
Company
Number
Date
Products
MYCOBUTINMylanN-050689 RX1992-12-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mycobutinNew Drug Application2023-05-30
taliciaNew Drug Application2021-10-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycobacterium avium-intracellulare infectionEFO_0007386D015270—
mycobacterium infections—D009164A31.9
pulmonary tuberculosisEFO_1000049D014397A15
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill
90502632034-02-12DPU-2660
94984452034-02-12DPU-2660
96038062034-02-12DPU-2660
102386062034-02-12DP
111351722034-02-12DPU-2660
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD16: Omeprazole, amoxicillin and rifabutin
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AB: Antibiotics, antitubercular
— J04AB04: Rifabutin
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.92561—14
Disease progressionD018450———1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory insufficiencyD012131HP_0002093J96.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD0485501————1
Renal insufficiencyD051437HP_0000083N191————1
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRIFABUTIN
INNrifabutin
Description
Rifabutin (Rfb) is an antibiotic used to treat tuberculosis and prevent and treat Mycobacterium avium complex. It is typically only used in those who cannot tolerate rifampin such as people with HIV/AIDS on antiretrovirals. For active tuberculosis it is used with other antimycobacterial medications. For latent tuberculosis it may be used by itself when the exposure was with drug-resistant TB.
Classification
Small molecule
Drug classantibiotics (rifamycin derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CO[C@H]1/C=C/O[C@@]2(C)Oc3c(C)c(O)c4c(c3C2=O)C2=NC3(CCN(CC(C)C)CC3)NC2=C(NC(=O)/C(C)=C\C=C\[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C4=O
Identifiers
PDB—
CAS-ID72559-06-9
RxCUI55672
ChEMBL IDCHEMBL444633
ChEBI ID45367
PubChem CID6323490
DrugBankDB00615
UNII ID1W306TDA6S (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,889 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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145 adverse events reported
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