Clarithromycin
/ Clarithromycin /, Clarithromycin, Voquezna Triple (clarithromycin) is a small molecule pharmaceutical. Clarithromycin was first approved as Biaxin on 1991-10-31. It is used to treat bacterial infections, bronchitis, chlamydia infections, duodenal ulcer, and haemophilus infections amongst others in the USA. The pharmaceutical is active against androgen receptor.
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Commercial
Trade Name
FDA
EMA
Combinations
Voquezna triple (generic drugs available since 2004-06-24, discontinued: Prevpac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Clarithromycin
+
Lansoprazole
Amoxicillin
+
Clarithromycin
+
Omeprazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN | Cumberland Pharmaceuticals | N-050824 DISCN | 2011-02-08 | 1 products, RLD |
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Amoxicillin
+
Clarithromycin
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Vonoprazan fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOQUEZNA TRIPLE PAK | Phathom Pharmaceuticals | N-215152 RX | 2022-05-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| biaxin | New Drug Application | 2012-02-22 |
| clarithromycin | ANDA | 2024-02-01 |
| clarithromycin clarithromycin | ANDA | 2018-02-14 |
| clarithromycin extended release | 2008-08-08 | |
| lansoprazole, amoxicillin, clarithromycin | ANDA | 2023-09-18 |
| omeclamox-pak | New Drug Application | 2023-08-17 |
| prevpac | New Drug Application | 2010-03-15 |
| voquezna dual pak voquezna triple pak | New Drug Application | 2023-11-06 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM | |||
| 2032-05-03 | GAIN | ||
| 2027-05-03 | NCE | ||
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
— A02BD04: Pantoprazole, amoxicillin and clarithromycin
— A02BD05: Omeprazole, amoxicillin and clarithromycin
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD09: Lansoprazole, clarithromycin and tinidazole
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
— A02BD12: Rabeprazole, amoxicillin and clarithromycin
— A02BD14: Vonoprazan, amoxicillin and clarithromycin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FA: Macrolides
— J01FA09: Clarithromycin
HCPCS
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Clinical
Clinical Trials
505 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 4 | 6 | 17 | 68 | 48 | 139 |
| Healthy volunteers/patients | — | — | — | 31 | — | — | 1 | 6 | 38 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | 3 | 7 | 9 | 5 | 22 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | 1 | 6 | 6 | 7 | 19 |
| Helicobacter pylori | D016480 | NCBITaxon_210 | B96.81 | 2 | 1 | 4 | 11 | 2 | 19 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 5 | 4 | 1 | 3 | 17 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | 1 | — | 9 | 2 | 13 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | 4 | 4 | 2 | 11 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | 1 | 8 | 1 | — | 10 |
| Peptic ulcer | D010437 | HP_0004398 | K27 | — | — | 1 | 9 | — | 10 |
Show 34 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 1 | 15 | 4 | — | — | 19 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | 1 | 5 | 4 | — | 3 | 13 |
| Lymphoma | D008223 | — | C85.9 | 1 | 3 | 1 | — | 1 | 6 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 1 | — | 4 | 5 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 2 | — | 1 | 4 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 1 | 1 | — | 1 | 4 |
| Bronchitis | D001991 | — | J40 | — | — | 1 | — | 3 | 4 |
| Aggressive periodontitis | D010520 | EFO_0006342 | K05.2 | — | 2 | 2 | — | 2 | 4 |
| Buruli ulcer | D054312 | EFO_1001281 | A31.1 | — | 3 | 2 | — | — | 3 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | — | — | 2 | — | — | 2 |
Show 25 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | 2 | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Narcolepsy | D009290 | HP_0030050 | G47.4 | — | 2 | — | — | — | 2 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | 2 | — | — | — | 2 |
| Virus diseases | D014777 | — | B34 | — | 1 | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Squamous cell neoplasms | D018307 | — | — | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 7 | — | — | — | 1 | 8 |
| Pharmacokinetics | D010599 | — | — | 5 | — | — | — | — | 5 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 1 | — | — | — | — | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | — | — | — | — | 1 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | — | — | 1 |
| Anovulation | D000858 | — | — | 1 | — | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Patient compliance | D010349 | — | — | — | — | — | — | 2 | 2 |
| Tracheitis | D014136 | EFO_0007518 | — | — | — | — | — | 2 | 2 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 1 | 1 |
| Radiotherapy | D011878 | — | — | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
| Drug resistance | D004351 | — | Z16.30 | — | — | — | — | 1 | 1 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | — | — | — | 1 | 1 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clarithromycin |
| INN | clarithromycin |
| Description | Clarithromycin is the 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis. It has a role as an antibacterial drug, a protein synthesis inhibitor, an environmental contaminant and a xenobiotic. |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strain) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O |
Identifiers
| PDB | — |
| CAS-ID | 81103-11-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1741 |
| ChEBI ID | 3732 |
| PubChem CID | 84029 |
| DrugBank | DB01211 |
| UNII ID | H1250JIK0A (ChemIDplus, GSRS) |
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Clarithromycin
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Amoxicillin
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Lansoprazole
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Clarithromycin
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Amoxicillin
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Omeprazole
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Clarithromycin
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Safety
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26,382 adverse events reported
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