Citanest forte, Fortacin(prilocaine)
Citanest, Fortacin, Oraqix (prilocaine) is a small molecule pharmaceutical. Prilocaine was first approved as Citanest forte on 1982-01-01. It is used to treat pain in the USA. It has been approved in Europe to treat physiological sexual dysfunction and premature ejaculation.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
| psychological phenomena | D011579 |
| mental disorders | D001523 |
| musculoskeletal and neural physiological phenomena | D055687 |
Trade Name
FDA
EMA
Combinations
Citanest, Oraqix (generic drugs available since 2003-08-18, discontinued: Emla)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Epinephrine bitartrate
+
Prilocaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CITANEST FORTE DENTAL | Dentsply Pharmaceutical | N-021383 RX | 1982-01-01 | 1 products, RLD, RS |
Show 1 discontinued
Lidocaine
+
Prilocaine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORAQIX | Dentsply Pharmaceutical | N-021451 RX | 2003-12-19 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| citanest plain | ANDA | 2021-11-10 |
| lidocaine and prilocaine | ANDA | 2023-04-17 |
| oraqix | New Drug Application | 2018-11-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
137 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 2 | 3 | 5 | 3 | 6 | 18 |
| Postoperative pain | D010149 | G89.18 | 1 | — | — | 3 | 2 | 6 | |
| Healthy volunteers/patients | — | 2 | — | — | 1 | 3 | 6 | ||
| Spinal anesthesia | D000775 | — | — | — | 1 | 3 | 4 | ||
| Contraception | D003267 | — | — | 2 | 2 | — | 4 | ||
| Actinic keratosis | D055623 | L57.0 | 3 | — | — | 1 | — | 4 | |
| Brachial plexus block | D065527 | — | — | — | 3 | — | 3 | ||
| Anesthesia | D000758 | — | — | — | 1 | 2 | 3 | ||
| Nerve block | D009407 | — | — | — | 2 | — | 2 | ||
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | — | 1 | 1 | — | 2 |
Show 18 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Local anesthesia | D000772 | — | 2 | 1 | — | 2 | 4 | ||
| Analgesia | D000698 | — | — | 1 | — | 2 | 3 | ||
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | 1 | — | 1 | 2 |
| Premature ejaculation | D061686 | HP_0012876 | F52.4 | — | 2 | 1 | — | — | 2 |
| Hemorrhoidectomy | D061865 | — | 1 | 1 | — | — | 1 | ||
| Bone marrow diseases | D001855 | — | — | 1 | — | — | 1 | ||
| Procedural pain | D000073818 | — | — | 1 | — | — | 1 | ||
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | 1 | — | — | 1 | |
| Postpartum period | D049590 | — | — | 1 | — | — | 1 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | T14.8 | — | 1 | — | — | — | 1 | |
| Postherpetic neuralgia | D051474 | — | 1 | — | — | — | 1 | ||
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | 1 | — | — | — | 1 |
| Memory disorders | D008569 | 1 | 1 | — | — | — | 1 | ||
| Cognitive dysfunction | D060825 | G31.84 | 1 | 1 | — | — | — | 1 | |
| Cataract | D002386 | EFO_0001059 | H26.9 | 1 | 1 | — | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 1 | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ambulatory surgical procedures | D000556 | — | — | — | — | 2 | 2 | ||
| Pruritus | D011537 | HP_0000989 | L29 | — | — | — | — | 2 | 2 |
| Musculoskeletal diseases | D009140 | — | — | — | — | 2 | 2 | ||
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | 1 | 1 | ||
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | — | 1 | 1 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | — | — | 1 | 1 |
| Umbilical hernia | D006554 | K42 | — | — | — | — | 1 | 1 | |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PRILOCAINE |
| INN | prilocaine |
| Description | Prilocaine is an amino acid amide in which N-propyl-DL-alanine and 2-methylaniline have combined to form the amide bond; used as a local anaesthetic. It has a role as a local anaesthetic and an anticonvulsant. It is an amino acid amide and a monocarboxylic acid amide. |
| Classification | Small molecule |
| Drug class | local anesthetics |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCCNC(C)C(=O)Nc1ccccc1C |
Identifiers
| PDB | — |
| CAS-ID | 721-50-6 |
| RxCUI | 8686 |
| ChEMBL ID | CHEMBL1194 |
| ChEBI ID | 8404 |
| PubChem CID | 4906 |
| DrugBank | DB00750 |
| UNII ID | 046O35D44R (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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,341 adverse events reported
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