clindamycin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 678 18323-44-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clindamycin hydrochloride hydrate
  • clindamycin
  • 7-Chloro-7-deoxylincomycin
  • 7-Chlorolincomycin
  • 7-Deoxy-7(S)-chlorolincomycin
  • chlolincocin
  • clincin
  • clinimycin
  • Dalacin C
  • dalacine
  • clindamycin hydrochloride
  • clindamycin HCl
An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.
  • Molecular weight: 424.98
  • Formula: C18H33ClN2O5S
  • CLOGP: 2.57
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 102.26
  • ALOGS: -2.14
  • ROTB: 7

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g V
1.20 g O
1.80 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 40 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 13 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 70.59 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 87 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.79 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 22, 1970 FDA PHARMACIA AND UPJOHN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 4030.82 52.78 902 972 45741 2310470
Rash 487.33 52.78 196 1678 59362 2296849
Pruritus 218.16 52.78 102 1772 43238 2312973
Rash maculo-papular 203.89 52.78 54 1820 4198 2352013
Urticaria 203.54 52.78 82 1792 24179 2332032
Toxic skin eruption 169.18 52.78 41 1833 2219 2353992
Acute generalised exanthematous pustulosis 123.62 52.78 30 1844 1628 2354583
Diarrhoea 121.98 52.78 88 1786 83476 2272735
Drug reaction with eosinophilia and systemic symptoms 120.33 52.78 38 1836 5480 2350731
Eosinophilia 110.83 52.78 31 1843 2939 2353272
Pyrexia 100.40 52.78 66 1808 53642 2302569
Abortion spontaneous 97.26 52.78 41 1833 13404 2342807
Vomiting 89.87 52.78 69 1805 71533 2284678
Nausea 70.34 52.78 73 1801 112116 2244095
Face oedema 68.96 52.78 23 1851 3925 2352286
Rash morbilliform 68.29 52.78 15 1859 520 2355691
Cholestasis 66.27 52.78 22 1852 3699 2352512
Angioedema 65.34 52.78 27 1847 8369 2347842
Drug eruption 65.03 52.78 21 1853 3238 2352973
Erythema 62.16 52.78 37 1837 25122 2331089
Dermatitis exfoliative 60.49 52.78 16 1858 1225 2354986
Clostridium difficile colitis 56.62 52.78 17 1857 2062 2354149
Acute kidney injury 53.40 52.78 35 1839 28087 2328124

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 929.53 52.45 224 783 14911 1730863
Rash 260.35 52.45 107 900 38586 1707188
Acute kidney injury 175.79 52.45 79 928 34865 1710909
Rash maculo-papular 163.88 52.45 43 964 3660 1742114
Eosinophilia 127.80 52.45 35 972 3492 1742282
Pruritus 101.98 52.45 48 959 23174 1722600
Toxic skin eruption 98.38 52.45 25 982 1858 1743916
Pyrexia 78.23 52.45 51 956 46349 1699425
Hepatocellular injury 76.29 52.45 23 984 3208 1742566
Urticaria 71.65 52.45 31 976 12210 1733564
Acute generalised exanthematous pustulosis 69.06 52.45 17 990 1105 1744669
Drug reaction with eosinophilia and systemic symptoms 62.26 52.45 22 985 5048 1740726
Diarrhoea 55.61 52.45 44 963 53808 1691966

Pharmacologic Action:

SourceCodeDescription
ATC D10AF01 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Antiinfectives for treatment of acne
ATC D10AF51 DERMATOLOGICALS
ANTI-ACNE PREPARATIONS
ANTI-ACNE PREPARATIONS FOR TOPICAL USE
Antiinfectives for treatment of acne
ATC G01AA10 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Antibiotics
ATC J01FF01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
Lincosamides
FDA PE N0000009982 Decreased Sebaceous Gland Activity
FDA EPC N0000175443 Lincosamide Antibacterial
FDA CS M0515779 Lincosamides
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011500 Protein Synthesis Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Anaerobic septicemia indication 1976008
Bacterial septicemia indication 10001005 DOID:0040085
Infection of skin AND/OR subcutaneous tissue indication 19824006
Staphylococcal pneumonia indication 22754005
Streptococcal septicemia indication 29577008
Pneumonia due to Streptococcus indication 34020007
Empyema of pleura indication 58554001 DOID:3798
Acne vulgaris indication 88616000
Infection of bone indication 111253001
Staphylococcal septicemia indication 111821004
Infectious disease of abdomen indication 128070006
Pneumococcal pneumonia indication 233607000
Gas gangrene caused by clostridium perfringens indication 266093005
Streptococcus pyogenes infection indication 302809008
Infectious disorder of joint indication 363162000
Infection due to Staphylococcus aureus indication 406602003
Bacterial vaginosis indication 419760006 DOID:3385
Aspiration pneumonia indication 422588002 DOID:3240
Infection due to anaerobic bacteria indication 423451008
Osteomyelitis due to Staphylococcus aureus indication 428783003
Inflammatory Disease of Female Pelvic Organs indication
Anaerobic Tubo-Ovarian Abscess indication
Anaerobic Joint Infection indication
Prevention of Bacterial Endocarditis indication
Anaerobic Peritonitis indication
Clostridium Perfringens Empyema indication
Anaerobic Pelvic Cellulitis indication
Anaerobic Lung Abscess indication
Skin and Skin Structure Anaerobic Infection indication
Bacteroides Endomyometritis indication
Anaerobic Endometritis indication
Intra-Abdominal Anaerobic Abscess indication
Pyrexia of unknown origin off-label use 7520000
Inhalational anthrax off-label use 11389007
Actinomycotic infection off-label use 11817007 DOID:8478
Babesiosis off-label use 21061004 DOID:9643
Sinusitis off-label use 36971009
Erysipelas off-label use 44653001 DOID:11330
Malaria off-label use 61462000 DOID:12365
Acute bacterial sinusitis off-label use 75498004
Cutaneous anthrax off-label use 84980006 DOID:7426
Gastrointestinal anthrax off-label use 111798006 DOID:13386
Bacterial infection of skin off-label use 128936008
Toxoplasmosis off-label use 187192000 DOID:9965
Diverticulitis of gastrointestinal tract off-label use 271366000
Infective otitis media off-label use 312218008
Rosacea off-label use 398909004 DOID:8881
Anthrax off-label use 409498004 DOID:7427
Pneumocystosis jiroveci pneumonia off-label use 415125002 DOID:11339
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Diabetic Foot Infection off-label use
Chloroquine Resistant Plasmodium Falciparum Malaria off-label use
Encephalitis due to Toxoplasmosis off-label use
Diabetic Foot Infection Due to Gram-Positive Bacteria off-label use
Gardnerella Vaginalis Bacterial Vaginosis off-label use
Sunburn contraindication 23346002
Atopic dermatitis contraindication 24079001 DOID:3310
Crohn's disease contraindication 34000006
Eczema contraindication 43116000
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Ulcerative colitis contraindication 64766004 DOID:8577
Candidal vulvovaginitis contraindication 72605008 DOID:2272
Pregnancy, function contraindication 289908002
Pseudomembranous enterocolitis contraindication 397683000
Erythroderma contraindication 399992009
Breastfeeding (mother) contraindication 413712001
Inflammatory dermatosis contraindication 703938007
Bloody Stools contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.85 acidic
pKa2 13.38 acidic
pKa3 7.52 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
50S ribosomal protein L10 Ribosomal protein WOMBAT-PK

External reference:

IDSource
D002981 MESH_DESCRIPTOR_UI
4019683 VUID
N0000147775 NUI
C0008947 UMLSCUI
D00277 KEGG_DRUG
3U02EL437C UNII
2550 INN_ID
58883005 SNOMEDCT_US
4019683 VANDF
002794 NDDF
2582 RXNORM
372786004 SNOMEDCT_US
4466 MMSL
d00043 MMSL
CHEMBL1753 ChEMBL_ID
CHEMBL1200588 ChEMBL_ID
21462-39-5 SECONDARY_CAS_RN
CLY PDB_CHEM_ID
DB01190 DRUGBANK_ID
CHEBI:3745 CHEBI
10607 IUPHAR_LIGAND_ID
446598 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cleocin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0009-0225 CAPSULE 150 mg ORAL NDA 14 sections
Cleocin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0009-0331 CAPSULE 75 mg ORAL NDA 14 sections
Cleocin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0009-0395 CAPSULE 300 mg ORAL NDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1381 CAPSULE 75 mg ORAL ANDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1382 CAPSULE 150 mg ORAL ANDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1383 CAPSULE 300 mg ORAL ANDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-2932 CAPSULE 300 mg ORAL ANDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-5708 CAPSULE 150 mg ORAL ANDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0713-3171 CAPSULE 150 mg ORAL ANDA 14 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0713-5256 CAPSULE 300 mg ORAL ANDA 14 sections
Clindamycin in 5 Percent Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0781-3288 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 13 sections
Clindamycin in 5 Percent Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0781-3289 INJECTION, SOLUTION 12 mg INTRAVENOUS ANDA 13 sections
Clindamycin in 5 Percent Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0781-3290 INJECTION, SOLUTION 18 mg INTRAVENOUS ANDA 13 sections
Clindamycin in 5 Percent Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0781-9220 INJECTION, SOLUTION 6 mg INTRAVENOUS ANDA 13 sections
Clindamycin in 5 Percent Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0781-9221 INJECTION, SOLUTION 12 mg INTRAVENOUS ANDA 13 sections
Clindamycin in 5 Percent Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0781-9222 INJECTION, SOLUTION 18 mg INTRAVENOUS ANDA 13 sections
Clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-5959 CAPSULE 150 mg ORAL ANDA 14 sections
Clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-153 CAPSULE 150 mg ORAL ANDA 15 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-154 CAPSULE 300 mg ORAL ANDA 14 sections
Clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 12634-092 CAPSULE 150 mg ORAL ANDA 15 sections
clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16590-057 CAPSULE 150 mg ORAL ANDA 13 sections
clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-033 CAPSULE 150 mg ORAL ANDA 15 sections
clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-034 CAPSULE 300 mg ORAL ANDA 15 sections
Clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-159 CAPSULE 150 mg ORAL ANDA 15 sections
Clindamycin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-448 CAPSULE 300 mg ORAL ANDA 15 sections
Clindamycin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42292-018 CAPSULE 150 mg ORAL ANDA 14 sections
CLINDAMYCIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 42549-532 CAPSULE 150 mg ORAL ANDA 15 sections
CLINDAMYCIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 42571-250 CAPSULE 75 mg ORAL ANDA 14 sections
CLINDAMYCIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 42571-251 CAPSULE 150 mg ORAL ANDA 14 sections
CLINDAMYCIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 42571-252 CAPSULE 300 mg ORAL ANDA 14 sections