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    Chemistry

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    Also known as: Cefalexin, 15686-71-2, Cephacillin, Keflex, Ceporexin, Cepexin
    Molecular Formula
    C16H17N3O4S
    Molecular Weight
    347.4  g/mol
    InChI Key
    ZAIPMKNFIOOWCQ-UEKVPHQBSA-N
    FDA UNII
    5SFF1W6677
    Cephalexin
    A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.
    Cephalexin anhydrous is a Cephalosporin Antibacterial.
    1 2D Structure

    Cephalexin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (6R,7R)-7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
    2.1.2 InChI
    InChI=1S/C16H17N3O4S/c1-8-7-24-15-11(14(21)19(15)12(8)16(22)23)18-13(20)10(17)9-5-3-2-4-6-9/h2-6,10-11,15H,7,17H2,1H3,(H,18,20)(H,22,23)/t10-,11-,15-/m1/s1
    2.1.3 InChI Key
    ZAIPMKNFIOOWCQ-UEKVPHQBSA-N
    2.1.4 Canonical SMILES
    CC1=C(N2C(C(C2=O)NC(=O)C(C3=CC=CC=C3)N)SC1)C(=O)O
    2.1.5 Isomeric SMILES
    CC1=C(N2[C@@H]([C@@H](C2=O)NC(=O)[C@@H](C3=CC=CC=C3)N)SC1)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    5SFF1W6677
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-methyl-8-oxo-, (6r-(6alpha,7beta(r*)))-

    2. Cefalexin

    3. Cephalexin Dihydride

    4. Cephalexin Hemihydrate

    5. Cephalexin Hydrochloride

    6. Cephalexin Monohydrate

    7. Cephalexin Monohydrochloride

    8. Cephalexin Monohydrochloride, Monohydrate

    9. Cephalexin, (6r-(6alpha,7alpha(r*)))-isomer

    10. Cephalexin, (6r-(6alpha,7beta(s*)))-isomer

    11. Cephalexin, (6r-(6alpha,7beta))-isomer

    12. Cephalexin, Monosodium Salt

    13. Cephalexin, Monosodium Salt, (6r-(6alpha,7beta))-isomer

    14. Ceporexine

    15. Palitrex

    2.3.2 Depositor-Supplied Synonyms

    1. Cefalexin

    2. 15686-71-2

    3. Cephacillin

    4. Keflex

    5. Ceporexin

    6. Cepexin

    7. Cephalexinum

    8. Cepastar

    9. Cephalexine

    10. Celexin

    11. Ceporex

    12. Alcephin

    13. Alsporin

    14. Carnosporin

    15. Cefablan

    16. Cefaleksin

    17. Cefalexina

    18. Cefalexine

    19. Cefalexinum

    20. Durantel

    21. Mamalexin

    22. Sinthecillin

    23. Uphalexin

    24. Cefadin

    25. Felexin

    26. Pyassan

    27. Tepaxin

    28. Keflet

    29. Palitrex

    30. Cefalessina [dcit]

    31. Cephalexin Anhydrous

    32. Cefaseptin

    33. Novolexin

    34. Biocef

    35. Keftab

    36. Cefalexine [inn-french]

    37. Cefalexinum [inn-latin]

    38. Cefalexina [inn-spanish]

    39. Panixine Disperdose

    40. Lilly 66873

    41. 7-(d-alpha-aminophenylacetamido)desacetoxycephalosporanic Acid

    42. Ceporexine

    43. Cefalexin Anhydrous

    44. Cefalexin [inn]

    45. Anhydrous Cephalexin

    46. Ceffanex

    47. Cephanasten

    48. 7-beta-(d-alpha-amino-alpha-phenylacetylamino)-3-methyl-3-cephem-4-carboxylic Acid

    49. Cefaloto

    50. Ceforal

    51. Chebi:3534

    52. Cophalexin

    53. Factagard

    54. Kefalospes

    55. Lexibiotico

    56. Lopilexin

    57. Neolexina

    58. Ortisporina

    59. Sartosona

    60. Sencephalin

    61. Servispor

    62. Tokiolexin

    63. Cefadal

    64. Cefadina

    65. Cefalin

    66. Cefovit

    67. Cephaxin

    68. Erocetin

    69. Ibrexin

    70. Inphalex

    71. Kefolan

    72. Kekrinal

    73. Kidolex

    74. Lafarine

    75. Larixin

    76. Lenocef

    77. Lonflex

    78. Madlexin

    79. Mamlexin

    80. Medoxine

    81. Oriphex

    82. Ospexin

    83. Pectril

    84. Sanaxin

    85. Sepexin

    86. Sialexin

    87. Sporicef

    88. Sporidex

    89. Zozarine

    90. Alexin

    91. Cefax

    92. Cephin

    93. Cepol

    94. Check

    95. Fexin

    96. Ibilex

    97. Neokef

    98. Nufex

    99. Oracef

    100. Oroxin

    101. Roceph

    102. Syncl

    103. Syncle

    104. Synecl

    105. Voxxim

    106. Winlex

    107. Cex

    108. Cefa-iskia

    109. Ceporex Forte

    110. Ceporexin-e

    111. Sq 20248

    112. Chembl1727

    113. Durantel Ds

    114. L-keflex

    115. (6r,7r)-7-{[(2r)-2-amino-2-phenylacetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    116. Cefalessina

    117. Ed A-ceph

    118. Roceph Distab

    119. 5sff1w6677

    120. Ncgc00159522-02

    121. Ceflax

    122. Dsstox_cid_2780

    123. Dsstox_rid_76726

    124. Dsstox_gsid_22780

    125. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    126. (6r,7r)-7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    127. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2r)-aminophenylacetyl]amino]-3-methyl-8-oxo-, (6r,7r)-

    128. L-cephalexin

    129. Cephalexin 1-hydrate

    130. Cerexin

    131. Optocef

    132. Cephalexin [usan:ban]

    133. (6r,7r)-7-[(2r)-2-amino-2-phenylacetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    134. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2r)-aminophenylacetyl)amino)-3-methyl-8-oxo-, (6r,7r)-

    135. Smr000338536

    136. S 6437

    137. Cas-15686-71-2

    138. Keflex (tn)

    139. Hsdb 3022

    140. Nsc-758162

    141. Einecs 239-773-6

    142. Brn 0965503

    143. Taicelexin

    144. 7-(d-2-amino-2-phenylacetamido)-3-methyl-delta3-cephem-4-carboxylic Acid

    145. Cerexins

    146. Amplex

    147. Unii-5sff1w6677

    148. Anhydrous Cefalexin

    149. Cefalexin,(s)

    150. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid

    151. 34632-04-7

    152. Cefadros

    153. Cephamasten

    154. Efalexin

    155. Garasin

    156. Iwalexin

    157. Kefloridina

    158. Oracocin

    159. Cefalexin (jp17)

    160. Cephalexin (cefalexin)

    161. Cefalexin [jan]

    162. Cephalexin [mi]

    163. Prestwick0_000358

    164. Prestwick1_000358

    165. Prestwick2_000358

    166. Prestwick3_000358

    167. Cephalexin [hsdb]

    168. Epitope Id:117132

    169. Cefalexin [who-dd]

    170. Schembl2961

    171. 7-(d-2-amino-2-phenylacetamido)-3-methyl-delta (sup 3)-cephem-4- Carboxylic Acid

    172. Bspbio_000455

    173. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-2-carbonsaeure

    174. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-methyl-8-oxo-, (6r-(6alpha,7beta(r*)))-

    175. Mls000759527

    176. Mls001424036

    177. Spbio_002376

    178. Bpbio1_000501

    179. Gtpl4832

    180. Dtxsid9022780

    181. Lilly-66873

    182. Bcpp000289

    183. Hms2051a04

    184. Hy-b0200

    185. Zinc3830500

    186. Tox21_111740

    187. Bdbm50139896

    188. Akos004119846

    189. Tox21_111740_1

    190. Bcp9000509

    191. Ccg-100831

    192. Cs-2137

    193. Db00567

    194. Nc00081

    195. Nsc 758162

    196. Ncgc00159522-03

    197. Ncgc00159522-05

    198. (6r,7r)-7-[[(2r)-2-amino-2-phenyl-acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    199. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(2-amino-2-phenylacetamido)-3-methyl-8-oxo-, D-

    200. Ds-11971

    201. B1692

    202. Cefalexin, Vetranal(tm), Analytical Standard

    203. C-2660

    204. C06895

    205. D00263

    206. H10995

    207. S-6437

    208. Cephalexin, Antibiotic For Culture Media Use Only

    209. Q411417

    210. Q-200819

    211. Brd-k90733503-002-03-6

    212. Cefalexin, British Pharmacopoeia (bp) Reference Standard

    213. Cephalexin Monohydrate, Antibiotic For Culture Media Use Only

    214. Cephalexin, Pharmaceutical Secondary Standard; Certified Reference Material

    215. 7-(d-.alpha.-amino-.alpha.-phenylacetamido)-3-methyl-3-cephem-4-carboxylic Acid

    216. 7beta-[(2r)-2-amino-2-phenylacetamido]-3-methyl-3,4-didehydrocepham-4-carboxylic Acid

    217. (6r,7r)-7-((r)-2-amino-2-phenyl-acetylamino)-3-methyl-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    218. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    219. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-methyl-8-oxo-,(6r-(6.alpha.,7.beta.(r*)))-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 347.4 g/mol
    Molecular Formula C16H17N3O4S
    XLogP30.6
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass347.09397721 g/mol
    Monoisotopic Mass347.09397721 g/mol
    Topological Polar Surface Area138 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity600
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCephalexin
    PubMed HealthCephalexin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelCephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D--Amino--phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S H2O and the m...
    Active IngredientCephalexin
    Dosage FormTablet; Capsule; For suspension
    RouteOral
    Strengtheq 750mg base; eq 250mg base/5ml; eq 500mg base; eq 333mg base; eq 250mg base; eq 125mg base/5ml
    Market StatusPrescription
    CompanyRanbaxy; Sun Pharm Inds (in); Belcher Pharms; Teva; Yung Shin Pharm; Alkem Labs; Aurobindo Pharma; Lupin; Hikma Pharms; Orchid Hlthcare; Hikma

    2 of 4  
    Drug NameKeflex
    PubMed HealthCephalexin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelKeflex Capsules (Cephalexin, USP) is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D--Amino--phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4...
    Active IngredientCephalexin
    Dosage FormCapsule
    RouteOral
    Strengtheq 750mg base; eq 500mg base; eq 250mg base
    Market StatusPrescription
    CompanyShionogi

    3 of 4  
    Drug NameCephalexin
    PubMed HealthCephalexin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelCephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D--Amino--phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S H2O and the m...
    Active IngredientCephalexin
    Dosage FormTablet; Capsule; For suspension
    RouteOral
    Strengtheq 750mg base; eq 250mg base/5ml; eq 500mg base; eq 333mg base; eq 250mg base; eq 125mg base/5ml
    Market StatusPrescription
    CompanyRanbaxy; Sun Pharm Inds (in); Belcher Pharms; Teva; Yung Shin Pharm; Alkem Labs; Aurobindo Pharma; Lupin; Hikma Pharms; Orchid Hlthcare; Hikma

    4 of 4  
    Drug NameKeflex
    PubMed HealthCephalexin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelKeflex Capsules (Cephalexin, USP) is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D--Amino--phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4...
    Active IngredientCephalexin
    Dosage FormCapsule
    RouteOral
    Strengtheq 750mg base; eq 500mg base; eq 250mg base
    Market StatusPrescription
    CompanyShionogi

    4.2 Therapeutic Uses

    Cephalosporins

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    /CEPHALEXIN/ HAS ANTIBACTERIAL SPECTRUM SIMILAR TO THAT OF PENICILLINS... AGAINST COCCI & GRAM-POSITIVE BACILLI, PENICILLIN G IS USUALLY MORE EFFECTIVE. ...MOST PENICILLINASES DO NOT AFFECT CEPHALEXIN...

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1119

    ...CEPHALOSPORINS ARE HIGHLY EFFECTIVE IN THERAPY OF VARIETY OF MILD-TO-SEVERE INFECTIONS DUE TO BOTH GRAM-POSITIVE & GRAM-NEGATIVE MICROORGANISMS. /CEPHALOSPORINS/

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1088

    ...CEPHALOSPORIN IS...DRUG OF 1ST CHOICE...FOR KLEBSIELLA INFECTIONS. ... THEY ARE...VALUABLE SECONDARY AGENTS, & THEY FREQUENTLY APPEAR AS ALTERNATIVE CHOICES TO PENICILLIN. /CEPHALOSPORINS/

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1091

    For more Therapeutic Uses (Complete) data for CEPHALEXIN (9 total), please visit the HSDB record page.

    4.3 Drug Warning

    PHYSICIAN MUST ALTER EITHER DRUG DOSAGE OR INTERVAL BETWEEN DOSES WHEN RENAL FUNCTION IS IMPAIRED.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1161

    CEPHALOSPORINS SHOULD NOT BE USED TO TREAT BACTERIAL MENINGITIS. THIS IS TRUE FOR ALL CAUSATIVE MICROORGANISMS. ...PENETRATION OF CEPHALOSPORINS INTO CSF IS POOR. /CEPHALOSPORINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1164

    INFECTIONS DUE TO ENTEROCOCCI ARE USUALLY UNAFFECTED BY THESE CMPD... ENTEROCOCCAL ENDOCARDITIS CANNOT BE CURED WITH CEPHALOSPORIN EVEN WHEN IT IS GIVEN CONCURRENTLY WITH GENTAMICIN OR STREPTOMYCIN. /CEPHALOSPORINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1163

    ENTEROBACTER (AEROBACTER) INFECTIONS ARE, AS A RULE, RESISTANT TO THESE CMPD. /CEPHALOSPORINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1163

    For more Drug Warnings (Complete) data for CEPHALEXIN (20 total), please visit the HSDB record page.

    4.4 Drug Indication

    Cephalexin is indicated for the treatment of certain infections caused by susceptible bacteria. These infections include respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Cephalexin (also called Cefalexin) is a first generation cephalosporin antibiotic. It is one of the most widely prescribed antibiotics, often used for the treatment of superficial infections that result as complications of minor wounds or lacerations. It is effective against most gram-positive bacteria through its inihibition of the cross linking reaction between N-acetyl muramicacid and N-acetylglucosamine in the cell wall, leading to cell lysis.

    5.2 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    CEPHALEXIN ANHYDROUS
    5.3.2 FDA UNII
    5SFF1W6677
    5.3.3 Pharmacological Classes
    Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]
    5.4 ATC Code

    J01DB01

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    J - Antiinfectives for systemic use

    J01 - Antibacterials for systemic use

    J01D - Other beta-lactam antibacterials

    J01DB - First-generation cephalosporins

    J01DB01 - Cefalexin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Well absorbed from the upper gastrointestinal tract with nearly 100% oral bioavailability. Cephalexin is not absorbed in the stomach but is absorbed in the upper intestine. Patients taking 250mg of cephalexin reach a maximum plasma concentration of 7.7mcg/mL and patients taking 500mg reach 12.3mcg/mL.

    Route of Elimination

    Cephalexin is over 90% excreted in the urine after 6 hours by glomerular filtration and tubular secretion with a mean urinary recovery of 99.3%. Cephalexin is unchanged in the urine.

    Volume of Distribution

    5.2-5.8L.

    Clearance

    Clearance from one subject was 376mL/min.

    LESS THAN 10 TO 15%...IS BOUND TO PLASMA PROTEIN, & PLASMA DRUG CONCN FALL RAPIDLY... MORE THAN 90%...IS EXCRETED UNALTERED IN URINE WITHIN 6 HR, PRIMARILY BY RENAL TUBULAR SECRETION. ...THERAPEUTICALLY EFFECTIVE CONCN ARE STILL ACHIEVED IN URINE OF PT WITH DECR RENAL FUNCTION.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1161

    CEPHALEXIN...IS WELL ABSORBED FROM GI TRACT. PEAK PLASMA CONCN, REACHED @ ABOUT 1 HR AFTER INGESTION OF DRUG, ARE APPROX 9 & 18 UG/ML AFTER ORAL DOSES OF 250 & 500 MG, RESPECTIVELY. INGESTION OF FOOD MAY DELAY ABSORPTION.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1161

    CEPHALEXIN IS ALSO EXCRETED INTO BILE.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1162

    BOTH ABSORPTION & EXCRETION OF CEPHALEXIN ARE IMPAIRED IN NEW-BORN INFANTS, WHERE 24-HR URINARY RECOVERY OF ANTIBIOTIC ACCOUNTED FOR 5-66% OF DAILY ORAL DOSE.

    The Chemical Society. Foreign Compound Metabolism in Mammals Volume 3. London: The Chemical Society, 1975., p. 177

    For more Absorption, Distribution and Excretion (Complete) data for CEPHALEXIN (14 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Cephalexin is not metabolized in the body.

    5.7 Biological Half-Life

    The half life of cephalexin is 49.5 minutes in a fasted state and 76.5 minutes with food though these times were not significantly different in the study.

    LESS THAN 10 TO 15%...IS BOUND TO PLASMA PROTEIN, & PLASMA DRUG CONCN FALL RAPIDLY, T/2 OF CEPHALEXIN NORMALLY BEING ABOUT 40 MIN.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1161

    /IN RATS/ RATIOS OF BONE TO SERUM CONCN AVG...1:9 FOR CEPHALEXIN DURING 0.25-4 HR AFTER /ORAL/ DOSING. DESPITE DIFFERENCES IN CONCN; T/2 IN BONE & SERUM WERE SIMILAR.

    The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 452

    PEAK TIME, T/2 OF ELIMINATION, T/2 OF ABSORPTION, & VOL OF DISTRIBUTION WERE ALL SIMILAR FOLOWING ADMIN OF EITHER 1 OR 2 G OF CEPHALEXIN.

    PMID:438352 CHOW M ET AL; J CLIN PHARMACOL 19 (4): 185-94 (1979)

    The serum half-life of cephalexin is 0.5-1.2 hr in adults with normal renal function. The serum half-life of the drug is reported to be about 5 hr in neonates and 2.5 hr in children 3-12 mo of age. In one study, the serum half-life was 7.7 hr in adults with creatinine clearances of 9.2 ml/min and 13.9 hr in adults with creatinine clearances of 4 ml/min.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 95. Bethesda, MD: American Society of Hospital Pharmacists, Inc., 1995 (Plus Supplements 1995)., p. 166

    5.8 Mechanism of Action

    Cephalexin is a first generation cephalosporin antibiotic. Cephalosporins contain a beta lactam and dihydrothiazide. Unlike penicillins, cephalosprins are more resistant to the action of beta lactamase. Cephalexin inhibits bacterial cell wall synthesis, leading breakdown and eventualy cell death.

    CEPHALOTHIN & ITS CONGENERS INHIBIT BACTERIAL CELL-WALL SYNTHESIS IN MANNER SIMILAR TO THAT OF PENICILLIN. /CEPHALOSPORINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1160

    The penicillins and their metabolites are potent immunogens because of their ability to combine with proteins and act as haptens for acute antibody-mediated reactions. The most frequent (about 95 percent) or "major" determinant of penicillin allergy is the penicilloyl determinant produced by opening the beta-lactam ring of the penicillin. This allows linkage of the penicillin to protein at the amide group. "Minor" determinants (less frequent) are the other metabolites formed, including native penicillin and penicilloic acids. /Penicillins/

    Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 953

    Bactericidal; action depends on ability to reach and bind penicillin-binding proteins located in bacterial cytoplasmic membranes; cephalosporins inhibit bacterial septum and cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited, and lysis and elongation of susceptible bacteria frequently occur. Rapidly dividing bacteria are those most susceptible to the action of cephalosporins. /Cephalosporins/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 679

    CEPHALOSPORIN C IS VERY RESISTANT TO ACTION OF PENICILLINASE, FOR WHICH IT IS BOTH COMPETITIVE & NONCOMPETITIVE INHIBITOR, DEPENDING ON SUBSTRATE TESTED... /CEPHALOSPORINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1160

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - EQ 250MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50405

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    DOSAGE - CAPSULE;ORAL - EQ 333MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50405

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    DOSAGE - CAPSULE;ORAL - EQ 500MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50405

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    DOSAGE - CAPSULE;ORAL - EQ 750MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50405

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    Looking for 15686-71-2 / Cephalexin API manufacturers, exporters & distributors?

    Cephalexin manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Cephalexin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cephalexin manufacturer or Cephalexin supplier for your needs.

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    PharmaCompass also assists you with knowing the Cephalexin API Price utilized in the formulation of products. Cephalexin API Price is not always fixed or binding as the Cephalexin Price is obtained through a variety of data sources. The Cephalexin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Cephalexin

    Synonyms

    Cefalexin, 15686-71-2, Cephacillin, Keflex, Ceporexin, Cepexin

    Cas Number

    15686-71-2

    Unique Ingredient Identifier (UNII)

    5SFF1W6677

    About Cephalexin

    A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.

    Pectril Manufacturers

    A Pectril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pectril, including repackagers and relabelers. The FDA regulates Pectril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pectril API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

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    Pectril Suppliers

    A Pectril supplier is an individual or a company that provides Pectril active pharmaceutical ingredient (API) or Pectril finished formulations upon request. The Pectril suppliers may include Pectril API manufacturers, exporters, distributors and traders.

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    Pectril USDMF

    A Pectril DMF (Drug Master File) is a document detailing the whole manufacturing process of Pectril active pharmaceutical ingredient (API) in detail. Different forms of Pectril DMFs exist exist since differing nations have different regulations, such as Pectril USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Pectril DMF submitted to regulatory agencies in the US is known as a USDMF. Pectril USDMF includes data on Pectril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pectril USDMF is kept confidential to protect the manufacturer’s intellectual property.

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    Pectril JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Pectril Drug Master File in Japan (Pectril JDMF) empowers Pectril API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Pectril JDMF during the approval evaluation for pharmaceutical products. At the time of Pectril JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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    Pectril WC

    A Pectril written confirmation (Pectril WC) is an official document issued by a regulatory agency to a Pectril manufacturer, verifying that the manufacturing facility of a Pectril active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pectril APIs or Pectril finished pharmaceutical products to another nation, regulatory agencies frequently require a Pectril WC (written confirmation) as part of the regulatory process.

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    Pectril NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pectril as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Pectril API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Pectril as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Pectril and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pectril NDC to their finished compounded human drug products, they may choose to do so.

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    Pectril GMP

    Pectril Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Pectril GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pectril GMP manufacturer or Pectril GMP API supplier for your needs.

    Pectril CoA

    A Pectril CoA (Certificate of Analysis) is a formal document that attests to Pectril's compliance with Pectril specifications and serves as a tool for batch-level quality control.

    Pectril CoA mostly includes findings from lab analyses of a specific batch. For each Pectril CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Pectril may be tested according to a variety of international standards, such as European Pharmacopoeia (Pectril EP), Pectril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pectril USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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