Cephalexin

Cephalexin

Cephalexin Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.

Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to cephalexin.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)

Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes.

Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis.

Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

 

History

There is currently no drug history available for this drug.

Other Information

Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S • H2O and the molecular weight is 365.41.

Cephalexin has the following structural formula:

MM1

The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.

The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.

The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.

 

Cephalexin Manufacturers


  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Virtus Pharmaceuticals
    Cephalexin Capsule [Virtus Pharmaceuticals]
  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Cephalexin Capsule [Proficient Rx Lp]
  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Direct Rx
    Cephalexin Capsule [Direct Rx]
  • Northwind Pharmaceuticals, Llc
    Cephalexin Capsule [Northwind Pharmaceuticals, Llc]
  • State Of Florida Doh Central Pharmacy
    Cephalexin Capsule [State Of Florida Doh Central Pharmacy]
  • Ranbaxy Pharmaceuticals Inc.
    Cephalexin (Cephalexin) Capsule Cephalexin (Cephalexin) Suspension [Ranbaxy Pharmaceuticals Inc.]
  • Rebel Distributors Corp.
    Cephalexin Capsule [Rebel Distributors Corp.]
  • Stat Rx Usa Llc
    Cephalexin Capsule [Stat Rx Usa Llc]
  • Altura Pharmaceuticals, Inc.
    Cephalexin Capsule [Altura Pharmaceuticals, Inc.]
  • Sun Pharmaceutical Industries Limited
    Cephalexin Capsule [Sun Pharmaceutical Industries Limited ]
  • Gen-source Rx
    Cephalexin Capsule [Gen-source Rx]
  • State Of Florida Doh Central Pharmacy
    Cephalexin Capsule [State Of Florida Doh Central Pharmacy]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Rebel Distributors Corp
    Cephalexin Powder, For Suspension [Rebel Distributors Corp]
  • Strategic Pharmaceutical Solutions, Inc. Dba Vetsource
    Cephalexin Capsule [Strategic Pharmaceutical Solutions, Inc. Dba Vetsource]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Stat Rx Usa Llc
    Cephalexin Powder, For Suspension [Stat Rx Usa Llc]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • American Antibiotics, Inc
    Cephalexin Capsule [American Antibiotics, Inc]
  • Belcher Pharmaceuticals, Llc
    Cephalexin Capsule [Belcher Pharmaceuticals, Llc]
  • Redpharm Drug Inc.
    Cephalexin Capsule [Redpharm Drug Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Cephalexin Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • H.j. Harkins Company, Inc.
    Cephalexin (Cephalexin ) For Suspension [H.j. Harkins Company, Inc.]
  • H.j. Harkins Company, Inc.
    Cephalexin Capsule [H.j. Harkins Company, Inc.]
  • H.j. Harkins Company, Inc.
    Cephalexin Capsule [H.j. Harkins Company, Inc.]
  • Gen-source Rx
    Cephalexin Capsule [Gen-source Rx]
  • Virtus Pharmaceuticals, Llc
    Cephalexin Capsule [Virtus Pharmaceuticals, Llc]
  • Golden State Medical Supply, Inc.
    Cephalexin Capsule [Golden State Medical Supply, Inc.]
  • Stat Rx Usa Llc
    Cephalexin Capsule [Stat Rx Usa Llc]
  • West-ward Pharmaceutical Corp
    Cephalexin Capsule [West-ward Pharmaceutical Corp]
  • Golden State Medical Supply, Inc.
    Cephalexin Capsule [Golden State Medical Supply, Inc.]
  • Rebel Distributors Corp
    Cephalexin Capsule [Rebel Distributors Corp]
  • Karalex Pharma Llc
    Cephalexin Capsule [Karalex Pharma Llc]
  • Physicians Total Care, Inc.
    Cephalexin Capsule [Physicians Total Care, Inc.]
  • Orchidpharma Inc
    Cephalexin Powder, For Suspension [Orchidpharma Inc]
  • Aidarex Pharmaceuticals Llc
    Cephalexin Capsule [Aidarex Pharmaceuticals Llc]
  • Lupin Pharmaceuticals, Inc.
    Cephalexin Capsule [Lupin Pharmaceuticals, Inc.]
  • Dispensing Solutions, Inc.
    Cephalexin Capsule [Dispensing Solutions, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Rebel Distributors Corp
    Cephalexin Powder, For Suspension [Rebel Distributors Corp]
  • Rebel Distributors Corp
    Cephalexin Capsule [Rebel Distributors Corp]
  • Unit Dose Services
    Cephalexin Capsule [Unit Dose Services]
  • Unit Dose Services
    Cephalexin Capsule [Unit Dose Services]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Cephalexin Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Cephalexin Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • A-s Medication Solutions Llc
    Cephalexin Powder, For Suspension [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Powder, For Suspension [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Cephalexin Capsule [A-s Medication Solutions Llc]
  • Medvantx, Inc.
    Cephalexin Capsule [Medvantx, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Cephalexin Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Medvantx, Inc.
    Cephalexin Capsule [Medvantx, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Cephalexin Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Medvantx, Inc.
    Cephalexin Capsule [Medvantx, Inc.]
  • Medvantx, Inc.
    Cephalexin Capsule [Medvantx, Inc.]
  • Liberty Pharmaceuticals, Inc.
    Cephalexin Capsule [Liberty Pharmaceuticals, Inc.]
  • Aurobindo Pharma Limited
    Cephalexin Capsule [Aurobindo Pharma Limited]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin (Cephalexin) Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Liberty Pharmaceuticals, Inc.
    Cephalexin Capsule [Liberty Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Cephalexin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]
  • Medvantx, Inc.
    Cephalexin Powder, For Suspension [Medvantx, Inc.]
  • Ascend Laboratories, Llc
    Cephalexin Capsule [Ascend Laboratories, Llc]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • State Of Florida Doh Central Pharmacy
    Cephalexin Capsule [State Of Florida Doh Central Pharmacy]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Readymeds
    Cephalexin Capsule [Readymeds]
  • Carlsbad Technology, Inc.
    Cephalexin Capsule [Carlsbad Technology, Inc.]
  • Proficient Rx Lp
    Cephalexin Capsule [Proficient Rx Lp]
  • Northwind Pharmaceuticals
    Cephalexin Capsule [Northwind Pharmaceuticals]
  • Avkare, Inc.
    Cephalexin Capsule [Avkare, Inc.]
  • Orchidpharma Inc
    Cephalexin Powder, For Suspension [Orchidpharma Inc]
  • Tya Pharmaceuticals
    Cephalexin Capsule [Tya Pharmaceuticals]
  • Tya Pharmaceuticals
    Cephalexin Capsule [Tya Pharmaceuticals]
  • Avpak
    Cephalexin Capsule [Avpak]
  • Northwind Pharmaceuticals
    Cephalexin Capsule [Northwind Pharmaceuticals]
  • Preferred Pharmaceuticals, Inc.
    Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Cephalexin Capsule [Preferred Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Cephalexin Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Medsource Pharmaceuticals
    Cephalexin Capsule [Medsource Pharmaceuticals]
  • Blenheim Pharmacal, Inc.
    Cephalexin Capsule [Blenheim Pharmacal, Inc.]
  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Cephalexin Capsule [Remedyrepack Inc. ]
  • Directrx
    Cephalexin Capsule [Directrx]

Login To Your Free Account