Label: CEPHALEXIN capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 20, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Respiratory Tract Infections - Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Adults and Pediatric Patients at Least 15 Years of Age - The usual dose of oral cephalexin is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Cephalexin Capsules USP - 250 mg: Swedish orange body and gray cap imprinted “TEVA” on the cap and “3145” on the body - 500 mg: Swedish orange body and Swedish orange cap imprinted “TEVA” on the cap ...
  • 4 CONTRAINDICATIONS
    Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions - Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been ...
  • 6 ADVERSE REACTIONS
    The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [see Warning and Precautions (5.1)] Clostridium ...
  • 7 DRUG INTERACTIONS
    7.1 Metformin - Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy -  Risk Summary - Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including Cephalexin use in ...
  • 10 OVERDOSAGE
    Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Cephalexin is a cephalosporin antibacterial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption: Cephalexin is acid stable and may be given without ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7224 - NDC: 50090-7224-0 100 CAPSULE in a BOTTLE
  • 17 PATIENT COUNSELING INFORMATION
    Allergic Reactions - Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any ...
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