Label: CEPHALEXIN capsule

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

Drug Label Information

Updated July 17, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP - CEPHALEXIN capsules ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Respiratory Tract Infections - Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of - Streptococcus pneumoniaeand ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Adults and Pediatric Patients at Least 15 Years of Age - The usual dose of oral cephalexin capsules USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered ...
  • 3. DOSAGE FORMS AND STRENGTHS
    500 mg Capsules - A white to yellowish-white granular powder filled into size "0" capsules (light green and dark green) that are imprinted with "500" on the dark green cap, and "LUPIN" on the light ...
  • 4 CONTRAINDICATIONS
    Cephalexin capsules are 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 ...
  • 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) ...
  • 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 ...
  • 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 capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid ...
  • 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 ...
  • 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
    Cephalexin capsules USP, are supplied as follows: 500 mg Capsules, Green, Capsule shape, Imprint: 500;LUPIN - PACKAGING: 10 in 1 BOTTLE PLASTIC   NDC 76420-831-10 (relabeled from NDC ...
  • 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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  • INGREDIENTS AND APPEARANCE
    Product Information