Label: CEPHALEXIN capsule
- NDC Code(s): 50090-7224-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0093-3147
- 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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 Respiratory Tract Infections - Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus ...
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSCephalexin 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 ...
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4 CONTRAINDICATIONSCephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
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5 WARNINGS AND PRECAUTIONS5.1 Hypersensitivity Reactions - Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been ...
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6 ADVERSE REACTIONSThe following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [see Warning and Precautions (5.1)] Clostridium ...
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7 DRUG INTERACTIONS7.1 Metformin - Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including Cephalexin use in ...
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10 OVERDOSAGESymptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis ...
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11 DESCRIPTIONCephalexin, 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 ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGProduct: 50090-7224 - NDC: 50090-7224-0 100 CAPSULE in a BOTTLE
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17 PATIENT COUNSELING INFORMATIONAllergic 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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Cephalexin
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INGREDIENTS AND APPEARANCEProduct Information