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| Product NDC Code | 59651-783 | ||||
|---|---|---|---|---|---|
| Drug Name | Cephalexin |
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| Type | Generic | ||||
| Pharm Class | Cephalosporin Antibacterial [EPC], Cephalosporins [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED | ||||
| RxCUI drug identifier | 197454, 309115 |
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| Application Number | ANDA218817 | ||||
| Labeler Name | Aurobindo Pharma Limited | ||||
| Packages |
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Overdosage of Cephalexin
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported. Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported. In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs: Other Adverse Reactions : Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy. Altered Laboratory Tests : Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.
Cephalexin Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Metformin: Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin (see CLINICAL PHARMACOLOGY ). Probenecid: The renal excretion of cephalexin is inhibited by probenecid. Coadministration of probenecid with cephalexin is not recommended. Drug/laboratory Test Interactions: A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solutions.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Human Pharmacology Cephalexin tablets are acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL). Cephalexin is approximately 10% to 15% bound to plasma proteins. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 1000, 2200, and 5000 mcg/mL, respectively. In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean C max and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug. Microbiology Cephalexin is a bactericidal agent that acts by the inhibition of cell-wall synthesis. Resistance Methicillin-resistant staphylococci and most isolates of enterococci are resistant to cephalexin. Cephalexin is not active against most isolates of Enterobacter spp. , Morganella morganii , and Proteus vulqaris . Cephalexin has no activity against Pseudomonas spp. , or Acinetobacter calcoaceticus . Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs. Antimicrobial Activity Cephalexin is active against most isolates of the following bacteria both in vitro and in clinical infections (see INDICATIONS AND USAGE ): Gram-positive bacteria Staphylococci aureus (methicillin-susceptible isolates only) Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus pyogenes Gram-negative bacteria Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Moraxella catarrhalis Proteus mirabilis Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Cephalexin tablets are contraindicated in patients with known allergy to cephalexin or other members of the cephalosporin class of antibacterial drugs.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Cephalexin tablets, USP contain the active ingredient cephalexin, which 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 monohydrate, USP has the molecular formula C 16 H 17 N 3 O 4 S•H 2 O and the molecular weight is 365.40. Cephalexin monohydrate, USP has the following structural formula: 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 as a monohydrate. It is a white to almost white powder with granules. Slightly soluble in water, practically insoluble in alcohol, chloroform and in ether. It dissolves in dilute solutions of acids and alkali hydroxides. 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 film-coated tablet contains cephalexin monohydrate USP equivalent to 250 mg or 500 mg of cephalexin. The tablet also contains colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. FDA approved dissolution test specifications differ from USP. str
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Cephalexin tablets are administered orally. Adults and Pediatric Patients at Least 15 Years of Age The usual dose is 250 mg every 6 hours but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days. For more severe infections larger doses of oral cephalexin may be needed, up to 4 grams in two to four equally divided doses. Pediatric Patients (over 1 year of age) The recommended total daily dose of oral cephalexin for pediatric patients is 25 to 50 mg/kg in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses. In the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg/day in equally divided doses. Dosage adjustments in Adults and Pediatric Patients at Least 15 years of Age with Renal Impairment Administer the following dosing regimens for cephalexin tablets to patients with renal impairment (see PRECAUTIONS ). Table 1. Recommended Dose Regimen for Patients with Renal Impairment Renal function Dose regimen recommendation Creatinine clearance ˃60 mL/min No dose adjustment Creatinine clearance 30 to 59 mL/min No dose adjustment; maximum daily dose should not exceed 1 g Creatinine clearance 15 to 29 mL/min 250 mg, every 8 hours or every 12 hours Creatinine clearance 5 to 14 mL/min not yet on dialysis* 250 mg, every 24 hours Creatinine clearance 1 to 4 mL/min not yet on dialysis* 250 mg, every 48 hours or every 60 hours *There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.
| Creatinine clearance ˃60 mL/min | No dose adjustment |
| Creatinine clearance 30 to 59 mL/min | No dose adjustment; maximum daily dose should not exceed 1 g |
| Creatinine clearance 15 to 29 mL/min | 250 mg, every 8 hours or every 12 hours |
| Creatinine clearance 5 to 14 mL/min not yet on dialysis* | 250 mg, every 24 hours |
| Creatinine clearance 1 to 4 mL/min not yet on dialysis* | 250 mg, every 48 hours or every 60 hours |
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Cephalexin tablets are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes Otitis media due to susceptible isolates of Streptococcu pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella Catarrhalis. Skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus , and Streptococcus pyogenes . Bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus Mirabilis. Genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniare. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin tablets and other antibacterial drugs, cephalexin tablets 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.
Spl product data elements
Usually a list of ingredients in a drug product.Cephalexin Cephalexin CEPHALEXIN CEPHALEXIN ANHYDROUS SILICON DIOXIDE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE white to off-white biconvex C250 Cephalexin Cephalexin CEPHALEXIN CEPHALEXIN ANHYDROUS SILICON DIOXIDE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE white to off-white biconvex C500
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg - (100 Tablets Bottle) NDC 59651-783-01 Rx only Cephalexin Tablets, USP 250 mg AUROBINDO 100 Tablets fig1
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg - (100 Tablets Bottle) NDC 59651-784-01 Rx only Cephalexin Tablets, USP 500 mg AUROBINDO 100 Tablets fig2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin tablets and other antibacterial drugs, cephalexin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cephalexin: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin, other beta-lactams (including cephalosporins) or other allergens (see WARNINGS ) . Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be counseled that antibacterial drugs including cephalexin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin or other antibacterial drugs in the future.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers Cephalexin is excreted in human milk. Caution should be exercised when cephalexin tablets are administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use The safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section (see DOSAGE AND ADMINISTRATION ).
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Cephalexin tablets, USP are supplied as follows: 250 mg: White to off-white capsule shaped biconvex film coated tablets debossed with “C 250” on one side and score line on the other side. Bottles of 100 NDC 59651-783-01 500 mg: White to off-white capsule shaped biconvex film coated tablets debossed with “C 500” on one side and score line on the other side. Bottles of 100 NDC 59651-784-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Issued: July 2023
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Prescribing cephalexin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Prescribing cephalexin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. Information for Patients Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin, other beta-lactams (including cephalosporins) or other allergens (see WARNINGS ) . Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be counseled that antibacterial drugs including cephalexin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin or other antibacterial drugs in the future. Drug Interactions Metformin: Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin (see CLINICAL PHARMACOLOGY ). Probenecid: The renal excretion of cephalexin is inhibited by probenecid. Coadministration of probenecid with cephalexin is not recommended. Drug/laboratory Test Interactions: A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solutions. Pregnancy Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Cephalexin is excreted in human milk. Caution should be exercised when cephalexin tablets are administered to a nursing woman. Pediatric Use The safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section (see DOSAGE AND ADMINISTRATION ). Geriatric Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Renal Impairment Cephalexin should be administered with caution in the presence of impaired renal function (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended (see DOSAGE AND ADMINISTRATION ).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Hypersensitivity Reactions Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin. Before therapy with cephalexin is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cephalexin occurs, discontinue the drug and institute appropriate treatment. Clostridium difficile-Associated Diarrhea 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. Direct Coomb’s Test Seroconversion Positive direct Coombs tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy. Seizure Potential Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cephalexin. Anticonvulsant therapy can be given if clinically indicated. Prolonged Prothrombin Time Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.
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