CEFALIN Cefalexin 250mg Capsule 50's
RXDRUG-DR-X5549
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
For the treatment of the following infections caused by susceptible microorganisms: Skin and skin structure infections; Bone and joint infections; Genitourinary tract infections, including acute prostatitis; Respiratory tract infections including acute and chronic bronchitis and infected bronchiectasis; Ear, nose and throat infections including otitis media, mastoiditis, sinusitis, follicular tonsillitis, and pharyngitis; Dental infections.
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cefalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin in the subsequent prevention of rheumatic fever are not available at present.
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cefalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin in the subsequent prevention of rheumatic fever are not available at present.
Dosage/Direction for Use
Cefalexin is administered orally.
Usual Adult Dose: 250 mg every 6 hours (Maximum Dose: 4 g/day).
For streptococcal pharyngitis, skin and skin structure infections and uncomplicated cystitis (in patients > 15 years old): 500 mg every 12 hours.
Larger doses (up to 4 g daily) may be needed for more severe infections or those caused by less susceptible organisms. If daily doses of cefalexin greater than 4 g are required, initial therapy with parenteral cephalosporins, in appropriate doses, should be considered.
Elderly: Follow the usual adult dose. However, dosage should be reduced in case of renal impairment.
Patients with Renal Impairment: The initial dose is the same as in patients with normal renal function.
Usual Adult Dose: 250 mg every 6 hours (Maximum Dose: 4 g/day).
For streptococcal pharyngitis, skin and skin structure infections and uncomplicated cystitis (in patients > 15 years old): 500 mg every 12 hours.
Larger doses (up to 4 g daily) may be needed for more severe infections or those caused by less susceptible organisms. If daily doses of cefalexin greater than 4 g are required, initial therapy with parenteral cephalosporins, in appropriate doses, should be considered.
Elderly: Follow the usual adult dose. However, dosage should be reduced in case of renal impairment.
Patients with Renal Impairment: The initial dose is the same as in patients with normal renal function.
Adult patients receiving intermittent dialysis should be given an additional 500 mg of cefalexin after each dialysis, i.e. a total dosage of up to 1 g on that day.
Usual Duration of Treatment: For mild to moderate infections: 5 to 7 days; For cystitis: 7 to 14 days; For β-hemolytic streptococcal infections: At least 10 days
Or, as prescribed by a physician.
Usual Duration of Treatment: For mild to moderate infections: 5 to 7 days; For cystitis: 7 to 14 days; For β-hemolytic streptococcal infections: At least 10 days
Or, as prescribed by a physician.
Overdosage
Symptoms of overdose may include nausea, vomiting, epigastric distress and hematuria.
Unless 5 to 10 times the normal dose of cefalexin has been ingested, gastrointestinal decontamination should not be necessary.
It is important to protect the patient's airway and support ventilation and perfusion during overdose. Meticulously, monitor and maintain within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cefalexin; however, it would be extremely unlikely that one of these procedures would be indicated.
There have been reports of hematuria, without renal impairment, in children accidentally ingesting more than 3.5 g of cefalexin in a day. Treatment has been supportive fluids and no sequelae have been reported.
Unless 5 to 10 times the normal dose of cefalexin has been ingested, gastrointestinal decontamination should not be necessary.
It is important to protect the patient's airway and support ventilation and perfusion during overdose. Meticulously, monitor and maintain within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cefalexin; however, it would be extremely unlikely that one of these procedures would be indicated.
There have been reports of hematuria, without renal impairment, in children accidentally ingesting more than 3.5 g of cefalexin in a day. Treatment has been supportive fluids and no sequelae have been reported.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
History of allergy to any ingredient in this product or other cephalosporins.
History of hypersensitivity to penicillins.
History of hypersensitivity to penicillins.
Special Precautions
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Cephalosporin therapy.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be instituted.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with nearly all antibacterial agents, including cefalexin, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea after administration of antibacterial agents.
If superinfection occurs during therapy, appropriate measures should be taken.
A false-positive Coombs' test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs' test may be due to the drug, e.g., Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition or in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed.
Use in patients with renal impairment: In patients with impaired renal function, decreases in doses and/or frequency of administration of Cefalexin may be required and should be based on the degree of renal impairment, severity of infection, susceptibility of the causative organism, and serum concentrations of Cefalexin.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be instituted.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with nearly all antibacterial agents, including cefalexin, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea after administration of antibacterial agents.
If superinfection occurs during therapy, appropriate measures should be taken.
A false-positive Coombs' test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs' test may be due to the drug, e.g., Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition or in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed.
Use in patients with renal impairment: In patients with impaired renal function, decreases in doses and/or frequency of administration of Cefalexin may be required and should be based on the degree of renal impairment, severity of infection, susceptibility of the causative organism, and serum concentrations of Cefalexin.
Use In Pregnancy & Lactation
Pregnancy: (Pregnancy Category B) Although there have been no reports of adverse effects to the fetus to date, safe use of cephalosporins during pregnancy has not been definitely established. The importance of the antibiotic therapy to the mother should outweigh the potential risks to the fetus.
Use in Labor and Delivery: No data available.
Lactation:Excretion of Cefalexin in milk increased up to 4 hours after a 500 mg dose; the drug reached a maximum level of 4 μg/mL, then decreased gradually, and disappeared 8 hours after administration. Caution should be exercised when the drug is given to a breastfeeding woman.
Use in Labor and Delivery: No data available.
Lactation:Excretion of Cefalexin in milk increased up to 4 hours after a 500 mg dose; the drug reached a maximum level of 4 μg/mL, then decreased gradually, and disappeared 8 hours after administration. Caution should be exercised when the drug is given to a breastfeeding woman.
Adverse Reactions
GI: Abdominal cramp/pain, anorexia, (e.g., oral thrush), CDAD and colitis, diarrhea, dyspepsia, gastritis, gastroenteritis, glossitis/stomatitis, nausea, vomiting.
Dermatologic/Hypersensitivity Reactions: Anaphylaxis, angioedema, eosinophilia, erythema multiforme, fever, genital and anal pruritus, intertrigo, pruritus, rash (maculopapular erythematous, or morbilliform), serum sickness-like reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Hematologic: Decreased hemoglobin and/or hematocrit, hemolytic anemia, reversible leukopenia; neutropenia, decreased platelets; positive direct and indirect antiglobulin (Coombs’) test results; thrombocytopenia.
Renal and Genitourinary: Transient increases in blood urea nitrogen (BUN) and serum creatinine concentrations; dysuria, reversible interstitial nephritis; nephrotoxicity, leukorrhea, pruritus vulvae, vaginal discharge, vulvo-vaginitis.
Hepatic: Transient increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase concentrations; increased serum bilirubin; transient hepatitis and cholestatic jaundice.
Nervous System: Agitation, confusion, diplopia, dizziness, fatigue, headache, hallucinations, insomnia, malaise, paresthesia, somnolence, tremor, toxic paranoid reactions (rarely in patients with renal impairment).
Vertigo, tinnitus, hearing loss and behavioral changes in young children have been reported with cefalexin use.
Other Adverse Effects (AEs): Arthralgia, myalgia, arthritis, joint disorder, back pain, nuchal swelling, cardiac arrhythmia, vasodilatation, dyspnea, superinfection, elevated cholesterol.
Dermatologic/Hypersensitivity Reactions: Anaphylaxis, angioedema, eosinophilia, erythema multiforme, fever, genital and anal pruritus, intertrigo, pruritus, rash (maculopapular erythematous, or morbilliform), serum sickness-like reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Hematologic: Decreased hemoglobin and/or hematocrit, hemolytic anemia, reversible leukopenia; neutropenia, decreased platelets; positive direct and indirect antiglobulin (Coombs’) test results; thrombocytopenia.
Renal and Genitourinary: Transient increases in blood urea nitrogen (BUN) and serum creatinine concentrations; dysuria, reversible interstitial nephritis; nephrotoxicity, leukorrhea, pruritus vulvae, vaginal discharge, vulvo-vaginitis.
Hepatic: Transient increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase concentrations; increased serum bilirubin; transient hepatitis and cholestatic jaundice.
Nervous System: Agitation, confusion, diplopia, dizziness, fatigue, headache, hallucinations, insomnia, malaise, paresthesia, somnolence, tremor, toxic paranoid reactions (rarely in patients with renal impairment).
Vertigo, tinnitus, hearing loss and behavioral changes in young children have been reported with cefalexin use.
Other Adverse Effects (AEs): Arthralgia, myalgia, arthritis, joint disorder, back pain, nuchal swelling, cardiac arrhythmia, vasodilatation, dyspnea, superinfection, elevated cholesterol.
Drug Interactions
No potentially hazardous interactions have been reported. However, it may share the interaction potential of other cephalosporins as with the following:
Alcohol: Disulfiram-like reactions have occurred when alcohol was ingested within 48 to 72 hours after administration of β-lactam antibiotics that contain a N-methylthiotetrazole side chain. The reactions appear to result from accumulation of acetaldehyde and do not occur if alcohol is ingested prior to the first dose of antibiotic. Ingestion of alcohol during and for 24 to 72 hours after administration of some cephalosporins should be avoided.
Probenecid: Concomitant administration of oral Probenecid competitively inhibits tubular secretion resulting in higher and more prolonged serum concentrations of most cephalosporins.
Nephrotoxic Drugs: Concurrent use of nephrotoxic agents such as aminoglycosides, colistin, polymyxin B, or vancomycin may increase the risk of nephrotoxicity with some cephalosporins and probably should be avoided, if possible.
Other Anti-infective Agents: In vitro studies indicate that the antibacterial activity of cephalosporins against some organisms may be additive or synergistic with aminoglycosides and penicillins. Although some in vitro studies showed additive or synergistic antibacterial activity between Chloramphenicol and a cephalosporin, there is more recent in vitro evidence of antagonism between cephalosporins and Chloramphenicol against a variety of gram-negative and gram-positive bacteria, particularly when Chloramphenicol was added to the medium before β-lactam. In addition, at least one case of in vivo antagonism has been reported in an infant with Salmonella meningitis. Therefore, it is recommended that combined therapy with Chloramphenicol and a cephalosporin be avoided, particularly when bactericidal activity is considered important.
Estrogens or Progestins: Some cephalosporins (e.g., ceftazidime) may affect gut flora, leading to lower estrogen reabsorption and reduced efficacy of oral contraceptives.
Metformin: When single 500 mg doses of cefalexin and metformin were given to 12 healthy subjects, plasma metformin Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin's renal clearance decreased by an average of 14%. Information on the interaction of cefalexin and metformin after multiple dose administration is unavailable. Careful patient monitoring and metformin dose adjustment is recommended during concomitant therapy.
Diuretics: Concurrent treatment with high doses of cephalosporins and potent diuretics (e.g., furosemide) may adversely affect renal function.
Alcohol: Disulfiram-like reactions have occurred when alcohol was ingested within 48 to 72 hours after administration of β-lactam antibiotics that contain a N-methylthiotetrazole side chain. The reactions appear to result from accumulation of acetaldehyde and do not occur if alcohol is ingested prior to the first dose of antibiotic. Ingestion of alcohol during and for 24 to 72 hours after administration of some cephalosporins should be avoided.
Probenecid: Concomitant administration of oral Probenecid competitively inhibits tubular secretion resulting in higher and more prolonged serum concentrations of most cephalosporins.
Nephrotoxic Drugs: Concurrent use of nephrotoxic agents such as aminoglycosides, colistin, polymyxin B, or vancomycin may increase the risk of nephrotoxicity with some cephalosporins and probably should be avoided, if possible.
Other Anti-infective Agents: In vitro studies indicate that the antibacterial activity of cephalosporins against some organisms may be additive or synergistic with aminoglycosides and penicillins. Although some in vitro studies showed additive or synergistic antibacterial activity between Chloramphenicol and a cephalosporin, there is more recent in vitro evidence of antagonism between cephalosporins and Chloramphenicol against a variety of gram-negative and gram-positive bacteria, particularly when Chloramphenicol was added to the medium before β-lactam. In addition, at least one case of in vivo antagonism has been reported in an infant with Salmonella meningitis. Therefore, it is recommended that combined therapy with Chloramphenicol and a cephalosporin be avoided, particularly when bactericidal activity is considered important.
Estrogens or Progestins: Some cephalosporins (e.g., ceftazidime) may affect gut flora, leading to lower estrogen reabsorption and reduced efficacy of oral contraceptives.
Metformin: When single 500 mg doses of cefalexin and metformin were given to 12 healthy subjects, plasma metformin Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin's renal clearance decreased by an average of 14%. Information on the interaction of cefalexin and metformin after multiple dose administration is unavailable. Careful patient monitoring and metformin dose adjustment is recommended during concomitant therapy.
Diuretics: Concurrent treatment with high doses of cephalosporins and potent diuretics (e.g., furosemide) may adversely affect renal function.
Storage
Store in a dry place at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Pharmacodynamics: Cefalexin exerts its bactericidal activity by interfering with the synthesis of the bacterial cell wall. It binds to specific penicillin-binding proteins responsible for the synthesis of peptidoglycan, a heteropolymeric structure that gives the cell wall its mechanical stability. The final stage of peptidoglycan synthesis involves completion of the cross-linking of the terminal glycine residue of the pentaglycine bridge to the fourth residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by cephalosporins. As a result, the bacterial cell wall is weakened, the cell swells and then ruptures.
Cefalexin is inactive against methicillin-resistant staphylococci and most strains of enterococci (e.g., Enterococcus faecalis), Enterobacter spp., Morganella morganii, and Proteus vulgaris. It has no activity against Pseudomonas spp. or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics.
It is suggested to carry out susceptibility tests.
Pharmacokinetics: Absorption: The mean peak serum concentrations after a single, oral 250- and 500-mg dose are 9 μg/mL and 18 μg/ml respectively, and are attained within 1 hour in healthy, fasting adults with normal renal functions. Serum concentrations are still detectable after 6 hours.
When Cefalexin is administered with food, peak serum concentrations are slightly lower and are attained later, although the total amount of drug absorbed remains unchanged.
Elimination: The serum half-life of Cefalexin is 0.5 to 1.2 hours in adults with normal renal function.
Cefalexin is excreted in the urine as unchanged drug via both glomerular filtration and tubular secretion. Approximately 70 to 90% of a single 250- or 500-mg oral dose is excreted within 8 to 12 hours in adults with normal renal function. Cefalexin concentrations of 0.2 mg/mL (range: 0.054 to 0.67) or 0.11 to 4 mg/mL have been reported in urine collected over a 6-hour period following a single 250- or 500-mg dose, respectively, in adults with normal renal function. Peak urine concentrations average about 2 mg/mL and occur 2 hours after a single 500 mg oral dose of Cefalexin.
It is suggested to carry out susceptibility tests.
Pharmacokinetics: Absorption: The mean peak serum concentrations after a single, oral 250- and 500-mg dose are 9 μg/mL and 18 μg/ml respectively, and are attained within 1 hour in healthy, fasting adults with normal renal functions. Serum concentrations are still detectable after 6 hours.
When Cefalexin is administered with food, peak serum concentrations are slightly lower and are attained later, although the total amount of drug absorbed remains unchanged.
Elimination: The serum half-life of Cefalexin is 0.5 to 1.2 hours in adults with normal renal function.
Cefalexin is excreted in the urine as unchanged drug via both glomerular filtration and tubular secretion. Approximately 70 to 90% of a single 250- or 500-mg oral dose is excreted within 8 to 12 hours in adults with normal renal function. Cefalexin concentrations of 0.2 mg/mL (range: 0.054 to 0.67) or 0.11 to 4 mg/mL have been reported in urine collected over a 6-hour period following a single 250- or 500-mg dose, respectively, in adults with normal renal function. Peak urine concentrations average about 2 mg/mL and occur 2 hours after a single 500 mg oral dose of Cefalexin.
MedsGo Class
Cephalosporins
Features
Brand
Cefalin
Full Details
Dosage Strength
250mg
Drug Ingredients
- Cefalexin
Drug Packaging
Capsule 50's
Generic Name
Cefalexin
Dosage Form
Capsule
Registration Number
DR-X5549
Drug Classification
Prescription Drug (RX)
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