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Keflex
Overview
What is Keflex?
Keflex Capsules (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 has the molecular formula CHNOS•HO and the molecular weight is 365.41.
Cephalexin 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 is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.
The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.
Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg or 750 mg of cephalexin. The capsules also contain cellulose, D & C Yellow No. 10, F D & C Blue No. 1, F D & C Yellow No. 6, gelatin, magnesium stearate, silicone, titanium dioxide, and other inactive ingredients.
What does Keflex look like?
What are the available doses of Keflex?
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What should I talk to my health care provider before I take Keflex?
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How should I use Keflex?
Keflex is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflex is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to ,
Skin and skin structure infections caused by and/or
Bone infections caused by and/or
Genitourinary tract infections, including acute prostatitis, caused by and
Note
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Keflex and other antibacterial drugs, Keflex 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.
Keflex is administered orally.
What interacts with Keflex?
Keflex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
What are the warnings of Keflex?
Central nervous system side effects including light headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to Keflex.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What are the precautions of Keflex?
General
Prescribing Keflex 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.
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to Keflex occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines, or corticosteroids).
Prolonged use of Keflex 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.
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug.
Keflex should be administered with caution in the presence of markedly impaired renal function. Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Information for Patients
Patients should be counseled that antibacterial drugs including Keflex should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Keflex 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 Keflex or other antibacterial drugs in the future.
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.
Drug Interactions
Metformin
Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems. Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin.
Probenecid
Drug / Laboratory Test Interactions
As a result of administration of Keflex, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions and also with Clinitest tablets.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon mg/m.
Pregnancy
Teratogenic effects — Pregnancy Category B
2
Nursing Mothers
The excretion of cephalexin in human 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 had disappeared 8 hours after administration. Caution should be exercised when Keflex is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of Keflex in pediatric patients was established in clinical trials for the dosages described in the section. In these trials, pediatric patients may have received Keflex capsules or Keflex for Oral Suspension. Keflex capsules should only be used in children and adolescents capable of ingesting the capsule.
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, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be 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, and it may be useful to monitor renal function ().
What are the side effects of Keflex?
Gastrointestinal
See
Hypersensitivity
Other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in AST and ALT have been reported.
In addition to the adverse reactions listed above that have been observed in patients treated with Keflex, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:
What should I look out for while using Keflex?
Keflex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to Keflex.
Clostridium difficile
associated diarrhea (CDAD)
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What might happen if I take too much Keflex?
How should I store and handle Keflex?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayKeflex Capsules (Cephalexin, USP), are available in:The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows:The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows:The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows:The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows:Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].Keflex Capsules (Cephalexin, USP), are available in:The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows:The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows:The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows:The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows:Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].Keflex Capsules (Cephalexin, USP), are available in:The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows:The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows:The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows:The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows:Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].Keflex Capsules (Cephalexin, USP), are available in:The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows:The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows:The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows:The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows:Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].Keflex Capsules (Cephalexin, USP), are available in:The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows:The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows:The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows:The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows:Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].Keflex Capsules (Cephalexin, USP), are available in:The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows:The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows:The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows:The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows:Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Keflex is 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 μg/mL respectively were obtained at 1 hour. Measurable levels were present 6 hours after administration. 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 μg/mL respectively.
Non-Clinical Toxicology
Keflex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to Keflex.
Clostridium difficile
associated diarrhea (CDAD)
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Prescribing Keflex 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.
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to Keflex occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines, or corticosteroids).
Prolonged use of Keflex 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.
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug.
Keflex should be administered with caution in the presence of markedly impaired renal function. Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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