Keflex Information
Keflex (Cephalexin monohydrate)
Keflex (Cephalexin monohydrate) Description
Keflex (Cephalexin monohydrate) 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 CHN0S•H0 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 to cream colored 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, 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.
Keflex (Cephalexin monohydrate) Clinical Pharmacology
Aerobes. Gram-positive:
Aerobes. Gram-negative:
Keflex (Cephalexin monohydrate) Indications And Usage
Keflex (Cephalexin monohydrate) 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 (Cephalexin monohydrate) is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex (Cephalexin monohydrate) in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to and
Skin and skin structure infections caused by and/or
Bone infections caused by and/or
Genitourinary tract infections, including acute prostatitis, caused by and
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Keflex (Cephalexin monohydrate) and other antibacterial drugs, Keflex (Cephalexin monohydrate) 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 (Cephalexin monohydrate) Contraindications
Keflex (Cephalexin monohydrate) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Keflex (Cephalexin monohydrate) Warnings
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 (Cephalexin monohydrate) .
Keflex (Cephalexin monohydrate) Precautions
Prescribing Keflex (Cephalexin monohydrate) 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 (Cephalexin monohydrate) 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 (Cephalexin monohydrate) 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 (Cephalexin monohydrate) 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.
Keflex (Cephalexin monohydrate) Adverse Reactions
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 (Cephalexin monohydrate) , the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:
Keflex (Cephalexin monohydrate) Overdosage
Signs and Symptoms
Protect the patient's airway and support ventilation and perfusion. 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 cephalexin; however, it would be extremely unlikely that one of these procedures would be indicated. The oral median lethal dose of cephalexin in rats is >5000 mg/kg.
Keflex (Cephalexin monohydrate) Dosage And Administration
Keflex (Cephalexin monohydrate) is administered orally.
Adults
Pediatric Patients
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of Keflex (Cephalexin monohydrate) should be administered for at least 10 days.
Keflex (Cephalexin monohydrate) How Supplied
Keflex (Cephalexin monohydrate) Capsules (Cephalexin, USP), are available in: The 250 mg capsules are a white to light yellow powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex (Cephalexin monohydrate) 250 mg on the white body in edible black ink. They are available as follows:
The 500 mg capsules are a white to light yellow powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex (Cephalexin monohydrate) 500 mg on the light green body in edible black ink. They are available as follows:
The 750 mg capsules are a white to light yellow powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex (Cephalexin monohydrate) 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 (Cephalexin monohydrate) References
Rev 10/10
Manufactured by:Sandoz GmbHKundi, Austria
Manufactured for:Victory Pharma, Inc.San Diego, CA 92130
Item Code 46045974Copyright © 2010, Victory PharmaAll rights reserved
Keflex (Cephalexin monohydrate) Principal Display Panel – Mg Strength
NDC 68453-112-10
250 mg
Keflex (Cephalexin monohydrate)
Cephalexin, USP
250 mg Capsules
Victory Pharma
Rx only
Keflex (Cephalexin monohydrate) Principal Display Panel – Mg Strength
NDC 68453-113-10
500 mg
Keflex (Cephalexin monohydrate)
Cephalexin, USP
500 mg Capsules
Victory Pharma
Rx only
Keflex (Cephalexin monohydrate) Principal Display Panel – Mg Strength
NDC 68453-116-05
750 mg
Keflex (Cephalexin monohydrate)
Cephalexin, USP
750 mg Capsules
Victory Pharma
Rx only
