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Basic Drug Info
Drug Name:Cephalexin
Manufacturer:ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)
Other Info:Karalex Pharma, LLC470 Chestnut Ridge Road, Woodcliff Lake, NJ 07677Issued: 10/07948025639



Clinical Trials:


Indications and Usage

Cephalexin is indicated for the treatment of the following infections when caused by susceptibile strains of the designated microorganisms:Respiratory tract infections caused by S.

pneumoniae and S.

pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)Otitis media due to S.

pneumoniae, H.

influenzae, staphylococci, streptococci, and M.

catarrhalisSkin and skin structure infections caused by staphylococci and/or streptococciBone infections caused by staphylococci and/or P.

mirabilisGenitourinary tract infections, including acute prostatitis, caused by E.

coli, P.

mirabilis, and K.

pneumoniaeNote - Culture and susceptibility tests should be initiated prior to and during therapy.

Renal function studies should be performed when indicated.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Streptococcal Infections -- Infections with bacteria of the genus STREPTOCOCCUS.

Rheumatic Fever -- A febrile disease occurring as a delayed sequela of infections with group A hemolytic streptococci and characterized by multiple focal inflammatory lesions of the connective tissue structures, especially of the heart, blood vessels, and joints (polyarthritis), and by the presence of Aschoff bodies in the myocardium and skin. (Dorland, 27th ed)

Otitis Media -- Inflammation of the MIDDLE EAR including the AUDITORY OSSICLES and the EUSTACHIAN TUBE.

Unspecified Staphylococcus infection in conditions classified elsewhere and of unspecified site --

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Acute Prostatitis --

Contraindications
Cephalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Immediate hypersensitivity -- Hypersensitivity reactions which occur within minutes of exposure to challenging antigen due to the release of histamine which follows the antigen-antibody reaction and causes smooth muscle contraction and increased vascular permeability.

Warnings

BEFORE CEPHALEXIN THERAPY IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS AND PENICILLIN.

CEPHALOSPORIN C DERIVATIVES SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS.SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.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 cephalexin.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cephalexin, and may range from mild to life threatening.

Therefore, it is important to consider this diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.

In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.Usage in Pregnancy: Safety of this product for use during pregnancy has not been established.
Branded Drugs
The following US Branded drugs contain Cephalexin


KEFLEX -- LEX PHARMACEUTICALS INC

PANIXINE DISPERDOSE -- RANBAXY LABORATORIES LTD

KEFLET -- ELI LILLY AND CO


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