Cephalexin for Oral Suspension USP, R_x Only, Rev. 09/09

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 C₁₆H₁₇N₃O₄S•H₂O 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 D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.

After mixing, each 5 mL of Cephalexin for Oral Suspension, USP, will contain cephalexin monohydrate equivalent to 125 mg (360 µcmol) or 250 mg (720 µcmol) of cephalexin. The suspensions also contain citric acid, guarana flavour, sodium saccharin, sucrose, xanthan gum. The 125-mg suspension contains FD&C Red No.40, and the 250-mg suspension contains FD&C Yellow No. 6.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Cephalexin for Oral Suspension USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

    Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin for Oral Suspension USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin for Oral Suspension USP in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis 

    Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes 

    Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis

    Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae 

Note— 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 for Oral Suspension USP and other antibacterial drugs, Cephalexin for Oral Suspension 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.

CONTRAINDICATIONS

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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Cephalexin for Oral Suspension USP is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

WARNINGS

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displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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 Cephalexin for Oral Suspension USP.
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.

DOSAGE AND ADMINISTRATION

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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

    Cephalexin for Oral Suspension USP is administered orally.
    Adults—The adult dosage ranges from 1 to 4 g daily in divided doses.

The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin for Oral Suspension greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients—The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

                              Cephalexin for Oral Suspension
                Weight                                                125 mg/5 mL
            10 kg (22 lb)                                           1/2 to 1 tsp q.i.d.
            20 kg (44 lb)                                           1 to 2 tsp q.i.d.
            40 kg (88 lb)                                           2 to 4 tsp q.i.d.

                Weight                                                250 mg/5 mL
            10 kg (22 lb)                                           1/4 to 1/2 tsp q.i.d.
            20 kg (44 lb)                                           1/2 to 1 tsp q.i.d.
            40 kg (88 lb)                                           1 to 2 tsp q.i.d.
                  
                  or

                Weight                                               125 mg/5 mL
            10 kg (22 lb)                                          1 to 2 tsp b.i.d.
            20 kg (44 lb)                                          2 to 4 tsp b.i.d.
            40 kg (88 lb)                                          4 to 8 tsp b.i.d.

                Weight                                               250 mg/5 mL
            10 kg (22 lb)                                         1/2 to 1 tsp b.i.d.
            20 kg (44 lb)                                         1 to 2 tsp b.i.d.
            40 kg (88 lb)                                         2 to 4 tsp b.i.d.

    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 ß-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Cephalexin For Oral Suspension USP, is available in:
The 125 mg per 5 mL oral suspension is available as follows:
       100-mL Bottles            
       200-mL Bottles            
The 250 mg per 5 mL oral suspension is available as follows:
       100-mL Bottles            
       200-mL Bottles  After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed.  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].

REFERENCES

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displayName: REFERENCES SECTION
FDA Article Code: 34093-5

1.    National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Tests for Bacteria that Grow Aerobically — Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS,Wayne, PA, January, 1997.

2.    National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.

3.    National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing — Eighth Informational Supplement. Approved Standard NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, Wayne, PA, January, 1998. Distributed by:
West-ward Pharmaceutical Corp.
Eatontowown, NJ 07724 USA Manufactured by:
Jazeera Pharmaceutical Industries (JPI)
Al-Kharj Road
P.O Box 106229
Riyadh 11666
Saudi Arabia An Affiliate of:
Hikma Pharmaceuticals
P.O. Box 182400
Amman 11118
Jordan Revised: September 2009

PRINCIPAL DISPLAY PANEL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Cephalexin for Oral Suspension, USP
125 mg per 5 mL
NDC 0143-9769-01  

PRINCIPAL DISPLAY PANEL

id: 8a6704c4-cdb2-4a63-99c1-d7a711198649
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Cephalexin for Oral Suspension, USP
250 mg per 5 mL
NDC 0143-9770-01