CEPHALEXIN
-
cephalexin capsule
Physicians Total Care, Inc.
----------
Rx onlyCephalexin 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.
Each capsule contains cephalexin monohydrate equivalent to
250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain
the following inactive ingredients: microcrystalline cellulose, croscarmellose
sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6,
gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate.
MIC (mcg/mL) |
Interpretation |
≤8 |
Susceptible (S) |
16 |
Intermediate (I) |
≥32 |
Resistant (R) |
Microorganism |
MIC (mcg/mL) |
E. coli ATCC 25922 |
4-16 |
S. aureus ATCC 29213 |
0.12-0.5 |
Zone Diameter (mm) |
Interpretation |
≥18 |
Susceptible (S) |
15-17 |
Intermediate (I) |
≤14 |
Resistant (R) |
Microorganism |
Zone Diameter (mm) |
E. coli ATCC 25922 |
15-21 |
S. aureus ATCC 25923 |
29-37 |
Cephalexin capsules are 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 capsules are generally effective in the eradication of streptococci
from the nasopharynx; however, substantial data establishing the efficacy of
cephalexin capsules 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 and other antibacterial
drugs, cephalexin 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.
Cephalexin capsules are 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
cephalexin.
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.
As a result of administration of cephalexin, 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
Gastrointestinal — Onset of pseudomembranous colitis
may occur during or after antibacterial treatment. (See WARNINGS.) Nausea and vomiting have been reported
rarely. The most frequent side effect has been diarrhea. It was very rarely
severe enough to warrant cessation of therapy. Dyspepsia, gastritis, and
abdominal pain have also occurred. As with some penicillins and some other
cephalosporins, transient hepatitis and cholestatic jaundice have been reported
rarely.
Hypersensitivity — Allergic reactions
in the form of rash, urticaria, angioedema, and, rarely, erythema multiforme,
Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed.
These reactions usually subsided upon discontinuation of the drug. In some of
these reactions, supportive therapy may be necessary. Anaphylaxis has also been
reported.
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
cephalexin, the following adverse reactions and altered laboratory tests have
been reported for cephalosporin class antibiotics:
Adverse Reactions — Fever, colitis, aplastic anemia,
hemorrhage, renal dysfunction, and toxic nephropathy.
Several
cephalosporins have been implicated in triggering seizures, particularly in
patients with renal impairment when the dosage was not reduced (see INDICATIONS AND USAGE and PRECAUTIONS, General). If seizures
associated with drug therapy should occur, the drug should be discontinued.
Anticonvulsant therapy can be given if clinically indicated.
Altered Laboratory Tests — Prolonged prothrombin time,
increased BUN, increased creatinine, elevated alkaline phosphatase, elevated
bilirubin, elevated LDH, pancytopenia, leukopenia, and agranulocytosis.
Signs and Symptoms —
Symptoms of oral overdose may include nausea, vomiting, epigastric
distress, diarrhea, and hematuria. If other symptoms are present, it is probably
secondary to an underlying disease state, an allergic reaction, or toxicity due
to ingestion of a second medication.
Treatment
— To obtain up-to-date information about the
treatment of overdose, a good resource is your certified Regional Poison Control
Center. Telephone numbers of certified poison control centers are listed in the
Physicians' Desk Reference (PDR). In managing
overdosage, consider the possibility of multiple drug overdoses, interaction
among drugs, and unusual drug kinetics in your patient.
Unless 5 to 10
times the normal dose of cephalexin has been ingested, gastrointestinal
decontamination should not be necessary.
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.
Cephalexin capsules are 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 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.
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
cephalexin should be administered for at least 10 days.
Cephalexin Capsules, USP are available in:
250 mg Capsule
Dark green opaque/white size “2” hard gelatin capsule filled with off
white granular powder and imprinted with “A 42” on dark green opaque cap and
“250 mg” on white body with black ink.
Bottles of
14 NDC
54868-0153-6
Bottles of 20 NDC 54868-0153-1
Bottles of 28 NDC
54868-0153-2
Bottles of 30 NDC 54868-0153-5
Blisterpack of 30 NDC 54868-0153-7
Bottles of 40 NDC 54868-0153-3
Bottles of 56 NDC 54868-0153-4
Bottles of 60 NDC
54868-0153-9
Bottles of 100 NDC 54868-0153-8
Bottles of 500 NDC 54868-0153-0
500 mg Capsule
Dark green opaque/light green opaque size “0” hard gelatin capsule
filled with off white granular powder and imprinted with “A 43” on dark green
opaque cap and “500 mg” on light green opaque body with black
ink.
Bottles of 06 NDC
54868-0154-8
Bottles of 10 NDC 54868-0154-7
Bottles of 14 NDC
54868-0154-6
Bottles of 20 NDC 54868-0154-1
Bottles of 28 NDC 54868-0154-3
Bottles of 30 NDC 54868-0154-2
Blisterpack of 30 NDC 54868-0154-5
Bottles of 40 NDC
54868-0154-4
Bottles of 60 NDC 54868-0154-9
Bottles of 500 NDC 54868-0154-0
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].
Cephalexin Capsules, USP, 250 mg
Cephalexin Capsules, USP, 500 mg
CEPHALEXIN
cephalexin capsule |
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065253 | 10/30/2006 |
CEPHALEXIN
cephalexin capsule |
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA065253 | 12/09/2004 |
Labeler - Physicians Total Care, Inc. (194123980) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Physicians Total Care, Inc. | 194123980 | repack, relabel |