CEFADROXIL powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFADROXIL (UNII: 280111G160) (CEFADROXIL ANHYDROUS - UNII:Q525PA8JJB)

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

CEFADROXIL

Composition:

CEFADROXIL ANHYDROUS 250 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefadroxil for oral suspension USP is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available. 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 a

Product summary:

Cefadroxil for oral suspension USP is an orange-pineapple flavored, and is supplied as follows: 250 mg/5 mL    NDC 68180-181-01      50 mL Bottle                           NDC 68180-181-02      100 mL Bottle 500 mg/5 mL    NDC 68180-182-01      50 mL Bottle                           NDC 68180-182-02      75 mL Bottle                           NDC 68180-182-03      100 mL Bottle Prior to reconstitution: Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]. After reconstitution: Store in refrigerator. Shake well before using. Keep container tightly closed.  Discard unused portion after 14 days.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFADROXIL- CEFADROXIL POWDER, FOR SUSPENSION
LUPIN PHARMACEUTICALS, INC.
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CEFADROXIL FOR ORAL SUSPENSION USP, 250 MG/5 ML AND 500 MG/5 ML
250 MG/5 ML AND 500 MG/5 ML
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
cefadroxil for oral suspension and other antibacterial drugs,
cefadroxil for oral
suspension should be used only to treat or prevent infections that are
proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic
intended for oral
administration. It is a white to yellowish-white crystalline powder.
It is soluble in water
and it is acid-stable. It is chemically designated as
5-Thia-1-azabicyclo[4.2.O]oct-2-ene-2-
carboxylic acid,
7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-,
monohydrate, [6R-[6(,7((R*)]]-. It has the formula C
H
N O S•H O and the molecular
weight of 381.40. It has the following structural formula:
Cefadroxil for oral suspension USP contains cefadroxil monohydrate
USP. After
reconstitution, each 5 mL contains cefadroxil monohydrate USP
equivalent to 250 mg or
500 mg of cefadroxil. In addition, cefadroxil for oral suspension USP
contains the
following inactive ingredients: colloidal silicon dioxide, FD&C Yellow
No. 6, powder flavor
orange, powder flavor pineapple, sodium benzoate, sucrose, and xanthan
gum.
Cefadroxil for oral suspension USP is a light orange colored powder,
forming orange
colored suspension on constitution.
CLINICAL PHARMACOLOGY
Cefadroxil monohydrate is rapidly absorbed after oral administration.
Following single
doses of 500 mg and 1000 mg, average peak serum concentrations were
approximately
16 and 28 mcg/mL, respectively. Measurable levels were present 12
hours after
administration. Over 90% of the drug is excreted unchanged in the
urine within 24
hours. Peak urine concentrations are approximately 1800 mcg/mL during
the period
following a single 500-mg oral dose. Increases in dosage generally
produce a
proportionate increase i