CEPHALEXIN suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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产品特点 产品特点 (SPC)
10-03-2010

有效成分:

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)

可用日期:

Physicians Total Care, Inc.

INN(国际名称):

CEPHALEXIN

组成:

CEPHALEXIN 125 mg in 5 mL

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for oral suspension 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 is indicated for the treatment of the following infections when caused by susceptible 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

產品總結:

Cephalexin For Oral Suspension, USP is available in: The 125 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows: 100 mL Bottles NDC 54868-0538-2 200 mL Bottles NDC 54868-0538-1 The 250 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows: 100 mL Bottles NDC 54868-1385-1 200 mL Bottles NDC 54868-1385-2 * 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 – 25° C (68 – 77° F). (See USP Controlled Room Temperature).

授权状态:

Abbreviated New Drug Application

产品特点

                                CEPHALEXIN - CEPHALEXIN SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules and cephalexin for oral suspension and other antibacterial
drugs, cephalexin capsules
and cephalexin for oral suspension should be used only to treat or
prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
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 C
H N O S•H O 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.
Each capsule for oral administration, contains cephalexin monohydrate
equivalent to 250 mg (720 µmol)
or 500 mg (1,439 µmol) of cephalexin.
In addition, each capsule contains the following inactive ingredients:
D&C Yellow No. 10, edible
printing ink with black iron oxide, FD&C Green No. 3, FD&C Yellow No.
6, gelatin, lactose
monohydrate, magnesium stearate and titanium dioxide.
Also, the 500 mg strength capsule contains FD&C Blue No.1.
After mixing, each 5 mL of Cephalexin for Oral Suspension will contain
cephalexin monohydrate
equivalent to
                                
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