AMPICILLIN capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)

Disponível em:

Blenheim Pharmacal, Inc.

DCI (Denominação Comum Internacional):

AMPICILLIN TRIHYDRATE

Composição:

AMPICILLIN 500 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin capsules, Ampicillin for Oral Suspension and other antibacterial drugs, Ampicillin capsules and Ampicillin for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.  When culture and susceptibility information are available, they should be considered in selecting of modifying anitimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy. Ampicillin capsules and Ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below: Infections of the genitourinary tract including gonorrhea - E. coli, P. mirabilis , enterococci, Shigella , S. typhosa and other Salmonella and nonpenicillinase-producing N. gonorrhoeae . Infections of the resp

Resumo do produto:

Ampicillin Capsules, USP 250 mg : Each capsule contains ampicillin trihydrate equivalent to 250 mg ampicillin. The number 2 size capsule has a gray opaque body with a light blue opaque cap, printed WC402. Bottles of 100 NDC 67253-180-10 Bottles of 500 NDC 67253-180-50 Ampicillin Capsules, USP 500 mg : Each capsule contains ampicillin trihydrate equivalent to 500 mg ampicillin. The number 0 size capsule has a gray opaque body with a light blue opaque cap, printed WC404. Bottles of 100 NDC 67253-181-10 Bottles of 500 NDC 67253-181-50 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Ampicillin for Oral Suspension, USP is available as a powder which when reconstituted as directed yields a white, bubble gum flavoured suspension. Ampicillin for Oral Suspension, USP 125 mg/5 mL: Each 5 mL of reconstituted suspension contains ampicillin trihydrate equivalent to 125 mg ampicillin. 100 mL bottles NDC 67253-182-10 200 mL bottles NDC 67253-182-20 Ampicillin for Oral Suspension, USP 250 mg/5 mL : Each 5 mL of reconstituted suspension contains ampicillin trihydrate equivalent to 250 mg ampicillin. 100 mL bottles NDC 67253-183-10 200 mL bottles NDC 67253-183-20 Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store the reconstituted suspension in a refrigerator. Discard any unused portion after 14 days. Manufactured for: DAVA Pharmaceuticals, Inc . Fort Lee, NJ 07024, USA by: STADA Production Ireland Ltd. Clonmel, Ireland. Rev. 01/11 181G451

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMPICILLIN- AMPICILLIN CAPSULE
BLENHEIM PHARMACAL, INC.
----------
AMPICILLIN CAPSULES, USP 250 MG AND 500 MG
AMPICILLIN FOR ORAL SUSPENSION, USP 125 MG/5 ML AND 250 MG/5 ML
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ampicillin
capsules, Ampicillin for Oral Suspension and other antibacterial
drugs, Ampicillin Capsules and
Ampicillin for Oral Suspension should be used only to treat or prevent
infections that are proven or
strongly suspected to be caused by bacteria.
CLINICAL PHARMACOLOGY
Ampicillin is bactericidal at low concentrations and is clinically
effective not only against the gram-
positive organisms usually susceptible to penicillin G but also
against a variety of gram-negative
organisms. It is stable in the presence of gastric acid and is well
absorbed from the gastrointestinal
tract. It diffuses readily into most body tissues and fluids; however,
penetration into the cerebrospinal
fluid and brain occurs only with meningeal inflammation. Ampicillin is
excreted largely unchanged in
the urine; its excretion can be delayed by concurrent administration
of probenecid which inhibits the
renal tubular secretion of ampicillin. In blood serum, ampicillin is
the least bound of all the penicillins;
an average of about 20 percent of the drug is bound to the plasma
proteins as compared to 60 to 90
percent of the other penicillins. The administration of 500 mg dose of
ampicillin trihydrate capsules
results in an average peak blood serum level of approximately 3.0
mcg/mL; the average peak serum
level for a 250 mg dose of ampicillin trihydrate for oral suspension
is approximately 2.3 mcg/mL.
Microbiology: While _in vitro_ studies have demonstrated the
susceptibility of most strains of the
following organisms, clinical efficacy for infections other than those
included in the INDICATIONS
AND USAGE section has not been documented.
GRAM-POSITIVE - strains of alpha- and beta-hemolytic streptococci,
_Streptococcus pneumoniae_, those
strains of staphylococci, which do not pro