AMPICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

AMPICILLIN TRIHYDRATE

Composition:

AMPICILLIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ampicillin Capsules, USP are indicated in the treatment of infections caused by susceptible strains of the designated organism 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 RESPIRATORY TRACT: Nonpenicillinase- producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae . INFECTIONS OF THE GASTROINTESTINAL TRACT: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci. MENINGITIS: N. Meningitides . To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and other antibacterial drugs, ampicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bact

Product summary:

500 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC 68071-1981-8 bottles of 28 NDC 68071-1981-3 bottles of 30 NDC 68071-1981-1 bottles of 21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN CAPSULE
NUCARE PHARMACEUTICALS, INC.
----------
AMPICILLIN CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ampicillin and other antibacterial drugs, ampicillin should be used
only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ampicillin trihydrate is a semisynthetic penicillin derived from the
basic penicillin nucleus,
6- aminopenicillanic acid. Ampicillin is designated chemically as (2S,
5 _R_, 6 _R_)-6-[( _R_)-2-
Amino-2-phenylacetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo
[3.2.0] heptane-2-
carboxylic acid. Its structural formula is:
Ampicillin Capsules, USP for oral administration provide ampicillin
trihydrate equivalent to
250 mg and 500 mg ampicillin. Inactive ingredients: black iron oxide,
gelatin, magnesium
stearate, titanium dioxide, shellac, propylene glycol, ammonium
hydroxide, and
potassium hydroxide.
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
plasma proteins as
compared to 60 to 90 percent of the other penicillins. The
administration of 500 mg
dose of ampicillin capsules results in an average peak blood serum
level of approximately
3.0 mcg/mL.
MICROBIOLOGY
Mechanism of Action
Ampicillin is similar to penicillin in its b