AMPICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 antimicrobial 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 respiratory tract - Nonpenicillinase-producing

Product summary:

Product: 63629-2609 NDC: 63629-2609-1 21 CAPSULE in a BOTTLE NDC: 63629-2609-2 30 CAPSULE in a BOTTLE NDC: 63629-2609-3 40 CAPSULE in a BOTTLE Product: 63629-2610 NDC: 63629-2610-1 20 CAPSULE in a BOTTLE NDC: 63629-2610-2 30 CAPSULE in a BOTTLE NDC: 63629-2610-3 40 CAPSULE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN CAPSULE
BRYANT RANCH PREPACK
----------
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.
DESCRIPTION
Ampicillin trihydrate is a semisynthetic penicillin derived from the
basic penicillin nucleus,
6-aminopenicillanic acid. Ampicillin is designated chemically as (2S,
5R, 6R)-6-[(R)-2-
Amino-2-phenylacetamido]-3,
3-dimethyl-7-oxo-4-thia-l-azabicyclo[3.2.0]heptane-2-
carboxylic acid trihydrate.
It has the following chemical structure:
The molecular formula is C
H
N O S.3H O, and the molecular weight is 403.45.
Ampicillin Capsules, USP for oral administration provide ampicillin
trihydrate equivalent to
250 mg and 500 mg ampicillin. Ampicillin Capsules also contain
magnesium stearate. The
capsule shell contains black iron oxide, D&C red No. 28, FD&C blue No.
1, gelatin, silicon
dioxide, sodium lauryl sulfate, and titanium dioxide.
Ampicillin for Oral Suspension, USP provides ampicillin trihydrate
equivalent to 125 mg/5
mL and 250 mg/5 mL ampicillin. Ampicillin for Oral Suspension also
contains
carboxymethylcellulose sodium, colloidal silicon dioxide, flavors,
microcrystalline
cellulose, sodium citrate, sodium propionate, and sucrose.
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
16
19
3
4
2
fluids; however, penetration into the cerebrospinal fluid and brain
occurs only