AMPICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

AMPICILLIN TRIHYDRATE

Composition:

AMPICILLIN 250 mg

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:

Ampicillin capsules, USP: Each capsule, for oral administration, contains ampicillin trihydrate equivalent to 250 mg or 500 mg ampicillin, and are supplied as: 250 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 850/GG 850. NDC 0781-2144-01 in bottles of 100 NDC 0781-2144-05 in bottles of 500 500 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC 0781-2145-01 in bottles of 100 NDC 0781-2145-05 in bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Clinitest® is a registered trademark of Miles, Inc. Clinistix® is a registered trademark of Bayer Corporation. Tes-Tape® is a registered trademark of Eli Lilly Company. Revised: August 2020 46275512 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN CAPSULE
SANDOZ INC
----------
AMPICILLIN CAPSULES, USP
RX ONLY
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:
Molecular formula: C
H N O S · 3 H O
Molecular weight: 403.5
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 A