AMPICILLIN TRIHYDRATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

AMPICILLIN TRIHYDRATE

Composition:

AMPICILLIN TRIHYDRATE 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN TRIHYDRATE- AMPICILLIN TRIHYDRATE CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
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AMPICILLIN CAPSULES, USP
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 designed chemically as (2S, 5R,
6R)-6-[(R)-2-Amino-2-
phenylacetamido]-3,
3-dimethyl-7-oxo-4-this-l-azabicyclo[3.2.0]heptane-2-carbxylic 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 provides ampicillin
trihydrate equivalent to 250 mg
and 500 mg ampicillin. Ampicillin capsules, USP also contain magnesium
stearate, NF. The capsule
shell contains black iron oxide; FD&C red No. 28; FD&C blue No. 1;
gelatin, NF; silicon dioxide, NF;
sodium lauryl sulfate, NF; titanium dioxide USP.
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
16
19
3
4
2
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