AMPICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

AMPICILLIN TRIHYDRATE

Composition:

AMPICILLIN 500 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 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 respiratory tract - Nonpenicillinase-produc

Product summary:

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]. Manufactured for: DAVA Pharmaceuticals, Inc . Fort Lee, NJ 07024, USA by: STADA Production Ireland Ltd. Clonmel, Ireland. Rev. 01/11 181G451

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN CAPSULE
H.J. HARKINS COMPANY, INC.
----------
AMPICILLIN CAPSULES, USP 500 MG
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, USP also contains magnesium
stearate, NF. The capsule shell
contains black iron oxide; D&C red No. 28; FD&C blue No. 1; gelatin,
NF; silicon dioxide, NF; sodium
lauryl sulfate, NF; titanium dioxide USP.
Ampicillin for Oral Suspension, USP provides ampicillin trihydrate
equivalent to 125 mg/5 mL and 250
mg/5 mL ampicillin. Ampicillin for Oral Suspension, USP also contains
flavors; microcrystalline
cellulose and carboxymethylcellulose sodium, NF; colloidal silicon
dioxide, NF; sodium citrate, USP;
sodium propionate, NF; sucrose, NF
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. Ampic