AMPICILLIN capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 respirat

Bidhaa muhtasari:

Ampicillin capsules, USP: Each capsule, for oral administration, contains ampicillin trihydrate equivalent to 500 mg ampicillin, and are supplied as: 500 mg: white, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC 70934-417-28 in bottles of 28 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

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

AMPICILLIN- AMPICILLIN CAPSULE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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
16
19
3
4
2
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