AMPICILLIN capsule AMPICILLIN suspension

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Par Pharmaceutical

INN (Mezinárodní Name):

AMPICILLIN TRIHYDRATE

Složení:

AMPICILLIN 250 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Ampicillin Capsules, USP 250 mg : Each capsule contains ampicillin trihydrate equivalent to 250 mg ampicillin. The number 2 size capsule has a gray opaque body with a light blue opaque cap, printed WC402. Bottles of 100 NDC 67253-180-10 Bottles of 500 NDC 67253-180-50 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]. Ampicillin for Oral Suspension, USP is available as a powder which when reconstituted as directed yields a white, bubble gum flavored suspension. Ampicillin for Oral Suspension, USP 125 mg/5 mL: Each 5 mL of reconstituted suspension contains ampicillin trihydrate equivalent to 125 mg ampicillin. 100 mL bottles NDC 67253-182-10 200 mL bottles NDC 67253-182-20 Ampicillin for Oral Suspension, USP 250 mg/5 mL : Each 5 mL of reconstituted suspension contains ampicillin trihydrate equivalent to 250 mg ampicillin. 100 mL bottles NDC 67253-183-10 200 mL bottles NDC 67253-183-20 Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store the reconstituted suspension in a refrigerator. Discard any unused portion after 14 days. Manufactured for: DAVA Pharmaceuticals, Inc. a Subsidiary of Qualitest Pharmaceuticals Huntsville, AL  35811 Manufactured by: Suir Pharma Ireland Ltd. Clonmel, Ireland. Rev. 07/15

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AMPICILLIN- AMPICILLIN CAPSULE
AMPICILLIN- AMPICILLIN SUSPENSION
PAR PHARMACEUTICAL
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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 fluids; however,
penetration into the cerebrospinal
fluid a