Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)
Par Pharmaceutical
AMPICILLIN TRIHYDRATE
AMPICILLIN 250 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN CAPSULE AMPICILLIN- AMPICILLIN SUSPENSION PAR PHARMACEUTICAL ---------- 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 Baca dokumen lengkap