Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)
Bryant Ranch Prepack
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
Product: 63629-2609 NDC: 63629-2609-1 21 CAPSULE in a BOTTLE NDC: 63629-2609-2 30 CAPSULE in a BOTTLE NDC: 63629-2609-3 40 CAPSULE in a BOTTLE Product: 63629-2610 NDC: 63629-2610-1 20 CAPSULE in a BOTTLE NDC: 63629-2610-2 30 CAPSULE in a BOTTLE NDC: 63629-2610-3 40 CAPSULE in a BOTTLE
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN CAPSULE BRYANT RANCH PREPACK ---------- 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 16 19 3 4 2 fluids; however, penetration into the cerebrospinal fluid and brain occurs only Pročitajte cijeli dokument