Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD)
Medical Purchasing Solutions, LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intraveno
Ampicillin for Injection, USP equivalent to 250 mg, 500 mg, 1 or 2 grams ampicillin as the sodium salt per vial is supplied as follows: NDC 44567-100-10 250 mg vial (Tray of 10) NDC 44567-101-10 500 mg vial (Tray of 10) NDC 44567-102-10 1 gram vial (Tray of 10) NDC 44567-103-10 2 gram vial (Tray of 10) Ampicillin for Injection, USP dry powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Italy 805163/01 Revised: April 2019
Abbreviated New Drug Application
AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SOLUTION MEDICAL PURCHASING SOLUTIONS, LLC ---------- AMPICILLIN FOR INJECTION, USP Rx only FOR INTRAMUSCULAR OR INTRAVENOUS USE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ampicillin for Injection, USP the monosodium salt of [2S-[2a, 5a, 6b(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2- carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. It has the following chemical structure: The molecular formula is C H N NaO S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8.0 to 10.0. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes. CLINICAL PHARMACOLOGY Ampicillin for Injection, USP diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Ampicillin is excreted largely unchanged in the urine and its excretion can be 16 18 3 4 delayed by concurrent administration of probenecid. Due to maturational changes in renal function, ampicillin half-life decreases as postmenstrual age (a sum of gestational age and postnatal age) increases for infants with postnatal age of less than 28 days. The active form appears in the bile in higher concentrations th Կարդացեք ամբողջական փաստաթուղթը