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Status:
US Approved Rx
(2019)
Source:
ANDA207594
(2019)
Source URL:
First approved in 1985
Source:
NDA050587
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Imipenem is a beta-lactam antibiotic belongings to the subgroup of carbapenems. Imipenem has a broad spectrum of activity against aerobic and anaerobic Gram positive as well as Gram negative bacteria. It is particularly important for its activity against Pseudomonas aeruginosa and the Enterococcus species. Imipenem is rapidly degraded by the renal enzyme dehydropeptidase when administered alone, and is always co-administered with cilastatin to prevent this inactivation. The bactericidal activity of imipenem results from the inhibition of cell wall synthesis. Its greatest affinity is for
penicillin binding proteins (PBPs) 1A, 1B, 2, 4, 5 and 6 of Escherichia coli, and 1A, 1B, 2, 4 and 5 of
Pseudomonas aeruginosa. The lethal effect is related to binding to PBP 2 and PBP 1B. Imipenem is marketed under the brand name Primaxin. PRIMAXIN I.M. (Imipenem and Cilastatin for Injectable Suspension) is a formulation of imipenem (a
thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I).
PRIMAXIN I.M. is a potent broad spectrum antibacterial agent for intramuscular administration.
Status:
Possibly Marketed Outside US
Source:
NCT01892488: Phase 4 Interventional Completed Chronic Obstructive Pulmonary Disease (COPD)
(2013)
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sultamicillin is the mutual prodrug of sulbactam and ampicillin. It is the
tosylate salt of the double ester of sulbactam plus ampicillin.
Sulbactam is a semisynthetic ß-lactamase inhibitor which, in
combination with ampicillin, extends the antibacterial activity of
the latter to include some ß-lactamase-producing strains of
bacteria that would otherwise be resistant. The combination of
sulbactam plus ampicillin for parenteral use has previously been
shown to be clinically and bacteriologically effective in a
variety of infections. Sultamicillin is marketed under a trade name Unasyn among others.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Ibafloxacin is a fluoroquinolone antibiotic drug used in veterinary medicine. Ibafloxacin, a fluorinated 4-quinolone, is a broad spectrum antibiotic with bactericidal action against
Gram-positive and Gram-negative bacteria. Ibafloxacin is presented in the form of a tablet/oral gel
containing a racemic mixture of S- and R-ibafloxacin. The antimicrobial activity of the racemate
originates mainly from the S-enantiomer. Ibafloxacin was marketed under the brand name Ibaflin. Ibaflin tablets were intended for use in dogs for treatment of respiratory tract infections, urinary tract
infections and dermal infections caused by ibafloxacin susceptible pathogens. Ibafloxacin, is an antibiotic belonging to the class ‘fluoroquinolones’. It works by blocking an enzyme called ‘DNA gyrase’, which is important in allowing bacteria to make copies of their DNA. This enzyme is only found in bacterial cells, and does not have a similar function in animal cells. By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Status:
Possibly Marketed Outside US
Source:
GENTAMICIN SULFATE by Weinstein, M.J. et al.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gentamicin is an antibiotic of the aminoglycoside group, is derived from the growth of Micromonospora purpurea, an actinomycete. Gentamicin is a complex of three different closely related aminoglycoside sulfates, Gentamicins C1, C2, and C1a that have different patterns of methylation at the 69 position of the ring. Gentamicin C1a is a broad-spectrum antibiotic against Gram-positive and Gram-negative bacteria but may cause ear and kidney damage. Gentamicin C1a binds to the A-site RNA of the 30S bacterial ribosomal subunit. Adverse reactions include adverse renal effects, neurotoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss, peripheral neuropathy or encephalopathy), respiratory depression, lethargy, confusion, depression, visual disturbances, etc.
Status:
US Approved Rx
(1984)
Source:
ANDA062533
(1984)
Source URL:
First approved in 1966
Source:
GARAMYCIN by SCHERING
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Gentamicin is an antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete. Gentamicin is a complex of three different closely related aminoglycoside sulfates, Gentamicins C1, C2, and C1a. Gentamicin is a broad-spectrum antibiotic, but may cause ear and kidney damage. Gentamicin binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria. Adverse reactions include adverse renal effects, neurotoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss, peripheral neuropathy or encephalopathy), respiratory depression, lethargy, confusion, depression, visual disturbances, etc.
Status:
Possibly Marketed Outside US
Class:
MIXTURE
Targets:
Conditions:
Sulfomyxin is an antibacterial sulfonamide. It is intended for use in chickens and turkeys as an aid in the treatment of disease caused or complicated by E. coli, such as colibacillosis and complicated chronic respiratory disease.
Status:
US Approved Rx
(2019)
Source:
ANDA207594
(2019)
Source URL:
First approved in 1985
Source:
NDA050587
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Imipenem is a beta-lactam antibiotic belongings to the subgroup of carbapenems. Imipenem has a broad spectrum of activity against aerobic and anaerobic Gram positive as well as Gram negative bacteria. It is particularly important for its activity against Pseudomonas aeruginosa and the Enterococcus species. Imipenem is rapidly degraded by the renal enzyme dehydropeptidase when administered alone, and is always co-administered with cilastatin to prevent this inactivation. The bactericidal activity of imipenem results from the inhibition of cell wall synthesis. Its greatest affinity is for
penicillin binding proteins (PBPs) 1A, 1B, 2, 4, 5 and 6 of Escherichia coli, and 1A, 1B, 2, 4 and 5 of
Pseudomonas aeruginosa. The lethal effect is related to binding to PBP 2 and PBP 1B. Imipenem is marketed under the brand name Primaxin. PRIMAXIN I.M. (Imipenem and Cilastatin for Injectable Suspension) is a formulation of imipenem (a
thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I).
PRIMAXIN I.M. is a potent broad spectrum antibacterial agent for intramuscular administration.
Status:
US Approved Rx
(1984)
Source:
ANDA062533
(1984)
Source URL:
First approved in 1966
Source:
GARAMYCIN by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gentamicin is an antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete. Gentamicin is a complex of three different closely related aminoglycoside sulfates, Gentamicins C1, C2, and C1a. Gentamicin is a broad-spectrum antibiotic, but may cause ear and kidney damage. Gentamicin binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria. Adverse reactions include adverse renal effects, neurotoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss, peripheral neuropathy or encephalopathy), respiratory depression, lethargy, confusion, depression, visual disturbances, etc.
Status:
US Approved Rx
(1984)
Source:
ANDA062533
(1984)
Source URL:
First approved in 1966
Source:
GARAMYCIN by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gentamicin is an antibiotic of the aminoglycoside group, is derived by the growth of Micromonospora purpurea, an actinomycete. Gentamicin is a complex of three different closely related aminoglycoside sulfates, Gentamicins C1, C2, and C1a. Gentamicin is a broad-spectrum antibiotic, but may cause ear and kidney damage. Gentamicin binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria. Adverse reactions include adverse renal effects, neurotoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss, peripheral neuropathy or encephalopathy), respiratory depression, lethargy, confusion, depression, visual disturbances, etc.
Status:
Possibly Marketed Outside US
Source:
NCT01892488: Phase 4 Interventional Completed Chronic Obstructive Pulmonary Disease (COPD)
(2013)
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sultamicillin is the mutual prodrug of sulbactam and ampicillin. It is the
tosylate salt of the double ester of sulbactam plus ampicillin.
Sulbactam is a semisynthetic ß-lactamase inhibitor which, in
combination with ampicillin, extends the antibacterial activity of
the latter to include some ß-lactamase-producing strains of
bacteria that would otherwise be resistant. The combination of
sulbactam plus ampicillin for parenteral use has previously been
shown to be clinically and bacteriologically effective in a
variety of infections. Sultamicillin is marketed under a trade name Unasyn among others.