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Status:
US Approved Rx
(2011)
Source:
ANDA201091
(2011)
Source URL:
First approved in 1984
Source:
NDA050575
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam
structurally related to the penicillins and possesses the ability to inactivate a wide variety of
β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active
against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred
drug resistance to penicillins and cephalosporins. Clavulanic acid is used in conjunction with amoxicillin for the treatment of bronchitis and urinary tract, skin, and soft tissue infections caused by beta-lactamase producing organisms. Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. Binding and irreversibly inhibiting the beta-lactamase results in a restauration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. By inactivating beta-lactamase (the bacterial resistance protein), the accompanying penicillin/cephalosporin drugs may be made more potent as well.
Status:
US Previously Marketed
Source:
CEFMAX by TAP PHARM
(1987)
Source URL:
First approved in 1987
Source:
CEFMAX by TAP PHARM
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cefmenoxime is a semisynthetic beta-lactam cephalosporin antibiotic with activity similar to that of cefotaxime. Like other 'third-generation' cephalosporins it is active in vitro against most common Gram-positive and Gram-negative pathogens, is a potent inhibitor of Enterobacteriaceae (including beta-lactamase-producing strains), and is resistant to hydrolysis by beta-lactamases. Cefmenoxime has a high rate of clinical efficacy in many types of infection and is at least equal in clinical and bacteriological efficacy to several other cephalosporins in urinary tract infections, respiratory tract infections, postoperative infections and gonorrhoea. The bactericidal activity of cefmenoxime results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Cefmenoxime is stable in the presence of a variety of b-lactamases, including penicillinases and some cephalosporinases. Cefmenoxime is marketed in Japan under the brand name Bestron, indicated for the treatment of otitis externa, otitis media, and sinusitis. Cefmenoxime hydrochloride was approved by the U.S. Food and Drug Administration (FDA) on Dec 30, 1987. It was developed and marketed as Cefmax®, but it has being discontinued.
Status:
US Previously Marketed
Source:
COLD CAPSULE IV by GRAHAM DM
(1985)
Source URL:
First approved in 1941
Class (Stereo):
CHEMICAL (MIXED)
Targets:
Phenylpropanolamine belongs to the sympathomimetic amine class of drugs and is structurally related to ephedrine. The effects of phenylpropanolamine are largely the result of alpha-adrenergic agonist activity resulting from both direct stimulation of adrenergic receptors and release of neuronal norepinephrine. Phenylpropanolamine is mainly used as a nasal decongestant. Phenylpropanolamine is also used as anorexiant in obesity and to treat urinary incontinence in veteranary. Phenylpropanolamine containing products has been withdrawn by FDA due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Tebipenem pivoxil is an oral carbapenem prodrug that was originated by Wyeth (now Pfizer). It was approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on Apr 22, 2009. It was developed and marketed as Orapenem® by Meiji Seika in Japan. Tebipenem pivoxil is a broad-spectrum orally-administered antibiotic, from the carbapenem subgroup of β-lactam antibiotics. Carbapenems are a class of beta-lactam antibiotics, which act by inhibiting the synthesis of the peptidoglycan layer of bacterial cell walls. It is used to treat otorhinolaryngological infection, otitis media and bacterial pneumonia. Orapenem® is available as granules for oral use, containing 100 mg Tebipenem pivoxil/g granules. According to the weight of children, 4 mg/kg, and twice a day after dinner.
Status:
Possibly Marketed Outside US
Source:
VISCLAIR
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Mecysteine is used as a mucolytic in respiratory disorders associated with productive cough. Mecysteine is known as a mucolytic
agent, it breaks down mucus. It works by breaking some
of the chemical bonds between the molecules in mucus. It is given orally in a usual dose of 200 mg three times daily before meals reduced to 200 mg twice daily after 6 weeks. A rapid clinical effect can be achieved by giving 200 mg four times daily for the first 2 days. Mecysteine has also been given by inhalation.
Status:
Possibly Marketed Outside US
Source:
Baycillin Mega by Japan
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Propicillin (Baycillin Mega) is this semisynthetic penicillin, analogous to penicillin V, was introduced in the early 1960s. Although it is better absorbed from the gastrointestinal tract, overall it is inferior to phenoxymethylpenicillin and phenoxyethylpenicillin because of its lower antibacterial activity. Propicillin is used by propicillin-susceptible pathogens in adults and adolescents from 14 years to treat mild to moderate bacterial infections. These include skin infections, ear, nose and throat infections (such as otitis media, sinusitis, tonsillitis, pharyngitis) and infections of the bronchi andlung inflammation. Moreover propicillin can for prevention and treatment of scarlet fever or against rheumatic fever are used (bacterial infection of the nose and throat). Even with tooth or jaw surgery the drug is used to treat an endocarditis endocarditis prevent. Its mechanism of action could be due to binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thus propicillin may inhibit the third and last stage of bacterial cell wall synthesis
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Fenspiride is an oxazolidinone spiro compound used as a drug in the treatment of certain respiratory diseases. It is approved for use in Russia for the treatment of acute and chronic inflammatory diseases of ENT organs and the respiratory tract (like rhinopharyngitis, laryngitis, tracheobronchitis, otitis and sinusitis), as well as for maintenance treatment of asthma. Fenspiride is marketed under the brand names Eurespal, Pneumorel, SYRESP, Oxofen and others. Erespal (fenspiride) is a drug with a bronchodilator and spasmolytic effect, which is often used in the complex therapy of bronchial asthma. Fenspiride has a clinically proven ability to increase the activity of the cilia of the bronchial ciliated epithelium, normalize the secretion of the bronchi and reduce its viscosity. Effectively removes bronchial obstruction, restores pulmonary gas exchange. Inhibits the metabolism of arachidonic acid, in parallel blocking histamine H1-receptors, since it is histamine that stimulates the chemical reactions of the transformation of arachidonic acid into the final metabolites-factors of inflammation. Reduces the production of other mediators of inflammation - serotonin and bradykinin.
It blocks α-adrenergic receptors, the activation of which increases the secretion of bronchial glands. The complex effect of fenspiride reduces the pathological effect of a number of factors that promote hypersecretion of anti-inflammatory substances and cause obstruction of the bronchial tree. Has a pronounced antispasmodic and myotropic effect.
Status:
US Approved Rx
(2011)
Source:
ANDA201091
(2011)
Source URL:
First approved in 1984
Source:
NDA050575
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam
structurally related to the penicillins and possesses the ability to inactivate a wide variety of
β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active
against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred
drug resistance to penicillins and cephalosporins. Clavulanic acid is used in conjunction with amoxicillin for the treatment of bronchitis and urinary tract, skin, and soft tissue infections caused by beta-lactamase producing organisms. Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. Binding and irreversibly inhibiting the beta-lactamase results in a restauration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. By inactivating beta-lactamase (the bacterial resistance protein), the accompanying penicillin/cephalosporin drugs may be made more potent as well.
Status:
US Approved Rx
(2011)
Source:
ANDA201091
(2011)
Source URL:
First approved in 1984
Source:
NDA050575
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam
structurally related to the penicillins and possesses the ability to inactivate a wide variety of
β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active
against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred
drug resistance to penicillins and cephalosporins. Clavulanic acid is used in conjunction with amoxicillin for the treatment of bronchitis and urinary tract, skin, and soft tissue infections caused by beta-lactamase producing organisms. Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. Binding and irreversibly inhibiting the beta-lactamase results in a restauration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. By inactivating beta-lactamase (the bacterial resistance protein), the accompanying penicillin/cephalosporin drugs may be made more potent as well.
Status:
US Approved Rx
(2011)
Source:
ANDA201091
(2011)
Source URL:
First approved in 1984
Source:
NDA050575
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam
structurally related to the penicillins and possesses the ability to inactivate a wide variety of
β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active
against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred
drug resistance to penicillins and cephalosporins. Clavulanic acid is used in conjunction with amoxicillin for the treatment of bronchitis and urinary tract, skin, and soft tissue infections caused by beta-lactamase producing organisms. Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. Binding and irreversibly inhibiting the beta-lactamase results in a restauration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. By inactivating beta-lactamase (the bacterial resistance protein), the accompanying penicillin/cephalosporin drugs may be made more potent as well.