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Status:
US Previously Marketed
Source:
HEXABRIX by GUERBET
(1985)
Source URL:
First approved in 1985
Source:
HEXABRIX by GUERBET
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ioxaglate Sodium Meglumine (trade name Hexabrix) is a new low osmolality ionic contrast agent, that used as a diagnostic radiopaque medium. Following intravascular injection, Ioxaglate Sodium Meglumine is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine. The joint spaces as well as the uterus and fallopian tubes may be visualized by the direct injection of the contrast medium into the region to be studied. The usual adult dose for left coronary arteriography is 8 mL (range 2-14 mL) and for right coronary arteriography is 5 mL (range 1-10 mL). The doses may be repeated as necessary Patients may have clinically insignificant ECG changes during the procedure. The following adverse effects have occurred in conjunction with the administration of iodinated intravascular contrast agents for this procedure: hypotension, shock, anginal pain, myocardial infarction, cardiac arrhythmias (bradycardia, ventricular tachycardia, ventricular fibrillation) and cardiac arrest.
Status:
US Previously Marketed
Source:
HEXABRIX by GUERBET
(1985)
Source URL:
First approved in 1985
Source:
HEXABRIX by GUERBET
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ioxaglate Sodium Meglumine (trade name Hexabrix) is a new low osmolality ionic contrast agent, that used as a diagnostic radiopaque medium. Following intravascular injection, Ioxaglate Sodium Meglumine is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine. The joint spaces as well as the uterus and fallopian tubes may be visualized by the direct injection of the contrast medium into the region to be studied. The usual adult dose for left coronary arteriography is 8 mL (range 2-14 mL) and for right coronary arteriography is 5 mL (range 1-10 mL). The doses may be repeated as necessary Patients may have clinically insignificant ECG changes during the procedure. The following adverse effects have occurred in conjunction with the administration of iodinated intravascular contrast agents for this procedure: hypotension, shock, anginal pain, myocardial infarction, cardiac arrhythmias (bradycardia, ventricular tachycardia, ventricular fibrillation) and cardiac arrest.
Status:
US Previously Marketed
First approved in 1984
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Nomifensine was developed by Hoechst AG as a potent inhibitor of noradrenaline, dopamine, and 5-HT uptake displayed antidepressant activity. It was first marketed in the UK in 1977 for the treatment of depression. Between 1977 and 1982 there were reports of hemolytic anemia in association with the drug, and this suspected adverse reaction was included in the 1981 edition of the data Sheet Compendium. FDA published a notice of its determination that Merital capsules were removed from the market for safety reasons.
Status:
US Previously Marketed
Source:
PRECEF by BRISTOL
(1984)
Source URL:
First approved in 1984
Source:
PRECEF by BRISTOL
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Ceforanide is a new cephalosporin with a longer elimination half-life than any currently available cephalosporin. Its activity is very similar to that of cefamandole, a second-generation cephalosporin, except that ceforanide is less active against most gram-positive organisms. The bactericidal activity of ceforanide results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Ceforanide is primarily indicated in conditions like bone and joint infection, endocarditis, respiratory tract infections, skin infections, surgical infections, urinary tract infection. Rash and pruritus, and nausea, vomiting and other mild gastrointestinal side effects were noted in a few of the subjects but were mild and transient.
Status:
US Previously Marketed
Source:
MONOCID by GLAXOSMITHKLINE
(1984)
Source URL:
First approved in 1984
Source:
MONOCID by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cefonicid is a semi-synthetic broad-spectrum cephalosporin antibiotic resistant to beta-lactamases. Similarly to other cephalosporins, cefonicid exerts its antibacterial activity through the inhibition of the bacterial cell-wall synthesis. Its in vitro and in vivo activity against a wide range of Gram-positive and Gram-negative microorganisms is documented.
Status:
US Previously Marketed
First approved in 1984
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Nomifensine was developed by Hoechst AG as a potent inhibitor of noradrenaline, dopamine, and 5-HT uptake displayed antidepressant activity. It was first marketed in the UK in 1977 for the treatment of depression. Between 1977 and 1982 there were reports of hemolytic anemia in association with the drug, and this suspected adverse reaction was included in the 1981 edition of the data Sheet Compendium. FDA published a notice of its determination that Merital capsules were removed from the market for safety reasons.
Status:
US Previously Marketed
Source:
TONOCARD by ASTRAZENECA
(1984)
Source URL:
First approved in 1984
Source:
TONOCARD by ASTRAZENECA
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Tocainide is a primary amine analog of lidocaine with antiarrhythmic properties useful in the treatment of ventricular arrhythmias. Tocainide, like lidocaine, produces dose-dependent decreases in sodium and potassium conductance, thereby decreasing the excitability of myocardial cells. In experimental animal models, the dose-related depression of sodium current is more pronounced in ischemic tissue than in normal tissue. Tocainide is a Class I antiarrhythmic compound with electrophysiologic properties in man similar to those of lidocaine, but dissimilar from quinidine, procainamide, and disopyramide. The recommended initial dosage is 400 mg every 8 hours. The usual adult dosage is between 1200 and 1800 mg/day in a three-dose daily divided regimen. Doses beyond 2400 mg per day have been administered infrequently. Patients who tolerate the t.i.d. the regimen may be tried on a twice-daily regimen with careful monitoring. Tocainide commonly produces minor, transient, nervous system and gastrointestinal adverse reactions, but is otherwise generally well tolerated.
Status:
US Previously Marketed
Source:
MONOCID by GLAXOSMITHKLINE
(1984)
Source URL:
First approved in 1984
Source:
MONOCID by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cefonicid is a semi-synthetic broad-spectrum cephalosporin antibiotic resistant to beta-lactamases. Similarly to other cephalosporins, cefonicid exerts its antibacterial activity through the inhibition of the bacterial cell-wall synthesis. Its in vitro and in vivo activity against a wide range of Gram-positive and Gram-negative microorganisms is documented.
Status:
US Previously Marketed
Source:
PRECEF by BRISTOL
(1984)
Source URL:
First approved in 1984
Source:
PRECEF by BRISTOL
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Ceforanide is a new cephalosporin with a longer elimination half-life than any currently available cephalosporin. Its activity is very similar to that of cefamandole, a second-generation cephalosporin, except that ceforanide is less active against most gram-positive organisms. The bactericidal activity of ceforanide results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Ceforanide is primarily indicated in conditions like bone and joint infection, endocarditis, respiratory tract infections, skin infections, surgical infections, urinary tract infection. Rash and pruritus, and nausea, vomiting and other mild gastrointestinal side effects were noted in a few of the subjects but were mild and transient.
Status:
US Previously Marketed
Source:
TORNALATE by SANOFI AVENTIS US
(1984)
Source URL:
First approved in 1984
Source:
TORNALATE by SANOFI AVENTIS US
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Bitolterol is a beta 2-adrenergic agonist. Since it in itself is biologically inactive, bitolterol is considered a pro-drug. When administered it is activated within the lung by esterase hydrolysis to the active compound colterol catecholamine N-t-butyl-arterenol. Bitolterol was marked under the name tornalate and was indicated to prevent and treat of reversible bronchospasm associated with asthma or chronic obstructive pulmonary diseases. But that drug was withdrawn from the market by Elan Pharmaceuticals in 2001.