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Search results for "PART 522 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS" in comments (approximate match)
Status:
US Previously Marketed
Source:
CENTRINE/PHENOBARBITAL AMINOPENTAMIDE HYDROGEN SULFATE by BRISTOL LABS
(1961)
Source URL:
First approved in 1953
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Aminopentamide is a potent antispasmodic agent. As a cholinergic blocking agent for smooth muscle, its action is similar to atropine. Aminopentamide hydrogen sulfate is marketed under the brand name Centrine indicated in the treatment of acute abdominal visceral spasm, pylorospasm or hypertrophic gastritis and associated nausea, vomiting and/or diarrhea of the dogs and cats. Centrine effectively reduces the tone and amplitude of colonic contractions to a greater degree and for a more extended period than does atropine. Centrine effects a reduction in gastric secretion, a decrease in gastric acidity and a marked decrease in gastric motility. Aminopentamide is a nonselective muscarinic cholinergic .
Status:
US Previously Marketed
Source:
CHLOROMYCETIN HYDROCORTISONE by PARKEDALE
(1953)
Source URL:
First approved in 1950
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Chloramphenicol is a broad-spectrum antibiotic that was first isolated from
Streptomyces venezuelae in 1947. The drug was subsequently chemically synthesized. It has both a bacteriostatic and bactericidal effect; in the usual therapeutic concentrations it is bacteriostatic. Chloramphenicol is used for the treatment of serious gram-negative, gram-positive, and anaerobic infections. It is especially useful in the treatment of meningitis, typhoid fever, and cystic fibrosis. It should be reserved for infections for which other drugs are ineffective or contraindicated. Chloramphenicol, a small inhibitor of bacterial protein synthesis, is active against a variety of bacteria and readily enters the CSF. It has been used extensively in the last decades for the treatment of bacterial meningitis. In industrialized countries, chloramphenicol is restricted mostly to topical uses because of the risk of induction of aplastic anemia. However, it remains a valuable reserve antibiotic for patients with allergy to β-lactam antibiotics or with CNS infections caused by multiresistant pathogens.
Status:
US Previously Marketed
Source:
SECOBARBITAL SODIUM by WEST WARD
(1982)
Source URL:
First marketed in 1929
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Secobarbital sodium, a barbiturate, is FDA approved for the treatment of insomnia and for pre-anesthetic use. This drug binds at a distinct site associated with a Cl- ionopore at the GABAA receptor, increasing the duration of time for which the Cl- ionopore is open. The post-synaptic inhibitory effect of GABA in the thalamus is, therefore, prolonged. Adverse reactions are drowsiness, lethargy, hangover, paradoxical excitement in elderly patients, somnolence. Rifampin may decrease secobarbital levels by increasing metabolism.
Status:
US Previously Marketed
Source:
PRELU-VITE IRON by GEIGY
(1961)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Direct reduced iron is an alternative iron source produced by heating an iron ore. In nature, most of the iron has an oxidized form.
Status:
US Previously Marketed
Source:
Diluted Hydrobromic Acid U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Diluted Hydrobromic Acid U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Hydrobromic acid is a useful reagent for generating organobromine compounds. It was shown that hydrobromic acid could initiate or exacerbate inflammatory pulmonary disease.
Status:
US Previously Marketed
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Melatonin (5-methoxy N-acetyltryptamine) is a hormone synthesized and released from the pineal gland at night, which acts on specific high affinity G-protein coupled receptors to regulate various aspects of physiology and behaviour, including circadian and seasonal responses, and some retinal, cardiovascular and immunological functions. Melatonin is also made synthetically and available without a prescription as an over-the-counter (OTC) dietary supplement in the U.S. Melatonin supplementation has many uses, however, it has been widely studied for treatment of jet lag and sleep disorders. Parents may consider using melatonin to help their child who has a trouble falling asleep. A medical professional should always evaluate insomnia or other sleeping disorders in children. Additionally, melatonin has been shown to protect against oxidative stress in various, highly divergent experimental systems. There are many reasons for its remarkable protective potential. In mammals, melatonin binds to a number of receptor subtypes including high-affinity (MT1 and MT2) and low-affinity (MT3, nuclear orphan receptors) binding sites, which are distributed throughout the central nervous system and periphery.
Status:
Possibly Marketed Outside US
Source:
NCT01486615: Phase 4 Interventional Completed Anxiety
(2011)
Source URL:
First approved in 2022
Source:
Azaperone by Menadiona, S.L.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Azaperone (Stresnil, Fluoperidol) is a pyridinylpiperazine and butyrophenone neuroleptic drug with sedative and antiemetic effects. It is mainly as a tranquilizer in veterinary medicine. Azaperone is officially indicated for the “control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 36.4 kg”. It is also used clinically as a general tranquilizer for swine, in particular with aggressive sows to allow piglets to be accepted, and as a preoperative agent prior to general anesthesia or cesarian section with local anesthesia. Azaperone has also been used as a neuroleptic in horses, but some horses develop adverse reactions (sweating, muscle tremors, panic reaction, CNS excitement) and IV administration has resulted in significant arterial hypotension in the horse; because of these effects, most clinicians avoid the use of this drug in equines. Azaperone appears to have minimal effects on respiration and may inhibit some of the respiratory depressant actions of general anesthetics. A slight reduction of arterial blood pressure has been measured in pigs after IM injections of azaperone, which is apparently due to slight alpha-adrenergic blockade. Azaperone has been demonstrated to prevent the development of halothane-induced malignant hyperthermia in susceptible pigs. Preliminary studies have suggested that the effects of butyrephenones may be antagonized by 4-aminopyridine. Azaperone acts primarily as a dopamine antagonist but also has some antihistaminic and anticholinergic properties as seen with similar drugs such as haloperidol. Azaperone may cause hypotension and while it has minimal effects on respiration in pigs, high doses in humans can cause respiratory depression which may be why it is rarely used in humans. Higher doses are used for anesthesia in combination with other drugs such as xylazine, tiletamine and zolazepam. Azaperone is also used in combination with strong narcotics such as etorphine or carfentanil for tranquilizing large animals such as elephants.
Status:
Possibly Marketed Outside US
First approved in 2018
Source:
NADA141342
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Alfaxalone is a rapidly acting hydrophobic synthetic neurosteroid. It is indicated for the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs. Alfaxalone induces anaesthesia through activity at the gamma amino butyric acid sub-type A receptor (GABAA) present on cells in the Central Nervous System (CNS). Alfaxalone enhances the effects of GABA at the GABAA receptors resulting in opening of channels into the cells and an influx of chloride ions. This causes hyperpolarisation of the cells and inhibition of neural impulse transmission. Alfaxalone can be safely combined with premedicants (xylazine, (dex)medetomidine, acepromazine, midazolam), opioids (morphine, methadone, hydromorphone, butorphanol, nalbuphine, buprenorphine, fentanyl), and NSAIDs. Alfaxalone’s adverse reactions are: hypotension, tachycardia, apnea, hypertension, bradypnea and others.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
NADA038233
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Zeranol is a non-steroidal anabolic growth promoter with potent estrogenic activity that is widely used as a growth promoter in the US beef industry. It is a mycotoxin, derived from fungi in the Fusarium family, it is an estrogen agonist. Zeranol is approved for use as a growth promoter in livestock, including beef cattle, in the United States. In Canada, it is approved for use in beef cattle only. Zeranol was officially banned in Europe due to safety concerns because of its potential carcinogenic and endocrine-disrupting biological activity. Merck Animal Health markets zeranol under the brand name Ralgro. It has being shown, that zeranol may increase cancer cell proliferation in already existing breast cancer.
Status:
Possibly Marketed Outside US
Source:
ZUPREVO by Merck
Source URL:
First approved in 2012
Source:
NADA141334
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Tildipirosin is a
semisynthetic derivative of the naturally occurring 16-membered macrolide tylosin. Tildipirosin is
intended for parenteral treatment of respiratory disease in cattle and swine. Tildipirosin will be
administered as a single-dose injection: subcutaneously in cattle and intramuscularly in swine. The
anticipated optimal clinical dose is 4 mg/kg bw.
Tildipirosin is not used in human medicine. It is marketed under the brand name Zuprevo. As for other macrolides, the antimicrobial activity of tildipirosin is due to its binding to the ribosomal
50S subunit of bacterial cells thereby inhibiting bacterial protein synthesis. The in vitro antimicrobial
activity against Gram-negative and Gram-positive pathogens indicates that tildipirosin is effective
against a range of bacterial pathogens frequently associated with bovine and swine respiratory
disease. Comparison of minimum inhibitory versus bactericidal concentrations shows that generally the
antimicrobial action of tildipirosin is bacteriostatic.