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Search results for unoprostone root_names_stdName in Standardized Name (approximate match)
Status:
US Previously Marketed
Source:
PLENAXIS by SPECIALITY EUROPEAN
(2003)
Source URL:
First approved in 2003
Source:
PLENAXIS by SPECIALITY EUROPEAN
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Abarelix is a synthetic decapeptide antagonist to gonadotropin releasing hormone (GnRH). It is marketed by Praecis Pharmaceuticals as Plenaxis. Used in the palliative treatment of advanced prostate cancer. Abarelix is a luteinizing hormone agonist that results in suppression of testicular or follicular steroidogenesis. Abarelix binds to the gonadotropin releasing hormone receptor and acts as a a potent inhibitor of gonadotropin secretion. Praecis announced in June 2006 that it was voluntarily withdrawing the drug from the market.
Status:
US Previously Marketed
Source:
RESCULA by SUCAMPO PHARMA LLC
(2000)
Source URL:
First approved in 2000
Source:
RESCULA by SUCAMPO PHARMA LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Unoprostone Isopropyl is a synthetic docosanoid and a structural analogue of an inactive biosynthetic cyclic derivative of arachidonic acid, 13,14-dihydro-15-keto-prostaglandin F 2a. Although the mechanism of action is unknown, unoprostone isopropyl is believed to reduce elevated intraocular pressure by increasing the outflow of aqueous humor through the trabecular meshwork. Unoprostone isopropyl (UI) may have a local effect on Big Potassium channels and ClC-2 chloride channels, but the exact mechanism is unknown at this time. Unoprostone is used for the management of open-angle glaucoma and ocular hypertension. The therapeutic efficacy of Unoprostone can be decreased when used in combination with Celecoxib, Diclofenac, Diflunisal, Etodolac and some other drugs. Unoprostone isopropyl ophthalmic solution may gradually increase the pigmentation of the iris, cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes, exacerbate active intraocular inflammation (e.g., uveitis), and cause macular edema. In clinical studies, the most common ocular adverse reactions with use of Rescula were burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes, and injection. These were reported in approximately 10–25% of patients. Ocular adverse reactions occurring in approximately 5–10% of patients were abnormal vision, eyelid disorder, foreign body sensation, and lacrimation disorder. Other adverse reactions occurred more rarely.
Status:
US Previously Marketed
Source:
Posicor
(1997)
Source URL:
First approved in 1997
Source:
Posicor
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Mibefradil is a calcium channel blocker, chemically unlike other compounds in the class, that was approved by the Food and Drug Administration (FDA), U.S.A. in June 1997 for the treatment of patients with hypertension and chronic stable angina. Shortly following its introduction, mibefradil was withdrawn from the market in the U.S.A. as well as in Europe. The reason for the voluntary withdrawal of the drug by Roche laboratories was claimed to be the result of new information about potentially harmful interactions with other drugs.
Mibefradil is calcium channel blocker with moderate selectivity for T-type Ca2+ channels displaying IC50 values of 2.7 uM and 18.6 uM for T-type and L-type channels respectively. Mibefradil is a tetralol calcium channel blocking agent that inhibits the influx of calcium ions across both the T (low-voltage) and L (high-voltage) calcium channels of cardiac and vascular smooth muscle, with a greater selectivity for T channels. Vasodilation occurs in vascular smooth muscle, causing a decrease in peripheral vascular resistance and a resulting decrease in blood pressure. Mibefradil causes a slight increase in cardiac output during chronic dosing. Mibefradil slows sinus and atrioventricular (AV) node conduction, producing a slight reduction in heart rate and a slight increase in the PR interval. It has also been shown to slightly lengthen the corrected sinus node recovery time and AH interval and to raise the Wenckebach point. The mechanism by which mibefradil reduces angina is not known, but is thought to be attributed to a reduction in heart rate, total peripheral resistance (afterload), and the heart rate-systolic blood pressure product at any given level of exercise. The result of these effects is a decrease in cardiac workload and myocardial oxygen demand. Mibefradil has been repurposed from an abandoned antihypertensive to a targeted solid tumor treatment, and it has been rescued from drug-drug interactions by using short-term dose exposure. Tau is using the early success of mibefradil as a proof of concept to build a platform technology of Cav3 blockers for broad antitumor applications in combination with new targeted cancer therapies, well-established.
Status:
US Previously Marketed
Source:
AMLEXANOX by ULURU
(2004)
Source URL:
First approved in 1996
Source:
APHTHASOL by ULURU
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Amlexanox is an ant allergic drug, clinically effective for atopic diseases, especially allergic asthma and rhinitis. Amlexanox as a topical paste is a well-tolerated treatment of recurrent aphthous ulcers. Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population. The mechanism of action by which amlexanox accelerates healing of aphthous ulcers is unknown. In vitro studies have demonstrated amlexanox to be a potent inhibitor of the formation and/or release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils and mononuclear cells. Given orally to animals, amlexanox has demonstrated anti-allergic and anti-inflammatory activities and has been shown to suppress both immediate and delayed type hypersensitivity reactions. The relevance of these activities of amlexanox to its effects on aphthous ulcers has not been established. Amlexanox inhibits chemical mediatory release of the slow-reacting substance of anaphylaxis (SRS-A) and may have antagonistic effects on interleukin-3. When cells are under stress, they release an inactive form of human fibroblast growth factor 1 (FGF-1), a potent mitogen (entity that causes mitosis). Amlexanox binds to FGF1, increasing its conformational stability, sterically blocking Cu(2+) induced oxidation which normally leads to activation of FGF-1. This drug has been discontinued in the U.S
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings w/ sales less than $25,000 isopropyl palmitate
Source URL:
First approved in 1996
Source:
Hydrocortisone Acetate Pramoxine Hcl by Padagis Israel Pharmaceuticals Ltd
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Isopropyl palmitate is the ester of isopropyl alcohol and palmitic acid. It is an emollient, moisturizer, thickening agent, and anti-static agent. Isopropyl Palmitate is a traditional, fast spreading emollient for modern cosmetic applications. Isopropyl palmitate is approved by ECOCERT for Natural and Organic Cosmetics. It is on FDA CFR - Code of Federal Regulations Title 21 list.
Status:
US Previously Marketed
Source:
SPECTAMINE by IMP
(1987)
Source URL:
First approved in 1987
Source:
SPECTAMINE by IMP
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Iofetamine hydrochloride I-123 is a radiopharmaceutical for cerebral perfusion imaging. lofetamine is the N-isopropyl derivative of amphetamine with iodine 123(1123) at the para position to serve
as the tracer. This configuration was systematically
derived by Winchell et al. to provide sufficient brain
uptake and retention for brain imaging, which typically
requires an acquisition time of 25-40 minutes. After
experimental intraarterial injection the drug has a high
extraction ratio (> 90 percent) in the brain. Iofetamine hydrochloride I-123 permits cerebral blood perfusion imaging with single photon emission computed tomography (SPECT). Iofetamine is an amphetamine analog that is rapidly taken up by the lungs, then redistributed principally to the liver and brain. The precise mechanism of localization has not been determined, but is believed to result from nonspecific receptor binding. Brain uptake peaks at 30 minutes postinjection and remains relatively constant through 60 minutes. The drug is metabolized and excreted in the urine, with negligible activity remaining at 48 hours. When compared with CT in stroke patients, visualization may be performed sooner after symptom onset and a larger zone of involvement may be evident with iofetamine. Localization of seizure foci and diagnosis of Alzheimer's disease may also be possible. As CT has revolutionized noninvasive imaging of brain anatomy, SPECT with iofetamine permits routine cerebral blood flow imaging. Iofetamine hydrochloride I-123 under the brand name Spectamine was approved for use in the United States as a diagnostic aid in determining the localization of and in the evaluation of non-lacunar stroke and complex partial seizures, as well as in the early diagnosis of Alzheimer's disease in 1987. However it was discontinued in USA.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(7) dandruff chloroxylenol
Source URL:
First approved in 1950
Source:
21 CFR 347
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Chlorothymol is a derivate of thymol. Thymol is a known antifungal agent, which was applied as a dusting powder for superficial infections now only found as a general antimicrobial agent used in mouthwashes. Chlorothymol more potent germicide, but severely irritating to the mucous membranes. It is used in cosmetic biocides, denaturants, deodorant agents, oral care agents, and preservatives. Chlorothymol was not considered an ocular irritant. Chlorothymol was nonmutagenic compound in the paper-disk method using E. coli. No adverse reactions were noted during the course of the study of AMA Laboratories in 1996 performed to assess the skin irritation and sensitization of an OTC topical cream. OTC topical cream containing 0.032% Chlorothymol under semiocclusion was considered a nonprimary irritant and a nonprimary sensitizer.
Status:
First approved in 1949
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Isofluorophate (diisopropyl fluorophosphate) is an irreversile acetylcholinesterase inhibitor. It was used in ophthalmology as a miotic agent in treatment of chronic glaucoma.
Status:
US Previously Marketed
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Thymol, a monoterpene, obtained from thyme oil or other volatile oils, is used as a stabilizer in pharmaceutic preparations. It has been used for its antiseptic, antibacterial, and antifungal actions to help reduce and prevent plaque and gingivitis. Recently was shown, that this substance was able to significantly reduce the oxidative stress associated with cataract. The results suggested that thymol might be a potential therapeutic approach in the prevention of diabetic complications through its aldose reductase enzyme inhibitory and antioxidant activities.
Status:
US Previously Marketed
Source:
67 FR 31123 vaginal contraceptive menfegol
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Menfegol-coated condom represents a new birth control method in which the contraceptive efficacy of the condom is enhanced by the spermicidal activity of menfegol. Menfegol possesses in vitro activity against human immunodeficiency virus (HIV). A randomized placebo-controlled safety study covered the use of menfegol foaming tablets for 14 days at increasing frequencies of insertion by 125 prostitutes in Dakar, Senegal. The frequencies of colposcopically diagnosed genital lesions were 5.0%, 11.8%, 27.8%, 49.7%, and 29.4% among menfegol recipients when tablets were used once every other day or 1, 2, 4, or 8 times a day, respectively (P < .05). Among placebo recipients, frequencies were 11.1% and 23.5% when tablets were used < 8 times daily and 8 times daily, respectively. There was no association between subjective genital symptoms and the incidence of colposcopically detected lesions. The high incidence of genital lesions when menfegol foaming tablets were used more than once daily suggests that their frequent use should not be recommended to prevent HIV transmission. In use at low frequency, the tablets' toxicity might be balanced by anti-HIV properties. Safety studies on vaginal microbicides should use objective methods, such as colposcopy, to assess the incidence of lesions.