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Showing 8271 - 8280 of 8297 results

mixture
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(i)(B) skin protectant:w/ sales less than $25,000 glyceryl stearate
Source URL:

Class:
MIXTURE


Conditions:

Glyceryl 1-stearate (Glycerol monostearate), commonly known as GMS, is an organic molecule used as an emulsifier. GMS is a white, odorless, and sweet-tasting flaky powder that is hygroscopic. It is a glycerol ester of stearicacid. It occurs naturally in the body as a product of the breakdown of fats by pancreatic lipase, and is also found in fatty foods. GMS is a food additive used as a thickening, emulsifying, anti-caking, and preservative agent; an emulsifying agent for oils, waxes, and solvents; a protective coating for hygroscopic powders; a solidifier and control release agent in pharmaceuticals; and a resin lubricant. It is also used in cosmetics and hair care products. Used in antiperspirants and deodorants, baby care, body care, facial care, sun care, conditioners, facial make-up, creams and lotions-skin care, sprayable emulsions, feet, hands and nails, self-tanning, nail grooming and color cosmetics. GMS is largely used in baking preparations to add "body" to the food. It is responsible for giving ice cream and whipped cream its smooth texture. It is sometimes used as an anti-staling agent in bread. Glycerol 1-stearate is affirmed by FDA as GRAS.
mixture
Status:
US Previously Marketed
Source:
CAPREOMYCIN SULFATE by MYLAN LABS LTD
(2017)
Source URL:
First approved in 1971

Class:
MIXTURE



Capreomycin is an antibiotic, which is used in combination other antituberculosis drugs fro the treatment of pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli. Little is known about capreomycin's exact mechanism of action, but it is thought to inhibit protein synthesis by binding to the 70S ribosomal unit. Capreomycin also binds to components in the bacterial cell which result in the production of abnormal proteins.
Acriflavine (ACF) is a topical antiseptic. The hydrochloride form is more irritating than the neutral form. It is derived from acridine. Commercial preparations are often mixtures with proflavine. Acriflavine was developed in 1912 by Paul Ehrlich, a German medical researcher, and was used during the First World War against sleeping sickness. ACF has known trypanocidal, antibacterial, and antiviral activities. Effects of ACF on cancer cells were first reported 50 years ago. By present time was demonstrated that ACF a drug, that binds directly to HIF-1 alpha and HIF-2 alpha and inhibits HIF-1 dimerization and transcriptional activity and thus has potent inhibitory effects on tumor growth and vascularization. Also Acriflavine in combination with 3,6-diaminoacridine (proflavine) could prove to be a potential antimalarial drug and its pharmacological action can be due to inhibition of gyrase activity. This is achieved through interaction of the ACF with the DNA substrate. This interaction may lead to conformation change in DNA unsuitable for binding of gyrase with DNA.
Aconitic Acid found in leaves and tubers of Aconitum napellus L., Ranunculaceae, in various species of Achillea (Compositae) and Equisetum (Equisetaceae), in beet root, and in sugar cane. It is indicated for the temporary relief of symptoms of chronic illness including fatigue, effects of toxin buildup, slowed metabolism, weakened constitution. The limited data on trans-aconitic acid indicate it to be less toxic than citric acid. Trans-aconitate salts appear to be excreted readily by the kidneys. There is no direct evidence that trans-aconitic acid is utilized as is the cis-aconitic acid isomer in mammalian metabolism although non-specific oxidation probably occurs.
mixture
Status:
Possibly Marketed Outside US
Source:
Japan:Kanamycin Monosulfate
Source URL:
First approved in 2022
Source:
Kanamycin Sulfates by KDG Impresa LLC, Aqion
Source URL:

Class:
MIXTURE



Kanamycin (a mixture of kanamycin A, B and C) is an aminoglycoside bacteriocidal antibiotic, available in oral, intravenous, and intramuscular forms, and used to treat a wide variety of infections. It is effective against Gram-negative bacteria and certain Gram-positive bacteria. Aminoglycosides work by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Serious side effects include tinnitus or loss of hearing, toxicity to kidneys, and allergic reactions to the drug. Mixing of an aminoglycoside with beta-lactam-type antibiotics (penicillins or cephalosporins) may result in a significant mutual inactivation. Even when an aminoglycoside and a penicillin-type drug are administered separately by different routes, a reduction in aminoglycoside serum half-life or serum levels has been reported in patients with impaired renal function and in some patients with normal renal function.
Tetraprenylacetone (Geranylgeranylacetone) is an anti-peptic ulcer drug developed and approved in Japan in 1984. Tetraprenylacetone is shown to suppress H. pylori induced tissue and cell injury and inflammatory reaction, so it is expected to show beneficial effects on H. pylori-infected tissues. Tetraprenylacetone is used to treat patients suffering from peptic ulcers and gastritis. In Japan it is sold under the brand name Selbex.
Farnesol, (2E,6E)- is an isoprenoid found in many aromatic plants and is also produced in humans, where it acts on numerous nuclear receptors and has received considerable attention due to its apparent anticancer properties. Farnesol is present in many essential oils such as citronella, neroli, cyclamen, lemon grass, tuberose, rose, musk, balsam, and tolu. It is used in perfumery to emphasize the odors of sweet floral perfumes. Its method of action for enhancing perfume scent is as a co-solvent that regulates the volatility of the odorants. It is especially used in lilac perfumes. Farnesol is a natural pesticide for mites and is a pheromone for several other insects. In a 1994 report released by five top cigarette companies, farnesol was listed as one of 599 additives to cigarettes. Farnesol has been suggested to function as a chemopreventative and anti-tumor agent. Farnesol is subject to restrictions on its use in perfumery as some people may become sensitized to it, however, the evidence that farnesol can cause an allergic reaction in humans is disputed.
Maltose, a disaccharide, is found mainly in grains and cereals. Nutritionally, maltose provides the same number of calories as starches and other sugars. Maltose can be the agent responsible for the primary signals to induce the sensations of hunger and satiation in human beings. It was shown, that parenterally administered maltose could be of clinical value.
mixture
Status:
Possibly Marketed Outside US
Source:
Cetrimide Cream 0.5% by Canadian Custom Packaging Company [Canada]
Source URL:

Class:
MIXTURE



Cetrimide is a quaternary ammonium compound. Cetrimide was first introduced as a combined cleanser and skin antiseptic by Barnes (1942). Cetrimide combines excellent detergent properties and minimal toxicity with a useful antiseptic action. Cetrimide affects membrane permeability allowing ‘leaking’ of essential cell constituents leading to cell death. This medication is a skin antiseptic and disinfectant prescribed for seborrhoeic dermatitis and wound cleansing. The cream has a bactericidal activity against gram-positive bacteria and incompatible with soaps and other anionic surfactants.
mixture
Status:
Possibly Marketed Outside US
Source:
Japan:Acetylkitasamycin
Source URL:

Class:
MIXTURE



Kitasamycin (INN) is a macrolide antibiotic. It is produced by Streptomyces kitasatoensis. The drug has antimicrobial activity against a wide spectrum of pathogens. Kitasamycin Tartrate In 1953, HATA, et al. reported the isolation of a new antibiotic complex known as kitasamycin (leucomycin). The organism producing this antibiotic complex was obtained from soil samples and named Streptotnyces kitasatoensis HATA. In 1967, eight components were separated and their chemical structures determined. This antibiotic was approved by Ministry of Agriculture in 2001 as the growth promoter additive in poultry and swine to control and prevent digestive and respiratory diseases. Belonging to the macrolide antibiotic, its antibacterial activity is similar to tylosin, erythromycin, spiramycin and oleandomycin. The mode of action is to inhibit the protein synthesis process. Its inhibition spectrum includes Mycoplasmas, Gram-positive bacteria, some Gram-negative bacteria, Leptospira, Rickettsia. It also inhibits most bacteria resistant to penicillin, oxytetracycline, chlortetracycline, erythromycin and chloramphenicol bacteria strains. It is a safe and high efficacy growth-promoting additive for swine and poultry. Although this antibiotic was evaluated many years ago, it was felt of interest to determine its activity against recent isolates of gram-positive cocci. Consequently, the in vitro activity of kitasamycin was determined against 214 gram-positive cocci isolated from clinical specimens. Kitasamycin has activity against the vast majority of clinical isolates of S. aureus, Str. pyogenes and Dipl. pneumoniae, but in vitro studies do not suggest that it has any advantages over currently available antibiotics, although it would be expected to be effective in clinical situations in which erythromycin is indicated.

Showing 8271 - 8280 of 8297 results