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Search results for vitamin root_codes_comments in Code Comments (approximate match)
Status:
US Approved OTC
Source:
21 CFR 333.110(a) first aid antibiotic:ointment bacitracin
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Bacitracin is a polypeptide antibiotic produced by Bacillus subtilis and Bacillus licheniformis. Bacitracin in combination with neomycin and polymyxin B is indicated for the treatment of many bacterial diseases. The antibacterial properties of bacitracin are mediated by its binding to C55-isoprenyl pyrophosphate, resulting in inhibition of cell wall biosynthesis.
Status:
US Previously Marketed
Source:
LUTREPULSE KIT by FERRING
(1989)
Source URL:
First approved in 1978
Source:
NADA098379
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings w/ sales less than $25,000 glyceryl stearate
Source URL:
First approved in 1971
Source:
ANDA090256
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.
Status:
US Previously Marketed
Source:
CAPASTAT SULFATE by EPIC PHARMA LLC
(1971)
Source URL:
First approved in 1971
Source:
CAPASTAT SULFATE by EPIC PHARMA LLC
Source URL:
Class:
MIXTURE
Targets:
Conditions:
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.
Status:
US Previously Marketed
Source:
SPOROSTACIN BENZALKONIUM CHLORIDE by ORTHO
(1961)
Source URL:
First marketed in 1921
Class:
MIXTURE
Benzalkonium chloride, also known as BZK, BKC, BAC, alkyldimethylbenzylammonium chloride and ADBAC, is a type of cationic surfactant. It is an organic salt called a quaternary ammonium compound. In 2011, a large clinical trial designed to evaluate the efficacy of hand sanitizers based on different active ingredients in preventing virus transmission amongst schoolchildren was re-designed to exclude sanitizers based on benzalkonium chloride due to safety concerns. Benzalkonium chloride has been in common use as a pharmaceutical preservative and antimicrobial since the 1940s. While early studies confirmed the corrosive and irritant properties of benzalkonium chloride, investigations into the adverse effects of, and disease states linked to, benzalkonium chloride have only surfaced during the past 30 years. Benzalkonium chloride is classed as a Category III antiseptic active ingredient by the United States Food and Drug Administration. Ingredients are categorised as Category III when "available data are insufficient to classify as safe and effective, and further testing is required”. Benzalkonium chloride is excluded from the current United States Food and Drug Administration review of the safety and effectiveness of consumer antiseptics and topical antimicrobial over-the-counter drug products, meaning it will remain a Category III ingredient. The mechanism of bactericidal/microbicidal action is thought to be due to disruption of intermolecular interactions. This can cause dissociation of cellular membrane lipid bilayers, which compromises cellular permeability controls and induces leakage of cellular contents. Other biomolecular complexes within the bacterial cell can also undergo dissociation. Enzymes, which finely control a wide range of respiratory and metabolic cellular activities, are particularly susceptible to deactivation. Critical intermolecular interactions and tertiary structures in such highly specific biochemical systems can be readily disrupted by cationic surfactants. Benzalkonium chloride is a human skin and severe eye irritant. It is a suspected respiratory toxicant, immunotoxicant, gastrointestinal toxicant and neurotoxicant.
Status:
Possibly Marketed Outside US
First approved in 1999
Source:
21 CFR 358H
Source URL:
Class:
MIXTURE
Conditions:
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.
Status:
US Approved Rx
(2003)
Source:
BLA103979
(2003)
Source URL:
First approved in 2003
Source:
BLA103979
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1996)
Source:
BLA020604
(1996)
Source URL:
First approved in 1976
Class:
PROTEIN
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ASPEN GLOBAL INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ASPEN GLOBAL INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.