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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
(2002)
Source:
NDA021321
(2002)
Source URL:
First marketed in 1921
Class:
POLYMER
Conditions:
Icodextrin is a colloid osmotic agent, derived from maltodextrin, used in form of an aqueous solution for peritoneal dialysis under the trade name Extraneal and after gynecological laparoscopic surgery for the reduction of post-surgical adhesions (fibrous bands that form between tissues and organs) under the trade name Adept. Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds. Icodextrin. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, Extraneal also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status. Absorption of icodextrin from the peritoneal cavity follows zero-order kinetics consistent with convective transport via peritoneal lymphatic pathways. Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization, including maltose, maltotriose, maltotetraose, and higher molecular weight species
Status:
US Approved OTC
Source:
21 CFR 349.12(d)(4) ophthalmic:demulcents polysorbate 80
Source URL:
First approved in 1949
Class:
POLYMER
Conditions:
Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.
Status:
US Previously Marketed
Source:
TODAY by MAYER LABS INC
(1983)
Source URL:
First approved in 1959
Class:
POLYMER
Conditions:
Nonoxynol-9, is an organic compound that is used as a surfactant and vaginal spermicide used for contraception in spermicidal creams, jellies, foams, gel, and lubricants. It is also used in conjuction with other methods of contraception, including condoms, cervical caps and diaphragms. Nonoxynol-9 interacts with the lipids in the membranes of the acrosome and the midpiece of the sperm. The sperm membranes are lysed; the acrosome, neck and midpiece of the spermatozoa are loosened and then detached which results in their immobilization and death. Nonoxynol-9 offers no protection against sexually transmitted infections such as gonorrhoea, chlamydia and does not prevent HIV infection and may even favour infection if used frequently. A possible reason, is that nonoxynol-9 can disrupt the epithelium, or wall, of the vagina, thereby potentially facilitating invasion by an infective organism and virus. Nonoxynol-9 and related compounds are ingredients in various cleaning and cosmetic products.
Status:
First approved in 1953
Class:
POLYMER
Conditions:
Tyloxapol is a nonionic liquid polymer of the alkyl aryl polyether alcohol type that is used as a surfactant to aid liquefaction and removal of mucopurulent (containing mucus and pus) bronchopulmonary secretions. Tyloxapol is also used as a detergent, dispersing agent, encapsulating agent and a hydroxy radical scavenger. Tyloxapol has been used as a mucolytic agent for over 50 years and has proven to be well tolerated during this time. Tyloxapol influences the respiratory system by the following four different action mechanisms: secretolytic action, reduction of surface tension, dissolution of coatings and down-regulation of inflammation. Several studies have shown that small quantities of Tyloxapol applied as an aerosol liquefy sputum. The viscosity of sputum is reduced by 10% to 20% according to rotational viscosimetry measurements. Tyloxapol also penetrates the mucous wall and dissolves viscous and dried secretions, thus enabling increased ciliary activity in the respiratory tract. Although the mechanism of Tyloxapol has been well described, and there is a long-standing basis for its clinical usefulness, there are almost no randomized, double-blind, placebo-controlled trials available that demonstrate the superiority of Tyloxapol vs. saline. Side-effects in the form of hypersensitivity reactions have only occurred very rarely.
Status:
US Previously Marketed
Source:
INULIN AND SODIUM CHLORIDE by ISO TEX
(1940)
Source URL:
First approved in 1940
Source:
INULIN AND SODIUM CHLORIDE by ISO TEX
Source URL:
Class:
POLYMER
Conditions:
Inulin is a water soluble storage polysaccharide used as a prebiotic, fat replacer, sugar replacer, and texture modifier. Inulin is a soluble fiber which is not digested by human enzymes and produces distinctive fiber-alike results on the effectiveness of the gut, thus, lowering the pH of intestine, providing assistance in relieving constipation and increasing stool load or rate. Inulin decrease the risk of many diseases of the intestinal tract, particularly irritable bowel diseases and colon cancer. Inulin products contain mainly short-chain molecules which enhance the sweetness of sucrose up to 35%, thus it is useful to partially replace sucrose molecule’s flavor. Inulin has been proved an attractive applicant as a low-calorie bulking agent in chocolate, mostly in combination with a polyol which replaces sugar contents without any effect on fat contents. Further uses of inulin include colon specific drug administration and stabilizing and adjuvating vaccine formulations.
Status:
Possibly Marketed Outside US
Source:
Sonifilan by Kaken Pharmaceutical
Source URL:
First approved in 2023
Source:
M016
Source URL:
Class:
POLYMER
Targets:
Conditions:
Sizofiran (Schizophyllan, SPG, Sonifilan, Sizofilan) is a soluble beta-D-glucan produced by the Basidiomycetes fungus, Schizophyllum commune Fries, with potential immunomodulating and antitumor activities. Although sizofiran’s exact mechanism of action has yet to be fully elucidated, this agent appears to stimulate the immune system by increasing cytokine production, activating macrophages and Langerhans cells and enhancing the activity of polymorphonuclear leukocytes (PML) and natural killer (NK) cells. Sizofiran was found rather ineffective against gastric cancer, but extended survival time in patients with head and neck cancer. In cervical cancer, Sizofiran prolonged survival and time to recurrence for stage II cases but not stage III, and showed added effectiveness when injected directly into the tumor mass. Sonifilan is used as a biological response modifier (BRM) with radiation therapy for cancer treatment in Japan. It was launched for cervical cancer in South Korea in 1998.
Status:
Possibly Marketed Outside US
Source:
ageLOC
Source URL:
First approved in 2012
Source:
21 CFR 347
Source URL:
Class:
POLYMER
Conditions:
Status:
Possibly Marketed Outside US
Source:
NCT04671914: Phase 4 Interventional Recruiting Asherman Syndrome
(2021)
Source URL:
First approved in 2002
Source:
ANDA076559
Source URL:
Class:
POLYMER
Conditions:
Hyaluronic acid (HA) is a high molecular weight biopolysacharide, discovered in 1934, by Karl Meyer and his assistant, John Palmer in the vitreous of bovine eyes. Hyaluronic acid is a naturally occurring biopolymer, which has important biological functions in bacteria and higher animals including humans. It is found in most connective tissues and is particularly concentrated in synovial fluid, the vitreous fluid of the eye, umbilical cords and chicken combs. It is naturally synthesized by a class of integral membrane proteins called hyaluronan synthases, and degraded by a family of enzymes called hyaluronidases. Hyaluronan synthase enzymes synthesize large, linear polymers of the repeating disaccharide structure of hyaluronan by alternating addition of glucuronic acid and N-acetylglucosamine to the growing chain using their activated nucle¬otide sugars (UDP – glucuronic acid and UDP-N-acetlyglucosamine) as substrates. The number of repeat disaccharides in a completed hyaluronan molecule can reach 10 000 or more, a molecular mass of ~4 million daltons (each disaccharide is ~400 daltons). The average length of a disaccharide is ~1 nm. Thus, a hyaluronan molecule of 10 000 repeats could ex¬tend 10 μm if stretched from end to end, a length approximately equal to the diameter of a human erythrocyte. Although the predominant mechanism of HA is unknown, in vivo, in vitro, and clinical studies demonstrate various physiological effects of exogenous HA. Hyaluronic acid possesses a number of protective physiochemical functions that may provide some additional chondroprotective effects in vivo and may explain its longer term effects on articular cartilage. Hyaluronic acid can reduce nerve impulses and nerve sensitivity associated with pain. In experimental osteoarthritis, this glycosaminoglycan has protective effects on cartilage. Exogenous HA enhances chondrocyte HA and proteoglycan synthesis, reduces the production and activity of proinflammatory mediators and matrix metalloproteinases, and alters the behavior of immune cells. In addition to its function as a passive structural molecule, hyaluronan also acts as a signaling molecule by interacting with cell surface receptors and regulating cell proliferation, migration, and differentiation. Hyaluronan is essential for embryogenesis and is likely also important in tumorigenesis. HA plays several important organizational roles in the extracellular matrix (ECM) by binding with cells and other components through specific and nonspecific interactions. Hyaluronan-binding pro¬teins are constituents of the extracellular matrix, and stabilize its integrity. Hyaluronan receptors are involved in cellular signal transduction; one receptor family includes the binding proteins aggrecan, link protein, versican and neurocan and the receptors CD44, TSG6, GHAP and LYVE-1. The chondroprotective effects of hyaluronic acid, e.g., that it stimulates the production of tissue in¬hibitors of matrix metalloproteineses (TIMP-1) by chondrocytes, inhibits neutrophil-mediated cartilage degradation and attenuates IL-1 induced matrix de¬generation and chondrocyte cytotoxicity have been observed in vitro. Articular chondrocytes cultured in the presence of HA have a significantly greater rate of DNA proliferation and ex¬tracellular matrix production, compared with chon¬drocytes cultured without HA.
Status:
Possibly Marketed Outside US
Source:
LACRISERT
Source URL:
First approved in 1995
Source:
Bio-Groom Lido-Med Veterinary Strength by Bio-Derm Laboratories Inc.
Source URL:
Class:
POLYMER
Targets:
Hydroxypropyl cellulose (HPC) is an ether of cellulose where some of the hydroxyl groups of the cellulose have been hydroxypropylated. Hydroxypropyl cellulose is used as an excipient, and topical ophthalmic protectant and lubricant. Hydroxypropyl cellulose, manufactured by Aton Pharma, is a formulation of HPC used for artificial tears. It is used to treat medical conditions characterized by insufficient tear production such as keratoconjunctivitis sicca), recurrent corneal erosions, decreased corneal sensitivity, exposure, and neuroparalytic keratitis. HPC is also used as a lubricant for artificial eyes. Hydroxypropyl cellulose acts to stabilize and thicken the precorneal tear film and prolong the tear film breakup time which is usually accelerated in patients with dry eye states. Hydroxypropyl cellulose usually reduces the signs and symptoms resulting from moderate to severe dry eye syndromes, such as conjunctival hyperemia, corneal and conjunctival staining with rose bengal, exudation, itching, burning, foreign body sensation, smarting, photophobia, dryness, and blurred and cloudy vision. Progression visual deterioration which occurs in some patients may be retarded, halted, or sometimes reversed.