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Search results for "Codex Alimentarius" in comments (approximate match)
Status:
US Approved Rx
(1990)
Source:
NDA019481
(1990)
Source URL:
First approved in 1990
Source:
NDA019481
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gluconolactone, a lactone of D-glucuronic acid, is a food additive with the E number E575. Gluconolactone is commonly found in honey, fruit juices, wine. In medcine, gluconolactone is used as a component of irrigation solution Renacidin for dissolution of bladder calculi of the struvite or apatite variety, and to prevent or minimize encrustations of indwelling urinary tract catheters.
Status:
US Approved Rx
(1978)
Source:
NDA050514
(1978)
Source URL:
First approved in 1978
Source:
NDA050514
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Natamycin (Pimaricin, Pimafucin, Natadrops, Natacyn) is a polyene antifungal agent originally isolated from Streptomyces natalensis found in a soil sample from Natal, South Africa. Natamycin was discovered in DSM laboratories in 1955. Similar to other polyenes, natamycin binds to ergosterol in the fungal cell membrane. Natamycin blocks fungal growth by binding specifically to ergosterol with¬out permeabilizing the membrane where it inhibits vacuole fusion at the priming phase and interferes with membrane protein functions. Natamycin is also used in the food industry as an effective preservative. Natamycin is active against most Candida spp. Aspergillus spp., Fusarium spp. and other rarer fungi that cause keratitis. Secondary or acquired resistance is probably rare, but not extensively studied. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. Natamycin is poorly soluble in water and not absorbed through the skin or mucous membranes, including the vagina. Very little is absorbed through the gastrointestinal tract. After ocular application, therapeutic concentrations are present within the infected cornea, but not in intra-ocular fluid Natamycin may cause some irritation on skin or mucous membranes
Status:
US Approved Rx
(1993)
Source:
NDA020006
(1993)
Source URL:
First approved in 1955
Source:
Levsin by Alaven Pharmaceutical LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitol is a polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. Used as a non-stimulant laxative via an oral suspension or enema. Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements. Sorbitol plays a vital step in the 'polyol pathway'. The sudden injection of extra sorbitol can ruin the equilibrium of enzymes that regulate the conversion of glucose to fructose in a process associated with the onset of diabetes and its complications. Further, the polyol pathway is involved with a complex network of metabolic activities; disruption leads to a cascade of problems (citations here, here and here) such as mitochondrial failure, cell apoptosis (cell death), and DNA fragmentation. In general, sorbitol induces cell hyperosmotic stress resulting in phosphorylation (uptake of phosphorus into cell) — an important on/off switch regulating enzymes and signaling networks.
Status:
US Approved Rx
(1993)
Source:
NDA020006
(1993)
Source URL:
First approved in 1955
Source:
Levsin by Alaven Pharmaceutical LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitol is a polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. Used as a non-stimulant laxative via an oral suspension or enema. Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements. Sorbitol plays a vital step in the 'polyol pathway'. The sudden injection of extra sorbitol can ruin the equilibrium of enzymes that regulate the conversion of glucose to fructose in a process associated with the onset of diabetes and its complications. Further, the polyol pathway is involved with a complex network of metabolic activities; disruption leads to a cascade of problems (citations here, here and here) such as mitochondrial failure, cell apoptosis (cell death), and DNA fragmentation. In general, sorbitol induces cell hyperosmotic stress resulting in phosphorylation (uptake of phosphorus into cell) — an important on/off switch regulating enzymes and signaling networks.
Status:
US Approved Rx
(2020)
Source:
NDA211281
(2020)
Source URL:
First approved in 1953
Source:
ANDA040621
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lactitol is a sugar alcohol. This ingredient has been determined to be GRAS for specified uses as a direct food additive and foods containing lactitol are eligible for a health claim related to dental caries. Lactitol is used as an oral powder or solution in the management of hepatic encephalopathy and in case of short-term treatment of occasional constipation. Intestinal flora of large intestine is metabolize lactitol to low-molecular organic acid, which leads to an increase in osmotic pressure in intestine, increase in volume of fecal masses bowel function normalization. This drug might cause abdominal discomfort, especially flatulence and abdominal pain rarely or sometimes abdominal distension. These effects tend to diminish or disappear after a few days of regular intake of the drug. Since 'antacids and neomycin can neutralize ' acidifying effect of lactitol on stool, they should not be co-administered with lactitol in cirrhotic patients with hepatic encephalopathy; however both substances do not alter the 'laxative effect in patients with constipation.
Status:
US Approved Rx
(2001)
Source:
NDA021265
(2001)
Source URL:
First approved in 1953
Source:
M.V.I.-12 ADULT by HOSPIRA
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Riboflavin (vitamin B2) is part of the vitamin B group. Riboflavin 5’-phosphate is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways. FAD and riboflavin phosphate in foods are hydrolyzed in the intestinal lumen by nucleotide diphosphatase and a variety of nonspecific phosphatases to yield free riboflavin, which is absorbed in the upper small intestines by a sodium-dependent saturable mechanism. Riboflavin has been used in several clinical and therapeutic situations. For over 30 years, riboflavin supplements have been used as part of the phototherapy treatment of neonatal jaundice. Corneal ectasia is a progressive thinning of the cornea; the most common form of this condition is keratoconus. Collagen cross-linking is a non-surgical treatment intended to slow progression of corneal ectasia by strengthening corneal tissue. The standard protocol calls for application directly to the eye of a 0.1% riboflavin solution for 30 minutes followed by 30 minutes of ultraviolet-A irradiation with a wavelength of 370 nm and power of 3 mW/cm2. Under the conditions used for corneal collagen cross-linking, riboflavin 5‘-phosphate functions as a photo enhancer and generates singlet oxygen which is responsible for the cross-linking.
Status:
US Approved Rx
(2001)
Source:
NDA021265
(2001)
Source URL:
First approved in 1947
Source:
BEROCCA PN by ROCHE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ascorbic acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a slight acidic taste. Ascorbic acid is an electron donor, and this property accounts for all its known functions. As an electron donor, ascorbic acid is a potent water-soluble antioxidant in humans. Ascorbic acid acts as an antioxidant under physiologic conditions exhibiting a cross over role as a pro-oxidant in pathological conditions. Oxidized ascorbic acid (dehydroascorbic acid (DHA) directly inhibits IkappaBalpha kinase beta (IKKbeta) and IKKalpha enzymatic activity in vitro, whereas ascorbic acid did not have this effect. These findings define a function for vitamin C in signal transduction other than as an antioxidant and mechanistically illuminate how vitamin C down-modulates NF-kappaB signaling. Vitamin C is recommended for the prevention and treatment of scurvy. Its parenteral administration is desirable for patients with an acute deficiency or for those whose absorption of orally ingested ascorbic acid (vitamin c) is uncertain. Symptoms of mild deficiency may include faulty bone and tooth development, gingivitis, bleeding gums, and loosened teeth. Febrile states, chronic illness, and infection (pneumonia, whooping cough, tuberculosis, diphtheria, sinusitis, rheumatic fever, etc.) increase the need for ascorbic acid (vitamin c). Hemovascular disorders, burns, delayed fracture and wound healing are indications for an increase in the daily intake.
Status:
US Approved Rx
(2013)
Source:
NDA205815
(2013)
Source URL:
First marketed in 1925
Class (Stereo):
CHEMICAL (ACHIRAL)
Carbon dioxide is a colorless gas occurring naturally in Earth's atmosphere. Carbon dioxide is a primary carbon source for life on Earth. It is produced by all aerobic organisms during metabolism of carbohydrates and lipids. Carbon dioxide is used in food industry as an acidity regulator and for production of carbonated soft drinks and soda water. In medicine, carbon dioxide is commonly used as an insufflation gas for minimally invasive surgery (laparoscopy, endoscopy, and arthroscopy) to enlarge and stabilize body cavities to provide better visibility of the surgical area. A mixture of carbon dioxide and oxygen is used for stimulation of breathing after apnea, in anesthetic procedures to increase the depth of respiration, to facilitate blind intubations in anesthetic practice.
Status:
US Approved Rx
(2016)
Source:
ANDA205880
(2016)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Benzoic acid is a natural ingredient occurring in many foodstuffs and in plant extracts. Benzoic acid, its salts and esters are used as preservatives in cosmetic products, with a maximum concentration of 0.5 %. Benzoic acid and sodium benzoate are on the FDA list of substances that are generally recognized as safe (GRAS). Both may be used as antimicrobial agents, flavouring agents and as adjuvants with a current maximum level of 0.1% in food. Benzoic acid is a constituent of Whitfield Ointment, which is used for the treatment of fungal skin diseases such as tinea, ringworm, and athlete's foot. Adverse effect of Whitfield Ointment: occasionally, a localized mild inflammatory response occurs.
Status:
US Approved Rx
(2003)
Source:
NDA021388
(2003)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Talcum powder is made from talc, a mineral made up mainly of the elements magnesium, silicon, and oxygen. As a powder, it absorbs moisture well and helps cut down on friction, making it useful for keeping skin dry and helping to prevent rashes. It is widely used in cosmetic products such as baby powder and adult body and facial powders, as well as in a number of other consumer products. The therapeutic action of talc instilled into the pleural cavity is believed to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. Sterile Talc Powder, administered intrapleurally via chest tube, is indicated as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients. The most often reported adverse experiences to intrapleurally-administered talc were fever and pain.