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Restrict the search for
icosapent ethyl
to a specific field?
Status:
US Approved Rx
(2001)
Source:
NDA021074
(2001)
Source URL:
First marketed in 0652
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Alcohols exhibit rapid broad-spectrum antimicrobial activity against vegetative bacteria (including mycobacteria), viruses, and fungi but are not sporicidal. They are, however, known to inhibit sporulation and spore germination, but this effect is reversible. Because of the lack of sporicidal activity, alcohols are not recommended for sterilization but are widely used for both hard-surface disinfection and skin antisepsis. Lower concentrations may also be used as preservatives and to potentiate the activity of other biocides. Many alcohol products include low levels of other biocides (in particular chlorhexidine), which remain on the skin following evaporation of the alcohol, or excipients (including emollients), which decrease the evaporation time of the alcohol and can significantly increase product efficacy. Ethanol in combination with: chlorhexidine gluconate 1% was approved to use in surgical hand antiseptic. It significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. Ethanol is also used as a co-solvent to dissolve many insoluble drugs and to serve as a mild sedative in some medicinal formulations. Ethanol is metabolized by the hepatic enzyme alcohol dehydrogenase. Ethanol affects the brain’s neurons in several ways. It alters their membranes as well as their ion channels, enzymes, and receptors. Alcohol also binds directly to the receptors for acetylcholine, serotonin, GABA, and the NMDA receptors for glutamate. The sedative effects of ethanol are mediated through binding to GABA receptors and glycine receptors (alpha 1 and alpha 2 subunits). It also inhibits NMDA receptor functioning. In its role as an anti-infective, ethanol acts as an osmolyte or dehydrating agent that disrupts the osmotic balance across cell membranes.
Status:
US Approved OTC
Source:
21 CFR 341.16(g) cough/cold:bronchodilator racepinephrine hydrochloride
Source URL:
First approved in 2000
Source:
21 CFR 341
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Racepinephrine or racemic epinephrine is a mixture of levo and dextro isomers of epinephrine act as a nonselective agonist at adrenergic receptors. It is a bronchodilator used in the temporary relief of mild symptoms of intermittent asthma including wheezing, shortness of breath. Inhaled racepinephrine became available in September 2012 as a nonprescription treatment for bronchospasm based on a 1986 US Food and Drug Administration rule. Besides, racemic epinephrine relieves respiratory distress in hospitalized infants with bronchiolitis and is safe but does not abbreviate hospital stay. Morbidity associated with bronchiolitis as identified by parents persists for at least one week after hospital discharge in most infants.
Status:
US Approved OTC
Source:
21 CFR 333.310(a) acne benzoyl peroxide
Source URL:
First approved in 1984
Source:
NDA050557
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl peroxide is used as an acne treatment, for bleaching hair and teeth. Adverse reactions are: dryness and urticarial reaction, contact dermatitis, application site burning, application site irritation and skin irritation.
Status:
US Approved OTC
Source:
21 CFR 333.210(c) antifungal miconazole nitrate
Source URL:
First approved in 1974
Source:
MONISTAT-DERM by INSIGHT PHARMS
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Miconazole is a synthetic imidazole derivative, a topical antifungal agent for use in the local treatment of vaginal, and skin and nail infections due to yeasts and dermatophytes. It is particularly active against Candida spp., Trichophyton spp., Epidermophyton spp., Microsporum spp. and Pityrosporon orbiculare (Malassezia furfur), but also possesses some activity against Gram-positive bacteria. It binds to the heme moiety of the fungal cytochrome P-450 dependent enzyme lanosterol 14-alpha-demethlyase. Inhibits 14-alpha-demethlyase, blocks formation of ergosterol and leads to the buildup of toxic methylated 14-a-sterols. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of active oxygen species within the cell.
Status:
US Approved OTC
Source:
21 CFR 341.16(f) cough/cold:bronchodilator racephedrine hydrochloride
Source URL:
First approved in 1961
Source:
CHOLARACE RACEPHEDRINE HYDROCHLORIDE by WC
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Racephedrine in combination with theophylline, phenobarbital was used to treat bronchial asthma. However, its application was substituted more effective agent. In addition, FDA has reviewed the final monograph for over-the-counter bronchodilator drug products to add additional warnings and to revise the indications in the labeling of products containing racephedrine hydrochloride.
Status:
US Approved OTC
Source:
21 CFR 341.20(a)(3) cough/cold:nasal decongestant pseudoephedrine sulfate
Source URL:
First approved in 1961
Source:
DISOPHROL by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Pseudoephedrine is a sympathomimetic drug. Pseudoephedrine acts as an adrenomimetic and inhibitor of monoamine transporters. Ephedra sinica, a species of ephedra (ma huang), contains ephedrine and pseudoephedrine. Ephedra has been found to stimulate the nervous system, increase airflow into the lungs and constrict blood vessels. In combination with caffeine, ephedra appears to cause weight loss. Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies.
Status:
US Approved OTC
Source:
21 CFR 341.14(a)(1) cough/cold:antitussive chlophedianol hydrochloride
Source URL:
First approved in 1960
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Chlophedianol (Clofedanol) is a centrally-acting cough suppressant, although the mechanism of action is not known. It is available in Canada under the trade name Ulone. It is not available in the United States. Chlophedianol (Clofedanol) suppresses the cough reflex by a direct effect on the cough center in the medulla of the brain. It also has local anesthetic and antihistamine properties, and may have anticholinergic effects at high doses.
Status:
US Approved OTC
Source:
21 CFR 341.12(a) cough/cold:antihistamine brompheniramine maleate
Source URL:
First approved in 1956
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Brompheniramine is an antihistaminergic medication of the propylamine class. It is a first-generation antihistamine, which is used for the treatment of the symptoms of the common cold and allergic rhinitis, such as runny nose, itchy eyes, watery eyes, and sneezing. In allergic reactions, an allergen interacts with and cross-links surface IgE antibodies on mast cells and basophils. Once the mast cell-antibody-antigen complex is formed, a complex series of events occurs that eventually leads to cell-degranulation and the release of histamine (and other chemical mediators) from the mast cell or basophil. Once released, histamine can react with local or widespread tissues through histamine receptors. Brompheniramine is a histamine H1 antagonist of the alkylamine class. It provides effective, temporary relief of sneezing, watery and itchy eyes, and runny nose due to hay fever and other upper respiratory allergies. Brompheniramine is metabolised by cytochrome P450s. The halogenated alkylamine antihistamines all exhibit optic isomerism and brompheniramine products contain racemic brompheniramine maleate whereas dexbrompheniramine (Drixoral) is the dextrorotary (right-handed) stereoisomer.
Status:
US Approved OTC
Source:
21 CFR 341.12(c) cough/cold:antihistamine chlorpheniramine maleate
Source URL:
First approved in 1949
Source:
CHLOR-TRIMETON by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Chlorpheniramine is an antihistamine. Chlorpheniramine binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. Chlorpheniramine is used for relieving symptoms of sinus congestion, sinus pressure, runny nose, watery eyes, itching of the nose and throat, and sneezing due to upper respiratory infections (eg, colds), allergies, and hay fever. In addition to being a histamine H1 receptor (HRH1) antagonist, chlorphenamine has been shown to work as a serotonin-norepinephrine reuptake inhibitor or SNRI.
Status:
US Approved OTC
Source:
21 CFR 341.12(l) cough/cold:antihistamine thonzylamine hydrochloride
Source URL:
First approved in 1948
Class (Stereo):
CHEMICAL (ACHIRAL)
Thonzylamine (also known as neohetramine) is an antihistamine and anticholinergic drug, which is used in combination with others compounds for the temporarily relieves symptoms due to the common cold: hay fever (allergic rhinitis) or other upper respiratory allergies: nasal congestion; runny nose and so on. In addition, thonzylamine was investigated for the treatment of tuberculosis, when this drug caused a slight reduction in the extent of tuberculosis in experimentally infected guinea pigs and caused a slight but significant increase in the length of survival.
