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Restrict the search for
telotristat ethyl
to a specific field?
Status:
US Approved Rx
(1999)
Source:
ANDA040319
(1999)
Source URL:
First approved in 1950
Source:
BENTYL by ALLERGAN
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Dicyclomine is an anticholinergic tertiary amine used frequently by oral and parenteral route as an effective anti-spasmodic agent. Dicyclomine hydrochloride salt is approved under brand name bentyl for the treatment of functional bowel/irritable bowel syndrome. In addition is known, that dicyclomine is also used in morning and motion sickness, dysmenorrheal, intestinal hypermotility. It was shown, that Dicyclomine is a selective M1 and M3 muscarinic receptors antagonist, but os shown pharmacological activity via the M1 receptor.
Status:
US Approved Rx
(2017)
Source:
ANDA206332
(2017)
Source URL:
First approved in 1950
Source:
PRONESTYL by APOTHECON
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Procainamide is a derivative of procaine with less CNS action. Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Procainamide (PA) increases the effective refractory period of the atria, and to a lesser extent the bundle of His-Purkinje system and ventricles of the heart. It reduces impulse conduction velocity in the atria, His-Purkinje fibers, and ventricular muscle, but has variable effects on the atrioventricular (A-V) node, a direct slowing action and a weaker vagolytic effect, which may speed A-V conduction slightly. Myocardial excitability is reduced in the atria, Purkinje fibers, papillary muscles, and ventricles by an increase in the threshold for excitation, combined with inhibition of ectopic pacemaker activity by retardation of the slow phase of diastolic depolarization, thus decreasing automaticity especially in ectopic sites. Contractility of the undamaged heart is usually not affected by therapeutic concentrations, although slight reduction of cardiac output may occur, and may be significant in the presence of myocardial damage. Therapeutic levels of PA may exert vagolytic effects and produce slight acceleration of heart rate, while high or toxic concentrations may prolong A-V conduction time or induce A-V block, or even cause abnormal automaticity and spontaneous firing by unknown mechanisms. Procainamide is sodium channel blocker. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action.
Status:
US Approved Rx
(1981)
Source:
ANDA087204
(1981)
Source URL:
First approved in 1949
Source:
EURAX by JOURNEY
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Crotamiton is a scabicidal and antipruritic agent available as a cream or lotion for topical use. The drug was approved by FDA for the treatment of scabies and pruritic skin. Crotamiton is a mixture of the cis and trans isomers of N-ethyl-N-(o-methylphenyl)-2butenamide. Although the activity of crotamiton was shown both in vitro and in vivo, the mechanism of its action is still unknown.
Status:
US Approved Rx
(2023)
Source:
ANDA211703
(2023)
Source URL:
First approved in 1948
Source:
ISUPREL by SANOFI AVENTIS US
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Isoproterenol (trade names Medihaler-Iso and Isuprel) is a medication used for the treatment of bradycardia (slow heart rate), heart block, and rarely for asthma. Isoproterenol is a non-selective β adrenoreceptor agonist and TAAR1 agonist that is the isopropylaminomethyl analog of epinephrine. Isoprenaline's effects on the cardiovascular system (non-selective) relate to its actions on cardiac β1 receptors and β2 receptors on smooth muscle within the tunica media of arterioles. Isoprenaline has positive inotropic and chronotropic effects on the heart. β2 adrenoceptor stimulation in arteriolar smooth muscle induces vasodilation. Its inotropic and chronotropic effects elevate systolic blood pressure, while its vasodilatory effects tend to lower diastolic blood pressure. The overall effect is to decrease mean arterial pressure due to the β2 receptors' vasodilation. The adverse effects of isoprenaline are also related to the drug's cardiovascular effects. Isoprenaline can produce tachycardia (an elevated heart rate), which predisposes patients to cardiac arrhythmias.
Status:
US Approved Rx
(2018)
Source:
ANDA210484
(2018)
Source URL:
First approved in 1947
Source:
NDA021624
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Methadone, sold under the brand names Dolophine among others, is an synthetic opioid that is used as the hydrochloride to treat pain and as maintenance therapy or to help with detoxification in people with opioid dependence. Methadone hydrochloride is a mu-agonist; a synthetic opioid analgesic with multiple actions qualitatively similar to those of morphine. Some data also indicate that methadone acts as an antagonist at the NMDA-receptor. The contribution of NMDA receptor antagonism to methadone’s efficacy is unknown. Most common adverse reactions are: lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. Avoid use mixed agonist/antagonist and partial agonist opioid analgesics with DOLOPHINE because they may reduce analgesic effect of DOLOPHINE or precipitate withdrawal symptoms.
Status:
US Approved Rx
(2004)
Source:
ANDA040541
(2004)
Source URL:
First approved in 1946
Source:
SOTRADECOL by ELKINS SINN
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. Sodium tetradecyl sulfate is the active component of the sclerosant drug Sotradecol. Sotradecol (sodium tetradecyl sulfate injection) is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent. Sotradecol® (sodium tetradecyl sulfate injection) is indicated in
the treatment of small uncomplicated varicose veins of the lower
extremities that show simple dilation with competent valves. The
benefit-to-risk ratio should be considered in selected patients who are great surgical risks. Sodium tetradecyl sulfate is a potent toxin for endothelial cells in that brief exposure to even low concentrations are effective in stripping endothelium over a considerable distance and exposing highly thrombogenic endothelium in the process. Diluted sodium tetradecyl sulfate is also able to induce a hypercoagulable state, possibly by selective inhibition of protein C, and can also promote platelet aggregation. In the UK, Ireland, Italy, Australia, New Zealand and South Africa, it is sold under the trade-name Fibro-Vein in concentrations of 0.2%, 0.5%, 1.0%, and 3%
Status:
US Approved Rx
(1999)
Source:
ANDA040331
(1999)
Source URL:
First approved in 1942
Source:
NDA021171
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Pethidine, also known as meperidine and Demerol, a narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Meperidine is an opioid agonist with multiple actions qualitatively similar to those of morphine. Most common adverse reactions were lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. Pethidine has serious interactions that can be dangerous with monoamine oxidase inhibitors (e.g., furazolidone, isocarboxazid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine). Pethidine can interact with muscle relaxants, some antidepressants, benzodiazepines, and ethanol.
Status:
US Approved Rx
(2017)
Source:
ANDA204829
(2017)
Source URL:
First approved in 1942
Source:
NDA021642
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cyanocobalamin (commonly known as Vitamin B12) is the most chemically complex of all the vitamins. Cyanocobalamin's structure is based on a corrin ring, which, although similar to the porphyrin ring found in heme, chlorophyll, and cytochrome, has two of the pyrrole rings directly bonded. The central metal ion is Co (cobalt). Cyanocobalamin is naturally found in foods including meat (especially liver and shellfish), eggs, and milk products.Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein
and myelin synthesis. Cells characterized by rapid division (e.g., epithelial cells, bone
marrow, myeloid cells) appear to have the greatest requirement for vitamin B12. Vitamin
B12 can be converted to coenzyme B12 in tissues, and as such is essential for conversion
of methylmalonate to succinate and synthesis of methionine from homocysteine, a
reaction which also requires folate. In the absence of coenzyme B12, tetrahydrofolate
cannot be regenerated from its inactive storage form, 5- methyltetrahydrofolate, and a
functional folate deficiency occurs. Vitamin B12 also may be involved in maintaining
sulfhydryl (SH) groups in the reduced form required by many SH-activated enzyme
systems. Through these reactions, vitamin B12 is associated with fat and carbohydrate
metabolism and protein synthesis. Vitamin B12 deficiency results in megaloblastic
anemia, GI lesions, and neurologic damage that begins with an inability to produce
myelin and is followed by gradual degeneration of the axon and nerve head.
Cyanocobalamin is the most stable and widely used form of vitamin B12, and has
hematopoietic activity apparently identical to that of the antianemia factor in purified
liver extract. Parenteral (intramuscular) administration of vitamin B12 completely reverses the
megaloblastic anemia and GI symptoms of vitamin B12 deficiency.
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
(1976)
Source:
NDA017641
(1976)
Source URL:
First marketed in 1921
Source:
Elixir of Iron Lactate N.F.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Sodium lactate is primarily indicated as a source of bicarbonate for prevention or control of mild to moderate metabolic acidosis in patients
with restricted oral intake whose oxidative processes are not seriously impaired. Sodium Lactate is most commonly associated with an E number of “E325” Sodium Lactate blends are commonly used in meat and poultry products to extend shelf life and increase food safety. They have a broad antimicrobial action and are effective at inhibiting most spoilage and pathogenic bacteria. In addition sodium lactate is used in cosmetics as a humectant, providing moisture.
