Country: United States
Language: English
Source: NLM (National Library of Medicine)
Dihydroergocornine Mesylate (UNII: 42RX8KPW29) (Dihydroergocornine - UNII:IK4C1OC8NE), Dihydroergocristine Mesylate (UNII: DS7CL18UAM) (Dihydroergocristine - UNII:05D48LUM4Z), Dihydro-.alpha.-ergocryptine mesylate (UNII: Z4I7BU58DN) (Dihydro-.alpha.-ergocryptine - UNII:202229IR8Y), Dihydro-.beta.-ergocryptine mesylate (UNII: 79Y4U49I29) (Epicriptine - UNII:5M64643B5U)
Sun Pharmaceutical Industries, Inc.
Dihydroergocornine Mesylate
Dihydroergocornine Mesylate 0.333 mg
ORAL
PRESCRIPTION DRUG
A proportion of individuals over sixty who manifest signs and symptoms of an idiopathic decline in mental capacity (i.e., cognitive and interpersonal skills, mood, self-care, apparent motivation) can experience some symptomatic relief upon treatment with ergoloid mesylates preparations. The identity of the specific trait(s) or condition(s), if any, which would usefully predict a response to ergoloid mesylates therapy is not known. It appears, however, that those individuals who do respond come from groups of patients who would be considered clinically to suffer from some ill-defined process related to aging or to have some underlying dementing condition (i.e., primary progressive dementia, Alzheimer's dementia, senile onset, multi-infarct dementia). Before prescribing ergoloid mesylates, the physician should exclude the possibility that the patient's signs and symptoms arise from a potentially reversible and treatable condition. Particular care should be taken to exclude delirium and dementiform illness secon
Ergoloid mesylates tablets, USP (oral) 1 mg are white, round, unscored, debossed MP 20 Bottles of 50 NDC 53489-281-02 Bottles of 100 NDC 53489-281-01 Bottles of 250 NDC 53489-281-03 Bottles of 500 NDC 53489-281-05 Bottles of 1000 NDC 53489-281-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
ERGOLOID MESYLATES- DIHYDROERGOCORNINE MESYLATE, DIHYDROERGOCRISTINE MESYLATE, DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE, AND DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE TABLET SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- ERGOLOID MESYLATES TABLETS USP (ORAL) RX ONLY DESCRIPTION Each tablet for oral use contains ergoloid mesylates USP; a mixture of the methanesulfonate salt of the following hydrogenated alkaloids: R Dihydroergocornine -CH(CH ) Dihydroergocristine -CH C H Dihydro-α-ergocryptine -CH CH(CH ) Dihydro-β-ergocryptine -CH(CH )CH CH C H N O • CH O S (dihydroergocornine mesylate) 659.79 C H N O • CH O S (dihydroergocristine mesylate) 707.84 C H N O • CH O S (dihydro-α-ergocryptine mesylate) 673.82 C H N O • CH O S (dihydro-β-ergocryptine mesylate) 673.82 * 1 mg Dihydroergocristine mesylate 0.333 mg Dihydroergocornine mesylate 0.333 mg Dihydroergocryptine mesylate 0.333 mg 3 2 2 6 5 2 3 2 3 2 3 31 41 5 5 4 3 35 41 5 5 4 3 32 43 5 5 4 3 32 43 5 5 4 3 exists as a mixture of alpha and beta isomers in a ratio of 2:1 * Inactive ingredients for oral tablets are: butylated hydroxyanisol, corn starch, hydrogenated vegetable oil, lactose, mannitol, polyvinyl pyrrolidone, stearic acid and talc. CLINICAL PHARMACOLOGY There is no specific evidence which clearly establishes the mechanism by which ergoloid mesylates preparations produce mental effects, nor is there conclusive evidence that the drug particularly affects cerebral arteriosclerosis or cerebrovascular insufficiency. PHARMACOKINETIC PROPERTIES Pharmacokinetic studies have been performed in normal volunteers with the help of radiolabelled drug as well as employing a specific radioimmunoassay technique. From the urinary excretion quotient of orally and intravenously administered tritium-labelled ergoloid mesylates the absorption of ergoloid was calculated to be 25%. Following oral administration, peak levels of 0.5 ngEq/mL/mg were achieved within 1.5–3 hr. Bioavailability studies with the specific radioimmunoassay confirm that ergoloid is rapidly absorbed Read the complete document