ERGOLOID MESYLATES- dihydroergocornine mesylate, dihydroergocristine mesylate, dihydro-.alpha.-ergocryptine mesylate, and dihydr

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Carilion Materials Management

INN (International Name):

DIHYDROERGOCORNINE MESYLATE

Composition:

DIHYDROERGOCORNINE MESYLATE 0.333 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Product: 68151-2780 NDC: 68151-2780-0 1 TABLET in a PACKAGE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOLOID MESYLATES- DIHYDROERGOCORNINE MESYLATE, DIHYDROERGOCRISTINE
MESYLATE,
DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE, AND DIHYDRO-.BETA.-ERGOCRYPTINE
MESYLATE TABLET
CARILION MATERIALS MANAGEMENT
----------
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
*
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 from the gast