Ergoloid Mesylates

Ergoloid Mesylates

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FDA Labeling Changes

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Uses

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 secondary to systemic disease, primary neurological disease, or primary disturbance of mood. Ergoloid mesylates preparations are not indicated in the treatment of acute or chronic psychosis, regardless of etiology (see ). CONTRAINDICATIONS

The decision to use ergoloid mesylates in the treatment of an individual with a symptomatic decline in mental capacity of unknown etiology should be continually reviewed since the presenting clinical picture may subsequently evolve sufficiently to allow a specific diagnosis and a specific alternative treatment. In addition, continued clinical evaluation is required to determine whether any initial benefit conferred by ergoloid mesylates therapy persists with time.

The efficacy of ergoloid mesylates was evaluated using a special rating scale known as the SCAG (Sandoz Clinical Assessment-Geriatric). The specific items on this scale on which modest but statistically significant changes were observed at the end of twelve weeks include: mental alertness, confusion, recent memory, orientation, emotional lability, self-care, depression, anxiety/fears, cooperation, sociability, appetite, dizziness, fatigue, bothersome(ness), and an overall impression of clinical status.

History

There is currently no drug history available for this drug.

Other Information

Each tablet for oral use contains ergoloid mesylates USP; a mixture of the methanesulfonate salt of the following hydrogenated alkaloids:

Chemical Structure

R
Dihydroergocornine -CH(CH ) 32
Dihydroergocristine -CH C H 265
Dihydro-α-ergocryptine -CH CH(CH ) 232
Dihydro-β-ergocryptine -CH(CH )CH CH 323

C H N O • CH O S (dihydroergocornine mesylate)    659.79 31415543

C H N O • CH O S (dihydroergocristine mesylate)    707.84 35415543

C H N O • CH O S (dihydro-α-ergocryptine mesylate)    673.82 32435543

C H N O • CH O S (dihydro-β-ergocryptine mesylate)    673.82 32435543

*
exists as a mixture of and isomers in a ratio of 2:1 alpha beta
1 mg
Dihydroergocristine mesylate 0.333 mg
Dihydroergocornine mesylate 0.333 mg
Dihydroergocryptine mesylate * 0.333 mg

Inactive ingredients for oral tablets are: butylated hydroxyanisol, hydrogenated vegetable oil, lactose, mannitol, polyvinyl pyrrollidone, corn starch, stearic acid and talc.

Ergoloid Mesylates Manufacturers


  • Carilion Materials Management
    Ergoloid Mesylates (Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate) Tablet [Carilion Materials Management]
  • Mutual Pharmaceutical Company, Inc.
    Ergoloid Mesylates (Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate) Tablet [Mutual Pharmaceutical Company, Inc.]
  • Avkare, Inc.
    Ergoloid Mesylates (Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate) Tablet [Avkare, Inc.]

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