Product Description.:
MP 20
tablet , white , round round
Debossed
Each tablet for sublingual use contains 1 mg of Ergoloid Mesylates USP, a mixture of the methanesulfonate salt of the following hydrogenated alkaloids: Dihydroergocornine mesylate 0.333 mg Dihydroergocristine mesylate 0.333 mg Dihydroergocryptine mesylate*1 0.333 mg
INDICATIONS AND USAGE
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 therapy, 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 section). The decision to use ergoloid mesylates therapy 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 therapy 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.
CONTRAINDICATIONS
Ergoloid mesylates tablets are contraindicated in individuals who have previously shown hypersensitivity to the drug. Ergoloid mesylates preparations are also contraindicated in patients who have psychosis, acute or chronic, regardless of etiology.
PRECAUTIONS
Practitioners are advised that because the target symptoms are of unknown etiology carefuI diagnosis should be attempted before prescribing ergoloid mesylates tablets.
ADVERSE REACTIONS
Ergoloid mesylates tablets have not been found to produce serious side effects. Some sublingual irritation with the sublingual tablets, transient nausea, and gastric disturbances have been reported. Ergoloid mesylates preparations do not possess the vasoconstrictor properties of the natural ergot alkaloids.
