Rx only

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

C31H41N5O5 • CH4O3S (dihydroergocornine mesylate)

   659.79

C35H41N5O5 • CH4O3S (dihydroergocristine mesylate)

   707.84

C32H43N5O5 • CH4O3S (dihydro-α-ergocryptine mesylate)

   673.82

C32H43N5O5 • CH4O3S (dihydro-β-ergocryptine mesylate)

   673.82

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

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.

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.

Ergoloid mesylates preparations 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.

Practitioners are advised that because the target symptoms are of unknown etiology, careful diagnosis should be attempted before prescribing ergoloid mesylates preparations.

Ergoloid mesylates preparations have not been found to produce serious side effects. Transient nausea and gastric disturbances have been reported. Ergoloid mesylates preparations do not possess the vasoconstrictor properties of the natural ergot alkaloids.

1 mg three times a day.

Alleviation of symptoms is usually gradual and results may not be observed for 3–4 weeks.

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

Distributed by: Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Rev 02, August 2014