Ergoloid

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.

Available as oval, white sublingual tablets, debossed 2959, containing 1 mg Ergoloid mesylates USP, packaged in bottles of 100, 250 and 1000 tablets.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required).

Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).

MANUFACTURED BY

IVAX PHARMACEUTICALS, INC.

MIAMI, FL 33137

0172

07/02

B8

Applies to ergoloid mesylates: compounding powder, oral capsule, oral solution, oral tablet, sublingual tablet

General

The most commonly reported adverse events have included transient nausea and gastric disturbances.[Ref]

Gastrointestinal

Frequency not reported: Nausea, gastric disturbances[Ref]

Some side effects of ergoloid mesylates may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

Administration advice:
-Take orally 3 times a day

Storage requirements: Protect from light

General:
-As treatment with this drug means target symptoms are of unknown etiology, careful diagnosis should be attempted prior to prescribing.
-Once therapy begins, alleviation of symptoms may not be observed for 3 to 4 weeks.
-Modest efficacy was shown on the SCAG (Sandoz Clinical Assessment-Geriatric) scale including improvements to mental alertness, confusion, recent memory, orientation, emotional lability, self-care, depression, anxiety/fears, cooperation, sociability, appetite, dizziness, fatigue, bothersome (ness), and overall impression of clinical status at 12-weeks.

Monitoring:
-Monitor for reversible and treatable conditions
-Continually assess and rate improvements to ensure any initial benefit persists with time.

Patient advice:
-Transient nausea and gastric disturbances may occur.
-This drug does not possess the vasoconstrictor properties of natural ergot alkaloids.

Use is not recommended Risk Summary: There is no specific information on the use of this drug in pregnancy; however, this drug belongs to a class of drugs (ergot alkaloids) that are contraindicated for use during pregnancy as they may cause fetal vascular disruption.