Ergoloid mesylate

Ergoloid mesylate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Ergoloid mesylate is a Central Nervous System Agent that is FDA approved for the treatment of Alzheimer's disease - dementia. Common adverse reactions include nausea and gastric disturbances.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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 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.

Dosage

1 mg three times a day.

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ergoloid mesylate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergoloid mesylate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Ergoloid mesylate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ergoloid mesylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergoloid mesylate in pediatric patients.

Contraindications

• 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.

Warnings

Precautions

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

Adverse Reactions

Clinical Trials Experience

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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ergoloid mesylate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

There is limited information regarding Ergoloid mesylate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ergoloid mesylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ergoloid mesylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ergoloid mesylate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ergoloid mesylate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ergoloid mesylate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ergoloid mesylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ergoloid mesylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ergoloid mesylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ergoloid mesylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ergoloid mesylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ergoloid mesylate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Ergoloid mesylate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Ergoloid mesylate in the drug label.

Overdosage

There is limited information regarding Overdose of Ergoloid mesylate in the drug label.

Pharmacology

There is limited information regarding Ergoloid mesylate Pharmacology in the drug label.

Mechanism of Action

• 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.

Structure

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

This image is provided by the National Library of Medicine.

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

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ergoloid mesylate in the drug label.

Pharmacokinetics

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 gastrointestinal tract, with mean peak levels of 0.05–0.13 ng/mL/mg (with extremes of 0.03 and 0.18 ng/mL/mg) achieved within 0.6–1.3 hr (with extremes of 0.4 and 2.8 hr). The finding of lower peak levels of ergoloid compared to the total drug-metabolite composite is consistent with a considerable first pass liver metabolism, with less than 50% of the therapeutic moiety reaching the systemic circulation. The elimination of radioactivity, representing ergoloid plus metabolites bearing the radiolabel, was biphasic with half-lives of 4 and 13 hr. The mean half-life of unchanged ergoloid in plasma is about 2.6–5.1 hr; after 3 half-lives ergoloid plasma levels are less than 10% of radioactivity levels, and by 24 hr no ergoloid is detectable.

Bioequivalence studies were performed comparing ergoloid mesylates oral tablets (administered orally) with ergoloid mesylates sublingual tablets (administered sublingually). The oral tablet and sublingual tablet were shown to be bioequivalent.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ergoloid mesylate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ergoloid mesylate in the drug label.

How Supplied

• NDC:68151-2780-0 in a PACKAGE of 1 TABLETS

Storage

Store at 20° to 25°C (68° to 77°F) DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Images

Drug Images

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Package and Label Display Panel

ERGOLOID MESYLATES 1 MG TAB

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ergoloid mesylate in the drug label.

Precautions with Alcohol

• Alcohol-Ergoloid mesylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ERGOLOID MESYLATES®

Look-Alike Drug Names

There is limited information regarding the look alike drug names.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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