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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 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.
- 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.
- 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)
There is limited information regarding Off-Label Guideline-Supported Use of Ergoloid mesylate in adult patients.
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)
There is limited information regarding Off-Label Guideline-Supported Use of Ergoloid mesylate in pediatric patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergoloid mesylate in pediatric patients.
- 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.
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.
There is limited information regarding Postmarketing Experience of Ergoloid mesylate in the drug label.
There is limited information regarding Ergoloid mesylate Drug Interactions in the drug label.
Use in Specific Populations
- Pregnancy Category
- 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.
There is no FDA guidance on the use of Ergoloid mesylate with respect to nursing mothers.
There is no FDA guidance on the use of Ergoloid mesylate with respect to pediatric patients.
There is no FDA guidance on the use of Ergoloid mesylate with respect to geriatric patients.
There is no FDA guidance on the use of Ergoloid mesylate with respect to specific gender populations.
There is no FDA guidance on the use of Ergoloid mesylate with respect to specific racial populations.
There is no FDA guidance on the use of Ergoloid mesylate in patients with renal 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.
There is no FDA guidance one the use of Ergoloid mesylate in patients who are immunocompromised.
Administration and Monitoring
There is limited information regarding Monitoring of Ergoloid mesylate in the drug label.
There is limited information regarding IV Compatibility of Ergoloid mesylate in the drug label.
There is limited information regarding Overdose of Ergoloid mesylate in the drug label.
℞ Prescription only
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.
- Each tablet for oral use contains ergoloid mesylates USP; a mixture of the methanesulfonate salt of the following hydrogenated alkaloids:
- Inactive ingredients for oral tablets are: butylated hydroxyanisol, hydrogenated vegetable oil, lactose, mannitol, polyvinyl pyrrollidone, corn starch, stearic acid and talc.
There is limited information regarding Pharmacodynamics of Ergoloid mesylate in the drug label.
- 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.
There is limited information regarding Nonclinical Toxicology of Ergoloid mesylate in the drug label.
There is limited information regarding Clinical Studies of Ergoloid mesylate in the drug label.
- NDC:68151-2780-0 in a PACKAGE of 1 TABLETS
Store at 20° to 25°C (68° to 77°F) DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Package and Label Display Panel
ERGOLOID MESYLATES 1 MG TAB
Ingredients and Appearance
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.
- ERGOLOID MESYLATES®
Look-Alike Drug Names
There is limited information regarding the look alike drug names.
The contents of this FDA label are provided by the National Library of Medicine.