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Ergoloid mesylates: Drug information

Ergoloid mesylates: Drug information
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For additional information see "Ergoloid mesylates: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • Hydergine [DSC]
Pharmacologic Category
  • Ergot Derivative
Dosing: Adult
Mental capacity decline

Mental capacity decline: Oral: 1 mg 3 times daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Avoid use (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Adverse effects are minimal.

Cardiovascular: Bradycardia, flushing, orthostatic hypotension

Dermatologic: Skin rash

Gastrointestinal: Gastrointestinal distress (sublingual administration), nausea (sublingual administration; transient)

Local: Local irritation (sublingual administration)

Ophthalmic: Blurred vision

Respiratory: Nasal congestion

Contraindications

Hypersensitivity to ergoloid mesylates, ergot, or any component of the formulation; acute or chronic psychosis regardless of etiology.

Canadian labeling: Additional contraindications (not in US labeling): Severe bradycardia; severe hypotension.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiac valvular fibrosis: Ergot alkaloids have been associated with fibrotic valve thickening (eg, aortic, mitral, tricuspid); usually associated with long-term, chronic use.

• Pleural/retroperitoneal fibrosis: Rare cases of pleural and/or retroperitoneal fibrosis have been reported with prolonged daily use.

Other warnings/precautions:

• Appropriate use: Careful diagnosis should be attempted before prescribing. Because target symptoms are of unknown etiology, exclude potentially reversible and treatable conditions; particular care should be taken to exclude delirium and dementiform illness secondary to systemic disease, primary neurological disease, or primary disturbance of mood.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Generic: 1 mg [DSC]

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Ergoloid Mesylates Oral)

1 mg (per each): $8.10

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Hydergine: 1 mg [DSC]

Use: Labeled Indications

Mental capacity decline: Treatment of signs and symptoms of an idiopathic decline in mental capacity.

Note: Efficacy most often observed in patients with an ill-defined process related to aging or underlying dementing condition (ie, primary progressive dementia, Alzheimer dementia, senile onset, multi-infarct dementia).

Medication Safety Issues
Older Adult: High-Risk Medication:

Beers Criteria: Ergoloid mesylates are identified in the Beers Criteria as potentially inappropriate medications to be avoided in patients 65 years and older (independent of diagnosis or condition) due to lack of efficacy (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

Substrate of CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Bromocriptine: Ergot Derivatives may increase adverse/toxic effects of Bromocriptine. Risk X: Avoid

Dihydroergotamine: Ergot Derivatives may increase vasoconstricting effects of Dihydroergotamine. Risk X: Avoid

Lisuride: May increase adverse/toxic effects of Ergot Derivatives. Risk X: Avoid

Metergoline: Ergot Derivatives may increase adverse/toxic effects of Metergoline. Management: Combined use of metergoline with other ergot alkaloids after birth and during the postpartum period is specifically not recommended. Risk D: Consider Therapy Modification

Methysergide: Ergot Derivatives may increase vasoconstricting effects of Methysergide. Risk X: Avoid

Nefazodone: Ergot Derivatives may increase serotonergic effects of Nefazodone. This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor

Serotonergic Agents (High Risk): Ergot Derivatives may increase serotonergic effects of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor

Sulprostone: May increase vasoconstricting effects of Ergot Derivatives. Risk C: Monitor

Mechanism of Action

Ergoloid mesylates do not have the vasoconstrictor effects of the natural ergot alkaloids; exact mechanism in dementia is unknown; originally classed as peripheral and cerebral vasodilator, now considered a "metabolic enhancer"; there is no specific evidence that clearly establishes the mechanism by which ergoloid mesylate preparations produce mental effects, nor is there conclusive evidence that the drug particularly affects cerebral arteriosclerosis or cerebrovascular insufficiency.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Alleviation of symptoms is usually gradual; response may require 3 to 4 weeks of treatment.

Absorption: Rapid yet incomplete.

Metabolism: Hepatic, including first-pass metabolism.

Bioavailability: 25%.

Half-life elimination, serum: ~2.6 to 5.1 hours.

Time to peak, serum: 1.5 to 3 hours.

  1. 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. doi:10.1111/jgs.18372 [PubMed 37139824]
  2. Ergoloid mesylates [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries Inc; August 2014.
  3. Hydergine [product monograph]. Mississauga, Ontario, Canada; SteriMax Inc; May 2010.
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