Dihydroergocristine: Difference between revisions
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|genericName=dihydroergocornine mesylate | |genericName=dihydroergocornine mesylate | ||
|aOrAn=an | |aOrAn=an | ||
|drugClass=ergot alkaloid | |drugClass=[[ergot]] alkaloid | ||
|indicationType=treatment | |indicationType=treatment | ||
|indication=dementia | |indication=[[dementia]] | ||
|adverseReactions=flushing, rash, nausea, vomiting, headache, blurred vision, congestion of nasal sinus | |adverseReactions=[[flushing]], [[rash]], [[nausea]], [[vomiting]], [[headache]], [[blurred vision]], congestion of [[nasal sinus]] | ||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
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<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult=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). | |fdaLIADAdult=* 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. | |||
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. | |||
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. | * 1 mg three times a day. | ||
* Alleviation of symptoms is usually gradual and results may not be observed for 3–4 weeks. | |||
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. | |offLabelAdultGuideSupport= | ||
1 mg three times a day. | |||
Alleviation of symptoms is usually gradual and results may not be observed for 3–4 weeks. | |||
|offLabelAdultGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|fdaLIADPed= | |||
|fdaLIADPed= | |||
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | ||
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<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport= | |offLabelPedGuideSupport= | ||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport= | |offLabelPedNoGuideSupport= | ||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications= | |contraindications======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. | * 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=* Practitioners are advised that because the target symptoms are of unknown etiology, careful diagnosis should be attempted before prescribing ergoloid mesylates preparations. | |warnings=* Practitioners are advised that because the target symptoms are of unknown etiology, careful diagnosis should be attempted before prescribing ergoloid mesylates preparations. | ||
|clinicalTrials=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. | |clinicalTrials=* 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=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
|drugInteractions=* Drug | |drugInteractions=* Drug | ||
:* Description | :* Description | ||
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<!--Administration and Monitoring--> | <!--Administration and Monitoring--> | ||
|administration=* Oral | |administration=* [[Oral]] | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
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<!--Overdosage--> | <!--Overdosage--> | ||
|overdose= | |overdose= | ||
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label. | There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label. | ||
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<!--How Supplied--> | <!--How Supplied--> | ||
|howSupplied=* Ergoloid mesylates tablets, USP (oral) 1 mg are white, round, unscored, debossed MP 20 | |howSupplied=* Ergoloid mesylates tablets, USP (oral) 1 mg are white, round, unscored, debossed MP 20 | ||
* Bottles of 50 NDC 53489-281-02 | |||
Bottles of 50 NDC 53489-281-02 | * Bottles of 100 NDC 53489-281-01 | ||
Bottles of 100 NDC 53489-281-01 | * Bottles of 250 NDC 53489-281-03 | ||
Bottles of 250 NDC 53489-281-03 | * Bottles of 500 NDC 53489-281-05 | ||
Bottles of 500 NDC 53489-281-05 | * Bottles of 1000 NDC 53489-281-10 | ||
Bottles of 1000 NDC 53489-281-10 | |||
|storage=Store at 20° to 25°C (68° to 77°F) | |storage=Store at 20° to 25°C (68° to 77°F) | ||
|packLabel=<!--Patient Counseling Information--> | |packLabel=<!--Patient Counseling Information--> |
Revision as of 13:58, 2 April 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
Disclaimer
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Overview
Dihydroergocristine is an ergot alkaloid that is FDA approved for the treatment of dementia. Common adverse reactions include flushing, rash, nausea, vomiting, headache, blurred vision, congestion of nasal sinus.
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)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dihydroergocristine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Dihydroergocristine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dihydroergocristine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dihydroergocristine in pediatric patients.
Contraindications
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
- 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 Dihydroergocristine in the drug label.
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dihydroergocristine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dihydroergocristine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dihydroergocristine with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Dihydroergocristine with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Dihydroergocristine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dihydroergocristine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dihydroergocristine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dihydroergocristine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dihydroergocristine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dihydroergocristine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dihydroergocristine in patients who are immunocompromised.
Administration and Monitoring
Administration
Monitoring
There is limited information regarding Monitoring of Dihydroergocristine in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Dihydroergocristine in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Dihydroergocristine in the drug label.
Pharmacology
There is limited information regarding Dihydroergocristine Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dihydroergocristine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dihydroergocristine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dihydroergocristine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Dihydroergocristine in the drug label.
How Supplied
- 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
Storage
Store at 20° to 25°C (68° to 77°F)
Images
Drug Images
{{#ask: Page Name::Dihydroergocristine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Dihydroergocristine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Dihydroergocristine in the drug label.
Precautions with Alcohol
- Alcohol-Dihydroergocristine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ERGOLOID MESYLATES®[1]
Look-Alike Drug Names
There is limited information regarding Dihydroergocristine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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