Ergoloid Mesylates
Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate
Sun Pharmaceutical Industries, Inc.
Human Prescription Drug
NDC 53489-281Ergoloid Mesylates also known as Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate is a human prescription drug labeled by 'Sun Pharmaceutical Industries, Inc.'. National Drug Code (NDC) number for Ergoloid Mesylates is 53489-281. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Ergoloid Mesylates drug includes Dihydro-.alpha.-ergocryptine Mesylate - .222 mg/1 Dihydro-.beta.-ergocryptine Mesylate - .111 mg/1 Dihydroergocornine Mesylate - .333 mg/1 Dihydroergocristine Mesylate - .333 mg/1 . The currest status of Ergoloid Mesylates drug is Active.
Drug Information:
| Drug NDC: | 53489-281 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ergoloid Mesylates |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine Mesylate, And Dihydro-.beta.-ergocryptine Mesylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sun Pharmaceutical Industries, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE - .222 mg/1
DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE - .111 mg/1
DIHYDROERGOCORNINE MESYLATE - .333 mg/1
DIHYDROERGOCRISTINE MESYLATE - .333 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 31 Oct, 1991 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA081113 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sun Pharmaceutical Industries, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 318179
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0353489281010
|
| UPC stands for Universal Product Code. |
| UNII: | Z4I7BU58DN
79Y4U49I29
42RX8KPW29
DS7CL18UAM
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53489-281-01 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-281-01) | 31 Oct, 1991 | N/A | No |
| 53489-281-02 | 50 TABLET in 1 BOTTLE, PLASTIC (53489-281-02) | 31 Oct, 1991 | N/A | No |
| 53489-281-03 | 250 TABLET in 1 BOTTLE, PLASTIC (53489-281-03) | 31 Oct, 1991 | N/A | No |
| 53489-281-05 | 500 TABLET in 1 BOTTLE, PLASTIC (53489-281-05) | 31 Oct, 1991 | N/A | No |
| 53489-281-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (53489-281-10) | 31 Oct, 1991 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Ergoloid mesylates dihydroergocornine mesylate, dihydroergocristine mesylate, dihydro-.alpha.-ergocryptine mesylate, and dihydro-.beta.-ergocryptine mesylate dihydroergocornine mesylate dihydroergocornine dihydroergocristine mesylate dihydroergocristine dihydro-.alpha.-ergocryptine mesylate dihydro-.alpha.-ergocryptine dihydro-.beta.-ergocryptine mesylate epicriptine butylated hydroxyanisole starch, corn hydrogenated cottonseed oil lactose, unspecified form mannitol povidone k90 stearic acid talc mp;20
Indications and Usage:
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 de
Read more...lirium 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 and Administration:
Dosage and administration 1 mg three times a day. alleviation of symptoms is usually gradual and results may not be observed for 3â4 weeks.
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.
Adverse Reactions:
Adverse reactions 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.
Description:
Description each tablet for oral use contains ergoloid mesylates usp; a mixture of the methanesulfonate salt of the following hydrogenated alkaloids: r dihydroergocornine -ch(ch 3 ) 2 dihydroergocristine -ch 2 c 6 h 5 dihydro-α-ergocryptine -ch 2 ch(ch 3 ) 2 dihydro-β-ergocryptine -ch(ch 3 )ch 2 ch 3 c 31 h 41 n 5 o 5 ⢠ch 4 o 3 s (dihydroergocornine mesylate) 659.79 c 35 h 41 n 5 o 5 ⢠ch 4 o 3 s (dihydroergocristine mesylate) 707.84 c 32 h 43 n 5 o 5 ⢠ch 4 o 3 s (dihydro-α-ergocryptine mesylate) 673.82 c 32 h 43 n 5 o 5 ⢠ch 4 o 3 s (dihydro-β-ergocryptine mesylate) 673.82 1 mg dihydroergocristine mesylate 0.333 mg dihydroergocornine mesylate 0.333 mg dihydroergocryptine mesylate exists as a mixture of alpha and beta isomers in a ratio of 2:1 0.333 mg inactive ingredients for oral tablets are: butylated hydroxyanisol, corn starch, hydrogenated vegetable oil, lactose, mannitol, polyvinyl pyrrolidone, stearic acid and talc. chemical structure
Clinical Pharmacology:
Clinical pharmacology 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. pharmacokinetic properties 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 1.5â3 hr. bioavailability studies with the specific radioimmunoassay confirm that ergoloid is rapidly absorbed from the gastrointestinal tract, with mean peak levels of 0.05â0.13 ng/ml/mg (with extremes of 0.03 and 0.18 ng/ml/mg) achieved within 0.6â1.3 hr (with e
Read more...xtremes 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 2.6â5.1 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.
Pharmacokinetics:
Pharmacokinetic properties 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 1.5â3 hr. bioavailability studies with the specific radioimmunoassay confirm that ergoloid is rapidly absorbed from the gastrointestinal tract, with mean peak levels of 0.05â0.13 ng/ml/mg (with extremes of 0.03 and 0.18 ng/ml/mg) achieved within 0.6â1.3 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 ra
Read more...dioactivity, 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 2.6â5.1 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.
How Supplied:
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 store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature] dispense in tight, light-resistant container.
Package Label Principal Display Panel:
Principal display panel - 100 tablet bottle label principal display panel - 100 tablet bottle label