today Ergoloid Generic Name: Ergoloid mesylates Dosage Form: Sublingual Tablets Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Ergoloid MESYLATES TABLETS USP Sublingual Ergoloid Description Each tablet for sublingual use contains 1 mg of Ergoloid Mesylates USP, a mixture of the methanesulfonate salt of the following hydrogenated alkaloids: Dihydroergocornine mesylate 0.333 mg Dihydroergocristine mesylate 0.333 mg Dihydroergocryptine mesylate* 1 0.333 mg Ergoloid mesylates tablets, USP for sublingual use contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, and stearic acid. 1 * Exists as a mixture of alpha and beta isomers in a ratio of 2:1 Slideshow Insomnia and Sleep Deprivation: The Case For A Good Night's Sleep Ergoloid - Clinical Pharmacology There is no specific evidence which clearly establishes the mechanism by which Ergoloid mesylates tablets 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 radio-labelled 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 ng Eq/mL/mg were achieved within 1.5-3 hrs. Bioavailability studies with the specific radio-immunoassay 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 hrs.). 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. Bioavailability 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 have similar bioavailability. Indications and Usage for Ergoloid 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 therapy, 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 section). The decision to use Ergoloid mesylates therapy 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 therapy 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. Contraindications Ergoloid mesylates tablets 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. Precautions Practitioners are advised that because the target symptoms are of unknown etiology carefuI diagnosis should be attempted before prescribing Ergoloid mesylates tablets. Adverse Reactions Ergoloid mesylates tablets have not been found to produce serious side effects. Some sublingual irritation with the sublingual tablets, transient nausea, and gastric disturbances have been reported. Ergoloid mesylates preparations do not possess the vasoconstrictor properties of the natural ergot alkaloids. Ergoloid Dosage and Administration 1 mg three times a day. Alleviation of symptoms is usually gradual and results may not be observed for 3-4 weeks. How is Ergoloid Supplied Available as oval, white sublingual tablets, debossed 2959, containing 1 mg Ergoloid mesylates USP, packaged in bottles of 100, 250 and 1000 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at controlled room temperature 15 -30 C (59 -86 F) (See USP). MANUFACTURED BY IVAX PHARMACEUTICALS, INC. MIAMI, FL 33137 0172 07/02 B8 Ergoloid MESYLATES Ergoloid mesylates tablet, orally disintegrating Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0172-2959 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ergoloid Mesylates (Ergoloid Freebase) Ergoloid Freebase 1 mg Inactive Ingredients Ingredient Name Strength anhydrous lactose colloidal silicon dioxide microcrystalline cellulose pregelatinized starch stearic acid Product Characteristics Color WHITE Score no score Shape OVAL Size 11mm Flavor Imprint Code 2959 Contains Coating false Symbol false Packaging # Item Code Package Description 1 NDC:0172-2959-60 100 TABLET, ORALLY DISINTEGRATING (100 TABLET) in 1 BOTTLE 2 NDC:0172-2959-65 250 TABLET, ORALLY DISINTEGRATING (250 TABLET) in 1 BOTTLE 3 NDC:0172-2959-80 1000 TABLET, ORALLY DISINTEGRATING (1000 TABLET) in 1 BOTTLE Labeler - IVAX Pharmaceuticals, Inc. Revised: 03/2007 IVAX Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about ergoloid mesylates Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous central nervous system agents Consumer resources Ergoloid mesylates Ergoloid mesylates Oral, Sublingual (Advanced Reading) Professional resources Ergoloid Tablets (FDA) Ergoloid Mesylates (Wolters Kluwer) Other brands: Hydergine Related treatment guides Alzheimer's Disease Arteriosclerotic Dementia Dementia FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Sun Pharmaceutical Industries Inc. 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