Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1519
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| rdf:type | |
| rdfs:label |
Hydergine (Tablet)
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| dailymed-instance:dosage |
1 mg three times daily. Alleviation of symptoms is usually gradual and results may not be observed for 3-4 weeks.
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| dailymed-instance:descripti... |
Hydergine Tablet 1 mg andHydergine LC Liquid Capsule 1 mg: Each contains ergoloid mesylates, USP as follows: dihydroergocornine mesylate 0.333 mg, dihydroergocristine mesylate 0.333 mg, and dihydroergocryptine (dihydro-alpha-ergocryptine and dihydro-beta-ergocryptine in the proportion of 2:1) mesylate 0.333 mg, representing a total of 1 mg. Inactive Ingredients Oral Tablets: lactose, povidone, starch, stearic acid, and talc. Liquid Capsules: ascorbic acid, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, propylene glycol, sorbitol, and titanium dioxide.<br/>Hydergine Liquid 1 mg/mL: Each mL contains ergoloid mesylates, USP as follows: dihydroergocornine mesylate 0.333 mg, dihydroergocristine mesylate 0.333 mg, and dihydroergocryptine (dihydro-alpha-ergocryptine and dihydro-beta-ergocryptine in the proportion of 2:1) mesylate 0.333 mg, representing a total of 1mg; alcohol, 28.5% by volume. Inactive Ingredients: alcohol, glycerin, propylene glycol, and purified water.<br/>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 Hydergine (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. Bioavailabilitystudies 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 Hydergine (ergoloid mesylates) oral tablets (administered orally) with Hydergine (ergoloid mesylates) sublingual tablets (administered sublingually), Hydergine (ergoloid mesylates) oral tablets with Hydergine (ergoloid mesylates) liquid, and Hydergine (ergoloid mesylates) oral tablets with Hydergine LC (ergoloid mesylates, USP) liquid capsules. The oral tablet, sublingual tablet, and liquid capsule oral forms were shown to be bioequivalent. Within the bioequivalence limits, the liquid capsule showed a statistically significant (12%) greater bioavailability than the oral tablet. In the study comparing the oral tabletand liquid forms, both forms tested showed an equivalent rate of absorption and an equivalent peak plasma concentration (C).
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| dailymed-instance:contraind... |
Hydergine (ergoloid mesylates) preparations are contraindicated in individuals who have previously shown hypersensitivity to the drug. Hydergine (ergoloid mesylates) preparations are also contraindicated in patients who have psychosis, acute or chronic, regardless of etiology.
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| dailymed-instance:supply |
Hydergine (ergoloid mesylates) Tablets, USP (Oral):<br/>1 mg: Round, white, engraved���HYDERGINE 1���on one side,������other side. NDC 0078-0070-05: bottles of 100 NDC 0078-0070-06: unit-dose packages of 100 NDC 0078-0070-08: bottles of 500<br/>Hydergine (ergoloid mesylates) Liquid, USP:<br/>1 mg/mL: Supplied with an accompanying dropper graduated to deliver 1 mg. NDC 0078-0100-36: bottles of 100 mL<br/>Hydergine LC (ergoloid mesylates, USP) Liquid Capsule:<br/>1 mg: Oblong, off-white, branded���HYDERGINE LC 1 mg��� on one side,������other side. NDC 0078-0101-05: bottles of 100 NDC 0078-0101-06: unit-dose packages of 100 NDC 0078-0101-08: bottles of 500
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
Practitioners are advised that because the target symptoms are of unknown etiology, careful diagnosis should be attempted before prescribing Hydergine (ergoloid mesylates) preparations.
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| dailymed-instance:genericMe... |
ergoloid mesylates
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| dailymed-instance:fullName |
Hydergine (Tablet)
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| dailymed-instance:adverseRe... |
Hydergine (ergoloid mesylates) preparations have not been found to produce serious side effects. Transient nausea and gastric disturbances have been reported. Hydergine (ergoloid mesylates) preparations do not possess the vasoconstrictor properties of the natural ergot alkaloids.
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| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Hydergine
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