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Drug Catalog - Product Detail

CABERGOLINE TABS 0.5MG 8CT

NDC Mfr Size Str Form
50742-0118-08 INGENUS PHARMACEUTICALS 8 0.5MG TABLET
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Generic Name
CABERGOLINE
Substance Name
CABERGOLINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA204735
Description
DESCRIPTION Cabergoline Tablets, USP contain Cabergoline USP a dopamine receptor agonist. The chemical name for Cabergoline USP is 1-[(6-allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its molecular formula is C 26 H 37 N 5 O 2 , and its molecular weight is 451.62. The structural formula is as follows: Cabergoline USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water. Cabergoline Tablets, USP for oral administration, contains 0.5 mg of Cabergoline USP. Inactive ingredients consist of microcrystalline cellulose, croscarmellose sodium, citric acid, and magnesium stearate. structural formula
How Supplied
HOW SUPPLIED Cabergoline Tablets, USP are white to off-white, oval shaped, flat face, beveled edge tablet containing 0.5 mg Cabergoline USP. Each tablet is scored on one side and has the letters "IN" and the letter "G" on either side of breakline. The other side of the tablet is engraved with the number "118". Cabergoline Tablets, USP are available as follows: Bottle of 8 tablets NDC 50742-118-08 Storage Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Dispense in original container. Rx only Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in India Revised: 05/2023 ingenus logo
Indications & Usage
INDICATIONS AND USAGE Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dosage of Cabergoline Tablets, USP for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease. Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered. After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established.