Drug Catalog - Product Detail
CABERGOLINE TABS 0.5MG 8CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50742-0118-08 | INGENUS PHARMACEUTICALS | 8 | 0.5MG | TABLET |
PACKAGE FILES
Generic Name
CABERGOLINE
Substance Name
CABERGOLINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA204735
Description
11 DESCRIPTION Cabergoline, USP is an ergot derivative and dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin -8ß-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its empirical 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, contain 0.5 mg of cabergoline, USP. Inactive ingredients consist of microcrystalline cellulose, croscarmellose sodium, anhydrous citric acid, and magnesium stearate. Image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Cabergoline Tablets, USP are white to off-white, oval shaped, flat face, beveled edge tablet with functional score on one side with the letters "IN" and the letter "G" on either side of the breakline, engraved with the number "118" on the opposite side and they are available in the following configuration: 0.5 mg strength, 8-count bottle, and NDC number 50742-118-08. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] . Store the tablets in the original container.
Indications & Usage
1 INDICATIONS AND USAGE Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. ( 1 ) Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions. ( 5.4 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Before initiating cabergoline tablets evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer cabergoline tablets. ( 2.1 ) Recommended starting dosage of cabergoline tablets is 0.25 mg orally twice weekly. ( 2.2 ) Titrate cabergoline tablets to achieve normal serum prolactin levels by increasing cabergoline tablets by 0.25 mg orally twice weekly at intervals of no less than 4 weeks. ( 2.2 ) Maximum recommended dosage is 1 mg orally, twice weekly. ( 2.2 ) 2.1 Recommended Evaluation Before Initiating Cabergoline Tablets Before initiating cabergoline tablets evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer cabergoline tablets [see Contraindications (4) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage The recommended starting dosage of cabergoline tablets is 0.25 mg orally twice weekly. Titrate cabergoline tablets to achieve normal serum prolactin levels by increasing cabergoline tablets by 0.25 mg orally twice weekly at intervals of no less than 4 weeks. The maximum recommended dosage is 1 mg orally, twice weekly [see Warnings and Precautions (5.2) ] . Administer cabergoline tablets with or without food [see Clinical Pharmacology (12.3) ]. If cabergoline tablets are discontinued, monitor the serum prolactin level periodically to determine whether cabergoline tablets should be reinstituted.