Cabergoline (Page 4 of 4)

OVERDOSAGE

Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.

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.

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 32839-6408

Made in India

Revised: 10/2019

ingenus logoingenus logo

PRINCIPAL DISPLAY PANEL

Bottle Label 0.5 mg

							8 Tablets
(click image for full-size original)

Bottle Label 0.5 mg

CABERGOLINE cabergoline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CABERGOLINE (CABERGOLINE) CABERGOLINE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CITRIC ACID MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White) Score 2 pieces
Shape OVAL (OVAL) Size 2mm
Flavor Imprint Code IN;G;118
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-118-08 8 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204735 08/09/2018
Labeler — Ingenus Pharmaceuticals, LLC (833250017)
Registrant — Ingenus Pharmaceuticals, LLC (833250017)
Establishment
Name Address ID/FEI Operations
Centaur Pharmaceuticals Pvt. Ltd. 675596622 MANUFACTURE (50742-118)

Revised: 10/2019 Ingenus Pharmaceuticals, LLC

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