Cabergoline (Page 4 of 4)

Post-Marketing Surveillance Data

The following events have been reported in association with cabergoline: cardiac valvulopathy and extracardiac fibrotic reactions (see WARNINGS: Cardiac Valvulopathy and WARNINGS: Extracardiac Fibrotic Reactions).

Others events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (see PRECAUTIONS: Psychiatric). In addition, cases of alopecia, aggression and psychotic disorder have been reported in patients taking cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.

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 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 available containing 0.5 mg of cabergoline, USP.

The 0.5 mg tablets are white to off-white, oval, scored tablets debossed with M on one side of the tablet and C on the left of the score and G on the right of the score on the other side. They are available as follows:

NDC 0378-2800-26
bottles of 8 tablets

NDC 0378-2800-93
bottles of 30 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

OCTOBER 2011
CABE:R1

PRINCIPAL DISPLAY PANEL — 0.5 mg

NDC 0378-2800-26

Cabergoline
Tablets, USP

0.5 mg

Rx only 8 Tablets

Each tablet contains:
Cabergoline, USP 0.5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM2800CF1

Cabergoline Tablets, USP 0.5 mg Bottle Label
(click image for full-size original)
CABERGOLINE
cabergoline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-2800
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
ANHYDROUS LACTOSE
LEUCINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 8mm
Flavor Imprint Code M;C;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-2800-26 8 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202947 12/02/2013
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 10/2011 Mylan Pharmaceuticals Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.