CABERGOLINE (Page 4 of 4)

Postmarketing Surveillance data

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

Other events have been reported in association with cabergoline: hypersexuality, increased libido and 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 are white, capsule-shaped, flat, scored tablets containing 0.5 mg cabergoline. Each tablet is engraved “APO” on one side and “CA” bisect “0.5” on the other side.

Cabergoline tablets are available as follows:

Bottles of 8 tablets NDC 60505-2597-2

Storage

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Rx only

APOTEX INC. CABERGOLINE TABLETS 0.5 mg

Manufactured by Manufactured for
Apotex Research Pvt. Ltd. Apotex Corp.
Bangalore — 560 099 Weston, Florida
India USA, 33326

Revised: October 2016

Rev. 1

PRINCIPAL DISPLAY PANEL — 0.5 MG BOTTLE LABEL

APOTEX CORP. NDC 60505-2597-2

Cabergoline Tablets

0.5 mg

Rx only

8 Tablets

//medlibrary.org/lib/images-rx/cabergoline-8/caber-0-5mg-panel-300x100.jpg
(click image for full-size original)
CABERGOLINE
cabergoline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2597
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
LEUCINE
LACTOSE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Capsule-Shaped) Size 8mm
Flavor Imprint Code APO;CA;0;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-2597-2 8 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201503 03/08/2013
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Research Private Limited 862584104 analysis (60505-2597), manufacture (60505-2597)

Revised: 05/2017 Apotex Corp.

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