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).

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 0.5 mg are white to off-white, capsule shaped, flat-faced, bevel-edged tablets with ‘C’ breakline ‘5’ on one side and ‘>’ partial bisect ‘>’ on the other side.

Cabergoline tablets, USP 0.5 mg are available as follows:

Bottles of 8 tablets NDC 16252-536-08

STORAGE

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F); Excursions permitted to 15° to 30°C (59° to 86°F) [See USP].

Manufactured by:
Cobalt Pharmaceuticals Inc.
Mississauga, Ontario, Canada, L5N 2B8

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: October 2012
103-773-02

PRINCIPAL DISPLAY PANEL

NDC 16252-536-08
Cabergolne Tablets, USP
0.5 mg
Watson Rx only 8 Tablets

NDC 16252-536-08 Cabergolne Tablets, USP 0.5 mg Watson 8 Tablets Rx only
(click image for full-size original)

CABERGOLINE
cabergoline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-536
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
LACTOSE MONOHYDRATE
LEUCINE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 7mm
Flavor Imprint Code C;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16252-536-08 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 8 TABLET (8 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (16252-536-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078035 04/21/2008
Labeler — Cobalt Laboratories (619646818)
Establishment
Name Address ID/FEI Operations
Cobalt Pharmaceuticals Company 251489217 ANALYSIS (16252-536), MANUFACTURE (16252-536), PACK (16252-536)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging 143213275 RELABEL (16252-536), REPACK (16252-536)

Revised: 02/2013 Cobalt Laboratories

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