Cabergoline (Page 3 of 3)

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 a white to off-white, oval shape, flat face, beveled edge tablet containing 0.5 mg cabergoline. Each tablet is debossed “P” bisect line “P” on one side and “673″ on the other side.

Cabergoline Tablets are available as follows:

Bottles of 8 tablets NDC 49884-673-14

Storage

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

Dispense in original container.

Manufactured by:

PAR PHARMACEUTICAL

Chestnut Ridge, NY 10977

R11/2019

PRINCIPAL DISPLAY PANEL 0.5 MG TABLETS

Cabergoline Tablets 0.5 mg Label
(click image for full-size original)
CABERGOLINE
cabergoline tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-673
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
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (TO OFF WHITE) Score 2 pieces
Shape OVAL Size 7mm
Flavor Imprint Code P;P;673
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-673-14 8 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076310 12/29/2005
Labeler — Par Pharmaceutical, Inc. (092733690)
Registrant — Par Pharmaceutical Inc. (092733690)

Revised: 11/2019 Par Pharmaceutical, Inc.

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