Cabergoline: Package Insert and Label Information (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, 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 logo
PRINCIPAL DISPLAY PANEL
Bottle Label 0.5 mg
| CABERGOLINE cabergoline tablet | ||||||||||||||||||
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| 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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