CYCLOSET- bromocriptine mesylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

bromocriptine mesylate (UNII: FFP983J3OD) (bromocriptine - UNII:3A64E3G5ZO)

Available from:

VEROSCIENCE LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis. - Limited efficacy data in combination with thiazolidinediones. - Efficacy has not been confirmed in combination with insulin. CYCLOSET is contraindicated in: - Patients with known hypersensitivity to bromocriptine, ergot-related drugs, or any of the excipients in CYCLOSET. - Patients with syncopal migraine. Bromocriptine increases the likelihood of a hypotensive episode among patients with syncopal migraine. Loss of consciousness during a migraine may reflect dopamine receptor hypersensitivity. CYCLOSET is a dopamine receptor agonist and may, therefore, potentiate the risk for syncope in these patients. - Women who are nursing their children. CYCLOSET may inhibit lactation. There are postmarketing reports of stroke in this patient population although causality has not been proven [see Use in Specific Popu

Product summary:

CYCLOSET 0.8 mg tablets are WHITE and round with "C" on one side and "9" on the other. The tablets are supplied as follows: NDC 73515-123-30 unit-of-use bottles of 200 NDC 73515-123-21 unit-of-use bottles of 21 (samples only). Storage Store and dispense: At 20-25°C (68-77°F) in a tight, light-resistant container. See USP Controlled Room Temperature.

Authorization status:

New Drug Application

Summary of Product characteristics

CYCLOSET- BROMOCRIPTINE MESYLATE TABLET
VEROSCIENCE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOSET SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CYCLOSET.
CYCLOSET (BROMOCRIPTINE MESYLATE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
CYCLOSET is a dopamine receptor agonist indicated as an adjunct to
diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus. (1.1, 11)
Important Limitations of Use:
Should not be used to treat type 1 diabetes or diabetic ketoacidosis.
(1.2)
Limited efficacy data in combination with thiazolidinediones. (1.2)
Efficacy has not been confirmed in combination with insulin. (1.2)
DOSAGE AND ADMINISTRATION
Taken within two hours after waking in the morning with food (2.1)
Initial dose is one tablet (0.8 mg) daily increased weekly by one
tablet until maximal tolerated daily dose of 1.6 to 4.8 mg
is achieved. (2.2)
Limit dose to 1.6 mg daily during concomitant use of a moderate CYP3A4
inhibitor. Avoid concomitant use with strong
CYP3A4 inhibitors. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.8 mg (3)
CONTRAINDICATIONS
Do not use in patients with hypersensitivity to ergot-related drugs,
bromocriptine or to any of the excipients in
CYCLOSET. (4)
Do not use in patients with syncopal migraines. May precipitate
hypotension. (4)
Do not use in nursing women. May inhibit lactation. Postmarketing
reports of stroke in this patient population. (4, 6.2,
8.3)
WARNINGS AND PRECAUTIONS
Hypotension: Can cause orthostatic hypotension and syncope,
particularly upon initiation or dose escalation. Use
caution in patients taking antihypertensive medications. Assess
orthostatic vital signs prior to initiation of CYCLOSET
and periodically thereafter. Advise patients during early treatment to
avoid situations that could lead to injury if syncope
was to occur. (5.1, 6.1)
Psychosis: May exacerbate psychotic disorders or reduce the
effectiveness of drugs that treat psycho