CYCLOSET .8 mg/1

bromocriptine mesylate · TABLET · Avvisto Therapeutics LLC

No Recall History

Plain English

CYCLOSET is a tablet containing bromocriptine mesylate at .8 mg/1, taken oral. Manufactured by Avvisto Therapeutics LLC.

Key Facts

Brand Name: CYCLOSET
Generic Name: bromocriptine mesylate
NDC Code (Product): 73515-123
Manufacturer: Avvisto Therapeutics LLC
Strength: .8 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA020866
Marketing Start: 05/23/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea46 reports

drug ineffective37 reports

headache35 reports

vomiting33 reports

dizziness31 reports

pyrexia29 reports

fatigue28 reports

drug exposure during pregnancy25 reports

neuroleptic malignant syndrome24 reports

tremor22 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. CYCLOSET is an ergot derivative indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Should not be used to treat type 1 diabetes or diabetic ketoacidosis. ( 1 ) Limited efficacy data in combination with thiazolidinediones. ( 1 ) Efficacy has not been confirmed in combination with insulin. ( 1 ) Limitations of Use 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.

Dosage & Administration

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 ) 2.1 Recommended Dosing The recommended dose of CYCLOSET is 1.6 mg to 4.8 mg administered once daily within two hours after waking in the morning. CYCLOSET should be taken with food to potentially reduce gastrointestinal side effects such as nausea. If the morning dose is missed, instruct patients to take their usual dose the following morning. Doses of CYCLOSET should not be doubled the following morning. 2.2 Titration CYCLOSET should be initiated at one tablet (0.8 mg) and increased by one tablet per week until a maximum daily dose of 6 tablets (4.8 mg) or until the maximal tolerated number of tablets between 2 and 6 per day is reached. 2.3 Use with Concomitant Therapy CYCLOSET dose should not exceed 1.6 mg once daily during concomitant use of a moderate CYP3A4 inhibitor (e.g., erythromycin). Avoid con…

Contraindications

4 CONTRAINDICATIONS 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. Postpartum patients. Serious and life-threatening adverse reactions have been reported with bromocriptine use in this population [see Warnings and Precautions (5.7) , Adverse Reactions (6.2) ] . Lactating patients. CYCLOSET contains bromocriptine which inhibits lactation [see Use in Specific Populations (8.2) ] . Hypersensitivity to ergot-related drugs, bromocriptine or to any of the excipients in CYCLOSET. ( 4 ) History of syncopal migraines. ( 4 ) Postpartum patients ( 4 , 5.7 ) Lactating patients ( 4 , 8.2 )

Drug Interactions

7 DRUG INTERACTIONS The active ingredient in CYCLOSET (bromocriptine mesylate) is highly bound to serum proteins. Therefore, CYCLOSET may increase the unbound fraction of other concomitantly used highly protein-bound therapies (e.g., salicylates, sulfonamides, chloramphenicol and probenecid), which may alter their effectiveness and risk for side effects. CYCLOSET is a dopamine receptor agonist. Concomitant use of dopamine receptor antagonists, such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes), or metoclopramide may diminish the effectiveness of CYCLOSET, and CYCLOSET may diminish the effectiveness of these other therapies. The concurrent use of CYCLOSET with these agents has not been studied in clinical trials and is not recommended [see Warnings and Precautions (5.5) ]. CYCLOSET in combination with ergot-related drugs may cause an increase in the occurrence of ergot-related side effects, such as nausea, vomiting, and fatigue, and may also reduce the effectiveness of these ergot therapies when used to treat migraine. The concurrent use of these ergot agents within 6 hours of CYCLOSET dosing is not recommended. CYCLOSET is extensively metabolized by the live…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1) ] Psychotic Disorders [see Warnings and Precautions (5.2) ] Somnolence [see Warnings and Precautions (5.4) ] Risks in Postpartum Women [see Warnings and Precautions (5.7) ] In controlled clinical trials, adverse reactions reported in ≥5% of patients treated with CYCLOSET and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache. ( 6.1 ) Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact VeroScience, LLC at 1-888-621-1215 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial and may not reflect the rates actually observed in clinical practice. The CYCLOSET safety trial…

Frequently Asked Questions

What is CYCLOSET used for?

CYCLOSET contains bromocriptine mesylate. It is a tablet taken oral. Consult your doctor for specific uses.

Is CYCLOSET a controlled substance?

CYCLOSET is not classified as a controlled substance by the DEA.

What is the generic name for CYCLOSET?

The generic name for CYCLOSET is bromocriptine mesylate. There are 9 other brand versions of bromocriptine mesylate.

What is the NDC code for CYCLOSET .8 mg/1?

The NDC (National Drug Code) for CYCLOSET .8 mg/1 is 73515-123, listed by Avvisto Therapeutics LLC.

Product NDC

73515-123

Package NDC

73515-123-21

Other Bromocriptine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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