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bromocriptine mesylate
Overview
What is CYCLOSET?
CYCLOSET Tablets contain micronized bromocriptine mesylate, a dopamine receptor agonist. Bromocriptine mesylate is chemically designated [Ergotaman-3',6',18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-, monomethanesulfonate (salt), (5'α)-]. CYCLOSET is a single enantiomer with absolute configuration 5, 8, 2', 5', 11', 12'.
The structural formula of bromocriptine is shown below:
Bromocriptine mesylate in CYCLOSET is a white or slightly colored micronized crystalline powder with a molecular formula of CHBrNO∙CHSO and a molecular weight of 750.72. CYCLOSET Tablets contain bromocriptine mesylate USP in an amount equivalent to 0.8 mg. of bromocriptine. Each tablet contains the following inactive ingredients: lactose, corn starch, magnesium stearate, colloidal silicon dioxide, and citric acid.
What does CYCLOSET look like?
What are the available doses of CYCLOSET?
Tablets: 0.8 mg ()
What should I talk to my health care provider before I take CYCLOSET?
Pediatrics: Safety and effectiveness have not been established. ()
How should I use CYCLOSET?
CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.
What interacts with CYCLOSET?
Sorry No Records found
What are the warnings of CYCLOSET?
Sorry No Records found
What are the precautions of CYCLOSET?
Sorry No Records found
What are the side effects of CYCLOSET?
Sorry No records found
What should I look out for while using CYCLOSET?
CYCLOSET is contraindicated in:
What might happen if I take too much CYCLOSET?
With another formulation of bromocriptine mesylate, the most commonly reported signs and symptoms associated with acute overdose were nausea, vomiting, constipation, diaphoresis, dizziness, pallor, severe hypotension, malaise, confusion, lethargy, drowsiness, delusions, hallucinations, and repetitive yawning. The lethal dose has not been established.
Treatment of overdose consists of removal of the drug by emesis (if conscious), gastric lavage, activated charcoal, or saline catharsis. Careful supervision and recording of fluid intake and output is essential. Hypotension should be treated by placing the patient in the Trendelenburg position and administering intravenous fluids. If satisfactory relief of hypotension cannot be achieved by using the above measures to their fullest extent, vasopressors should be considered.
How should I store and handle CYCLOSET?
Risperidone oral solution should be stored at controlled room temperature 15°- 25°C (59°-77°F). Protect from light and freezing.Keep out of reach of children.Risperidone oral solution should be stored at controlled room temperature 15°- 25°C (59°-77°F). Protect from light and freezing.Keep out of reach of children.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:NDCNDCCYCLOSET 0.8 mg tablets are WHITE and round with "C" on one side and "9" on the other.The tablets are supplied as follows:NDCNDCCYCLOSET 0.8 mg tablets are WHITE and round with "C" on one side and "9" on the other.The tablets are supplied as follows:NDCNDCCYCLOSET 0.8 mg tablets are WHITE and round with "C" on one side and "9" on the other.The tablets are supplied as follows:NDCNDC
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CYCLOSET contains bromocriptine mesylate, a sympatholytic, dopamine D2 receptor agonist. In patients with type 2 diabetes, timed morning administration of CYCLOSET is associated with increased insulin sensitivity and glucose disposal and reduced fasting and postprandial hyperglycemia throughout the meals of the day without raising plasma insulin levels.
Non-Clinical Toxicology
CYCLOSET is contraindicated in:(Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets USP)
Glyburide—In a single-dose interaction study in type 2 diabetes patients, coadministration of Metformin and glyburide did not result in any changes in either Metformin pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and C were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain (see ).
Furosemide
Nifedipine
Cationic drugs
Other
Tablets USP, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Metformin Hydrochloride Tablets USP, the patient should be observed closely for hypoglycemia.
In healthy volunteers, the pharmacokinetics of Metformin and propranolol, and Metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.
Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Hypotension, including orthostatic hypotension, can occur, particularly upon initiation of CYCLOSET therapy and with dose escalation. In a 52-week, randomized clinical trial of 3070 patients, hypotension was reported in 2.2% of patients randomized to CYCLOSET compared to 0.8% of patients randomized to placebo. Among CYCLOSET-treated patients reporting symptomatic hypotension, 98% were on at least one blood pressure medication compared to 73% on such medication in the total study population. In this trial, six CYCLOSET-treated patients (0.3%) reported an adverse event of orthostatic hypotension compared to 2 (0.2%) placebo-treated patients. All six patients were taking antihypertensive medications. Hypotension can result in syncope. In this trial, syncope due to any cause was reported in 1.6% of CYCLOSET-treated patients and 0.7% of placebo-treated patients . As a precaution, assessment of orthostatic vital signs is recommended prior to initiation of CYCLOSET and periodically thereafter. During early treatment with CYCLOSET, patients should be advised to make slow postural changes and to avoid situations that could lead to serious injury if syncope was to occur. Use caution in patients taking antihypertensive medications.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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