Cycloset tablets contain micronized bromocriptine in a quick release formulation.

Cycloset is used together with diet and exercise to improve blood sugar control in adults with type 2 type 2 diabetes mellitus.

Cycloset is not for treating type 1 diabetes.

This medication guide provides information about the Cycloset brand of bromocriptine. Parlodel is another brand of bromocriptine that is not covered in this medication guide.

You should not use Cycloset if you have migraine headaches that cause you to faint, if you are in a state of diabetic ketoacidosis, or if you recently had a baby.

Do not breastfeed.

Tell your doctor right away if you become pregnant while taking Cycloset.

Before taking this medicine

You should not use Cycloset if you are allergic to bromocriptine or to an ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

You should not use Cycloset if:

• you are breastfeeding;

• you had a baby recently;

• you have migraine headaches that cause you to faint; or

• you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Cycloset is safe for you, tell your doctor if you have:

• high or low blood pressure, heart disease, or a heart attack;

• liver or kidney disease;

• a tumor of the pituitary gland;

• a stomach ulcer, stomach or intestinal bleeding; or

• mental illness or psychosis.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Do not breastfeed while using this medicine.

Take Cycloset exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Cycloset is usually taken each morning with food, within 2 hours after you wake up.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Cycloset is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Diabetes Type 2:

Initial: 0.8 mg orally once a day
-Increase in increments of 0.8 mg weekly as tolerated
Maintenance: 1.6 to 4.8 mg orally once a day
Maximum Dose: 4.8 mg/day

Dose should be taken within 2 hours of waking in the morning with food

Concomitant Administration with CYP450 3A4 inhibitors:
-Moderate CYP450 3A4 inhibitors (e.g., erythromycin): Do not exceed 1.6 mg/day
-Strong CYP450 3A4 inhibitors (e,g., azole antimycotics, HIV protease inhibitors): Avoid concomitant use and ensure adequate washout of strong CYP450 3A4 inhibitors before initiating therapy

Comments:
-Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis
-Limited efficacy data in combination with thiazolidinediones
-Efficacy has not been confirmed in combination with insulin

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

You should not use Cycloset if you are allergic to bromocriptine or to an ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

You should not use Cycloset if:

• you are breastfeeding;

• you had a baby recently;

• you have migraine headaches that cause you to faint; or

• you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Cycloset is safe for you, tell your doctor if you have:

• high or low blood pressure, heart disease, or a heart attack;

• liver or kidney disease;

• a tumor of the pituitary gland;

• a stomach ulcer, stomach or intestinal bleeding; or

• mental illness or psychosis.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Do not breastfeed while using this medicine.

Use the medicine as soon as you can, but skip the missed dose if you are more than 2 hours late for your morning dose after waking. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, constipation, sweating, pale skin, dizziness, drowsiness, yawning, confusion, hallucinations, and fainting.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to Cycloset: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe drowsiness; or

• a light-headed feeling, like you might pass out.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Cycloset side effects may include:

• dizziness, feeling tired;

• nausea, vomiting; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cycloset can make certain migraine headache medicines less effective when taken at the same time. Avoid taking Cycloset within 6 hours before or 6 hours after you take an ergot headache medicine (such as dihydroergotamine, ergotamine, ergonovine, methylergonovine).

Tell your doctor about all your current medicines. Many drugs can interact with bromocriptine, especially medicine to treat:

• type 2 diabetes;

• headaches;

• psychotic conditions such as bipolar disorder or schizophrenia;

• Parkinson's disease;

• high blood levels of a hormone called prolactin;

• restless leg syndrome; or

• acromegaly (too much growth hormone).

This list is not complete and many other drugs may interact with bromocriptine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.