Cycloset

Oral Administration

Parlodel

• Take with food

Cycloset

• Take with food; administer within 2 hours after waking in the morning
• If dose missed, wait until the next morning to take medication

Storage

Cycloset and Parlodel: Store ≤25°C (77°F)

Parlodel: Store in tight, light-resistant container

• Santarus, Incorporated

Tell your doctor if you are breastfeeding or plan to breastfeed. Do not breastfeed while you are taking Cycloset.

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 are breast-feeding, if you have migraine headaches that cause you to faint, or if you are in a state of diabetic ketoacidosis (Call your doctor for treatment with insulin).

You should not breast-feed a baby while taking bromocriptine.

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

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

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• vision problems, constant runny nose;

• chest pain, pain when you breathe, fast heart rate, rapid breathing, feeling short of breath (especially when lying down);

• back pain, swelling in your ankles or feet, urinating less than usual or not at all;

• confusion, hallucinations, feeling like you might pass out;

• low blood sugar (headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating);

• muscle movements you cannot control, loss of balance or coordination;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• dizziness, mild drowsiness, feeling weak or tired;

• mild headache;

• stuffy nose;

• upset stomach, nausea, vomiting, loss of appetite, diarrhea, constipation; or

• cold feeling or numbness in your fingers.

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.

Many other drugs can interact with bromocriptine. Below is just a partial list. Tell your doctor if you are using:

• an antidepressant, a sedative or narcotic medication, medicines to treat psychiatric disorders;

• an antibiotic or antifungal medication, anti-malaria drugs;

• asthma or allergy medication;

• cancer medicine, medicines used to prevent organ transplant rejection;

• cholesterol-lowering drugs such as simvastatin (Zocor);

• an oral diabetes medication;

• heart or blood pressure medications, heart rhythm medication;

• HIV or AIDS medications;

• seizure medications;

• sildenafil (Viagra) and other erectile dysfunction medicines; or

• stomach acid reducers.

This list is not complete and there are many other drugs that can interact with bromocriptine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

In the U.S.

• Cycloset
• Parlodel

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Dopamine Agonist

Use Cycloset as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Take with food to prevent an upset stomach.
• Take within 2 hours of waking up.

What do I do if I miss a dose?

• If you miss a dose, wait until the next day to take your normal dose.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

0.8 mg tablets are white and round, imprinted with "C" on one side and "9" on the other.

Pregnancy

Pregnancy Category B:

Two strains of pregnant rats were dosed orally with 3, 10, and 30 mg/kg/day (up to 72 times the human 4.8 mg daily dose, based on mg/m2 comparison) from gestation day 6-15 and with a single dose of 10 mg/kg on gestation day 5. Implantation was inhibited at 10 and 30 mg/kg (24 and 72 times the human 4.8 mg daily dose, based on mg/m2 comparison). When rats were dosed with 3, 10, and 30 mg/kg/day from gestation day 8-15 there was an increase in resorptions at 10 and 30 mg/kg. These effects were probably due to the dependence of implantation and the maintenance of gestation on prolactin in the rat and are not relevant for humans in which these events are not dependent on prolactin but on luteinizing hormone. There was no evidence of teratogenic effects in the rat.

In a small study in macaque monkeys given oral doses of 2 mg/kg/day (10 times the human 4.8 mg daily dose, based on mg/m2 comparison) during organogenesis no embryotoxic or teratologic effects were observed.

When male rats given oral doses of 2, 10, or 50 mg/kg/day (up to 120 times the human 4.8 mg daily dose, based on mg/m2 comparison) were mated with untreated females, there was a slight increase in pup loss in the 10 and 50 mg/kg/day groups (24-120 times the human 4.8 mg daily dose, based on mg/m2 comparison).

In two strains of pregnant rabbits treated from gestation day 6-18 with oral doses of 3, 10, 30, 100, and 300 mg/kg/day (up to 1400 times the human 4.8 mg daily dose, based on mg/m2 comparison) there was maternal toxicity and embryolethality at doses ≥10 mg/kg/day (48 times the human 4.8 mg daily dose, based on mg/m2 comparison). Low incidences of fetal abnormalities were observed at maternally toxic doses of 100-300 mg/kg/day (480-1400 times the human 4.8 mg daily dose, based on mg/m2 comparison). There were no treatment-related fetal abnormalities at doses ≤30 mg/kg/day (140 times the human 4.8 mg daily dose, based on mg/m2 comparison). Implantation was not affected in rabbits treated from gestation day 1-6 with oral doses of 100-300 mg/kg/day (480-1400 times the human 4.8 mg daily dose, based on mg/m2 comparison).

Studies in pregnant women have not shown that bromocriptine increases the risk of abnormalities when administered during pregnancy. Information concerning 1,276 pregnancies in women taking bromocriptine has been collected. In the majority of cases, bromocriptine was discontinued within the first 8 weeks of pregnancy (mean 29 days); however, 8 patients received the drug continuously throughout pregnancy. The mean daily dose for all patients was 5.8 mg (range 1-40 mg). Of these 1,276 pregnancies, there were 1,088 full-term deliveries (4 stillborn), 145 spontaneous abortions (11.4%), and 28 induced abortions (2.2%). Twelve extrauterine gravidities and 3 hydatidiform moles (twice in the same patient) caused early termination of pregnancy. These data compare favorably with the abortion rate (11-25%) cited for pregnancies induced by clomiphene citrate, menopausal gonadotropin, and chorionic gonadotropin. Although spontaneous abortions often go unreported, especially prior to 20 weeks of gestation, their frequency has been estimated to be 10-15% in the general population. The incidence of birth defects in the general population ranges from 2-4.5%. The incidence of birth defects in 1,109 live births from patients receiving bromocriptine was 3.3%. There is no suggestion that bromocriptine contributed to the type or incidence of birth defects in this group of infants.

A review of 4 different multicenter surveillance programs analyzed 2,351 pregnancies of 2,185 women treated with bromocriptine. In 583 children born of these women and followed for a minimum of 3-12 months, there was no suggestion of any adverse effect of intra-uterine exposure to bromocriptine on postnatal development. Most (≥75%) women had taken bromocriptine for 2-8 weeks and at 5-10 mg per day. Among 86 women having 93 pregnancies and treated with bromocriptine throughout pregnancy or from week 30 of pregnancy onwards (mostly for treatment of prolactinoma), there was only 1 spontaneous abortion. Similar results have been obtained in a Japanese hospital survey of 442 children born to 434 patients treated with bromocriptine during pregnancy and followed for at least one year.

Because the studies in humans cannot rule out the possibility of harm, Cycloset should be used during pregnancy only if clearly needed.

Nursing Mothers

Cycloset is contraindicated in women who are nursing their children. Cycloset contains bromocriptine which inhibits lactation. The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn based on postmarketing reports of stroke in this setting [see Contraindications (4), Adverse Reactions (6.2)].

Pediatric Use

The safety and effectiveness of Cycloset in pediatric patients have not been established.

Geriatric Use

In the two clinical trials of Cycloset add-on to sulfonylurea therapy and in the monotherapy trial, a total of 54 patients randomized to Cycloset were ≥65 years old. In the 52-week safety trial, 601 of the 2,054 Cycloset-treated patients (29%) were ≥65 years old. No overall differences in safety or effectiveness were observed between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. [See Clinical Studies (14).]

You should not use Cycloset if you are breast-feeding, if you have migraine headaches that cause you to faint, or if you are in a state of diabetic ketoacidosis (Call your doctor for treatment with insulin). You should not breast-feed a baby while taking Cycloset. Tell your doctor right away if you become pregnant while taking this medicine.