Bromocriptine Mesylate

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

The Parlodel brand of bromocriptine is used to treat certain conditions caused by a hormone imbalance in which there is too much prolactin in the blood (hyperprolactinemia). Symptoms include lack of sexual development in adolescents. Women may have missed menstrual periods, loss of interest in sex, hot flashes, infertility, or unexpected breast milk production and leakage from the nipples. Men may have enlarged breasts, decreased libido, decreased facial or body hair, and loss of muscle. Parlodel is also used to treat these disorders when they are caused by brain tumors that can produce prolactin.

Parlodel is sometimes used together with surgery or radiation in treating acromegaly, a condition caused by a pituitary gland tumor that produces too much growth hormone. Parlodel is also used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

Bromocriptine may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to bromocriptine or to an ergot medicine (Ergomar, Cafergot, Migergot, D.H.E. 45, Migranal, Methergine).

You should not use Parlodel if you have:

• uncontrolled high blood pressure (hypertension);
• hypertension caused by pregnancy (including eclampsia and preeclampsia);
• if you are also using an ergot medicine to treat migraine headaches; or
• if you have recently had a baby and you have a history of coronary artery disease or severe heart disease.

Bromocriptine may contain lactose. Before taking Parlodel, tell your doctor if you have a hereditary form of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

To make sure you can safely take bromocriptine, tell your doctor if you have any of these other conditions:

• high or low blood pressure, heart disease, or a history of heart attack;
• liver or kidney disease;
• a tumor of the pituitary gland;
• a stomach ulcer or history of stomach or intestinal bleeding; or
• a history of mental illness or psychosis.

FDA pregnancy category B. Bromocriptine is not expected to harm an unborn baby. However, a pituitary tumor in the mother can expand during pregnancy. High blood pressure can also occur during pregnancy and bromocriptine could be dangerous if taken by a pregnant woman with high blood pressure. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Some women take Parlodel in order to normalize menstrual periods and increase their chances of becoming pregnant. Tell your doctor as soon as you become pregnant. You may need to stop taking Parlodel. Follow your doctor's instructions.

If you are not taking Parlodel to help you get pregnant, use a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy during treatment. Your doctor may also want you to have a pregnancy test every 4 weeks during treatment.

Bromocriptine lowers the hormone needed to produce breast milk. Do not breast-feed a baby while taking this medication.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Parlodel is usually taken twice daily with meals.

While using bromocriptine, you may need blood tests at your doctor's office. Visit your doctor regularly.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking Parlodel.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

Store at room temperature away from moisture, heat, and light.

Take the missed Parlodel*dose with food as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. *Do not take extra medicine to make up the missed dose.

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 using an ergot medicine at any time while you are taking Parlodel. Ergot medicine are used to treat migraine headaches, and include ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), and methylergonovine (Methergine):

Bromocriptine may impair your thinking or reactions. Some people taking Parlodel have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

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 taking 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, spinning sensation, mild drowsiness, feeling tired;
• mild headache, depressed mood, sleep problems (insomnia);
• dry mouth, stuffy nose;
• upset stomach, nausea, vomiting, stomach pain, 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.

Your doctor or pharmacist can provide more information about bromocriptine (Parlodel).