Parlodel (Bromocriptine Mesylate)

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Bromocriptine (Parlodel) is used to treat symptoms of hyperprolactinemia (high levels of a natural substance called prolactin in the body) including lack of menstrual periods, discharge from the nipples, infertility (difficulty becoming pregnant) and hypogonadism (low levels of certain natural substances needed for normal development and sexual function). Bromocriptine (Parlodel) may be used to treat hyperprolactinemia caused by certain types of tumors that produce prolactin, and may shrink these tumors. Bromocriptine (Parlodel) is also used alone or with other treatments to treat acromegaly (condition in which there is too much growth hormone in the body) and Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Bromocriptine (Cycloset) is used with a diet and exercise program and sometimes with other medications to control blood sugar levels in people with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Bromocriptine (Cycloset) is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Bromocriptine is in a class of medications called dopamine receptor agonists. It treats hyperprolactinemia by decreasing the amount of prolactin in the body. It treats acromegaly by decreasing the amount of growth hormone in the body. It treats Parkinson's disease by stimulating the nerves that control movement. The way bromocriptine works to treat diabetes is not known.

Bromocriptine (Parlodel) comes as a capsule and a tablet to take by mouth. Bromocriptine (Cycloset) comes as a tablet to take by mouth. When bromocriptine (Parlodel) is used to treat hyperprolactinemia, it is usually taken once a day with food. When bromocriptine (Parlodel) is used to treat acromegaly, it is usually taken once a day at bedtime with food. When bromocriptine (Parlodel) is used to treat Parkinson's disease, it is usually taken twice a day with food. Bromocriptine (Cycloset) is usually taken once a day with food within 2 hours of waking in the morning. Take bromocriptine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bromocriptine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor will probably start you on a low dose of bromocriptine and gradually increase your dose, not more than once every 2 to 28 days. The timing of the dose increases depends on the condition being treated and on your response to the medication. Bromocriptine may help to control your condition but will not cure it. It may take some time for you to feel the full benefit of bromocriptine. Do not stop taking bromocriptine without talking to your doctor. If you stop taking bromocriptine, your condition may worsen. If you are taking bromocriptine (Cycloset) for diabetes, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking bromocriptine,
• tell your doctor and pharmacist if you are allergic to bromocriptine; ergot alkaloids such as cabergoline (Dostinex), dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), methysergide (Sansert), and pergolide (Permax); any other medications; or any of the ingredients in bromocriptine tablets or capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amitriptyline (Elavil); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); antihistamines; chloramphenicol; dexamethasone (Decadron, Dexpak); other dopamine agonists such as cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), and methysergide (Sansert); haloperidol (Haldol); imipramine (Tofranil); insulin; macrolide antibiotics such as clarithromycin (Biaxin, in PrevPac) and erythromycin (E.E.S., E-Mycin, Erythrocin); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); oral medications for diabetes; medications for asthma, colds, high blood pressure, migraines, and nausea; medications for mental illness such as clozapine (Clozaril, FazaClo), olanzapine (Zyprexa, in Symbyax), thiothixene (Navane), and ziprasidone (Geodon); methyldopa (in Aldoril); metoclopramide (Reglan); nefazodone; octreotide (Sandostatin); pimozide (Orap); probenecid (in Col-Probenecid, Probalan); reserpine; rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); and sumatriptan (Imitrex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with bromocriptine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have high blood pressure or migraine headaches that cause fainting. Your doctor may tell you not to take bromocriptine.
• tell your doctor if you have recently given birth, if you have ever fainted, and if you have or have ever had a heart attack; a slow, fast, or irregular heartbeat; mental illness; low blood pressure;ulcers; bleeding in the stomach or intestines; Raynaud's syndrome (condition in which the hands and feet become numb and cool when exposed to cold temperatures); heart, kidney, or liver disease; or any condition that prevents you from digesting foods containing sugar, starch, or dairy products normally.
• tell your doctor if you are pregnant or plan to become pregnant. If you are taking bromocriptine (Parlodel) to treat lack of menstrual periods and infertility caused by hyperprolactinemia, use a method of birth control other than hormonal contraceptives (birth control pills, patches, rings, or injections) until you have regular menstrual periods; then stop using birth control. You should be tested for pregnancy once every 4 weeks as long as you do not menstruate. Once your menstrual period returns, you should be tested for pregnancy any time your menstrual period is 3 days late. If you do not wish to become pregnant, use a method of birth control other than hormonal contraceptives while you are taking bromocriptine. If you become pregnant during your treatment with bromocriptine, stop taking the medication and call your doctor.
• do not breast-feed while you are taking bromocriptine.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking bromocriptine (Cycloset).
• you should know that bromocriptine may make you drowsy and cause you to suddenly fall asleep. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking bromocriptine. Alcohol can make the side effects from bromocriptine worse.
• you should know that bromocriptine may cause dizziness, nausea, sweating, and fainting when you get up too quickly from a lying position. This is more common when you first start taking bromocriptine or when your dose is increased. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of bromocriptine (Cycloset) you may need.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.

If you take bromocriptine (Parlodel), take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you take bromocriptine (Cycloset) once a day and miss your morning dose, wait until the next morning to take your medication. Do not take a double dose to make up for a missed one.

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms. Bromocriptine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• stomach cramps
• heartburn
• loss of appetite
• headache
• weakness
• tiredness
• dizziness or lightheadedness
• drowsiness
• difficulty falling asleep or staying asleep
• depression

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fainting
• watery discharge from the nose
• numbness, tingling, or pain in your fingers especially in cold weather
• black and tarry stools
• bloody vomit
• vomiting material that looks like coffee grounds
• swelling of the feet, ankles, or lower legs
• seizures
• severe headache
• blurred or impaired vision
• slow or difficult speech
• weakness or numbness of an arm or leg
• chest pain
• pain in the arms, back, neck or jaw
• shortness of breath
• confusion
• hallucinations (seeing things or hearing voices that do not exist)

Bromocriptine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor, eye doctor, and the laboratory. Your blood pressure should be checked periodically. Your doctor may order regular eye examinations and certain lab tests to check your body's response to bromocriptine. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to bromocriptine (Cycloset). Your doctor will also tell you how to check your response to bromocriptine (Cycloset) by measuring your blood or urine sugar levels at home. Follow these directions carefully. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.