Parlodel

Parlodel is a prescription medication used to treat hyperprolactinemia (condition of having high levels of prolactin), acromegaly (condition of abnormal growth), and Parkinson's disease (condition affecting the motor system of the body).

Parlodel belongs to a group of drugs 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 acting like dopamine, affecting the brain processes that control movement. 

Parlodel comes in capsule and tablet form. This medication should be taken with food.

Common side effects include nausea, headache, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Parlodel is a prescription medication used to:

• treat the effects of hyperprolactinemia (high levels of a natural hormonal substance called prolactin) including lack of menstrual periods, discharge from the nipples, infertility and hypogonadism (low levels of certain natural substances needed for normal development and sexual function)
• shrink prolactin-secreting tumors which cause hyperprolactinemia
• treat acromegaly (condition in which there is too much growth hormone in the body)
• treat Parkinson's disease

This medication may be prescribed for more uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

• Validus Pharmaceuticals, Inc.

Common side effects of Parlodel include:

Hyperprolactinemia

• Nausea
• Headache
• Dizziness
• Extreme tiredness 
• Lightheadedness
• Vomiting
• Stomach (abdomen) cramps 
• Stuffy nose
• Constipation
• Diarrhea
• Drowsiness

Acromegaly

• Nausea
• Constipation
• Certain forms of low blood pressure
• Loss of appetite
• Dry mouth
• Stuffy nose
• Acid indigestion
• Condition where blood vessels constrict
• Drowsiness
• Vomiting

Parkinson's disease

• Nausea
• Abnormal, uncontrolled movements
• Hallucinations
• Confusion
• "On-off" phenomenon which is a condition where patients switch between being able to move and unable to move
• Dizziness
• Drowsiness
• Fainting
• Vomiting
• Lack of energy
• Stomach (abdomen) discomfort
• Visual changes
• Loss of control of body movements
• Difficulty sleeping
• Depression
• Low blood pressure
• Shortness of breath
• Constipation
• Vertigo (feeling like your surroundings are spinning)

This is not a complete list of Parlodel side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. No drug interactions have been studied by the manufacturer but possible interactions may occur with the following medications when used with Parlodel:

• medications that block the effects of a substance in the body called dopamine such as quetiapine (Seroquel) and metoclopramide (Reglan)
• haloperidol (Haldol)
• pimozide (Orap)
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• a group of medicines called ergot Alkaloids such as ergotamine (Ergomar) and dihydroergotamine (Migranal)

This is not a complete list of Parlodel drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Parlodel including the following:

• Hyperprolactinemia associated with abnormal menstrual cycles and infertility (the inability to conceive) has been found in patients with pituitary tumors, a complete evaluation of the pituitary is indicated before treatment with Parlodel
• If pregnancy occurs during Parlodel administration, careful observation of these patients is mandatory. Tumors may expand and compression of nerves in the brain may occur, emergency surgery may become necessary. 
• Parlodel has been associated with sleepiness. Sudden onset of sleep during daily activities may occur. It is not advised to drive or operate machines during treatment with Parlodel.
• Low blood pressure can occur. Regularly monitor your blood pressure.

Do not take Parlodel if you:

• are allergic to Parlodel or to any of its ingredients
• have sensitivity to any ergot alkaloids
• have uncontrolled high blood pressure
• become pregnant
• recently gave birth (postpartum period) and have a history of coronary artery disease

Grapefruit and grapefruit juice may interact with Parlodel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Parlodel tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• if you are allergic to Parlodel or to any of its ingredients
• if you are allergic to 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)
• you have high blood pressure or migraine headaches that cause fainting. Your doctor may tell you not to take Parlodel.
• have recently given birth
• have ever fainted
• have or have ever had a heart attack
• have a slow, fast, or irregular heartbeat
• have a mental illness
• have low blood pressure
• have ulcers or bleeding in the stomach or intestines
• have Raynaud's syndrome (condition in which the hands and feet become numb and cool when exposed to cold temperatures)
• have heart, kidney, or liver disease
• have any condition that prevents you from digesting foods containing sugar, starch, or dairy products normally
• are pregnant or plan to become pregnant.  If you become pregnant during your treatment with Parlodel, stop taking the medication and call your doctor.
• you are breastfeeding or planning on breasfeeding while you are taking Parlodel.
• are having surgery, including dental surgery

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Ask your doctor about the safe use of alcoholic beverages while you are taking Parlodel. Alcohol can make the side effects from Parlodel worse.

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 Parlodel you may need.

Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant during your treatment with Parlodel, stop taking the medication and call your doctor.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Parlodel falls into category B. If pregnancy occurs during Parlodel use, careful observation of these patients is mandatory. 

If you do not wish to become pregnant, use a method of birth control other than hormonal contraceptives while you are taking Parlodel. If you become pregnant during your treatment with Parlodel, stop taking the medication and call your doctor.

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

Take Parlodel exactly as prescribed.

Parlodel comes in capsule and tablet form. This medication should be taken with food. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Parlodel at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• other medicines you are taking

The recommended dose range of Parlodel for the treatment of hyperprolactinemia in adults is 2.5 to 15 mg/day. For children, the recommended dose is 2.5 - 10 mg/day.

The recommended dose range of Parlodel for the treatment of acromegaly is 20 to 30 mg/day. The maximum dose is 100 mg/day for acromegaly. 

The initial dose of Parlodel for the treatment of Parkinson’s Disease is 1/2 of a 2.5 mg SnapTabs twice daily with meals. Increases are then made on an individual basis. Your doctor will start you on a low dosage and will slowly increase the dose. Safety information is not known for doses over 100 mg/day. 

If you take too much Parlodel, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store below 25ºC (77ºF) in a tight, light-resistant container. 
• Keep this and all medicines out of the reach of children.