Parlodel (Bromocriptine) – Oral

What Is Parlodel?

Parlodel contains the active drug bromocriptine, which belongs to the dopamine receptor agonist drug class. The drug is approved to treat Parkinson's disease and hormonal disorders like acromegaly (too much growth hormone in the body).

Parlodel binds directly to special dopamine D2 receptors in the brain, stimulating nerves that control movement. This leads to decreased prolactin in the body, reducing the harmful effects of hyperprolactinemia (a disease with very high blood levels of prolactin, a hormone released by the pituitary gland). In acromegaly, bromocriptine blocks the release of a specific growth hormone (somatotropin), decreasing its blood concentrations.

Parlodel is a prescription medicine available as oral capsules and tablets.

What Is Parlodel Used For?

Parlodel is used alone or with other drugs to treat Parkinson's disease. Parkinson's is a nervous system disorder that causes difficulty with movement, muscle control, and balance. Parlodel improves the ability to move and decreases shakiness (tremors), stiffness, slowed movement, and instability. It may also reduce the number of episodes of not being able to move ("on-off syndrome").

Parlodel therapy may provide additional therapeutic benefits in people who are currently maintained on an optimal dose of levodopa (a central nervous system agent that converts to dopamine in the brain), and in those who are beginning to develop tolerance to levodopa therapy and experiencing "end of dose failure" (when the effects wear off) on levodopa therapy.

Parlodel is also indicated for the treatment of conditions associated with hyperprolactinemia, including amenorrhea (lack of menstrual periods) with or without galactorrhea (discharge from the nipples), infertility or hypogonadism (low levels of hormones required for normal development and sexual function).

Hyperprolactinemia is caused by high levels of a natural substance called prolactin in the body caused by certain types of tumors. High prolactin levels may cause problems such as unwanted breast milk, missed periods, difficulty becoming pregnant, decreased sperm production, decreased sexual ability, and headaches.

It is also used to treat certain hormonal disorders called acromegaly, a condition caused by too much growth hormone in the body).

How to Take Parlodel

Read the directions carefully on your prescription label. Ask your healthcare provider or pharmacist to explain if you need help understanding any of the information.

Parlodel comes as an oral capsule and a tablet.

• When used to treat hyperprolactinemia, it is usually taken once a day with food.
• When used to treat acromegaly, it is usually taken once a day at bedtime with food.
• When used to treat Parkinson's disease, it is usually taken twice a day with food.
  
• Take your dose at the same time every day to avoid missing them.
• Take Parlodel exactly as directed.
• Do not take less or more often than prescribed by your healthcare provider.

Your healthcare provider will prescribe the best suitable dose for you, depending on your clinical condition. They will probably start you on a low dose of Parlodel and gradually increase the dose once every two to 28 days. Your dose depends on the condition being treated and how your condition responds to the medication. You may need some time to see the full benefits of the drug.

Parlodel may help to control a particular condition but may not cure it. Do not stop taking Parlodel without talking to your healthcare provider. Sudden discontinuation may result in a lack of interest or concern for usual activities, anxiety, depression, tiredness, sleep problems, sweating, or pain. 

Storage

Keep Parlodel in its original container, and store it at room temperature. Keep it away from heat and moisture, such as in the bathroom or near a sink. Do not store it in the car or on a windowsill.

Keep all medications out of sight and reach of children and pets. Always lock safety caps to avoid accidental poisoning, and/or locked in a cabinet or closet.

Try to avoid pouring unused and expired drugs down the drain or in the toilet. Ask your pharmacist or healthcare provider about the best ways to dispose of this medicine. Visit the Food and Drug Administration (FDA) website to know where and how to discard all unused and expired drugs. Disposal boxes may be available in your area. Ask your pharmacist or healthcare provider if you have any questions about the best ways to dispose of your medications.

If you plan to travel with Parlodel, get familiar with your final destination's regulations. In general, be sure to make a copy of your Parlodel prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.

Off-Label Uses

Parlodel has also been used off-label to treat: 

• Neuroleptic malignant syndrome (a neurologic emergency associated with the use of antipsychotic drugs)
• Restless leg syndrome (RLS, a condition causing an uncontrollable urge to move the legs due to discomfort)
  

What Are the Side Effects of Parlodel?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Parlodel may cause some side effects, such as:

• Constipation
• Diarrhea
• Dizziness or light-headedness
• Drowsiness
• Depression
• Heartburn
• Headache
• Nausea
• Vomiting
• Loss of appetite
• Sleep problems
• Stomach cramps
• Tiredness
• Weakness

Call your healthcare provider if these symptoms worsen or do not go away.

Severe Side Effects

Contact your healthcare provider right away if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms include:

• Black, tarry stools
• Bloody vomit
• Chest pain
• Confusion
• Fainting
• Hallucinations
• Impaired or blurred vision
• Numbness, tingling, or pain in the fingers, especially in cold weather
• Pain in the arms, back, neck, or jaw
• Swelling of the feet, ankles, or lower legs
• Seizures
• Severe headache
• Slow or difficult speech
• Shortness of breath
• Vomiting material that looks like coffee grounds
• Watery discharge from the nose
• Weakness or numbness of an arm or leg
  

Dosage: How Much Parlodel Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Parlodel:

Severe allergic reaction: You should not use Parlodel if you are allergic to bromocriptine or any other ingredient in the tablets or capsules. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: The safety and effectiveness of Parlodel have not been established in pregnant people and their fetuses. Discuss with your healthcare provider if you are or plan to become pregnant, and weigh the benefits and risks of taking Parlodel during your pregnancy.

Breastfeeding: Parlodel should not be taken by breastfeeding people.

Adults over the age of 65 years: There is not enough clinical data available to show how Paradalol affects the adults over the age of 65 years of age or above.

Children: The safety and effectiveness of Parlodel have not been established in children for any of the indications listed above. The safety and effectiveness of Parlodel for the treatment of prolactin-secreting pituitary adenomas have been established in children 16 and above.

Other modifications: The effect of Parlodel on renal (kidney) function has not been studied. Renal impairment may not significantly affect the metabolism of the drug.

The effect of Parlodel on liver function has not been studied. Parlodel is mainly eliminated by metabolism through the liver; liver impairment may increase the plasma levels of the drug. Caution is advised.

Administration modifications: Always take this medicine with food even if you are taking it at bedtime.

Missed Dose

If you accidentally forgot your Parlodel dose, take it as soon as you remember. If it's already close to your next scheduled dose, however, skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways that work for you to help yourself remember to routinely keep your appointments and take your medication. If you miss too many doses, Parlodel might be less effective.

Overdose: What Happens If I Take Too Much Parlodel?

If you think that you're experiencing an overdose or life-threatening symptoms, however, seek immediate medical attention. The symptoms of a suspected overdose of Parlodel include:

• Confusion
• Constipation
• Dizziness
• Discomfort or uneasiness
• Drowsiness
• Fainting
• Hallucinations 
• Lack of energy
• Nausea
• Sweating
• Pale skin
• Vomiting
• Yawning repeatedly

If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Parlodel?

Parlodel is contraindicated (not recommended) in people with:

• Hypersensitivity to any of its ingredients
• Uncontrolled high blood pressure (hypertension) 
• Sensitivity to any ergot alkaloids such as Dostinex (cabergoline), D.H.E. 45 (dihydroergotamine), ergoloid mesylates, Ergotrate(ergonovine), Ergomar (ergotamine), Methergine (methylergonovine), and others
  
• Mental health illness

Other considerations include:

• Pregnancy: If Parlodel is necessary for pregnant people, the benefit of continuing the treatment must outweigh the risk.
• The postpartum period, specifically in women with a history of coronary artery disease and other severe cardiovascular conditions. If the use of the drug is required during the postpartum period, the individual should be monitored closely.
  

What Other Medications Interact With Parlodel?

Parlodel has not been studied carefully in combination with other drugs. Parlodel may interact with certain drugs and may require caution when used with the following medications:

Antipsychotics:

• Haldol (haloperidol)
• Mellaril or Melleril (thioridazine)
• Thorazine and Largactil (chlorpromazine)

Dopamine antagonists:

• Dostinex (cabergoline)
• Larodopa (levodopa)
• Permax (pergolide)
• Requip (ropinirole)
• Butyrophenones

Azole antimycotics:

• Sporanox (itraconazole)
• Nizoral (ketoconazole)

HIV (human immunodeficiency virus) protease inhibitors:

• Crixivan (indinavir)
• Viracept (nelfinavir)
• Norvir (ritonavir)

Macrolide antibiotics:

• Biaxin (clarithromycin) 
• Erythrocin (erythromycin)

Ergot alkaloids:

• Dostinex (cabergoline)
• D.H.E. 45, (dihydroergotamine)
• Hydergine (ergoloid mesylates)
• Ergotrate (ergonovine)
• Bellergal-S (ergotamine)
• Methergine (methylergonovine)
• Sansert (methysergide)
• Permax (pergolide)

Dose adjustment may be required when high doses of Parlodel are used in Parkinson’s disease.

Parlodel may interact with alcohol and cause severe side effects. Don’t get up too fast from a sitting or lying position, or you may feel dizzy.

Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Parlodel. Be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC) and nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Dopaminergic antiparkinsonian agents (medications) aim to replace dopamine or prevent the degradation of dopamine (keep dopamine circulating in the brain). Antiparkinsonian drugs replace dopamine in the central nervous system, either releasing dopamine or mimicking the action of dopamine.

Antiparkinsonian agents treat Parkinson's disease, a degenerative disorder of movement that occurs due to dopamine deficiency in the brain, particularly in the basal ganglia (an area deep in the brain).

Some of the other drugs belonging to the antiparkinsonian class are:

• Requip (ropinirole)
• Mirapex (pramipexole)
• Neupro (rotigotine)
• Emsam (selegiline)
• Sinemet (carbidopa/levodopa)
• Rytary (carbidopa/levodopa)
• Azilect (rasagiline)
• Stalevo (carbidopa/entacapone/levodopa)
• Comtan (entacapone)
• Xadago (safinamide)
• Symmetrel (amantadine)
• Sinemet CR (carbidopa/levodopa)
• Apokyn (apomorphine)
• Zelapar (selegiline)

Prolactin inhibitors are agents that are dopamine agonists that effectively treat hyperprolactinemia (too high levels of prolactin in the blood). These drugs include:

• Dostinex (cabergoline)
• Parlodel (bromocriptine)
• Cycloset (bromocriptine)

Your healthcare provider will prescribe the best suitable brand for you. Don't switch brands on your own without asking your healthcare provider. 

How Can I Stay Healthy While Taking Parlodel?

Taking Parlodel may cause physical and psychotic side effects. People taking Parlodel need to be closely monitored and cared for. Psychotic episodes may include a sudden onset of sleep during daily activities and loss of awareness or concentration. All individuals receiving Parlodel must be advised not to drive or engage in activities in which reduced alertness or lack of attention may put themselves or others at risk.

It helps to take the drug doses regularly to get the maximum therapeutic effects. The discontinuation of the drug may be associated with recurrence of initial symptoms, withdrawal effects, or rapid regrowth of tumors if taking it for that condition.

Some people may experience intense urges to spend their fortune uncontrollably or to gamble, hypersexuality (increased desire to have sex), mania, depression, or other intense cravings. Individuals or caregivers must closely observe and contact their healthcare provider with any questions or concerns. 

Consider discussing with your provider how to access additional mental health and emotional support systems for yourself and your loved ones when navigating Parkinson's, acromegaly (too much growth hormone in the body), or hyperprolactinemia (high levels of prolactin in the body).