Pergolide

PER-goe-lide

Oral routeTablet

• CARDIAC VALVULOPATHY
  • The use of pergolide has been shown to increase the risk of cardiac valvular disease involving one or more valves. Some patients have required valve replacement, and deaths have been reported. Cases have been reported after exposures to pergolide ranging from several months to several years. The histopathology of explanted valves is similar to that of other drug-induced valvulopathies. Precise risk estimates of pergolide-induced cardiac valvular disease are not available.
  • Specific risk factors predisposing patients to developing cardiac valvular disease with pergolide have not been identified. Cardiac valvulopathy has been reported with all doses of pergolide; however, available data suggest that the risk may be greater with higher doses. Doses of pergolide above 5 mg/day are not recommended.
  • Pergolide is not recommended for use in patients with a history of cardiac valvulopathy.
  • Before initiating treatment with pergolide, all patients should undergo a cardiovascular evaluation, including an echocardiogram, to determine whether valvular disease is present and to provide a baseline for subsequent monitoring. Although the risk of disease progression in patients with asymptomatic valvular disease is unknown, pergolide ordinarily should not be initiated if valvulopathy is detected at screening.
  • All patients taking pergolide should undergo periodic echocardiograms to screen for the development of valvulopathy. Patients should also be monitored for signs and symptoms of valvulopathy, including dyspnea, edema, congestive heart failure and new cardiac murmurs. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation, including echocardiogram, has been performed. Pergolide should ordinarily be discontinued if a patient is diagnosed with cardiac valvular disease. In some cases, signs and/or symptoms of cardiac valvulopathy improved after discontinuation of pergolide .
• FIBROTIC COMPLICATIONS
  • Case reports have demonstrated that pergolide increases the risk of fibrotic complications including pulmonary, pleural, and/or retroperitoneal fibrosis, pericarditis, pleuritis, and pericardial and/or pleural effusions. Cases have been reported after exposures to pergolide ranging from about one to several years. Precise risk estimates of pergolide-induced fibrotic complications are not available.
  • Specific risk factors predisposing patients to developing fibrotic complications with pergolide have not been identified. Fibrotic complications have been reported with all therapeutic doses of pergolide.
  • Pergolide is not recommended for use in patients with a history of fibrotic conditions.
  • Patients should also be monitored for signs and symptoms of fibrotic complications, including dyspnea, persistent edema, cough, congestive heart failure, new cardiac rub, and/or signs of urinary tract obstruction. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation has been performed. Pergolide should ordinarily be discontinued if a patient is diagnosed with a specific fibrotic complication. In some cases, signs and/or symptoms of fibrotic complications improved after discontinuation of pergolide .

The use of pergolide has been shown to increase the risk of cardiac valvular disease and is not recommended for use in patients with a history of cardiac valvulopathy. Some patients have required valve replacement, and deaths have been reported. Periodic echocardiograms are recommended during therapy. Pergolide increases the risk of fibrotic complications including pulmonary, pleural, and/or retroperitoneal fibrosis, pericarditis, pleuritis, and pericardial and/or pleural effusions. Pergolide is not recommended for use in patients with a history of fibrotic conditions and patients should be monitored for fibrotic complications during therapy .

Commonly used brand name(s):

In the U.S.

• Permax

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Dopamine Agonist

Uses For pergolide

Pergolide belongs to the group of medicines known as ergot alkaloids. It is used with levodopa or with carbidopa and levodopa combination to treat people who have Parkinson's disease. It works by stimulating certain parts of the central nervous system (CNS) that are involved in this disease.

Pergolide was available only with your doctor's prescription.

pergolide was withdrawn from the U.S. market in March 2007 due to an increased risk for heart valve problems .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, pergolide is used in certain patients with the following medical condition:

• Restless legs syndrome

Before Using pergolide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pergolide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pergolide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on pergolide have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

pergolide has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Using pergolide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Frovatriptan

Using pergolide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Kava

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pergolide. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Mental problems (history of)—Pergolide may make the condition worse.

Proper Use of pergolide

If pergolide upsets your stomach, it may be taken with meals. If stomach upset continues, check with your doctor.

Dosing

The dose of pergolide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pergolide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • Adults—50 micrograms a day for the first two days. The dose may be increased every three days as needed. However, the usual dose is not more than 5000 micrograms.

Missed Dose

If you miss a dose of pergolide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using pergolide

It is important that your doctor check your progress at regular visits, to make sure that pergolide is working and to check for unwanted effects.

pergolide may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to pergolide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur after the first doses of pergolide, especially when you get up from a lying or sitting position. Getting up slowly may help. Taking the first dose at bedtime or when you are able to lie down may also lessen problems. If the problem continues or gets worse, check with your doctor.

Pergolide may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

It may take several weeks for pergolide to work. Do not stop taking pergolide or reduce the amount you are taking without first checking with your doctor.

pergolide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Chest pain (severe)
• convulsions (seizures)
• difficulty in breathing
• fainting
• fast heartbeat or irregular pulse
• headache (severe or continuing)
• high fever
• high or low (irregular) blood pressure
• increased sweating
• loss of bladder control
• nausea and vomiting (continuing or severe)
• nervousness
• severe muscle stiffness
• sudden weakness
• unexplained shortness of breath
• unusual tiredness or weakness
• unusually pale skin
• vision changes, such as blurred vision or temporary blindness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Anxiety
• bloody or cloudy urine
• confusion
• difficult or painful urination
• frequent urge to urinate
• hallucinations (seeing, hearing, or feeling things that are not there)
• uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body

Less common

• Dizziness
• headache
• swelling in hands and legs

Rare

• Abdominal pain or pressure
• chills
• cough
• decreased flow of urine
• fever
• pain in side or lower back

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Chest congestion
• constipation
• dizziness or lightheadedness, especially when getting up from a lying or sitting position
• drowsiness
• heartburn
• lower back pain
• muscle pain
• nausea
• runny or stuffy nose
• trouble in sleeping
• weakness

Less common

• Diarrhea
• dryness of mouth
• loss of appetite
• swelling of the face
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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• pergolide Concise Consumer Information (Cerner Multum)
• Pergolide Prescribing Information (FDA)
• Permax Prescribing Information (FDA)
• Permax MedFacts Consumer Leaflet (Wolters Kluwer)