Pronunciation:

PER-goe-lide

Brand Names:

• Permax

Dosage Forms:

• Tablet

Warnings:

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 .

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Dopamine Agonist

Uses of This Medicine:

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.

This medicine was withdrawn from the U.S. market in March 2007 due to an increased risk for heart valve problems .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

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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

Older adults—

This medicine 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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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 this medicine 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

Other interactions—

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 this medicine. 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 This Medicine:

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

Dosing—

The dose of this medicine 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 this medicine. 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 this medicine, 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 This Medicine:

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

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine 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 this medicine or reduce the amount you are taking without first checking with your doctor.

Side Effects of This Medicine:

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.