Permax

(Generic versions may still be available.)

DRUG DESCRIPTION

Permax (Pergolide Mesylate) is an ergot derivative dopamine receptor agonist at both D1 and D2 receptor sites. Pergolide mesylate is chemically designated as 8B-[(Methylthio)methyl]-6-propylergoline monomethanesulfonate.

The formula weight of the base is 314.5; 1 mg of base corresponds to 3.18 Ámol. Permax (pergolide mesylate) is provided for oral administration in tablets containing 0.05 mg (0.159 Ámol), 0.25 mg (0.795 Ámol), or 1 mg (3.18 Ámol) pergolide as the base. The tablets also contain croscarmel lose sodium, iron oxide, lactose, magnesium stearate, and povidone. The 0.05-mg tablet also contains methionine, and the 0.25mg tablet also contains FD&C Blue No.2.

What are the possible side effects of pergolide (Permax)?

Stop taking pergolide and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • irregular heartbeats;
  • hallucinations (seeing or hearing things that are not real), confusion, or altered consciousness; or
  • dizziness (especially when rising from a sitting or lying position).

Other, less serious side...

Read All Potential Side Effects and See Pictures of Permax

What are the precautions when taking pergolide mesylate (Permax)?

Before taking pergolide, tell your doctor or pharmacist if you are allergic to it; or to other ergot medications (e.g., bromocriptine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (e.g., fast/ irregular heartbeat, heart failure, heart valve problems), kidney problems, lung problems (e.g., pulmonary fibrosis), mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), sleep disorder (e.g., sleep apnea, narcolepsy).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or...

Read All Potential Precautions of Permax


Permax Consumer (continued)

SIDE EFFECTS: Nausea, dizziness, drowsiness, trouble sleeping, diarrhea, heartburn, runny nose, constipation, headache, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., confusion, depression, hallucinations, memory problems), increased difficulty moving/walking, muscle cramps/spasm, restlessness, decreased sexual function.

Some people taking pergolide have reported falling asleep suddenly during their usual daily activities (e.g., watching television, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur any time during treatment with pergolide, including up to 1 year after starting the medication. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy.

You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, sweating, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.

In rare cases, this medication may cause very serious heart valve problems or swelling around the heart and lungs (e.g., pleural fibrosis/effusion, pericarditis). Tell your doctor immediately if you develop any of the following symptoms: difficult/painful breathing, chest pain, unusually slow/fast/irregular heartbeat, swelling of the ankles/feet, unusual weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pergolide, tell your doctor or pharmacist if you are allergic to it; or to other ergot medications (e.g., bromocriptine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (e.g., fast/ irregular heartbeat, heart failure, heart valve problems), kidney problems, lung problems (e.g., pulmonary fibrosis), mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), sleep disorder (e.g., sleep apnea, narcolepsy).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects such as dizziness and hallucinations.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. It may affect milk production. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Permax Patient Information Including Side Effects

Brand Names: Permax

Generic Name: pergolide (Pronunciation: PER go lide)

  • What is pergolide (Permax)?
  • What are the possible side effects of pergolide (Permax)?
  • What is the most important information I should know about pergolide (Permax)?
  • What should I discuss with my healthcare provider before taking pergolide (Permax)?
  • How should I take pergolide (Permax)?
  • What happens if I miss a dose (Permax)?
  • What happens if I overdose (Permax)?
  • What should I avoid while taking pergolide (Permax)?
  • What other drugs will affect pergolide (Permax)?
  • Where can I get more information?

What is pergolide (Permax)?

Pergolide was withdrawn from the U.S. market on March 29, 2007.

Pergolide is used to treat Parkinson's disease. Parkinson's disease is associated with low levels of a chemical called dopamine (DOE pa meen) in the brain. Pergolide has some of the same effects as dopamine in the body.

Pergolide is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. Pergolide is often used in conjunction with other medicines in the treatment of Parkinson's disease.

Pergolide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pergolide (Permax)?

Stop taking pergolide and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • irregular heartbeats;
  • hallucinations (seeing or hearing things that are not real), confusion, or altered consciousness; or
  • dizziness (especially when rising from a sitting or lying position).

Other, less serious side effects may be more likely to occur. Continue to take pergolide and talk to your doctor if you experience

  • mild nausea, vomiting, upset stomach, or decreased appetite;
  • diarrhea or constipation;
  • dry mouth;
  • drowsiness;
  • insomnia; or
  • agitation or anxiety.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about pergolide (Permax)?

Pergolide was withdrawn from the U.S. market on March 29, 2007.

Use caution when driving, operating machinery, or performing other hazardous activities. Pergolide may cause drowsiness or low blood pressure (leading to dizziness and other symptoms), especially when rising from a sitting or lying position. Rise slowly and use caution when performing hazardous activities until you know how this medication affects you.

Do not stop taking pergolide without first talking to your doctor. Stopping pergolide suddenly may cause potentially dangerous side effects such as elevated body temperature, muscle rigidity, confusion or altered consciousness, and other problems.

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