Mirapex ER

DRUG DESCRIPTION

MIRAPEX ER (pramipexole dihydrochloride extended-release tablets) tablets contain pramipexole, a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S•2HCl•H2O, and its molecular weight is 302.26.

The structural formula is:

MIRAPEX® ER™ (pramipexole dihydrochloride) Structural Formula Illustration

Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane.

MIRAPEX ER (pramipexole dihydrochloride extended-release tablets) tablets, for oral administration, contain 0.375 mg, 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients are hypromellose, corn starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate.

What are the precautions when taking pramipexole dihydrochloride extended-release tablets (Mirapex ER)?

See also Side Effects section.

Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; 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 (such as irregular heartbeat, heart failure), kidney problems, mental/mood disorders (such as confusion, hallucinations, psychosis, schizophrenia), sleep disorder (such as sleep apnea, narcolepsy).

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

Read All Potential Precautions of Mirapex ER »


Mirapex ER Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Nausea, vomiting, dizziness, drowsiness, trouble sleeping, constipation, headache, cough, or dry mouth may occur. If these effects persist or worsen, tell your doctor 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: mental/mood changes (such as confusion, depression, hallucinations), muscle cramps/spasm.

Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of the ankles/feet, chest pain, trouble breathing, compulsive behaviors (such as pathological gambling), muscle pain/weakness, unusual tiredness, change in amount of urine, vision changes.

Some people taking pramipexole have reported falling asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur any time during treatment with pramipexole, 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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: See also Side Effects section.

Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; 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 (such as irregular heartbeat, heart failure), kidney problems, mental/mood disorders (such as confusion, hallucinations, psychosis, schizophrenia), sleep disorder (such as sleep apnea, narcolepsy).

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

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

This drug may pass into breast milk and could have undesirable effects on a nursing infant. It may also affect milk production. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.



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