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2010年3月23日，勃林格殷格翰制药公司宣布，美国食品药品管理局(FDA)已批准米拉帕缓释制剂(普拉克索)用于治疗特发性帕金森病(PD)的症状和体征。该药为口服缓释片剂，每日服用1次，早期或晚期PD患者均适用。先前获准的米拉帕(普拉克索)为速释型，每日服用3次。
FDA批准米拉帕缓释制剂用于治疗晚期PD患者是依据一项随机、双盲、安慰剂对照、3个平行组临床研究的疗效数据。该临床试验共纳入517例晚期PD患者，分别接受不同剂量的米拉帕缓释片或米拉帕治疗，或者安慰剂处置。
据生产厂家称，研究结果表明，晚期PD患者接受米拉帕缓释片治疗后，症状相对于安慰剂对照组有较大缓解。另外，与安慰剂对照组相比，米拉帕缓释片治疗组患者与米拉帕片剂治疗组患者均有收益且两治疗组的收益相近。米拉帕缓释片治疗组患者症状复发时间亦较对照组显著缩短。
在本研究中，联合左旋多巴治疗的晚期PD患者最常见的不良事件(发生率≥5%且高于安慰剂对照组)为运动障碍、恶心、便秘、幻觉、头痛及厌食。
早期PD患者服用米拉帕缓释片后最常见的不良事件为嗜睡、恶心、呕吐、便秘、头晕、乏力、幻觉、口干、肌肉痉挛及水肿。
Now available: Once-daily MIRAPEX ER.
Once a day and you're on your way.
Once-daily MIRAPEX ER may be right for you.
- Proven effective in relieving symptoms of early Parkinson's disease
- MIRAPEX ER is taken just once a day, which many people may find more convenient than medicines taken multiple times a day
- MIRAPEX ER contains the same medicine as Mirapex® (pramipexole dihydrochloride) tablets. MIRAPEX has been a trusted treatment for Parkinson's disease for more than 12 years
Only your doctor can determine if MIRAPEX ER is an appropriate choice for you. Your doctor may make changes to your MIRAPEX ER dose to make sure you are taking the right amount of medicine to help control your symptoms.
Already taking MIRAPEX?
If you are currently taking MIRAPEX, you may be able to switch overnight from MIRAPEX to MIRAPEX ER. Your doctor will work with you to make sure you are taking the right dose to help control your symptoms. Be sure you do not take MIRAPEX and MIRAPEX ER together.
Indications:
MIRAPEX ER and MIRAPEX tablets are prescription medicines to treat the signs and symptoms of Parkinson's disease (PD).
Important Safety Information:
MIRAPEX ER or MIRAPEX may cause you to fall asleep without warning during daily activities, including talking, eating, and driving, which may result in accidents. Tell your doctor if you feel new or increased sleepiness while taking MIRAPEX ER or MIRAPEX. Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER or MIRAPEX affects you.
Before taking MIRAPEX ER or MIRAPEX, talk to your doctor about all of your medical conditions, including if you feel sleepy during the day. Tell your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX ER or MIRAPEX will make you feel sleepy or fall asleep when you should be awake.
When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.
Some patients taking certain medicines to treat PD, including MIRAPEX ER and MIRAPEX, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.
The most common side effects in people taking MIRAPEX ER for early PD are sleepiness, nausea and vomiting, constipation, dizziness, tiredness, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).
The most common side effects in people taking MIRAPEX ER who have later-stage PD are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.
The most common side effects in people taking MIRAPEX for PD are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information, for MIRAPEX ER and MIRAPEX.
Mirapex
Why is Mirapex prescribed?
Although it is not a cure, Mirapex eases the symptoms of Parkinson's disease—a progressive disorder marked by muscle rigidity, weakness, shaking, tremor, and eventually difficulty with walking and talking. Parkinson's disease results from a shortage of the chemical messenger dopamine in certain areas of the brain. Mirapex is believed to work by boosting the action of whatever dopamine is available. The drug can be used with other Parkinson's medications such as selegiline and levodopa.
Most important fact about Mirapex
If you are taking levodopa, Mirapex may allow a reduction in your dosage. And if you suffer from the "on-off" effect that often develops during Parkinson's therapy (symptom-free periods alternating with severe attacks), Mirapex may extend the good "on" times and shorten your "off" periods.
How should you take Mirapex?
Take Mirapex exactly as prescribed. If it makes you nauseous, try taking it with food.
When discontinuing Mirapex therapy, it's best to do it gradually. Your doctor will tell you how to taper your dose over a week's time.
- If you miss a dose...
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
- Storage instructions...
Store at room temperature; protect from light.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Mirapex.
- Side effects may include:
Abnormal dreams, arthritis, chest pain, confusion, constipation, decreased sensitivity to touch, difficulty breathing, difficulty walking, dizziness, dizziness upon standing, drowsiness, dry mouth, hallucinations, increased muscle tone, increased urination, insomnia, involuntary movement (jerky motions), lack of appetite, memory loss, nasal inflammation, nausea, swelling, urinary tract infections, vision abnormalities, weakness
Why should Mirapex not be prescribed?
If Mirapex gives you an allergic reaction, you'll be unable to use it.
Special warnings about Mirapex
Mirapex can cause your blood pressure to drop when you first stand up, resulting in symptoms such as dizziness, nausea, fainting, blackouts, and, sometimes, sweating. To avoid or reduce these symptoms, try to stand up slowly, especially at the beginning of treatment with Mirapex.
Mirapex can cause drowsiness and may trigger hallucinations, especially if you are over 65 or have an advanced case of Parkinson's. You may even fall asleep—without warning and without feeling drowsy—while performing everyday activities. Check with your doctor immediately if you find that you're getting drowsy or falling asleep while eating, talking, or watching television. Do not drive a car or undertake other dangerous activities until you've spoken with the doctor. Be especially cautious when taking other drugs that cause sleepiness.
If you have a kidney condition, make sure the doctor is aware of it. You'll probably need regular blood tests to check your kidney function, and your dosage of Mirapex may have to be reduced.
In very rare cases, Mirapex may cause muscle wasting. If you develop muscle aches or soreness after you start Mirapex, be sure to tell your doctor. Also alert your doctor if you notice any changes in your eyesight.
Possible food and drug interactions when taking Mirapex
If Mirapex is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Mirapex with the following: Carbidopa/Levodopa Sedatives and tranquilizers such as chloral hydrate, codeine products, flurazepam, phenobarbital, and triazolam Cimetidine Diltiazem Major tranquilizers such as chlorpromazine, fluphenazine, haloperidol, prochlorperazine, thioridazine, thiothixene, and trifluoperazine Metoclopramide Quinidine Quinine Ranitidine Triamterene Verapamil
Combining Mirapex with levodopa sometimes triggers twitching and jerky movements. If this happens, tell your doctor. A reduction in your dose of levodopa may solve the problem.
Special information if you are pregnant or breastfeeding
The effects of Mirapex during pregnancy have not been adequately studied, so it's best to avoid it if you're expecting. If you are pregnant or plan to become pregnant, inform your doctor immediately.
It is not known whether Mirapex appears in breast milk. If the drug is considered essential to your health, your doctor may advise you to stop breastfeeding while taking the medication.
Recommended dosage for Mirapex
ADULTS
The usual starting dose is 0.125 milligrams 3 times a day. If necessary, your doctor may increase the dose every 5 to 7 days until the maximum dose of 4.5 milligrams a day is reached. Dosage is usually increased gradually to minimize the drug's potential side effects. If you have kidney disease, the doctor will keep the dosage quite low.
CHILDREN
The safety and effectiveness of Mirapex in children have not been established.
Overdosage
Although there is no information on Mirapex overdose, any medication taken in excess can have dangerous consequences. If you suspect an overdose, seek medical attention immediately.
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