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Mirapexin

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Indications:

Monotherapy or in combination w/ levodopa in the treatment of signs & symptoms of idiopathic Parkinson’s disease. Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome.

Contraindications:

Co-administration w/ antipsychotics. Lactation.

Adverse reactions:

he following side effects are listed under the use of this medicine: Abnormal dreams, amnesia, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality, compulsive shopping, and other abnormal behaviour; restlessness, somnolence, visual disturbance including blurred vision and reduced visual acuity, vomiting, weight decrease, weight increase, sudden onset of sleep; pruritus, rash and other hypersensitivity. The incidence of hypotension under this medicine, compared to placebo treatment, was not increased. However, in individual patients, hypotension may occur at the beginning of treatment, especially if this medicine is titrated too rapidly. this medicine may be associated with disorders of libido (increase or decrease). Patients treated with pramipexole have reported falling asleep during activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Some of them did not report a warning sign eg, somnolence, which is a common occurrence in patients receiving pramipexole at doses >1.5 mg/day, and which, according to the current knowledge of sleep physiology, always proceeds falling asleep. There was no clear relation to the duration of treatment. Some patients were taking other medication with potentially sedative properties. In most cases where information was available, there were no further episodes following reduction of dosage or termination of therapy. Patients treated with dopamine agonists for Parkinson’s disease, including this medicine, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.

Interactions:

Pramipexole is bound to plasma proteins to a very low (<20%) extent and little biotransformation is seen in man. Therefore, interactions with other medication affecting plasma-protein binding or elimination by biotransformation are unlikely. Medication that inhibit the active renal tubular secretion of basic (cationic) drugs eg, cimetidine, or are themselves eliminated by active renal tubular secretion, may interact with this medicine resulting in reduced clearance of either or both medication. In case of concomitant treatment with these kinds of drugs (including amantadine), attention should be paid to signs of dopamine over stimulation eg, dyskinesias, agitation or hallucinations. In such cases a dose reduction is necessary. Selegeline and levodopa do not influence the pharmacokinetics of pramipexole. The overall extent of absorption or elimination of levodopa is not changed by pramipexole. The interaction with anticholinergics and amantadine has not been examined. As anticholinergics are mainly eliminated by hepatic metabolism, pharmacokinetic drug-drug interactions with pramipexole are rather unlikely. With amantadine, an interaction is possible via the same system of excretion in the kidney. While increasing the dose of this medicine in Parkinson’s disease patients, it is recommended that the dosage of levodopa is reduced and the dosage of other antiparkinsonian medication kept constant. Because of possible additive effects, caution should be advised when patients are taking other sedating medication or alcohol in combination with this medicine and when taking concomitant medication that increase plasma levels of pramipexole (eg, cimetidine).

Warnings:

When prescribing this medicine in a patient with renal impairment, a reduced dose is suggested in line with section Dosage & Administration. Hallucinations and confusion are known side effects of treatment with dopamine agonists and levodopa in Parkinson’s disease patients. Hallucinations were more frequent when this medicine was given in combination with levodopa in Parkinson’s disease patients with advanced disease than in monotherapy in Parkinson’s disease patients with early disease. Within the RLS clinical development program for registration, one case of hallucinations has been reported. Patients should be informed that (mostly visual) hallucinations can occur. Patients and caregivers should be aware of the fact that behavioural changes can occur which may present as increased libido or urges eg, pathological gambling, hypersexuality, binge eating or compulsive shopping). Dose reduction/taper discontinuation should be considered. Pathologic changes (degeneration and loss of photoreceptor cells) were observed in the retina of albino rats in the 2-year carcinogenicity study. Evaluation of the retinas of albino mice, pigmented rats, monkeys, and minipigs did not reveal similar changes. The potential significance of this effect in humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (ie, disk shedding) may be involved. In case of severe cardiovascular disease, care should be taken. It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy. Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks. Co-administration of antipsychotic medicinal products with pramipexole should be avoided. Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors eg, drugs used to treat Parkinson’s disease, is unclear. For the reasons stated previously, patients and providers are advised to monitor for melanoma when using pramipexole or other dopaminergic drugs. Parkinson’s Disease: Symptoms suggestive of a neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. Augmentation in RLS: Reports in the literature indicate treatment of RLS with dopaminergic medications can result in augmentation. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities. The controlled trials of this medicine in patients with RLS were generally not of sufficient duration to adequately capture augmentation phenomena. The frequency of augmentation after longer use of this medicine and the appropriate management of these events have not been evaluated in controlled clinical trials. Effects on the Ability to Drive or Operate Machinery: Patients should be aware of the fact that hallucinations can occur and may adversely affect their ability to drive. Patients should be alerted to the potential sedating effects associated with this medicine, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor operate other complex machinery until they have gained sufficient experience with this medicine to gauge whether or not it affects their mental and/or motor performance adversely. Patients should be advised that if increased somnolence or episodes of falling asleep during activities of daily living (eg, conversations, eating, etc) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities and should contact their physician. Use in pregnancy: The effect on pregnancy has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses. this medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

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Dosage and Administration

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