Resostyl capsules

Resostyl

  • Active Ingredient: Selegiline
  • 5 mg
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What is Resostyl?

The active ingredient of Resostyl brand is selegiline. Selegiline prevents the breakdown of a chemical in your brain called dopamine (DO pa meen). Low levels of this chemical are associated with Parkinson's disease.

Used for

Resostyl is used to treat diseases such as: ADHD, Depression, Major Depressive Disorder, Parkinson's Disease.

Side Effect

Possible side effects of Resostyl include: poor coordination; unsteadiness, trembling, or other problems with muscle control or coordination; difficult or labored breathing; loss of appetite; numbness or tingling in the hands, feet, or lips.

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General

Some patients given Resostyl may experience an exacerbation of levodopa associated side effects, presumably due to the increased amounts of dopamine reaction with super sensitive, post-synaptic receptors. These effects may often be mitigated by reducing the dose of levodopa/carbidopa by approximately 10 to 30%.

The decision to prescribe Resostyl should take into consideration that the MAO system of enzymes is complex and incompletely understood and there is only a limited amount of carefully documented clinical experience with Resostyl. Consequently, the full spectrum of possible responses to Resostyl may not have been observed in pre-marketing evaluation of the drug. It is advisable, therefore, to observe patients closely for atypical responses.

Laboratory Tests: No specific laboratory tests are deemed essential for the management of patients on ELDEPRYL (Resostyl hcl) . Periodic routine evaluation of all patients, however, is appropriate.

The symptoms of Parkinson's disease - tremor, stiffness and slow movement - are due to there being less of a chemical called dopamine in your brain. Resostyl works by increasing the effect of dopamine in the brain, and this helps to ease these typical symptoms.

What Is Resostyl?

Resostyl prevents the breakdown of a chemical in your brain called dopamine (DO pa meen). Low levels of this chemical are associated with Parkinson's disease.

Resostyl is used together with other medicines to treat symptoms of Parkinson's disease.

Resostyl may also be used for purposes not listed in this medication guide.

Serious drug interactions can occur when certain medicines are used together with Resostyl. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

You should not use Resostyl if you are allergic to it, or if you have taken fluoxetine (Prozac, Sarafem and others) within the past 5 weeks.

Some medicines can cause unwanted or dangerous effects when used with Resostyl. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cough medicine that contains dextromethorphan;
  • cyclobenzaprine (Flexeril);
  • meperidine (Demerol) or other narcotic (opioid) pain medicine;
  • methadone;
  • St. John's wort;
  • tramadol (Ultram, Ultracet);
  • an antidepressant--citalopram, desvenlafaxine, duloxetine, escitalopram, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, nefazodone, paroxetine, venlafaxine, vilazodone, vortioxetine, and others; or
  • an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, Resostyl, tranylcypromine, and others.

After you stop taking Resostyl, you must wait at least 14 days before taking any of the medications listed above.

To make sure Resostyl is safe for you, tell your doctor if you have:

  • liver or kidney disease;
  • high blood pressure; or
  • phenylketonuria (Resostyl orally disintegrating tablets may contain phenylalanine).

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Resostyl passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Generic Name: Resostyl hydrochloride Dosage Form: capsule

Medically reviewed by Drugs.com. Last updated on Apr 1, 2019.

Can Resostyl cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with Resostyl. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Rated Resostyl for Depression Report

Works great for depression, helps a lot with ADD, without the jitteryness and other side-effects of stimulants like Ritalin or Adderall.

1) Resostyl and Parkinson’s Disease

One of the primary and most common uses for Resostyl is to treat the symptoms and progression of Parkinson’s disease (PD).

This use stems primarily from Resostyl’s ability to increase dopamine levels in the brain. This is important because many of the symptoms of Parkinson’s are caused by reduced levels of dopamine as cell death spreads throughout dopamine-related parts of the brain .

Relatedly, it is believed that increased dopamine levels may compensate for the loss of dopamine neurons in PD, which may be why dopamine-enhancing drugs such as Resostyl have been reported to improve the movement impairments characteristic of Parkinson’s disease (especially slowness of movement, or bradykinesia) .

For example, Resostyl was reported to improve motor symptoms in 292 patients with early Parkinson’s disease (double-blind randomized controlled trial) .

Similarly, in a double-blind randomized controlled trial of 157 Parkinson’s disease patients, Resostyl (10 mg/day) delayed the need for levodopa therapy. It was also reported to slow down the progression of Parkinson’s disease symptoms when used in combination with levodopa, compared to just levodopa alone .

In addition to increasing dopamine levels, some evidence suggests that Resostyl may also block the effects of MPTP, a neurotoxic compound that causes permanent symptoms of Parkinson’s .

Unfortunately, while several of the above studies have reported that Resostyl may slow down the progression of symptoms in Parkinson’s disease, it may not ultimately increase lifespan in PD patients. For example, one study found that while Resostyl delayed the motor impairments of Parkinson’s patients, this effect did not translate into reduced mortality rates .

Resostyl Dosage and Administration

Resostyl hydrochloride Capsules, USP are intended for administration to Parkinsonian patients receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment. The recommended regimen for the administration of Resostyl hydrochloride is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses. Moreover, higher doses should ordinarily be avoided because of the increased risk of side effects.

After two to three days of Resostyl treatment, an attempt may be made to reduce the dose of levodopa/carbidopa. A reduction of 10 to 30% was achieved with the typical participant in the domestic placebo controlled trials who was assigned to Resostyl treatment. Further reductions of levodopa/carbidopa may be possible during continued Resostyl therapy.

Rationale for the Use of a Selective Monoamine Oxidase Type B Inhibitor in Parkinson's Disease

Many of the prominent symptoms of Parkinson's disease are due to a deficiency of striatal dopamine that is the consequence of a progressive degeneration and loss of a population of dopaminergic neurons which originate in the substantia nigra of the midbrain and project to the basal ganglia or striatum. Early in the course of Parkinson's Disease, the deficit in the capacity of these neurons to synthesize dopamine can be overcome by administration of exogenous levodopa, usually given in combination with a peripheral decarboxylase inhibitor (carbidopa).

With the passage of time, due to the progression of the disease and/or the effect of sustained treatment, the efficacy and quality of the therapeutic response to levodopa diminishes. Thus, after several years of levodopa treatment, the response, for a given dose of levodopa, is shorter, has less predictable onset and offset (i.e., there is 'wearing off'), and is often accompanied by side effects (e.g., dyskinesia, akinesias, on-off phenomena, freezing, etc.).

This deteriorating response is currently interpreted as a manifestation of the inability of the ever decreasing population of intact nigrostriatal neurons to synthesize and release adequate amounts of dopamine.

MAO B inhibition may be useful in this setting because, by blocking the catabolism of dopamine, it would increase the net amount of dopamine available (i.e., it would increase the pool of dopamine). Whether or not this mechanism or an alternative one actually accounts for the observed beneficial effects of adjunctive Resostyl is unknown.

Resostyl's benefit in Parkinson's disease has only been documented as an adjunct to levodopa/carbidopa. Whether or not it might be effective as a sole treatment is unknown, but past attempts to treat Parkinson's disease with non-selective MAOI monotherapy are reported to have been unsuccessful. It is important to note that attempts to treat Parkinsonian patients with combinations of levodopa and currently marketed non-selective MAO inhibitors were abandoned because of multiple side effects including hypertension, increase in involuntary movement, and toxic delirium.

INFORMATION FOR PATIENTS

Patients should be advised of the possible need to reduce levodopa dosage after the initiation of Resostyl therapy.

Patients (or their families if the patient is incompetent) should be advised not to exceed the daily recommended dose of 10 mg. The risk of using higher daily doses of Resostyl should be explained, and a brief description of the ‘cheese reaction’ provided. Rare hypertensive reactions with Resostyl at recommended doses associated with dietary influences have been reported.

Consequently, it may be useful to inform patients (or their families) about the signs and symptoms associated with MAOI induced hypertensive reactions. In particular, patients should be urged to report, immediately, any severe headache or other atypical or unusual symptoms not previously experienced.

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease, including Resostyl. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Resostyl. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Resostyl. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Resostyl.

Off-Label Uses of Resostyl

Occasionally, doctors will prescribe medications to help treat conditions that fall outside of the official uses approved by the FDA – also known as “off-label” drug use . Usually this is done because there is actually decent evidence that the drug may help, although this evidence might not be quite strong enough to get full FDA approval (which generally has very strict requirements).

As always, however, always remember that the decision to use medications in this way can only be made by a licensed medical professional.

No pharmacokinetic information is available on Resostyl or its metabolites in renally impaired subjects.


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