Juprenil tablets

Juprenil

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

The active ingredient of Juprenil 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

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

Side Effect

Possible side effects of Juprenil include: indigestion; heartburn; shivering; muscle aching or cramping; dizziness; increased thirst; shakiness and unsteady walk; trouble concentrating.

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Juprenil Description

Juprenil hydrochloride, USP is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)-N α-dimethyl-N-2- propynylphenethylamine hydrochlor >13 H 17 N·HCl and the structural formula is as follows:

DRUG INTERACTIONS

The occurrence of stupor, muscular rigidity, severe agitation, and elevated temperature has been reported in some patients receiving the combination of Juprenil and meperidine. Symptoms usually resolve over days when the combination is discontinued. This is typical of the interaction of meperidine and MAOIs. Other serious reactions (including severe agitation, hallucinations, and death) have been reported in patients receiving this combination (see CONTRAINDICATIONS). Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and ELDEPRYL (Juprenil hcl) and selective serotonin reuptake inhibitors and ELDEPRYL. (See WARNINGS for details.) One case of hypertensive crisis has been reported in a patient taking the recommended doses of Juprenil and a sympathomimetic medication (ephedrine).

Prospective, randomized, double‐blind, placebo‐controlled studies.

UPDRS, Unified Parkinson's Disease Rating Scale.

From Riederer et al. (2004 ).

Table 34.5 . Juprenil as adjunct to levodopa (symptomatic efficacy)

What Is Juprenil?

Juprenil 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.

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

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

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

You should not use Juprenil 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 Juprenil. 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, Juprenil, tranylcypromine, and others.

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

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

  • liver or kidney disease;
  • high blood pressure; or
  • phenylketonuria (Juprenil 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 Juprenil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

DESCRIPTION

ELDEPRYL (Juprenil hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.

The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The structural formula is as follows:

Each aqua blue capsule is band imprinted with the Somerset logo on the cap and "Eldepryl (Juprenil hcl) 5 mg" on the body. Each capsule contains 5 mg Juprenil hydrochloride. Inactive ingredients are citric acid, lactose, magnesium stearate, and microcrystalline cellulose.

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 Juprenil is unknown.

Juprenil'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.

Pediatric Use

The effects of Juprenil hydrochloride in children have not been evaluated.

Other Side–Effects

Like other MOA blockers, Juprenil can have mild-to-severe side effects, such as :

  • Dizziness
  • Mouth sores (tablet only)
  • Nausea
  • Insomnia
  • Indigestion
  • Anxiety/agitation
  • Increased or abnormal sexual desire
  • Depression
  • Severe headache
  • Irregular heartbeat
  • Vomiting
  • Uncontrollable shaking
  • Hallucinations
  • REM behavior disorder, which is characterized by acting out in one’s dreams
  • Serotonin syndrome, which may possibly lead to seizures and coma

Juprenil withdrawal has also been reported to cause low blood pressure in Parkinson’s disease patients, although it’s still unclear whether this is a potential side-effect for people without Parkinson’s .

PATIENT INFORMATION

Patients should be advised of the possible need to reduce levodopa dosage after the initiation of ELDEPRYL (Juprenil hcl) 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 Juprenil should be explained, and a brief description of the 'cheese reaction' provided. Rare hypertensive reactions with Juprenil 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.

INFORMATION FOR PATIENTS

Patients should be advised of the possible need to reduce levodopa dosage after the initiation of Juprenil 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 Juprenil should be explained, and a brief description of the ‘cheese reaction’ provided. Rare hypertensive reactions with Juprenil 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 Juprenil. 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 Juprenil. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Juprenil. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Juprenil.

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You may be prescribed Juprenil as a treatment on its own, or alongside other medicines for Parkinson's disease which contain a medicine called levodopa. When it is prescribed with other medicines, Juprenil helps to prevent some of the problems which can occur with these other treatments. These problems may be referred to as 'end-of-dose' fluctuations, or 'on-off' symptoms.

2) Juprenil and Brain Repair

According to one animal study, Juprenil increased brain-derived neurotrophic factor (BDNF) and glial cell-derived neurotrophic factor (GDNF) levels in a mouse model of Parkinson’s disease . BDNF and GDNF are important for brain health and brain repair.

Similarly, one cell study reported that Juprenil may increase BDNF, GDNF, and nerve growth factor (NGF) levels in brain cells .

In theory, these effects could potentially protect the brain from the effects of aging or disease – but much more research will still be needed to know the full extent of these effects, as well as if they would apply to human users.

How should this medicine be used?

Juprenil comes as a capsule and an orally disintegrating (dissolving) tablet to take by mouth. The capsule is usually taken twice a day with breakfast and with lunch. The orally disintegrating tablet is usually taken once a day before breakfast without food, water, or other liquids. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Juprenil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you take too much Juprenil, you may experience a sudden and dangerous increase in your blood pressure.

If you are taking the orally disintegrating tablet, do not remove the blister that contains the tablets from the outer pouch until you are ready to take a dose. When it is time for your dose, remove the blister card from the outer pouch and use dry hands to peel open one blister. Do not try to push the tablet through the foil. Place the tablet on your tongue and wait for it to dissolve. Do not swallow the tablet. Do not eat or drink anything for 5 minutes before you take the tablet and for 5 minutes after you take the tablet.

If you are taking the orally disintegrating tablet, your doctor may start you on a low dose of Juprenil and increase your dose after six weeks.

Tell your doctor if you experience nausea, stomach pain, or dizziness. Your doctor may decrease your dose of levodopa/carbidopa during your treatment with Juprenil, especially if you experience these symptoms or other unusual symptoms. Follow these directions carefully and ask your doctor or pharmacist if you do not know how much medication you should take. Do not change the doses of any of your medications unless your doctor tells you that you should.

Juprenil may help to control the symptoms of PD, but it will not cure the condition. Do not stop taking Juprenil without talking with your doctor. If you suddenly stop taking medications for Parkinson's disease such as Juprenil, you may experience fever, sweating, stiff muscles, and loss of consciousness. Call your doctor if you experience these or other unusual symptoms after you stop taking Juprenil.

LABORATORY TESTS

No specific laboratory tests are deemed essential for the management of patients on Juprenil. Periodic routine evaluation of all patients, however, is appropriate.

Pregnancy

Pregnancy Category C: No teratogenic effects were observed in a study of embryo-fetal development in Sprague-Dawley rats at oral doses of 4, 12, and 36 mg/kg or 4, 12 and 35 times the human therapeutic dose on a mg/m 2 basis. No teratogenic effects were observed in a study of embryo-fetal development in New Zealand White rabbits at oral doses of 5, 25, and 50 mg/kg or 10, 48, and 95 times the human therapeutic dose on a mg/m 2 basis; however, in this study, the number of litters produced at the two higher doses was less than recommended for assessing teratogenic potential. In the rat study, there was a decrease in fetal body weight at the highest dose tested. In the rabbit study, increases in total resorptions and % post-implantation loss, and a decrease in the number of live fetuses per dam occurred at the highest dose tested. In a peri- and postnatal development study in Sprague-Dawley rats (oral doses of 4, 16, and 64 mg/kg or 4, 15, and 62 times the human therapeutic dose on a mg/m 2 basis), an increase in the number of stillbirths and decreases in the number of pups per dam, pup survival, and pup body weight (at birth and throughout the lactation period) were observed at the two highest doses. At the highest dose tested, no pups born alive survived to Day 4 postpartum. Postnatal development at the highest dose tested in dams could not be evaluated because of the lack of surviving pups. The reproductive performance of the untreated offspring was not assessed.

There are no adequate and well-controlled studies in pregnant women. Juprenil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

5) Juprenil, Wakefulness, and Narcolepsy

According to two double-blind randomized controlled trials with 30 and 17 narcoleptic patients, Juprenil was reported to decrease both the number and duration of daytime sleep episodes .

This early finding may be supported up by at least one animal study, which reported that Juprenil may increase wakefulness in rats (specifically, by increasing dopamine and noradrenaline levels in the brain) .

Forms and Dosage

Juprenil is only available legally via prescription. It typically comes in the form of capsules, tablets, orally disintegrating tablets (ODTs), or the transdermal patch.

Juprenil capsules or tablets (Eldepryl) are normally taken twice per day, with meals. However, dosages vary, with the most common being two 5 mg pills per day .

The patch (Emsam) is available in 6, 9, or 12 mg strengths .

According to several researchers, Juprenil patches may have one major advantage over other forms of this medication, in that they appear to be associated with significantly fewer side-effects than other forms . However, your doctor will work with you to choose the form that makes the most sense for you, based on your particular medical history and needs.

In general, higher doses of Juprenil (6-20mg per day) are reported to be more effective at treating depression . However, there are many different factors that go into choosing dose size, and only your doctor has the necessary training to determine which dose size is best for any individual case.

Use During Pregnancy and Breastfeeding

Juprenil was classified as a category “C” risk drug during pregnancy under the old FDA risk classifications. The risks of Juprenil use during pregnancy have not been properly investigated. Therefore, make sure you let your doctor know if you are pregnant (or are planning on becoming pregnant while being treated with Juprenil).

It also is not yet known if Juprenil is found in breast milk, and caution is therefore generally advised during breastfeeding. In general, discontinuation is advised unless the therapy is absolutely necessary – but .


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