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SELEGILINE HYDROCHLORIDE is a brand name for Selegiline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Selegiline is indicated for the treatment of Parkinson's disease or symptomatic parkinsonism which is being treated with levodopa alone or levodopa and peripheral decarboxylase inhibitor. Selegiline, in conjunction with maximal levodopa treatment, is indicated particularly in patients during maximal levodopa treatment…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage (dose and interval) and duration When used as an adjunct to established Levodopa therapy, the initial dose of Selegiline is 5mg in the morning. g. on/off symptoms and little response is achieved with 5mg Selegiline daily, the dose of Selegiline can be increased to 10mg in the morning.
When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage by an average of 10-30%. Reduction of levodopa dose should be gradual in steps of 10% every 3 to 4 days. Dosage adjustment in renal or liver insufficiency, dialysis, concomitant disease No dosage adjustment is indicated Maximum tolerated daily dose and the maximum dose for an entire course of therapy The maximum recommended daily dose is 10mg, although no problems have been reported with overdosage (due to the low toxicity of Selegiline hydrochloride).
Monitoring advice No special monitoring required. Special Populations Patients with hepatic impairment No data are known on dose adjustment in patients with mild hepatic impairment. Patients with renal impairment No data are known on dose adjustment in patients with mild renal impairment.
In monotherapy, selegiline has been found to be well tolerated. Dry mouth, transient rise of serum alanine aminotransferase (ALAT) values and sleeping disorders have been reported more frequently than in patients receiving placebo. g.
restlessness, hyperkinesis, abnormal movements (such as dyskinesias), nausea, agitation, confusion, hallucinations, headache, postural hypotension, cardiac arrhythmias and vertigo, may be enhanced in combination therapy (levodopa should be given in association with a peripheral decarboxylase inhibitor), particularly if the dose of levodopa is too high.
Such adverse reactions usually disappear when the levodopa dosage is decreased. Levodopa dosage can be reduced by an average of 30% when selegiline is added to the treatment. Once the optimum levodopa dose level has been established, the side-effects produced by the combination will usually be less than those caused by the levodopa therapy on its own.
Micturition difficulties and skin reactions have also been reported during selegiline treatment. Follow-up of these possible adverse reactions is important. Hypersexuality has been very rarely reported in association with selegiline use, either as monotherapy or in combination with other dopaminergic antiparkinsonian medication.
The following undesirable effects have been reported with selegiline during clinical trials and/or post- marketing use. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Very common (≥ 1/10); Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (cannot be established from the available data).
System Organ Class Frequency Undesirable effects Infections and infestations Uncommon Pharyngitis Blood and lymphatic system disorders Uncommon Leucocytopenia, thrombocytopenia Metabolism and nutrition disorders Uncommon Loss of appetite Common Sleeping disorders, confusion, hallucinations, depression Uncommon Mood change, abnormal dreams, agitation, anxiety, psychoses.
The precise dose at which selegiline becomes a non-selective inhibitor of all MAO has not been determined, but with doses higher than 10 mg/day there is a theoretical risk of hypertension after ingestion of tyramine-rich food. Concomitant treatment with medicines which inhibit MAO-A, (or non- selective MAO inhibitors) can cause hypotensive reactions.
Hypotension, sometimes sudden in onset, has been reported with conventional selegiline. Selegiline should be administered cautiously to patients with history of or who have peptic or duodenal ulceration, labile hypertension, cardiac arrhythmias, severe angina pectoris, or psychosis as aggravation of these conditions may occur during treatment.
Although serious hepatic toxicity has not been observed, caution is recommended in patients with a history of hepatic dysfunction. Transient or continuing abnormalities with a tendency for elevated plasma concentrations of liver enzymes have been described during long-term therapy with conventional tablets of selegiline.
Selegiline should be used with caution in severe liver or kidney dysfunction. In higher doses (higher than recommended one, 10 mg) the selectivity of selegiline begins to diminish resulting in loss of its MAO-B selectivity and increased inhibition of MAO-A.
Thus in higher doses there is a risk of hypertension. Since the selegiline potentiates the effect of levodopa, the side effects of levodopa may be more pronounced, especially if patients are receiving levodopa therapy with high doses.
These patients should be monitored. The addition of selegiline to maximum tolerated dose of levodopa therapy may cause creation of involuntary movements and/or agitation. These undesirable effects disappear after levodopa doses reduction.
Dosage of levodopa could be reduced to about 30 % in combination with selegiline. 2). When an optimum dose of levodopa is reached, adverse effects from the combination are less than those observed with levodopa on its own. Some studies concluded in an increased risk of mortality in patients receiving selegiline and levodopa compared to those receiving levodopa only.
1. g. sumatriptan, naratriptan, zolmitriptan and rizatriptan). 5). 5). g. linezolid. 5). • Selegiline should not be used in patients with active duodenal or gastric ulcer. • Selegiline should not be used in patients with other extrapyramidal disorders not related to dopamine deficiency.
• When selegiline is prescribed in combination with levodopa, the contraindications which apply to levodopa must be taken into account. Selegiline in combination with levodopa is contra-indicated in severe cardiovascular disease, arterial hypertension, hyperthyroidism, phaeochromocytoma, narrow-angle glaucoma, prostatic adenoma with appearance of residual urine, tachycardia, arrhythmias, severe angina pectoris, psychoses, advanced dementia and thyrotoxicosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Psychiatric disorders Not known Impulse control disorders and compulsions* Common Abnormal movements (such as dyskinesias), akinesia, bradykinesia dizziness , headache, impaired balance, tremor Nervous system disorders Uncommon Mild transient sleep disorder Eye disorders Uncommon Blurred vision Ear and labyrinth disorders Common Vertigo Common Bradycardia Uncommon Supraventricular tachycardia, cardiac arrhythmia, palpitations, angina pectoris Cardiac disorders Common hypotension, hypertension Uncommon Orthostatic hypotension Vascular disorders Rare Postural hypotension Common Nasal congestion, sore throatRespiratory, thoracic and mediastinal disorders Uncommon Dyspnoea Gastrointestinal disorders Very common Stomatitis Common Nausea, constipation, diarrhoea, mouth ulceration Uncommon Dry mouth Hepato-biliary disorders Common Transient rise of serum alanine aminotransferase (ALAT) Common Sweating increased Uncommon Hair loss, skin eruptions Skin and subcutaneous tissue Rare Skin reactions Common Arthralgia, back pain, muscle crampsMusculoskeletal and lymphatic system disorders Uncommon Myopathy Uncommon Micturition disorders Renal and urinary disorders Not known Urinary retention Common Fatigue General disorders and administration site conditions Uncommon Chest pain, irritability, ankle oedema Injury, poisoning and procedural complications Common Fall Investigations Common Mild hepatic enzymes increased *Parkinson’s disease patients treated with dopamine agonists and other dopaminergic treatments have been reported as exhibiting impulse control disorders and compulsions like pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and complusive eating, and different kinds of compulsive/repetitive activities (punding).
These may also be possible with selegiline but very few cases have been reported to date. In combination with levodopa As selegiline potentiates the effects of levodopa (levodopa should be usually given in association with a peripheral decarboxylase inhibitor), the side effects of levodopa may be emphasised unless the dosage of levodopa is reduced.
Selegiline combination therapy may permit further reduction of levodopa dose (even by 30%). The most common undesirable effect reported for conventional tablets is dyskinesia (4% of patients) other side effects include restlessness, hyperkinesis, abnormal movements, agitation, confusion, hallucination, postural hypotension, cardiac arrhythmias.
Once the optimum dose level has been established, the side effects produced by the combination will be less than those caused by the levodopa therapy on its own. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
However, it is noteworthy that multiple methodological bias were identified in these studies and that a meta analysis and large cohort studies concluded that there was no significant difference in mortality in patients treated with selegiline to those treated with comparators or with the association selegiline/levodopa.
Studies have related the risk of an increased hypotensive response to concomitant administration of selegiline and levodopa, in patients with cardiovascular risk. The addition of selegiline to levodopa may not be beneficial in those patients who experience fluctuations in response which are not dose dependent.
Caution should be exercised in patients receiving MAO inhibitors during general anaesthesia in surgery. MAO inhibitors, including selegiline, may potentiate the effects of CNS depressants used for general anaesthesia. 5). Caution is advised when selegiline is taken in combination with other centrally acting medicinal products and substances.
The concomitant intake of alcohol should be avoided. Parkinson’s disease patients treated with dopamine agonists and other dopaminergic treatments have been reported as exhibiting impulse control disorders and compulsions like pathological gambling, increased libido, hypersexuality, binge eating, shopping and different kinds of compulsive /repetitive activities (punding).
These may also be possible with selegiline but very few cases have been reported to date. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.