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APO-ENTACAPONE is a brand name for Entacapone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
APO-ENTACAPONE (entacapone) is contraindicated in patients with known hypersensitivity to entacapone or to any of the excipients (see PHARMACEUTICAL INFORMATION – Composition for a complete listing). APO-ENTACAPONE is contraindicated in patients with hepatic impairment.
g. phenelzine and tranylcypromine). The combination of selective MAO-A and selective MAO-B inhibitors is equivalent to non-selective MAO- inhibition, therefore, they should not both be given concomitantly with APO- ENTACAPONE and levodopa preparations.
Non-selective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with entacapone. g. selegiline 10 mg/day) when co-administered with APO-ENTACAPONE and levodopa (see PRECAUTIONS, Drug Interactions, Selegiline).
APO-ENTACAPONE should not be given to patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, pulmonary (including bronchial asthma), or renal disease. APO-ENTACAPONE is contraindicated in patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
APO-ENTACAPONE should not be given when administration of a sympathomimetic amine is contraindicated. APO-ENTACAPONE is contraindicated in patients with pheochromocytoma due to the increased risk of hypertensive crisis. APO-ENTACAPONE should not be given to patients with narrow angle glaucoma.
Because levodopa may activate a malignant melanoma, APO-ENTACAPONE should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma. Page 10 of 54 WARNINGS Sudden Onset of Sleep Patients receiving treatment with APO-ENTACAPONE in combination with levodopa/DDC inhibitor and/or other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including the driving of a car, which sometimes resulted in accidents.
Although some of the patients reported somnolence while treated with levodopa/DDC inhibitor and APO-ENTACAPONE, others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Physicians should alert patients of the reported cases of sudden onset of sleep, bearing in mind that these events are NOT limited to initiation of therapy. Patients should also be advised that sudden onset of sleep has occurred without warning signs and should be specifically asked about factors that may increase the risk with APO-ENTACAPONE used in combination with levodopa/decarboxylase DDC inhibitor, such as concomitant medications or the presence of sleep disorders.
Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence), physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking APO- ENTACAPONE in combination with levodopa/decarboxylase DDC inhibitor.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Entacapone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If drowsiness or sudden onset of sleep should occur, patients should be informed to refrain from driving or operating machines and to immediately contact their physician (see PRECAUTIONS- Information for Patients). Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents, therefore, symptoms may not be alleviated by substituting these products.
While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living. Currently, the precise cause of this event is unknown.
It is known that many Parkinson’s disease patients experience alterations in sleep architecture, which results in excessive daytime sleepiness or spontaneous dozing, and that dopaminergic agents can also induce sleepiness.
Skin Melanoma:
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 Page 11 of 54 risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear.
For the reasons stated above, patients and healthcare providers are advised to monitor for melanomas frequently and on a regular basis when using APO-ENTACAPONE for any indication (see PRECAUTIONS- Information for Patients). , dermatologists).
Prostate Cancer Prostate cancer has been reported in elderly males during the use of entacapone in combination with levodopa/carbidopa in clinical trials. The clinical relevance of these adverse events is not known (see ADVERSE REACTIONS).
Physicians are advised to adhere to the routine examination schedule for all male patients for symptoms and risk factors of prostate cancer including evaluation prior to initiating treatment with APO-ENTACAPONE. Physicians should emphasize to patients the importance of adhering to routine examinations for prostate cancer during extended treatment with entacapone (see PRECAUTIONS- Information for Patients).
Drugs metabolized by Catechol-O-methyltransferase (COMT) When a single 400 mg dose of entacapone was given together with intravenous isoprenaline (isoproterenol) and epinephrine without coadministered levodopa/DDC inhibitor, the overall mean maximal changes in heart rate during infusion were about 50% and 80% higher than with placebo, for isoprenaline and epinephrine, respectively.
Therefore, drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine and bitolterol should […]