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SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE is a brand name for Levodopa, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
• Patients with known hypersensitivity to Sandoz Levodopa-Carbidopa-Entacapone (levodopa, carbidopa and entacapone) or to the excipients of the drug product. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
• Patients with hepatic impairment (see WARNINGS AND PRECAUTIONS-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 Sandoz Levodopa-Carbidopa-Entacapone.
As with levodopa/carbidopa non-selective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with Sandoz Levodopa-Carbidopa-Entacapone. g. selegiline 10 mg/day) when co-administered with Sandoz Levodopa-Carbidopa- Entacapone (see DRUG INTERACTIONS, Selegiline).
• Patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, pulmonary (including bronchial asthma), or renal disease. • Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non- traumatic rhabdomyolysis.
• As with levodopa, Sandoz Levodopa-Carbidopa-Entacapone should not be given when administration of a sympathomimetic amine is contraindicated. • Patients with pheochromocytoma due to the increased risk of hypertensive crisis. • Patients with narrow angle glaucoma.
• Because levodopa may activate a malignant melanoma, Sandoz Levodopa-Carbidopa- Entacapone should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma. WARNINGS AND PRECAUTIONS Sudden Onset of Sleep Patients receiving treatment with entacapone in combination with levodopa/dopa decarboxylase (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 5 inhibitor and 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 Sandoz Levodopa-Carbidopa-Entacapone (levodopa, carbidopa and entacapone), such as concomitant medications or the presence of sleep disorders.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Sandoz Levodopa-Carbidopa- Entacapone.
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. 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 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 Sandoz Levodopa-Carbidopa-Entacapone for any indication. , 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 Sandoz Levodopa-Carbidopa-Entacapone.
Physicians should emphasize to patients the importance of adhering to routine examinations for prostate cancer during extended treatment with Sandoz Levodopa-Carbidopa-Entacapone (see WARNINGS AND PRECAUTIONS - Information for Patients).
6 General Sandoz Levodopa-Carbidopa-Entacapone is not recommended for the treatment of drug-induced extrapyramidal reactions. Periodic evaluation of hepatic, hematopoietic, cardiovascular and renal function is recommended during extended therapy with Sandoz Levodopa-Carbidopa-Entacapone.
g. dyskinesias, “on-off” phenomenon, nausea, vomiting and hallucinations may occur at lower doses and earlier with levodopa preparations containing carbidopa and entacapone than […]