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Numient is a brand name for Levodopa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symptomatic treatment of adult patients with Parkinson’s disease.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Numient is recommended to be dosed orally, approximately every 6 hours. Medicinal product no longer authorised 3 Each capsule strength may be used alone, or in combination with other capsule strengths as required. Use of this medicinal product with other levodopa containing medicinal products has not been studied.
Dose recommendations should be followed at initiation of treatment and adapted according to clinical response. 25 mg carbidopa three times daily from Day 4 of treatment. Further increases should be individualized based on clinical response.
The daily dose must be determined by careful titration. Patients should be maintained on the lowest dose required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea. There is limited experience with a total daily dose of more than 1,170 mg of levodopa when administered in levodopa-naïve patients.
2). When patients are initially converted from immediate release levodopa/DDC inhibitor medicinal products to Numient, the dosing conversion guidelines provided in Table 1 are recommended for initial dosing.
Table 1:
Guidelines for initial conversion from immediate release (IR) levodopa/DDC inhibitor medicinal products to Numient in Parkinson’s disease patients. 25 mg TID When converting patients from levodopa/DDC inhibitor medicinal products to Numient, the dose should be adjusted to maintain sufficient symptomatic control.
The dosing frequency may be changed from three times a day to a maximum of five times a day if sufficient symptomatic control is not observed. 5 mg of carbidopa given as Numient. The final total daily dose of levodopa from Numient is about double that of the final total daily dose of levodopa from immediate release tablets while the final total daily dose of levodopa from Numient is about three times that of the final total daily dose of levodopa from the combination of levodopa/DDC inhibitor/entacapone.
Converting patients specifically from other levodopa/DDC inhibitor modified-release medicinal products to Numient For patients currently treated with other levodopa/DDC inhibitor modified-release medicinal products, limited information regarding conversion to Numient is available.
The initial total daily dose of Numient described in Table 1 above may need to be decreased by approximately 30% for patients converting specifically from levodopa/DDC inhibitor modified-release medicinal products to Numient. Maintenance Because Parkinson's disease is progressive, periodic clinical evaluations are recommended.
Therapy should be individualized and adjusted for each patient according to the desired therapeutic response. Addition of other medicinal products for the treatment of Parkinson’s disease Modified-release levodopa/carbidopa may be used together with other medicinal products for the treatment of Parkinson’s disease.
Summary of the safety profile The most frequently reported adverse reactions with Numient were nausea, occurring in approximately 12% of all patients; dizziness, headache, and dyskinesia, each occurring in approximately 8% of all patients; and insomnia, occurring in approximately 6% of all patients.
Serious events of gastrointestinal haemorrhage (uncommon) and of allergic oedema (uncommon) were reported in the clinical studies with Numient. A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/carbidopa medicinal products, although no cases have been identified in clinical studies with Numient.
Tabulated list of adverse reactions Adverse reactions are listed below by system organ class (SOC) and frequency (Table 3). Frequencies are defined as: 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 estimated from the available data).
Medicinal product no longer authorised 11 Table 3. 3), hair loss, exanthema, dark sweat Musculoskeletal and connective tissue disorders Muscle spasms Renal and urinary disorders Urinary retention Dark urine, urinary incontinence Reproductive system and breast disorders Priapism General disorders and administration site conditions Fall, peripheral oedema, non-cardiac chest pain, asthenia, fatigue Malaise Investigations Elevated AST, ALT, LDH, bilirubin, blood sugar, creatinine, uric acid; lowered values of haemoglobin and haematocrit; blood in urine Elevated urea nitrogen, alkaline phosphatases; positive Coomb’s test; leucocytes, and bacteria in the urine a) Adverse reactions not observed in the clinical development of Numient, but reported for other levodopa/carbidopa medicinal products.
b) Combined term that includes atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia Description of selected adverse reactions Sudden sleep onset Numient is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
7). Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. 7). Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Furthermore a reduction of dose or termination of therapy may be considered. Neuroleptic malignant syndrome (NMS) Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of levodopa/carbidopa medicinal products.
NMS is a life-threatening syndrome characterized by fever or hyperthermia and can be associated with rhabdomyolysis. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnoea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leucocytosis, myoglobinuria, and increased serum myoglobin have been reported.
2). Mental disturbances Patients may experience new or worsening mental status and behavioural changes, which may be severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or increasing the dose of levodopa.
This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously with levodopa/carbidopa because of the risk of exacerbating psychosis. In addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of levodopa/carbidopa.
1. - Narrow-angle glaucoma. - Phaeochromocytoma. - Co-administration with non-selective monoamine oxidase (MAO) inhibitors. 5). Medicinal product no longer authorised 6
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5). Interruption of therapy Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been associated with dose reductions and withdrawal of levodopa/carbidopa containing medicinal products. 4). If general anaesthesia is required, the modified-release levodopa/carbidopa capsule medicinal product may be continued as long as the patient is permitted to take oral medicinal products.
Medicinal product no longer authorised […]
4). Laboratory values Cases of falsely diagnosed phaeochromocytoma in patients on levodopa/carbidopa therapy have been reported very rarely. Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/carbidopa therapy.
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. Medicinal product no longer authorised 13
5). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating, and dopamine dysregulation syndrome can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa.
Review of treatment is recommended if such symptoms develop. Dyskinesias Medicinal products containing levodopa cause dyskinesias that may require treatment adjustment. Carbidopa permits more levodopa to reach the brain and more dopamine to be formed increasing the risk for certain adverse CNS reactions including dyskinesia.
It is recommended to monitor patients for the onset or evolution of dyskinesia and to adjust levodopa/carbidopa doses accordingly. Orthostatic hypotension Levodopa/carbidopa can cause orthostatic hypotension. g. Medicinal product no longer authorised 7 Glaucoma Patients with chronic wide-angle glaucoma may be treated cautiously with levodopa/carbidopa provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
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 medicinal products used to treat Parkinson’s disease, is unclear.
For the reasons stated above, patients and prescribing physicians are advised to monitor for melanomas frequently and on a regular basis when using levodopa/carbidopa, especially in patients with suspicious, undiagnosed skin lesions or a history of melanoma.
, dermatologists) are recommended. Laboratory testing Decreased haemoglobin and haematocrit have been observed on long-term levodopa/carbidopa treatment. Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy.
Levodopa/carbidopa preparations may provide a false-positive test result for ketone bodies, if a test strip is used for determining any ketonuria. This reaction does not change upon boiling the urine sample. False negative results might be obtained upon application of glucose-oxidase methods for glucosuria.
Special populations Levodopa/carbidopa should be administered cautiously to patients with ischemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage) and a history of convulsions.
Care should be exercised in administering levodopa/carbidopa to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dose adjustment.