Loading…
CARAMET is a brand name for Carbidopa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Idiopathic Parkinson’s disease in particular to shorten the ‘off’ period in patients who have previously been treated with immediate-release levodopa/decarboxylase inhibitors or with just levodopa and who showed motor fluctuations. Experience with Caramet 25 mg/100 mg Prolonged Release Tablets is limited in patients,…
Verbatim from this product's MHRA label. Tap a section to expand.
The daily dose of Caramet 25 mg/100 mg Prolonged Release Tablets should be carefully determined. Patients should be closely monitored during the period of dose adjustment, especially with regard to the occurrence or exacerbation of nausea and abnormal involuntary movements such as dyskinesia, chorea and dystonia.
). The dosage level and intervals must be determined individually after careful examination by the physician. Blepharospasm may be an early sign of overdosing. Most other medicines, used to treat Parkinson’s disease, except for levodopa, can be continued during administration of Caramet 25 mg/100 mg Prolonged Release Tablets.
However their dosage may need to be adjusted. Posology Initial dose Patients not previously treated with levodopa 1 prolonged-release tablet Caramet 25 mg/100 mg Prolonged Release Tablets two to three (or four) times per day. In patients requiring more levodopa the treatment may be started with 1 prolonged-release tablet Caramet 50 mg/200 mg Prolonged Release Tablets twice daily.
The initial daily dose of levodopa must not exceed 600 mg and the doses should be administered with minimum intervals of six hours. Depending upon the severity of disease, six months of treatment may be required to achieve optimal disease control.
Patients who have previously received levodopa as monotherapy Levodopa must be discontinued at least 12 hours before therapy with Caramet 25 mg/100 mg Prolonged Release Tablets is started. • Caramet 25 mg/100 mg Prolonged Release Tablets In patients with mild to moderate disease, the recommended initial dose is 2 prolonged- release tablets of Caramet 25 mg/100 mg Prolonged Release Tablets 100 mg/25 mg twice daily.
• Caramet 50 mg/200 mg Prolonged Release Tablets In patients with mild to moderate disease, the recommended initial dose is 1 prolonged- release tablet of Caramet 25 mg/100 mg Prolonged Release Tablets 200 mg/50 mg twice daily. Patients previously treated with immediate-release levodopa/decarboxylase inhibitor Patients previously treated with non-prolonged-release levodopa/decarboxylase inhibitor products should receive approximately 10% more levodopa than previously at the start of treatment with Caramet 25 mg/100 mg Prolonged Release Tablets.
The levodopa dose may need to be up to 30% higher. Levodopa and decarboxylase inhibitor should be discontinued at least 12 hours before the administration of Caramet 25 mg/100 mg Prolonged Release Tablets. The dose interval should be prolonged by 30%-50% at intervals in the range of 4 to 12 hours.
Summary of the safety profile During controlled clinical trials in patients with moderate to severe motor fluctuations, levodopa/carbidopa caused no side effects which were unique to the modified release formulations. The most frequently reported adverse reaction was dyskinesia (a form of abnormal involuntary movements).
Tabulated list of adverse reactions Adverse reactions from clinical trials and post-marketing experience are listed per System Organ Class and per frequency. 4), Henoch- Schoenlein purpura Musculoskeletal and connective tissue disorders muscle cramp muscle twitching Renal and urinary disorders dark discolouration of the urine urinary incontinence, urinary retention Reproductive system and breast disorders priapism General disorders and administration site conditions chest pain, fatigue, asthenia gait disturbances, hot flushes, oedema, malaise Injury, poisoning and procedural complications falling 1 Levodopa/carbidopa has been associated with somnolence and has been associated very rarely with extreme daytime somnolence and sudden onset of sleep.
2 During use of levodopa/carbidopa prolonged-release tablets, dyskinesia has been observed more frequently than with use of immediate-release levodopa/carbidopa dosage forms. 3 An (on-off episodes) bradykinesia may occur some months to years after the beginning of treatment with levodopa and is probably associated to the progression of the disease.
Adjustment of the dosage regimen and dosing interval may be required. 4 “Special warnings and precautions for use”). Dopamine dysregulation syndrome Dopamine dysregulation syndrome (DDS) is an addictive disorder seen in some patients treated with levodopa/carbidopa.
4). 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, or search for MHRA Yellow Card in the Google Play or Apple App Store.
g. hyperthyroidism, phaeochromocytoma) disease or with a history of peptic ulcer disease or convulsions • to patients with tachycardia • to patients with severe disorders of the haematopoietic system • if administration of a sympathomimetic agent is contraindicated • to patients with psychiatric diseases with a psychotic component Care should be exercised when levodopa/carbidopa is administered to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias.
Cardiac function should be monitored with particular care in such patients during the period of initial dosage adjustment. In the adjustment phases, more frequent monitoring of liver and kidney function and of the blood count is recommended.
If there is a history of myocardial infarction, arrhythmias or coronary ischaemia, circulation and ECG checks should be carried out regularly and frequently, particularly at the start of treatment. Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function are recommended during extended therapy.
In patients who have previously received levodopa as monotherapy, treatment with levodopa must be discontinued at least 12 hours before starting with the therapy of levodopa/carbidopa. Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed.
The occurrence of dyskinesias may require dosage reduction. Levodopa/carbidopa is not recommended for the treatment of drug-induced extrapyramidal reactions or for the treatment of Huntington’s chorea. Abrupt withdrawal After many years of treatment with products containing levodopa, sudden withdrawal or a very rapid reduction in the dose of Caramet 25 mg/100 mg Prolonged Release Tablets can lead to a malignant levodopa withdrawal syndrome (neuroleptic malignant syndrome with hyperthermia, muscle rigidity, altered mental status and an increase in serum creatine phosphokinase) or akinetic crisis.
1. • Non-selective monoamine oxidase (MAO) inhibitors and selective MAO-A inhibitors. Administration of these MAO inhibitors should be discontinued at least 2 weeks before starting treatment with levodopa/carbidopa. 5). • Malignant melanoma.
Since levodopa may activate a malignant melanoma, it should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma. • Narrow-angle glaucoma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Carbidopa in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
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 the divided doses are not equal it is recommended to administer the lowest dose at the end of the day. As described below under ‘dose adjustment’, the dose should be adjusted in line with the patient’s response to treatment. Guidelines for changing from immediate-release levodopa/decarboxylase inhibitor tablets to Caramet 25 mg/100 mg Prolonged Release Tablets: Caramet 25 mg/100 mg Prolonged Release Tablets immediate-release levodopa/decarboxylase inhibitor tablets Caramet 25 mg/100 mg Prolonged Release Tablets Daily dose of levodopa (mg) Daily dose of levodopa (mg) Number of prolonged-release tablets 100-200 200 1 tablet, twice daily 300-400 400 1 tablet, three to four times daily Caramet 50 mg/200 mg Prolonged Release Tablets immediate-release levodopa/decarboxylase inhibitor tablets Caramet 50 mg/200 mg Prolonged Release Tablets Daily dose of levodopa (mg) Daily dose of levodopa (mg) Number of prolonged-release tablets 300-400 400 1 tablet, twice daily 500-600 600 1 tablet, three times daily 700-800 800 4 tablets, in three or more divided doses 900-1000 1000 5 tablets, in three or more divided doses 1100-1200 1200 6 tablets, in three or more divided doses 1300-1400 1400 7 tablets, in three or more divided doses 1500-1600 1600 8 tablets, in three or more divided doses Dose adjustment Once the dosage has been established, the dose or the dosing interval can be increased or decreased, according to the patient’s response to treatment.
Most patients are adequately treated with 400 mg levodopa/100 mg carbidopa to 1600 mg levodopa/400 mg carbidopa per day. The prolonged-release tablets should be taken in single doses at intervals of 4-12 h during the day. Higher doses (up to 2400 mg levodopa/600 mg carbidopa) and shorter intervals (less than four hours) have been used, but are generally not recommended.
When doses of Caramet 25 mg/100 mg Prolonged Release Tablets are given at intervals of less than four hours or if the divided doses are not equal, it is recommended to administer the lowest dose at the end of the day. The effect of the first morning dose can be delayed in some patients for up to one hour compared to the usual reaction of the first morning dose of immediate-release levodopa/carbidopa.
Adjustments of the dosage should occur in intervals of at least three days. Maintenance dose Because Parkinson’s disease is progressive, periodic clinical check-ups are recommended and an adjustment of the dose schedule of Caramet 25 mg/100 mg Prolonged Release Tablets may be needed.
Use of additional anti-Parkinson medications Anticholinergic agents, dopamine agonists and amantadine can be administered concomitantly with levodopa/carbidopa. It might be necessary to adjust the dose of {Product name} when these medicinal products are added to an ongoing treatment with Caramet 25 mg/100 mg Prolonged Release Tablets.
4). If anaesthesia with halothane, cyclopropane or other substances that sensitise the heart to […]
Both conditions are life-threatening. Levodopa treatment breaks indicated for therapeutic reasons must therefore be carried out only in a hospital setting, especially if the patient is receiving neuroleptics. Dopamine dysregulation syndrome Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa.
8). 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 and hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa, including Caramet 25 mg/100 mg Prolonged Release Tablets.
Review of treatment is recommended if such symptoms develop. Psychiatric disorders All patients should be monitored carefully for the development of mental changes and depression with or without suicidal tendencies. Patients with a history of psychoses should be treated with caution.
Somnolence and episodes of sudden sleep onset Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence or an episode of sudden sleep onset must refrain from driving or operating machines.
A reduction of dosage or termination of therapy may be considered. Chronic wide-angle 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 eye pressure during the therapy.
Malignant melanoma Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk of developing melanoma than the general population (approximately 2-6 fold higher). It is unclear whether the increased risk observed was due to Parkinson’s disease, or other factors such as medicines used to treat Parkinson’s disease.
Therefore patients and providers are advised to monitor for melanomas on a regular basis when using levodopa/carbidopa. , dermatologists). Laboratory tests Levodopa and carbidopa have caused abnormalities: • in the detection of catecholamines, creatinine, uric acid, glucose, alkaline phosphatase, SGOT, SGPT, lactic acid dehydrogenase, bilirubin, blood urea nitrogen • decreased haemoglobin and haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine • when a test strip is used to determine ketonuria, levodopa/carbidopa can show a false positive result for urinary ketone bodies.
This reaction is not altered by boiling the urine sample. • false negative results in the examination of glycosuria with the use of glucose oxidase methods. • and a false positive Coombs test. Excipient(s) Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per prolonged release tablet, that is to say essentially ‘sodium-free’.