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CO-CARELDOPA is a brand name for Levodopa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For treatment of Parkinson's disease.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The optimum daily dosage of Co-Careldopa must be determined by careful titration in each patient. Co-Careldopa Tablets are available in a ratio of 1:4 or 1:10 of carbidopa to levodopa to provide facility for fine dosage titration for each patient.
General Considerations Studies show that the peripheral dopa-decarboxylase is fully inhibited (saturated) by carbidopa at doses between 70 and 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.
Standard antiparkinsonian drugs, other than levodopa alone, may be continued while Co-Careldopa is being administered, although their dosage may have to be adjusted. Because both therapeutic and adverse effects are seen more rapidly with Co- Careldopa than with levodopa, patients should be carefully monitored during the dosage adjustment period.
Involuntary movements, particularly blepharospasm, are a useful early sign of excess dosage in some patients. Patients not receiving levodopa Dosage may be best initiated with one tablet of Co-Careldopa 25 mg/100 mg three times a day.
This dosage schedule provides 75 mg of carbidopa per day. 5 mg/50 mg or Co-Careldopa 25 mg/100 mg' every day or every other day, as necessary, until a dosage equivalent of eight tablets of Co-Careldopa 25 mg/100 mg a day is reached.
5 mg/50 mg Tablets are used, dosage may be initiated with one tablet three or four times a day. Titration upward may be required in some patients to achieve optimum dosage of carbidopa. ) is reached. For patients starting with Co-Careldopa 25 mg/250 mg Tablets', the initial dose is one-half tablet taken once or twice daily.
However, this may not provide the optimal amount of carbidopa needed by many patients. If necessary, add one-half tablet every day or every other day until optimal response is reached. Response has been observed in one day, and sometimes after one dose.
Fully effective doses usually are reached within seven days as compared to weeks or months with levodopa alone. 5 mg/50 mg Tablets' or Co-Careldopa 10 mg/100 mg Tablets' may be used to facilitate dosage titration according to the needs of the individual patient.
Patients receiving levodopa Discontinue levodopa at least 12 hours (24 hours for slow-release preparations) before starting therapy with Co-Careldopa. The easiest way to do this is to give Co-Careldopa as the first morning dose after a night without any levodopa.
Side effects that occur frequently with Co-Careldopa are those due to the central neuropharmacological activity of dopamine. These reactions can usually be diminished by dosage reduction. The most common are dyskinesias including choreiform, dystonic and other involuntary movements and nausea.
Muscle twitching and blepharospasm may be taken as early signs to consider dosage reduction. Other side effects reported in clinical trials or in post-marketing experience include: Infections and Infestations: very common- Urinary tract infections General disorders and administration site conditions: syncope, chest pain, anorexia.
Cardiac disorders: cardiac irregularities and/or palpitations, orthostatic effects including hypotensive episodes, hypertension, phlebitis. Gastro-intestinal disorders: vomiting, gastro-intestinal bleeding, development of duodenal ulcer, diarrhoea, dark saliva.
Blood and lymphatic system disorders: leucopenia, haemolytic and non- haemolytic anaemia, thrombocytopenia, agranulocytosis. Immune system disorders: angioedema, urticaria, pruritus, Henoch-Schonlein purpura. 4), bradykinetic episodes (the “on-off” phenomenon), dizziness, paraesthesia, psychotic episodes including delusions, hallucinations and paranoid ideation, depression with or without development of suicidal tendencies, dementia, dream abnormalities, agitation, confusion, increased libido.
Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes. Respiratory, thoracic and mediastinal disorders: dyspnoea. Skin and subcutaneous tissue disorders: alopecia, rash, dark sweat.
Renal and urinary disorders: dark urine.
Psychiatric disorders:
Dopamine dysregulation syndrome (Unknown frequency) Rarely convulsions have occurred; however, a causal relationship with Co- Careldopa has not been established. Other side effects that have been reported with levodopa or levodopa/carbidopa combinations and may be potential side effects include: Gastrointestinal disorders: dyspepsia, dry mouth, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, abdominal pain and distress, constipation, flatulence, burning sensation of the tongue.
Co-Careldopa is not recommended for the treatment of drug-induced extrapyramidal reactions or Huntington’s chorea. Co-Careldopa should be administered cautiously to patients with 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).
Care should be exercised when Co-Careldopa 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.
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 and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered. All patients should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour.
Patients with current psychoses should be treated with caution. 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. As with levodopa, Co-Careldopa may cause involuntary movements and mental disturbances. Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone should be observed carefully when Co-Careldopa is substituted.
1. • Non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with Co-Careldopa. These inhibitors must be discontinued at least two weeks before starting Co-Careldopa Co-Careldopa. g. selegiline hydrochloride). ) • Co-Careldopa is contraindicated in patients with narrow-angle glaucoma • Since levodopa may activate a malignant melanoma, it should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.
• Use in patients with severe psychoses. 6 ‘Pregnancy and lactation’).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The dose of Co-Careldopa should be approximately 20% of the previous daily dosage of levodopa. Patients taking less than 1,500 mg levodopa a day should be started on one tablet of Co-Careldopa 25 mg/100 mg three or four times a day dependent on patient need.
The suggested starting dose for most patients taking more than 1,500 mg levodopa a day is one tablet of Co-Careldopa 25 mg/250 mg' three or four times a day. Maintenance Therapy with Co-Careldopa should be individualised and adjusted gradually according to response.
5 mg/50 mg'. When more levodopa is required, Co-Careldopa 25 mg/250 mg tablets should be substituted at a dosage of one tablet three or four times a day. If necessary, the dosage of Co-Careldopa 25 mg/250 mg tablets' may be increased by one tablet every day or every other day to a maximum of eight tablets a day.
Experience with a total daily dosage greater than 200 mg carbidopa is limited. Patients receiving levodopa with another decarboxylase inhibitor When transferring a patient to Co-Careldopa from levodopa combined with another decarboxylase inhibitor, discontinue dosage at least 12 hours before Co-Careldopa is started.
Begin with a dosage of Co-Careldopa that will provide the same amount of levodopa as contained in the other levodopa/decarboxylase inhibitor combination. Use in children The safety of Co-Careldopa in patients under 18 years of age has not been established and its use in patients below the age of 18 is not recommended.
Use in the elderly There is wide experience in the use of this product in elderly patients. The recommendations set out above reflect the clinical data derived from this experience. Patients receiving other antiparkinsonian agents Current evidence indicates that other antiparkinsonian agents may be continued when Co-careldopa is introduced, although dosage may have to be adjusted in line with manufacturers recommendations.
Method of administration To be taken orally
Metabolism and nutrition disorders: weight gain or loss, oedema. Nervous system disorders: asthenia, decreased mental acuity, disorientation, ataxia, numbness, increased hand tremor, muscle cramp, trismus, activation of latent Horner's syndrome, insomnia, anxiety, euphoria, falling and gait abnormalities and Dopamine Dysregulation Syndrome.
) Skin and subcutaneous tissue disorders: flushing, increased sweating. Special senses: diplopia, blurred vision, dilated pupils, oculogyric crises. Renal and urinary disorders: urinary retention, urinary incontinence, priapism. 3 Contraindications).
Description of selected adverse reactions Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/ levodopa. 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.
These reactions are thought to be due to increased brain dopamine following administration of levodopa, and use of Co-Careldopa may cause a recurrence. A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
Therefore, any abrupt dosage reduction or withdrawal of Co-Careldopa should be carefully observed, particularly in patients who are also receiving neuroleptics. Concomitant administration of psycho-active drugs such as phenothiazines or butyrophenones should be carried out with caution, and the patient carefully observed for loss of antiparkinsonian effect.
Patients with a history of convulsions should be treated with caution. As with levodopa, periodic evaluation of hepatic, haematopoetic, cardiovascular and renal function are recommended during extended therapy. Patients with chronic wide-angle glaucoma may be treated cautiously with Co- Careldopa, provided the intra-ocular pressure is well controlled and the patient monitored carefully for changes in intra-ocular pressure during therapy.
If general anaesthesia is required, therapy with Co-Careldopa may be continued for as long as the patient is permitted to take fluids and medication by mouth. If therapy has to be stopped temporarily, Co-Careldopa may be restarted as soon as oral medication can be taken at the same daily dosage as before.
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 drugs used to treat Parkinson's disease.
Therefore patients and providers are advised to monitor for melanomas on a regular basis when using Co-Careldopa for any indication. , dermatologists). 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 can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Co- Careldopa.
Review of treatment is recommended if such symptoms develop. Laboratory Tests Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of Co-Careldopa than with levodopa. Transient abnormalities include elevated levels of blood urea, AST (SGOT), ALT (SGPT), LDH, bilirubin, and alkaline phosphatase.
Decreased haemoglobin, haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine have been reported. Positive Coombs' tests have been reported, both with Co-Careldopa and levodopa alone. Co-Careldopa may cause a false positive result when a dipstick is used to test for urinary ketone; and this reaction is not altered by boiling the urine.
The use of glucose oxidase methods may give false negative results for glycosuria. Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/ levodopa.
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