Twindopa Special Precautions

Levodopa + Carbidopa (Twindopa) is not recommended for the treatment of drug-induced extrapyramidal reactions.
Levodopa + Carbidopa (Twindopa) 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 Levodopa + Carbidopa (Twindopa) 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 behavior. 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, Levodopa + Carbidopa (Twindopa) 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 Levodopa + Carbidopa (Twindopa) is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa, and use of Levodopa + Carbidopa (Twindopa) 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 Levodopa + Carbidopa (Twindopa) should be carefully observed, particularly in patients who are also receiving neuroleptics.
Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioral 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 Levodopa + Carbidopa (Twindopa). Review of treatment is recommended if such symptoms develop.
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 Levodopa + Carbidopa (Twindopa), 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 Levodopa + Carbidopa (Twindopa) 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, Levodopa + Carbidopa (Twindopa) 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 Levodopa + Carbidopa (Twindopa) for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
Laboratory Tests: Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of combination of levodopa and carbidopa than with levodopa alone. 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 combination of levodopa and carbidopa and levodopa alone.
Levodopa + Carbidopa (Twindopa) 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.
Effects On Ability to Drive and Use Machines: Individual responses to medication may vary and certain side effects that have been reported with Levodopa may affect some patient's ability to drive or operate machinery. Patients treated with levodopa and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines), until such recurrent episodes and somnolence have resolved (see also Precautions previously).