Generic Sinemet (Carbidopa-levodopa 10mg + 100/25mg + 100/25mg + 250mg)
- Denomination
Sinemet
- Active Substance
Carbidopa, Levodopa
- Indications for Use.
Parkinson’s disease, Parkinsonism syndrome (but for the Parkinsonism provoked with neuroptics).
- Action
The drug favors the reduction of immobility, mental petrification, tremor of the limbs and/or the body, head, inflammatory processes of the mouth cavity, salivation and other symptoms of Parkinsonism.
- Posology and Administration
A dose should be adjusted individually with a scope to reach the optimal therapeutic concentration in the blood plasm and to reduce the risk of side effects development.
The drug is recommended to be taken during meal or with a small amount of liquid; capsules (tablets) should be swallowed in whole. The optimal effect is reached after a week of continuous administration of the drug.
For patients not receiving Levodopa the treatment should be started with small doses, which should be gradually increased every day or every other day up to the optimal one for each patient. In terms of Levodopa the range of daily doses is approximately: starting doses - 150 - 250 mg. a daily dose of Levodopa should not exceed 2 g. The average daily dose of Carbidopa, necessary for suppression of peripheral change of Levodopa is 70-100 mg. The maximal daily dose for Carbidopa is 200 mg. A daily dose should be divided into 3 - 4 intakes. Usually the optimal effect is reached after 7 days of continuous intake of the drug, in terms of a Levodopa dose - 750 - 1500 mg a day. In cases of convulsions and closure of eye lids a dose reduction is needed.
In transferring of a patient from an average action duration Levodopa to a combination of Carbidopa with Levodopa - Levodopa administration should be stopped 8 hours before the combination administration, whereas in the case of transferring from a long action duration Levodopa – minimum before 12 hours.
A daily dose of the drug should be adjusted in such a manner that it could be roughly 25% from the previous daily dose of Levodopa.
If a daily dose of Levodopa was less than 1500 mg, then for the most patients the initial dose of Carbidopa - Levodopa is 300 - 400 mg in terms of Levodopa a day. If there is a need of further correction of dosage regimen, a daily dose may be increased or decreased by 125 - 250 mg of Levodopa a day. The optimal effect is reached after 7 days of continuous administration. In cases of muscle convulsions and closure of eye lids a dose should be reduced.
A supporting therapy is corrected in view of clinical effect. If a dose increase of Carbidopa is needed, there are used drugs with Levodopa / Carbidopa ratio 4/1; if there is a need to increase Levodopa dose the drugs should be administered with Levodopa / Carbidopa ratio 10/1.
A supporting dose is 300-400 mg in terms of Levodopa a day for most patients.
- Counterindications
- a known hypersensitivity to any component of the drug;
- closed angle glaucoma;
- severe psychoses, depressions, neuroses;
- cutaneous lesions with unspecified diagnosis;
- melanoma (also assumption of it);
- Huntington’s disease, essential tremor;
- simultaneous intake of monoamine oxidase inhibitors;
- evidenced compromised functions of liver and kidneys;
- heart failure, pulmonary heart;
- leucopenia, blood diseases;
- diseases of endocrine system;
- pregnancy and lactation;
- childhood (under 12 year of age, it is not recommended before 18 years of age);
- secondary Parkinsonism, application-specific of anti-psychotics (neuroleptics).
Use limitations: evidenced atherosclerosis, arterial hypertension, myocardial infarction with rhythm disturbance, bronchial asthma, lung diseases, convulsive syndrome and erosive-ulcer of gastrointestinal tract.
- Should Be Taken with Precautions, if…
Care should be taken in dose adjustment for elderly patients and for people who take other medications.
Care should be taken in administration of the drug to patients with severe cardiovascular and lung diseases, in manifested general atherosclerosis, arterial hypertension, bronchial asthma, lung diseases, manifested compromised liver and kidneys functions, endocrine diseases, evidenced ulcer disease or convulsive syndrome.
Care should be taken while administering the drug to the patients recently had myocardial infarction and who has remaining atrial, nodal or ventricular arrhythmia. Such patients need a very thorough monitoring of the heart performance, especially in the period of the initial dose adjustment.
During a long-lasting treatment periodic check of the functions of liver, blood formation, kidneys and cardiovascular system is needed.
Psychotic patients and patients with mental affections require particular care. Close observation should be provided for the patients having mental diseases or disorders, with a scope of early detection of depression and eventual suicidal tendencies.
Patients with open angle glaucoma should be administered Carbidopa – Levodopa with caution, provided that intraocular tension is monitored and close observation for its changes during the treatment is carried out.
The drug should be withdrawn gradually.
- Interface with Other Medications
Patients receiving Carbidopa – Levodopa should not take additionally any other medications without a doctor’s order.
- Overdosing
Symptoms: convulsive tic, convulsive closing of eyelids, nausea, vomit, diarrhea, irregular and frequent pulse, loss of consciousness, convulsions, agitation, hallucinations, coma. Ambulance should be called immediately if the patient is unconscious.
- Side Effects
The side effects emerging during Carbidopa – Levodopa therapy will disappear in event of a dose reduction or in the process of treatment. A dose reduction is needed when muscle convulsions are developed, also in sticky eyelids, various disorders of motion functions. If side effects persist the treatment should be phased out.
On the part of nervous system and mind: headache, dizziness, insomnia, drowsiness, unrest, nightmares, anxiety disorders, mania, euphoria, asthenia, fainting fit, lethargy, paranoid ideation, hallucinations, psychotic states, depression with development or without development of suicidal trends, convulsive states, motion disorders.
Vision disorders: blurring of vision, pupils dilatation.
On the part of gastrointestinal tract: nausea, vomit, anorexia, hiccup, dysphasia, elevated salivation, bitter taste, burning sensation in the mouth, dry mouth, diarrhea, constipation, pains in the pit of the stomach, meteorism; ulcers formation in gastrointestinal tract, bleedings from gastrointestinal tract.
On the part of cardiovascular system: seldom – bradycardia, heartbeat, tachycardia, blood compositional disorder.
On the part of breathing system: breathing rhythm disturbance, huskiness.
On the part of urogenital system: urination retention, urinary incontinence, haematuria, long-lasting erection in men.
Dermatologic disorders: perspiration, edemas, rash, hair loss.
Others: hot flash, hyperemia of face, weight gain, phlebitis, elevation of libido. Against the use of the drug urine discoloration is possible.
- Pregnancy and Lactation
If there is a need to use Carbidopa in combination with Levodopa during pregnancy, it is necessary to confirm that it is vitally important, and in this case it is possible to give up on breastfeeding.
- Driving
The drug may influence psychophysical abilities. The activity which demands high attention concentration and rapidness of psychomotor reactions should be avoided (vehicles driving).
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