On the right pill №100

Composition

1 pill contains Levodopa 250 mg, carbidopa 25 mg;
Excipients: microcrystalline cellulose, starch, pregelatinized, corn starch, blue dye (indigotin E-132), Magnesium stearate.

Packing

100 pieces.

Mechanism of action

Nacom is an anti-Parkinsonian drug.
Levodopa reduces the symptoms of Parkinson's disease by increasing the content of dopamine in the brain. Carbidopa, which does not penetrate through the BBB, prevents extracerebral decarboxylation of levodopa, thereby increasing its amount, which enters the brain and converts into dopamine.
It has a more pronounced therapeutic effect compared with levodopa, provides long-term maintenance of therapeutic concentration of levodopa in plasma at doses that are about 80% lower than those required when using a single dose of levodopa.
The effect of the drug is manifested during the first days from the beginning of the intake, sometimes after the first dose. The maximum effect is achieved within 7 days.

Indications and usage

Treatment of Parkinson's disease and Parkinson's syndrome.

Contraindications

- angle-closure glaucoma;
- melanoma established or suspected;
- skin diseases of unknown etiology;
- simultaneous use with non-selective MAO inhibitors;
- hypersensitivity to the drug.
Carefully should be used in patients with serious diseases of the cardiovascular system, including with myocardial infarction with cardiac arrhythmias (in history), with heart failure; with severe diseases of the respiratory system, including bronchial asthma; convulsive seizures (in history), including epileptic; with erosive and ulcerative lesions of the gastrointestinal tract (due to the possibility of bleeding from the upper GI tract); with decompensated diseases of the endocrine system, including diabetes mellitus; with severe renal failure; with severe liver failure; with open-angle glaucoma.

Pregnancy and Breastfeeding

The safety of the drug during pregnancy has not been studied. The use of the drug is possible only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
It is not known whether levodopa and carbidopa are excreted in breast milk.
There is one report on the excretion of levodopa with breast milk in a nursing mother with Parkinson's disease. Therefore, due to the possible serious adverse effects of the drug on the newborn and taking into account the importance of therapy for the mother, if necessary, use of the drug during lactation should decide whether to stop breastfeeding or cancel the drug Nacom.
ATexperimental studies A combination of levodopa and carbidopa has been found to cause visceral and skeletal changes in laboratory animals.

Adverse reactions

Nervous system: most often - dyskinesia, including involuntary movements (including choreiform, dystonic); possible neuroleptic malignant syndrome, episodes of bradykinesia ("on-off" syndrome), dizziness, drowsiness, paresthesia, episodes of psychotic states, including illusions, hallucinations and paranoid thinking, depression with the development of suicidal intentions or without them, dementia, sleep disorders, agitation, confusion, increased libido.
Early signs, on the basis of which a decision can be made to cancel the drug, are muscle twitching and blepharospasm.
In rare cases - convulsions (a causal relationship with taking the drug Nacom has not been established).
Gastrointestinal: nausea is most common; possible anorexia, vomiting, bleeding from the gastrointestinal tract, exacerbation of duodenal ulcer, diarrhea, saliva darkening.
On the part of the body as a whole: possible fainting, chest pain,
Cardiovascular: arrhythmias and / or heartbeat, orthostatic effects (including episodes of increase or decrease in blood pressure), phlebitis.
Hemic and lymphatic: leukopenia, anemia (including hemolytic), thrombocytopenia, agranulocytosis.
Allergic reactions: angioedema, urticaria, pruritus, Sch&№246;nlein-Genoch disease.
Respiratory: possible dyspnea.
Dermatologic:the alopecia, skin rash, darkening of a secret of sweat glands are possible.
From the genitourinary system: dark urine.
Other side effects that may occur as a result of taking levodopa:
Gastrointestinal: dyspepsia, dry mouth, bitterness in the mouth, sialorea, dysphagia, bruxism, attacks of hiccups, pain and discomfort in the stomach, flatulence, burning sensation of the tongue.
Metabolism: decrease or increase in body weight, swelling.
From the side of the central nervous system: weakness, fainting, fatigue, headache, asthenia, decreased mental activity, ataxia, numbness, increased hand tremor, muscle cramps, trismism, activation of hidden Bernard-Horner syndrome, insomnia, anxiety, euphoria, psychomotor agitation, instability of gait.
Special senses: diplopia, blurred vision, dilated pupils, oculogy crises.
From the genitourinary system: urinary retention, urinary incontinence, priapism.
Other: hoarseness, malaise, flushing of the skin of the face, neck and chest, dyspnea, malignant melanoma.
From the laboratory indicators: increased activity of alkaline phosphatase, AST, ALT, LDH, an increase in the content of bilirubin, urea nitrogen in the plasma, an increase in the content of serum creatinine, hyperuricemia, a positive Coombs test; reduction of hemoglobin and hematocrit, hyperglycemia, leukocytosis, bacteriuria, erythrocyturia are possible.
Preparations containing carbidopa and levodopa can cause a false-positive reaction to ketone bodies in the urine, if test strips are used to determine ketonuria. This reaction will not change after boiling urine samples. False negative results can be obtained using the glucose oxidase method for the determination of glucosuria.

Special notes

As in the case of the use of levodopa, when prescribing Nakoma to patients who have had a myocardial infarction and who have atrial, nodular, or ventricular arrhythmias, a thorough preliminary examination is necessary. In such patients, it is necessary to monitor cardiac activity, especially when prescribing the first dose and during the dose selection period.
Patients with open-angle glaucoma Nakom should be prescribed with caution and subject to continuous monitoring of intraocular pressure during treatment.
Since both therapeutic and side effects occur more often when using a combination of carbidopa and levodopa than of one levodopa, careful monitoring is necessary for patients during the dose selection period. In particular, Nacom causes involuntary movements more often than levodopa. The appearance of involuntary movements may require a dose reduction. An early sign of an overdose in some patients may be blepharospasm. If the therapeutic response to levodopa is variable, and the manifestations and symptoms of Parkinson's disease are not controlled throughout the day, then switching to Nacom usually allows you to reduce fluctuations in the reaction to the drug.
By reducing the specific negative effects caused by levodopa, Nacom provides patients with an adequate reduction in the symptoms of Parkinson's disease.
Nacom is also indicated for patients with parkinsonism taking vitamin preparations containing Pyridoxine hydrochloride (vitamin B₆).
It is not recommended for elimination of extrapyramidal disorders caused by drugs.
In patients who have previously taken levodopa, dyskinesia may occur, since Carbidopa allows more levodopa to reach the brain, and thus more dopamine is produced. The appearance of dyskinesia may require a dose reduction.
Like levodopa, Nakom can cause involuntary movements or mental disorders. It is assumed that these reactions are due to an increase in the content of dopamine in the brain. These effects may require a dose reduction. All patients taking Nacom should be monitored due to the possibility of developing a depressive state with suicidal tendencies. Patients who have experienced psychosis, require a careful approach in the selection of therapy.
It should be prescribed caution Nakom and psychotropic drugs. With the sudden cancellation of anti-parkinsonian drugs, a symptom complex resembling a neuroleptic malignant syndrome was described, including muscle rigidity, fever, mental disturbances and an increase in serum CPK concentration. Therefore, careful examination of patients is necessary during the period of a sharp reduction in the dose of Nakoma or its withdrawal, especially if the patient receives antipsychotics. As in the case of levodopa, during long-term treatment with Nakom, periodic monitoring of the functions of the liver, hematopoietic, cardiovascular systems and kidneys is recommended.
If general anesthesia is required, then Nacom can be taken as long as the patient is allowed oral administration of fluids and drugs.
If treatment is temporarily interrupted, then Nakoma intake can be resumed at the usual dose as soon as the patient is able to take the drug by mouth.
Use in pediatrics
The safety of the drug in young children and middle age has not been established.
It is not recommended to appoint Nakom children and adolescents under the age of 18 years.

When using Nakoma in patients receiving antihypertensive therapy, symptomatic orthostatic hypotension was observed (at the beginning of treatment with Nacom, in such cases it may be necessary to adjust the dose of the antihypertensive drug).
With simultaneous use of levodopa with MAO inhibitors (with the exception of MAO inhibitors of type B), circulatory disturbances are possible (taking MAO inhibitors should be stopped 2 weeks before starting to receive levodopa). This is due to the accumulation of dopamine and norepinephrine under the influence of levodopa, the inactivation of which is inhibited by MAO inhibitors. As a result, the likelihood of developing excitement, increasing blood pressure, tachycardia, facial flushing and dizziness is high.
There are separate reports of adverse reactions, including increased blood pressure and dyskinesia in the case of the combined use of tricyclic antidepressants and Nakoma.
The bioavailability of carbidopa and / or levodopa decreases with simultaneous use of iron sulfate or iron gluconate.
With simultaneous use of levodopa with beta-blockers, ditilinom and means for inhalation anesthesia may increase the risk of developing cardiac arrhythmias.
Dopamine D antagonists₂receptors (for example, phenothiazines, butyrophenones, and risperidone), as well as isoniazid, can reduce the therapeutic effect of levodopa. There are reports of blocking the positive therapeutic effects of levodopa in Parkinson's disease as a result of taking phenytoin and papaverine. Patients taking these medications at the same time as Nacom must be carefully monitored for the timely detection of a decrease in the therapeutic effect.
Lithium drugs increase the risk of dyskinesias and hallucinations; methyldopa increases the side effects, the simultaneous use of tubocurarine increases the risk of arterial hypotension.
Levodopa absorption may be impaired in some patients on a high protein diet, since levodopa competes with certain amino acids.
Carbidopa prevents the action of pyridoxine hydrochloride (vitamin B₆), which accelerates the biotransformation of levodopa into dopamine in peripheral tissues.

Symptoms: increased side effects.
Treatment: Careful monitoring and ECG monitoring should be provided to identify possible arrhythmias, and, if necessary, adequate antiarrhythmic therapy should be performed. It is necessary to take into account the possibility that the patient took other medications along with the drug Nakom.

Keep out of reach of children at a temperature not exceeding 25 ° C.