NAC

The NAC – protivoparkinsonichesky means.

Form of release and structure

Dosage form – tablets: oval, convex from two parties, blue color with white and separate dark-blue impregnations, with a notch on one party (on 10 pieces in the blister, in a box of cardboard 10 blisters).

The active agents which are contained in 1 tablet:

• Levodopa – 250 mg;
• Karbidopa – 25 mg.

Additional substances: magnesium stearate, starch corn, starch prezhelatinizirovanny, cellulose microcrystallic, dye blue (E132 indigotin).

Indications to use

By the NAC it is intended for treatment of a syndrome of parkinsonism and Parkinson's disease.

Contraindications

Absolute:

• Melanoma or suspicion on it;
• Skin diseases of an unknown etiology;
• Closed-angle glaucoma;
• Pregnancy (except for cases of vital need);
• Lactation (or feeding for the period of administration of drug should be stopped);
• Age up to 18 years;
• Co-administration of non-selective monoamine oxidase inhibitors and the period in 2 weeks after their cancellation;
• Hypersensitivity to drug components.

Relative:

• Serious illness of respiratory system, including bronchial asthma;
• Serious illness of cardiovascular system, including heart failure, a myocardial infarction with disturbances of a cordial rhythm (in the anamnesis);
• Convulsive attacks in the history of a disease, including epileptic;
• Dekompensirovanny diseases of endocrine system, including diabetes mellitus;
• Digestive tract erosive cankers;
• Open angle glaucoma;
• Heavy renal/liver failure.

Route of administration and dosage

The NAC accept inside. The optimum dose is defined by the doctor. In need of a tablet it is possible to halve (notches are for this purpose provided).

During treatment correction of an individual dose and/or frequency of reception can be required. According to data of researches, the average daily dose of drug on a karbidopa makes 70-100 mg.

To patients who before Nakom's appointment accepted standard medicines for treatment of parkinsonism (except for the drugs containing only a levodopa) their reception can be prolonged, but after dose adjustment.

The initial dose of Nakom depends on the indication and reaction of the patient to therapy and makes ½ tablets 1-2 times/days. In need of it increase up to 1 whole tablet every day or every other day.

The therapeutic effect of drug is usually observed in the first day of reception (sometimes – after the first dose), the full effect develops within 7 days.

At transfer of the patient on the NAC from the drugs containing a levodopa, their use should be stopped at least in 12 hours (in a case with a levodopa in dosage forms of the prolonged action – in 24 hours). At the same time the daily dose of Nakom has to provide about 20% of the previous daily dose of a levodopa.

For patients who received more than 1500 mg of a levodopa the recommended initial dose of Nakom makes 3-4 times/days on 1 tablet.

When carrying out a maintenance therapy the dose can be increased at most to the 8th tablets/days (a dose raise gradually, on ½-1 a tablet every day or every other day).

Side effects

Most often the NAC makes sick and dyskinesia, including the involuntary movements, including choreoid and dystonic (their precursory symptoms the nictitating spasm and muscular twitchings which can be the cause for drug withdrawal are).

Other possible side effects:

• Central and peripheral nervous system: confusion of consciousness, a depression (including with development of suicide intentions), dizziness, excitement, frustration of a dream, drowsiness, dementia, paresthesia, episodes of psychotic states (including paranoid thinking, hallucinations and illusions), bradykinesia episodes ("on-off" - a syndrome), increase in a libido, a malignant antipsychotic syndrome; seldom – spasms (relationship of cause and effect of their development is not established with administration of drug);
• Urinogenital system: urine darkening;
• System of a hemopoiesis: anemia (including hemolitic), thrombocytopenia, agranulocytosis, leukopenia;
• Cardiovascular system: tachycardia and/or arrhythmias, phlebitis, orthostatic effects (including episodes of decrease/increase in arterial pressure);
• Alimentary system: an aggravation of a peptic ulcer of a 12-perstny gut, diarrhea, anorexia, vomiting, saliva darkening, bleeding from digestive tract;
• Respiratory system: диспноэ;
• Dermatological and allergic reactions: alopecia, skin rash and itch, darkening of a secret of sweat glands, urticaria, Shenleyn-Genokh's disease, Quincke's disease;
• Others: stethalgias, faints.

The possible side effects caused by a levodopa:

• Sense bodys: expansion of pupils, diplopia, sight illegibility, okulogirny crises;
• Urinogenital system: delay or incontience of urine, priapism;
• Metabolism: hypostases, decrease or increase in body weight;
• Central nervous system: strengthening of a tremor of hands, muscular spasms, disorientation, lockjaw, faints, adynamy, decrease in cogitative activity, weakness, catalepsy, fatigue, activation of the hidden syndrome of Bernard-Horner, headache, euphoria, sleeplessness, psychomotor arousing, instability of gait, feeling of alarm, ataxy;
• Alimentary system: a meteorism, a sialorrhea, a lock, dyspepsia, a language burning sensation, dryness in a mouth, hiccups attacks, a bruxism, a dysphagy, feeling of bitterness in a mouth, pain and discomfort in a stomach;
• Others: an indisposition, hoarseness of a voice, диспноэ, a malignant melanoma, rushes of blood to skin of a thorax, a neck and the person;
• Laboratory indicators: positive test of Koombs, an erythrocyturia, a hyperglycemia, a leukocytosis, a hyperuricemia, a bacteriuria, decrease in a hematocrit and hemoglobin, increase in activity of an alkaline phosphatase and hepatic transaminases, increase in maintenance of an urea nitrogen and bilirubin in plasma, increase in content of serumal creatinine.

Also it must be kept in mind that the drugs containing a levodopa and a karbidopa can cause false positive reaction to ketonic bodies in urine if for definition of a ketonuria test strips were used. After boiling of tests of urine this reaction does not change. False-negative results are also possible when carrying out a glyukozooksidazny method of definition of a glucosuria.

Special instructions

Careful preliminary survey before Nakom's appointment is necessary for patients for whom arrhythmia is diagnosed (nodal, atrial or ventricular), and also had a myocardial infarction. During treatment by drug such patients need to control activity of cardiovascular system, especially during selection of a dose.

Patients with an open angle glaucoma should carry out therapy by Nakom under control of intraocular pressure.

The nictitating spasm which developed in the period of selection of a dose can testify to an excess dose therefore emergence of involuntary movements demands a dose decline.

Reduction of a daily dose is required also in case of dyskinesia in the patients accepting earlier a levodopa.

The NAC do not recommend to appoint for the purpose of elimination of the extrapyramidal frustration which appeared owing to reception of some medicines.

All patients during treatment by this drug have to be under medical control in connection with risk of development of depressions with suicide tendencies. Special approach at selection of therapy is necessary for patients with psychoses in the anamnesis.

With care the NAC the patients accepting psychotropic medicines should appoint.

In case of sharp cancellation of any protivoparkinsonichesky drug development of the symptom complex reminding a malignant antipsychotic syndrome (muscular rigidity, mental disturbances, fervescence, increase in concentration of a serumal kreatinfosfokinaza) is possible. For this reason at a sharp dose decline of Nakom and during his cancellation careful observation of a condition of patients is necessary.

During prolonged treatment it is recommended to control periodically functions of a liver and kidneys, the hemopoietic and cardiovascular systems.

If intervention using the general anesthesia is necessary to the patient, the NAC it is possible to accept until parenteral use of drugs is authorized.

In case of temporary interruption of a course of therapy, Nakom's reception can be resumed in a usual dose.

Medicinal interaction

Possible reactions of interaction at Nakom's use in combination with other medicines:

• Monoamine oxidase inhibitors (except for type B): blood circulation disturbances, excitement, face reddening, dizziness, tachycardia, increase in arterial pressure;
• Isoniazid, antagonists dopamine _{D2 receptors} (for example, phenyl propyl ketones, fenotiazina, рисперидон): reduction of therapeutic effect of a levodopa;
• Anti-hypertensive drugs: symptomatic orthostatic hypotension;
• Iron sulfate, iron gluconate: decrease in bioavailability of a karbidopa and/or levodopa;
• Lithium drugs: risk of development of diskineziya, emergence of hallucinations;
• Tricyclic antidepressants: increase in arterial pressure, dyskinesia;
• Means of inhalation anesthesia, beta адреностимуляторы, Dithylinum: disturbances of a cordial rhythm;
• Phenytoinum, papaverine: blocking of positive therapeutic action of a levodopa at parkinsonism;
• Pyridoxine hydrochloride (B6 vitamin): decrease in its efficiency;
• Tubocurarine: risk of developing of arterial hypotension;
• Methyldopum: strengthening of side effects of Nakom.

At some patients adhering to a high-protein diet absorption of a levodopa owing to its competition with some amino acids can be broken.

Terms and storage conditions

To store at a temperature up to 25 °C in the place unavailable to children protected from light and moisture.

Period of validity – 3 years.