Nakom - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

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Nakom: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Prices in pharmacies

Latin name: Nakom

ATX code: N04BA02

Active ingredient: levodopa + carbidopa (levodopum + carbidopum)

Manufacturer: Lek (Slovenia)

Description and photo update: 2019-14-08

Prices in pharmacies: from 1281 rubles.

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Nakom is an antiparkinsonian drug.

Release form and composition

Dosage form Nakoma - tablets: oval, convex on both sides, blue with white and separate dark blue blotches, with a notch on one side (10 pcs. In a blister, 10 blisters in a cardboard box).

Active substances contained in 1 tablet:

• levodopa - 250 mg;
• carbidopa - 25 mg.

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

Pharmacological properties

Pharmacodynamics

The antiparkinsonian combination drug Nakom is a combination of levodopa (a precursor of dopamine) and carbidopa (an inhibitor of aromatic 1-amino acid decarboxylase). Contributes to the weakening and elimination of the symptoms of Parkinson's disease, including rigidity, hypokinesia, tremor, dysphagia, salivation.

Carbidopa helps to reduce the formation of dopamine in peripheral tissues and indirectly causes an increase in the amount of levodopa entering the central nervous system.

The antiparkinsonian effect of levodopa is achieved through its conversion to dopamine in the central nervous system, which helps to reduce dopamine deficiency. Dopamine, which is formed in peripheral tissues, does not penetrate into the central nervous system (it does not participate in the mechanism of the antiparkinsonian action of levodopa) and is responsible for most of the side effects of levodopa.

In most patients, the use of Nakoma leads to an adequate reduction in the symptoms of Parkinson's disease. The effect of the drug is manifested during the first day of administration, sometimes immediately after the first dose. The time to achieve the maximum effect is approximately 7 days.

Pharmacokinetics

Carbidopa

In healthy people and patients with Parkinson's disease, after taking a single dose of carbidopa, the time to reach the maximum plasma concentration is 2–4 hours and 1.5–5 hours, respectively. For both groups, the excretion of the drug by the intestines and kidneys is approximately the same. In unchanged form, carbidopa is completely excreted by the kidneys within 7 hours. The results of urinalysis show only the presence of carbidopa metabolites without traces of hydrazine. The main metabolites that are excreted by the kidneys are α-methyl-3,4-dihydroxyphenylpropionic and α-methyl-3-methoxy-4-hydroxyphenylpropionic acids, the proportion of which is, respectively, about 10 and 14% of the excreted metabolites. The content of other metabolites of N-methyl-carbidopa and 3,4-dihydroxyphenylacetone does not exceed 5% of the total amount of metabolites. Also, carbidopa is found in the urine unchanged. The presence of conjugates has not been identified.

Levodopa

When taken orally, there is a rapid absorption of levodopa from the gastrointestinal tract. Absorption is from 20 to 30% of the dose taken, the time to reach the maximum concentration in the blood plasma is 2-3 hours. The absorption process is affected by pH and the rate of evacuation of stomach contents. In the presence of food in the stomach, absorption is slowed down. Levodopa can compete with a number of dietary amino acids for absorption from the intestine and transport across the blood-brain barrier.

In the small intestine, kidneys and liver, the substance is contained in large quantities, 1–3% penetrates into the brain. In unchanged form, 35% of levodopa is excreted within 7 hours by the kidneys, as well as through the intestines. The half-life from blood plasma is about 50 minutes, and when taken together with carbidopa, it is about 2 hours. It is metabolized in all tissues, mainly by decarboxylation, followed by the formation of dopamine, which does not penetrate the blood-brain barrier. Metabolites include dopamine, epinephrine, and norepinephrine, which are rapidly eliminated by the kidneys. Levodopa's metabolites are also dihydroxyphenylacetic acid, vanillyl almond [hydroxy (4-hydroxy-3-methoxyphenyl) acetic] and homovanillic (3-methoxy-4-hydroxyphenylacetic) acids. Trace amounts of 3-O-methyldopa were found in cerebrospinal fluid and blood plasma.

Effect of carbidopa on levodopa metabolism

In healthy people, in comparison with placebo, carbidopa in statistically significant amounts contributes to an increase in the content of levodopa in the blood plasma. This effect was observed when taking levodopa after carbidopa and when taking both substances together. Preliminary administration of carbidopa leads to an approximately 5-fold increase in the concentration of levodopa with a single dose. In this case, the residence time of levodopa in the blood plasma increases from 4 to 8 hours. In other studies, similar results were obtained with the simultaneous administration of both substances.

In one study in Parkinson's disease, patients received carbidopa first, followed by single-dose labeled levodopa. At the same time, the half-life of all levodopa metabolites from blood plasma increased from 3 to 15 hours. The content of radioactively labeled levodopa in unchanged levodopa increased at least 3 times when taking carbidopa. After preliminary administration of carbidopa, the concentration of homovanillic acid and dopamine in blood plasma decreased.

Indications for use

According to the instructions, Nakom is intended for the treatment of Parkinson's syndrome and Parkinson's disease.

Contraindications

Absolute:

• Melanoma or suspicion of it;
• Skin diseases of unknown etiology;
• Closed-angle glaucoma;
• Pregnancy (except in cases of vital necessity);
• Lactation (or feeding at the time of taking the drug should be discontinued);
• Age under 18;
• Simultaneous administration of non-selective monoamine oxidase inhibitors and a period of 2 weeks after their cancellation;
• Hypersensitivity to Nakoma components.

Relative:

• Severe diseases of the respiratory system, incl. bronchial asthma;
• Severe diseases of the cardiovascular system, including heart failure, myocardial infarction with cardiac arrhythmias (history);
• Seizures in the medical history, incl. epileptic;
• Decompensated diseases of the endocrine system, incl. diabetes;
• Erosive and ulcerative lesions of the gastrointestinal tract;
• Open-angle glaucoma;
• Severe renal / hepatic impairment.

Instructions for use of Nakoma: method and dosage

Nakom is taken orally. The doctor determines the optimal dose. If necessary, the tablets can be divided in half (notches are provided for this).

During treatment, it may be necessary to adjust the individual dose and / or frequency of administration. According to research data, the average daily dose of the drug for carbidopa is 70-100 mg.

Patients who, before the appointment of Nakoma, took standard medicines for the treatment of parkinsonism (with the exception of drugs containing only levodopa), their intake can be extended, but after a dose adjustment.

The initial dose of Nakoma depends on the indication and the patient's response to therapy and is ½ tablet 1-2 times / day. If necessary, it is increased to 1 whole tablet every day or every other day.

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

When transferring a patient to Nakom from drugs containing levodopa, their use should be discontinued at least 12 hours (in the case of levodopa in extended-release dosage forms - 24 hours). In this case, the daily dose of Nakoma should provide about 20% of the previous daily dose of levodopa.

For patients who received more than 1500 mg of levodopa, the recommended starting dose of Nakoma is 1 tablet 3-4 times / day.

When carrying out maintenance therapy, the dose can be increased up to a maximum of 8 tablets / day (the dose is increased gradually, by ½-1 tablet every day or every other day).

Side effects

Most often, Nakom causes nausea and dyskinesia, incl. involuntary movements, including chorea-like and dystonic (their early signs are blepharospasm and muscle twitching, which may be the reason for discontinuation of the drug).

Other possible side effects:

• Central and peripheral nervous system: confusion, depression (including the development of suicidal intentions), dizziness, agitation, sleep disorders, drowsiness, dementia, paresthesia, episodes of psychotic states (including paranoid thinking, hallucinations and illusions), episodes of bradykinesia (" on-off syndrome), increased libido, neuroleptic malignant syndrome; rarely - convulsions (the cause-and-effect relationship of their development with taking the drug has not been established);
• Genitourinary system: darkening of urine;
• Hematopoietic system: anemia (including hemolytic), thrombocytopenia, agranulocytosis, leukopenia;
• Cardiovascular system: heart palpitations and / or arrhythmias, phlebitis, orthostatic effects (including episodes of decrease / increase in blood pressure);
• Digestive system: exacerbation of duodenal ulcer, diarrhea, anorexia, vomiting, darkening of saliva, bleeding from the gastrointestinal tract;
• Respiratory system: dyspnea;
• Dermatological and allergic reactions: alopecia, skin rash and itching, darkening of the secretion of the sweat glands, urticaria, Shenlein-Henoch disease, angioedema;
• Others: chest pains, fainting.

Possible side effects of levodopa:

• Sense organs: dilated pupils, diplopia, blurred vision, oculogyric crises;
• Genitourinary system: urinary retention or incontinence, priapism;
• Metabolism: edema, decrease or increase in body weight;
• Central nervous system: increased hand tremor, muscle cramps, disorientation, trismus, fainting, asthenia, decreased mental activity, weakness, numbness, fatigue, activation of latent Bernard-Horner syndrome, headache, euphoria, insomnia, psychomotor agitation, gait instability, feeling anxiety, ataxia;
• Digestive system: flatulence, sialorrhea, constipation, dyspepsia, burning sensation of the tongue, dry mouth, hiccups, bruxism, dysphagia, bitterness in the mouth, pain and discomfort in the abdomen;
• Others: malaise, hoarseness, dyspnea, malignant melanoma, flushing of the skin of the chest, neck and face;
• Laboratory indicators: positive Coombs' test, erythrocyturia, hyperglycemia, leukocytosis, hyperuricemia, bacteriuria, decreased hematocrit and hemoglobin, increased activity of alkaline phosphatase and hepatic transaminases, increased content of urea nitrogen and bilirubin in plasma, increased serum creatinine.

It should also be borne in mind that Nakom can cause a false-positive reaction to ketone bodies in urine if test strips have been used to determine ketonuria. Boiling urine samples does not change this reaction. False negative results are also possible with the glucose oxidase method for the determination of glucosuria.

Overdose

In case of an overdose, the severity of side effects increases.

Treatment: gastric lavage, intake of activated charcoal, careful observation, electrocardiographic monitoring for the timely detection of arrhythmias, if necessary, adequate antiarrhythmic therapy. In acute Nakoma overdose, treatment methods are similar to those taken in cases of acute levodopa overdose. It should be borne in mind that pyridoxine does not reduce the effect of Nakoma.

Also, in case of Nakoma overdose, concomitant therapy received by the patient should be taken into account.

special instructions

A thorough preliminary examination before prescribing Nakoma is necessary for patients who have been diagnosed with arrhythmia (nodular, atrial or ventricular), as well as those who have had myocardial infarction. During treatment with the drug, such patients need to control the activity of the cardiovascular system, especially during the period of dose selection.

In patients with open-angle glaucoma, Nakom therapy should be carried out under the control of intraocular pressure.

Blepharospasm that develops during dose selection may indicate an excessive dose, therefore, the appearance of involuntary movements requires a dose reduction.

A decrease in the daily dose is also required in the event of dyskinesia in patients who have previously taken levodopa.

Nakom is not recommended to be prescribed in order to eliminate extrapyramidal disorders that have appeared as a result of taking certain medications.

All patients during treatment with this drug should be under medical supervision due to the risk of developing depressive conditions with suicidal tendencies. Patients with a history of psychosis need a special approach in the selection of therapy.

With caution, Nakom should be prescribed to patients taking psychotropic drugs.

In the event of a sharp withdrawal of any antiparkinsonian drug, a symptom complex may develop, resembling a malignant neuroleptic syndrome (muscle rigidity, mental disorders, an increase in body temperature, an increase in the concentration of serum creatine phosphokinase). For this reason, with a sharp decrease in the dose of Nakoma and during the period of its cancellation, careful monitoring of the patient's condition is necessary.

During long-term treatment, it is recommended to periodically monitor the functions of the liver and kidneys, hematopoietic and cardiovascular systems.

If the patient is to undergo an intervention using general anesthesia, Nakom can be taken as long as parenteral use of drugs is allowed.

In the event of a temporary interruption in the course of therapy, Nakoma can be resumed at the usual dose.

Application during pregnancy and lactation

There are no data on the effects of Nakoma on the course of pregnancy in humans. During animal studies, it was found that in rabbits, the combination of levodopa and carbidopa can cause a violation of the intrauterine development of the skeleton and internal organs, therefore, the use of Nakoma during pregnancy is allowed only in cases where the expected risk to the fetus is lower than the potential benefit to the mother.

There are no data on the excretion of levodopa and carbidopa in breast milk, therefore, when prescribing Nakoma during lactation, it is recommended to stop breastfeeding.

Pediatric use

It is forbidden to use Nakom to treat patients under the age of 18 years.

With impaired renal function

In severe renal failure, the drug should be used with caution. No dose adjustment of Nakoma is required.

For violations of liver function

In severe hepatic impairment, the drug should be used with caution. No dose adjustment of Nakoma is required.

Use in the elderly

When treating elderly patients, dose adjustment is not required.

Drug interactions

Possible interaction reactions when using Nakoma in combination with other drugs:

• Monoamine oxidase inhibitors (except type B): circulatory disorders, agitation, facial flushing, dizziness, tachycardia, increased blood pressure;
• Isoniazid, antagonists of dopamine D ₂ -receptors (for example, butyrophenones, phenothiazines, risperidone): reducing the therapeutic effect of levodopa;
• Antihypertensive drugs: symptomatic orthostatic hypotension;
• Iron sulfate, iron gluconate: decreased bioavailability of carbidopa and / or levodopa;
• Lithium preparations: risk of dyskinesias, hallucinations;
• Tricyclic antidepressants: increased blood pressure, dyskinesia;
• Means of inhalation anesthesia, beta-adrenostimulants, ditilin: cardiac arrhythmias;
• Phenytoin, papaverine: blocking the positive therapeutic effect of levodopa in parkinsonism;
• Pyridoxine hydrochloride (vitamin B6): decreased effectiveness;
• Tubocurarine: risk of arterial hypotension;
• Methyldopa: increased side effects of Nakoma.

In some patients on a high-protein diet, absorption of levodopa may be impaired due to its competition with certain amino acids.

Analogs

Analogues of Nakoma are: Levodopa / Carbidopa, Levokom, Tidomite Forte, Vero-Levocarbidopa, Tremonorm.

Terms and conditions of storage

Store at temperatures up to 25 ° C, protected from light and moisture, out of reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Nakoma

Reviews of Nakoma indicate the effectiveness of the drug in the treatment of parkinsonism. Reports of the development of side effects are rare. Some users report that Nakoma's performance may decrease over time.

The price of Nakom in pharmacies

The approximate price for Nakom is 1,460 rubles. for 100 tablets.

Nakom: prices in online pharmacies

Drug name Price Pharmacy

Nakom 250 mg + 25 mg tablets 100 pcs. 1281 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!