Nacom, tablets 250 mg+25 mg 100 pcs

Antiparkinsonian combination drug – combination of carbidopa (aromatic 1-amino acid decarboxylase inhibitor) and levodopa (dopamine precursor). It alleviates and relieves symptoms of Parkinson’s disease, including hypokinesia, rigidity, tremor, dysphagia, salivation.

The anti-Parkinsonian effect of levodopa is due to its conversion into dopamine directly in the CNS, which leads to replenishment of dopamine deficiency in the central nervous system (CNS). Dopamine formed in peripheral tissues does not participate in realization of anti-Parkinsonian effect of levodopa (it does not penetrate into CNS) and is responsible for most of levodopa side effects.

Carbidopa is an inhibitor of L-amino acid decarboxylase and decreases dopamine formation in peripheral tissues which indirectly causes increase of levodopa amount reaching CNS.

Nacom® provides adequate reduction of Parkinson’s disease symptoms in more patients. The action of the drug is manifested within the first day of administration, sometimes after the first dose. The maximum effect is achieved within 7 days.

Indications

Parkinson’s disease treatment.

Active ingredient

Composition

1 tablet contains:

the active ingredients:

levodopa – 250 mg,

carbidopa – 25 mg;

excipients:

pregelatinized starch, 45 mg;

corn starch, 6.5 mg;

p> blue dye (indigotine E132) – 0.-72 mg;

magnesium stearate – 4.2 mg;

MCC – up to 380 mg.

How to take, the dosage

Interaction

In concomitant use with hypotensive agents it is necessary to adjust the dose of the latter because of the risk of orthostatic hypotension.

Concomitant use of levodopa with monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors) may cause circulatory disorders (MAOIs should be stopped at least 2 weeks before taking the drug).

This is due to the accumulation of dopamine and norepinephrine under levodopa, which inactivation is inhibited by MAO inhibitors, and the high possibility of agitation, increased blood pressure (BP), tachycardia, facial flushing and dizziness.

The iron salts may decrease the bioavailability of levodopa and carbidopa; the clinical significance of this interaction is unknown.
Concomitant use of levodopa with β-adrenomimetics, ditiline and drugs for inhaled anesthesia may increase the risk of cardiac rhythm disturbances.

Dopamine receptor D2 antagonists (e.g., butyrophenone derivatives, diphenyl butylpiperidine, thioxanthene, phenothiazine, risperidone), and isoniazid reduce therapeutic effect of levodopa.

There have been reports of blocking the beneficial therapeutic effects of levodopa as a result of phenytoin and papaverine administration.

Lithium preparations increase the risk of dyskinesia and hallucinations.

Methyldopa increases side effects.

The concomitant use of tubocurarine increases the risk of arterial hypotension.

Levodopa absorption may be impaired in patients on a high-protein diet because levodopa competes with some amino acids.

Carbidopa interferes with pyridoxine hydrochloride (vitamin B6), which accelerates the metabolism of levodopa to dopamine in peripheral tissues.

Special Instructions

Nakom® can be administered to patients who are already taking levodopa in monotherapy. However, the intake of levodopa in mono form should be stopped at least 12 hours before prescribing Nakom®.

Patients who have previously taken only levodopa may experience dyskinesias because carbidopa allows more effective penetration of levodopa into the brain and therefore more dopamine is produced. Dyskinesia may require dose reduction if dyskinesia occurs.

Like levodopa, levodopa/carbidopa can cause involuntary movements and mental disturbances. These reactions are thought to be related to increased dopamine levels in the brain after levodopa administration, and use of levodopa/carbidopa may cause a relapse. Dose reduction may be necessary.

All patients should be closely monitored for the development of depression with concomitant suicidal tendencies.

Cautions should be taken when treating patients who have or are currently showing signs of psychosis.

Cautions should be taken with concomitant administration of psychoactive drugs and levodopa/carbidopa). An early sign of overdose in some patients may be blepharospasm.

As with levodopa, careful prior evaluation is required when prescribing Nacom® to patients who have had a myocardial infarction and a history of atrial, nodal or ventricular arrhythmias.
These patients should have regular cardiology evaluations, especially when prescribing the first dose and during the dose adjustment period.

Levodopa/carbidopa should be used with caution in patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal disease, liver disease, endocrine disease, or if there is a history of ulcer disease (because of the possibility of gastrointestinal bleeding from the upper digestive tract) or seizures.

Patients with open-angle glaucoma during treatment with Nacom® should have their intraocular pressure monitored regularly.

The use of MAO inhibitors should be discontinued at least two weeks before starting treatment with Nakom®.

If antiparkinsonian drugs are withdrawn suddenly, a symptom complex similar to malignant neuroleptic syndrome may develop (muscle rigidity, increased body temperature, psychiatric disorders, and increased serum creatinine phosphokinase concentration). Patients should be carefully evaluated during the period of abrupt reduction of the dose of Nacom® or its withdrawal, especially if the patient is receiving antipsychotic drugs.

The administration of levodopa has been accompanied by somnolence and episodes of sudden falling asleep.

Extremely rare episodes of sudden falling asleep during daily activities have been reported, in some cases without awareness or warning signs.

If such signs occur, it is advisable to consider reducing the dose.
Periodic blood tests should be performed, and periodic monitoring of cardiovascular, hepatic, and renal function is recommended for long-term therapy.

If general anesthesia is required, Nacom® may be taken as long as the patient is allowed to take the drug orally. If treatment is interrupted temporarily, the usual dose may be administered again as soon as the patient is able to take the drug orally again.

Studies have shown that patients with Parkinson’s disease have an increased risk of developing melanoma, so patients taking Nacom® should have regular checkups with a dermatologist.
It is unclear whether the increased risk is related to Parkinson’s disease or other factors, such as medications used to treat Parkinson’s disease.

Patients receiving dopamine antagonists show abnormal gambling cravings, hypersexuality, compulsive wasting (shopping cravings), gluttony and overeating, and increased libido. If the above symptoms develop, a dose/treatment adjustment is recommended.

Nacom® is not recommended for the treatment of drug-induced extrapyramidal disorders.

Protein-rich foods may interfere with absorption of the drug.

Impact on ability to drive, operate machinery

In very rare cases levodopa may cause somnolence and cases of sudden onset of sleep. During treatment with Nacom®, patients should be advised of the possibility of sudden falling asleep.

Patients with drowsiness and who have experienced sudden falling asleep (cases of sudden falling asleep) should refrain from driving motor vehicles and engaging in potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

– Hypersensitivity to the drug components;
– Simultaneous use of non-selective monoamine oxidase inhibitors (MAOIs);
– Interval of less than two weeks after the end of MAOI inhibitors;
– Closed angle glaucoma;
– melanoma or suspected melanoma;
– skin diseases of unknown etiology;
– age under 18 years (the safety of using the drug in young and middle-aged children has not been established);
– lactation period.

With caution

– myocardial infarction with arrhythmia (in anamnesis);
– Chronic heart failure and other severe diseases of the cardiovascular system;
– severe lung diseases, including bronchial asthma;
– epileptic and other seizures (in anamnesis);
– gastrointestinal erosive-ulcerative lesions (risk of upper gastrointestinal bleeding);
– diabetes and other decompensated endocrine diseases;
– severe renal and/or hepatic insufficiency;
– open-angle glaucoma;
– extrapyramidal reactions caused by the use of the drug;
– pregnancy.

Side effects

The most common side effects are dyskinesias, including choreiform, dystonic, and other involuntary movements, and nausea. Muscle twitching and blepharospasm may be considered early warning signs on the basis of which a dose reduction may be decided.

Benign, malignant, and unspecified neoplasms, including cysts and polyps
frequency unknown: malignant melanoma.

Hematopoietic disorders: rare: leukopenia, anemia (including hemolytic), thrombocytopenia, agranulocytosis.

Immune system disorders: rare: angioedema.

Metabolic disorders: common: anorexia; frequency unknown: weight loss or gain, edema.

Psychiatric disorders: often: sleep disturbance, including nightmares, hallucinations, depression (including suicidal ideation), confusion; infrequent: agitation; rarely: psychotic reactions, including delirium, and paranoid thinking, increased libido.

In patients receiving dopamine antagonists, abnormal gambling cravings, hypersexuality, compulsive wasting (shopping cravings), gluttony and overeating, and increased libido have been observed. The above reactions mostly disappeared after reducing the dose of the drug or stopping treatment.
frequency unknown: anxiety, disorientation, euphoria, insomnia, bruxism.

Nervous system disorders:

very common: dyskinesias, including chorea, dystonia and other involuntary movements;

often: episodes of bradykinesia (“on-off”-syndrome), dizziness, paresthesias, somnolence, including less frequently daytime sleepiness and episodes of sudden falling asleep;

infrequently: syncope;

rarely: dementia, convulsions;

frequency unknown: Ataxia, hand tremor, extrapramidal disorders, malignant neuroleptic syndrome, muscle twitching, headache, decreased intellectual acuity, trismus, activation of latent Bernard-Gorner syndrome, insomnia, nervousness, euphoria, numbness, fainting, falls, gait disturbances, feeling irritable, compulsions.

The development of seizures has been reported, but a causal relationship to the intake of Nacom® has not been established.

Sensory organs: frequency unknown: blepharospasm, diplopia, visual disturbances, dilated pupils, oculogyric crises (tonic cramps of the outer eyeball muscles).

Cardiovascular system: frequently: palpitations, orthostatic reactions, including episodes of decreased BP; rarely: arrhythmias, phlebitis, increased BP; frequency unknown: flushes, hyperemia.

Respiratory system: often: dyspnea; frequency unknown: hoarseness of voice, abnormal breathing pattern.

Gastrointestinal tract: frequently: vomiting, diarrhea; rarely: gastrointestinal bleeding, aggravation of duodenal ulcer, darkening of saliva; frequency unknown: Dry oral mucosa, salivation, dysphagia, abdominal pain, constipation, abdominal bloating, dyspepsia, tongue burning sensation, bitter feeling in mouth, nausea, belching.

Skin disorders: infrequent: urticaria; rare: itching, hemorrhagic vasculitis (Schönlein-Henoch purpura), alopecia, rash, darkened sweat; frequency unknown: increased sweating.

Urinary system disorders: rare: darkening of the urine; frequency unknown: urinary incontinence, urinary retention.

Skeletal, muscular and connective tissue disorders: infrequent: muscle cramps; frequency unknown: muscle twitching.

Reproductive system disorders: frequency unknown: priapism.

General disorders and disorders at the site of administration: frequently: chest pain; frequency unknown: asthenia, edema, weakness, malaise, increased fatigue, malignant neuroleptic syndrome.

Laboratory findings:

frequency unknown: increased activity of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, increased bilirubin, plasma urea nitrogen, plasma urea, hypercreatininemia, hyperuricemia, positive Coombs test.

Decreased hemoglobin and hematocrit levels, hyperglycemia, leukocytosis, bacteriuria, hematuria have been reported.

The drugs containing carbidopa and levodopa may cause a false-positive reaction for 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 may be obtained when using the glucose oxidase method to determine glucosuria.

Overdose