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Levodopa, Carbidopa

Sandoz
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2019-09-19
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Clinical Pharmacology

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 is converted to dopamine.
It has a more pronounced therapeutic effect compared to levodopa, provides long-term maintenance of therapeutic plasma levodopa concentrations 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

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

Composition

Pills 1 tab.
active substances:  
levodopa 250 mg
carbidopa 25 mg
excipients: pregelatinized starch - 45 mg; corn starch - 6.5 mg; blue dye (indigotin E132) - 0, -72 mg; magnesium stearate - 4.2 mg; MCC - up to 380 mg  

Levodopa, Carbidopa is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Nacom® Sandoz Switzerland pills
Tidomet forte Torrent India pills
Syndopa Sun Pharmaceutical Industries Ltd India pills

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Levodopa, Carbidopa

Dosage and Administration

The optimal daily dose is determined by careful individual selection. The form of the tablet allows you to divide it into two parts with minimal effort.
In the course of treatment, correction of both the individually selected dose and the frequency of taking the drug may be required. Studies have shown that peripheral dopa decarboxylase is saturated with carbidopa when taken last at a dose of about 70-100 mg / day. In patients receiving carbidopa, nausea and vomiting are possible in a lower dose.
In the case of the appointment of Nacom, the use of standard drugs for the treatment of parkinsonism, with the exception of those containing one levodopa, can be continued, and their doses should be adjusted anew.
The initial dose is selected in accordance with the indications and the patient's response to treatment. The initial dose of the drug Nakom is 1/2 tab. 1-2 times / day. However, such a dose may not provide the optimal amount of carbidopa the patient will need. Therefore, if necessary, add 1/2 tab. Nacom every day or every other day until the optimum effect. The therapeutic effect is observed on the first day, and sometimes after taking the first dose. The full effect is achieved within 7 days.
When switching from levodopa preparations, the latter should be stopped at least 12 hours before the start of treatment with Nacom (24 hours in the case of the use of levodopa preparations with prolonged action). The daily dose of the drug Nakom should provide about 20% of the previous daily dose of levodopa.
For patients taking more than 1.5 g of levodopa, the initial dose of Nacom is 1 tab. 3-4 times / day
With maintenance therapy, if necessary, the dose of Nacom can be increased by 1 / 2-1 tab. every day or every other day before reaching the maximum dose - 8 pills / day. Experience with carbidopa in a dose of more than 200 mg / day is limited.
The maximum recommended dose of Nakom is 8 pills / day (200 mg carbidopa and 2 g levodopa). This is approximately 3 mg of carbidopa and 30 mg of levodopa per 1 kg of body weight (with a patient's body weight of 70 kg).

Adverse reactions

From the side of the central nervous system and peripheral nervous system: most often - dyskinesias, including involuntary movements (including chorea-like, 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 muscular twitching and blepharospasm.
In rare cases - convulsions (a causal relationship with taking the drug Nacom has not been established).
From the digestive system: 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: fainting, chest pain,
Since the cardiovascular system: arrhythmias and / or heartbeat, orthostatic effects (including episodes of increase or decrease in blood pressure), phlebitis.
From the hemopoietic system: leukopenia, anemia (including hemolytic), thrombocytopenia, agranulocytosis.
Allergic reactions: angioedema, urticaria, pruritus, Schönlein-Genoch disease.
On the part of the respiratory system: possible dyspnea.
Dermatological reactions: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:
From the digestive system: 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 the latent Bernard-Horner syndrome, insomnia, anxiety, euphoria, psychomotor agitation, instability of gait.
From the 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 glycosuria.

Contraindications

- angle-closure glaucoma;
- established or suspected melanoma;
- 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 heart rhythm disturbances (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 glaucoma.

Drug interactions

When using Nacom 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 the start of levodopa administration). 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 Nacom.
The bioavailability of carbidopa and / or levodopa decreases with simultaneous use of iron sulfate or iron gluconate.
With the simultaneous use of levodopa with beta-adrenostimulyatory, ditilinom and means for inhalation anesthesia may increase the risk of developing heart rhythm disorders.
Dopamine D2 receptor antagonists (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 Nakom must be carefully monitored for timely detection of a decrease in the therapeutic effect.
Lithium drugs increase the risk of dyskinesias and hallucinations; methyldopa increases side effects, 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 some amino acids.
Carbidopa prevents the action of pyridoxine hydrochloride (vitamin B6), which accelerates the biotransformation of levodopa to dopamine in peripheral tissues.

Pregnancy and Lactation

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 It was revealed that the combination of levodopa and carbidopa causes visceral and skeletal changes in laboratory animals.

Special instructions

As in the case of levodopa, when prescribing Nacom 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, more often than levodopa, causes involuntary movements. 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 a depressive state with suicidal tendencies. Patients who have had 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 Nacom 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 medications.
If treatment is temporarily interrupted, then Nacom 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.

Overdosage

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.

  • Brand name: Nacom®
  • Active ingredient: Levodopa, Carbidopa
  • Dosage form: Pills.
  • Manufacturer: Sandoz
  • Country of Origin: Switzerland

Studies and clinical trials of Levodopa, Carbidopa (Click to expand)

  1. Quality control of benserazide-levodopa and carbidopa-levodopa tablets by capillary zone electrophoresis
  2. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: The STRIDE-PD study
  3. Erratum: Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: The STRIDE-PD study
  4. The effect of carbidopa on the pharmacokinetics of intravenously administered levodopa: The mechanism of action in the treatment of parkinsonism
  5. Voltammetric Studies and Determination of Levodopa and Carbidopa in Pharmaceutical Products
  6. Cyclodextrin Host-Guest Recognition Approach for Simultaneous Quantification and Voltammetric Studies of Levodopa and Carbidopa in Pharmaceutical Products
  7. Development and validation of a high-performance liquid chromatography–electrospray ionization–MS/MS method for the simultaneous quantitation of levodopa and carbidopa in human plasma
  8. Effect of pyridoxal 5-phosphate on carbidopa and decarboxylation of levodopa
  9. Quantitative description of loss of clinical benefit following withdrawal of levodopa–carbidopa and bromocriptine in early Parkinson's disease
  10. Carbidopa/levodopa–responsive myoclonus
  11. Short episode of seizures in a newborn of a mother treated with levodopa/carbidopa/entacapone and bromocriptine
  12. Quality of life in early Parkinson's disease treated with levodopa/carbidopa/entacapone
  13. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease
  14. Managing pathological gambling in Parkinson's disease with enteral levodopa/carbidopa infusions
  15. Comparison of orally dissolving carbidopa/levodopa (Parcopa) to conventional oral carbidopa/levodopa: A single-dose, double-blind, double-dummy, placebo-controlled, crossover trial
  16. Carbidopa/levodopa pharmacy errors in Parkinson's disease
  17. Transcutaneous port for continuous duodenal levodopa/carbidopa administration in Parkinson's disease
  18. Trichophagia affects response to duodenal levodopa/carbidopa gel administration
  19. Fluctuations in plasma levodopa and motor responses with liquid and tablet levodopa/carbidopa
  20. Pharmacokinetic comparison of sinemet and atamet (Generic carbidopa/levodopa): A single-dose study
  21. Hydrocephalic parkinsonism due to Paget's disease of bone: Dramatic improvement following ventriculoperitoneal shunt and temporary levodopa/carbidopa therapy
  22. Comparison of standard carbidopa–levodopa and sustained-release carbidopa–levodopa in parkinson's disease: Pharmacokinetic and quality-of-life measures
  23. Pharmacoscintigraphic and pharmacokinetic evaluation on healthy human volunteers of sustained-release floating minitablets containing levodopa and carbidopa
  24. Simultaneous determination of levodopa, carbidopa, 3-O-methyldopa and dopamine in plasma using high-performance liquid chromatography with electrochemical detection

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