Tidomet Forte

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

Tidomet Forte: instructions for use and reviews

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

Latin name: Tidomet Forte

ATX code: N04BA02

Active ingredient: levodopa (Levodopa), carbidopa (Carbidopa)

Manufacturer: Torrent Pharmaceuticals, Ltd. (Torrent Pharmaceuticals, Ltd.) (India)

Description and photo updated: 30.11.2018

Prices in pharmacies: from 549 rubles.

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Tidomet Forte is a combination drug (dopamine precursor and peripheral decarboxylase inhibitor) designed to eliminate or alleviate the symptoms of Parkinson's disease and Parkinson's syndrome.

Release form and composition

The drug is produced in the form of tablets: round, flat, from almost white to white, on one side there is a dividing line (10 pieces in strips of aluminum foil, in a cardboard box 5 or 10 strips and instructions for using Tidomet Forte).

One tablet contains:

active ingredients: levodopa - 250 mg, carbidopa - 25 mg;
auxiliary components: povidone K-30, magnesium stearate, colloidal silicon dioxide, starch (dry), microcrystalline cellulose, talc.

Pharmacological properties

Pharmacodynamics

Tidomet Forte is a combined antiparkinsonian drug that contains levodopa (a precursor of the hormone dopamine) and carbidopa (a peripheral decarboxylase inhibitor) as active ingredients, which doubles the bioavailability of levodopa.

The main pharmacodynamic properties of Tidomet Forte:

Levodopa: An amino acid derived from L-tyrosine. With the participation of aromatic L-amino acid decarboxylase (cytoplasmic enzyme), dopamine is formed directly from levodopa. Due to the influence of dopamine, neuronal activity in the striatum of the brain is inhibited. Penetrating into peripheral tissues under the influence of aromatic L-amino acid decarboxylase dependent on pyridoxine, levodopa is rapidly decarboxylated and biotransformed into dopamine, which is unable to cross the blood-brain barrier;
carbidopa: the action is aimed at inhibiting the process of decarboxylation of levodopa in peripheral tissues. It does not penetrate the blood-brain barrier, therefore it does not affect the conversion of levodopa to dopamine directly in the central nervous system. When taken orally with levodopa, it provides an increase in the amount of levodopa entering the brain without causing a complete inhibition of aromatic L-amino acid decarboxylase. It has been established that with age and with prolonged use of levodopa, the activity of decarboxylase of aromatic L-amino acids in tissues decreases.

Pharmacokinetics

Pharmacokinetic characteristics of levodopa:

absorption: after oral administration, absorption is carried out by active transport from the gastrointestinal tract, a limited amount of levodopa is absorbed in the stomach. The presence of aromatic L-amino acid decarboxylase in the intestinal wall is a barrier to absorption. Food and m-anticholinergics are factors that slow down gastric emptying, the entry of levodopa into the duodenum and its absorption. It should be borne in mind that the rate of gastric emptying plays a key role in the degree of absorption of levodopa. The maximum concentration (Cmax) of a substance in the blood is reached within 1–2 hours after ingestion;
distribution in organs and tissues: the volume of distribution (Vd) varies from 0.9 to 1.6 l / kg, the total clearance in blood plasma while maintaining the decarboxylase activity of aromatic L-amino acids is 0.5 l / kg / h. Levodopa crosses the blood-brain barrier by facilitated diffusion through active mechanisms. The content of decarboxylase of aromatic L-amino acids in the endothelium of the capillaries of the brain is the second potential barrier on the way of levodopa when it enters the brain, in the capillaries of which only a small part of the administered dose is decarboxylated;
metabolism: approximately 75% of the dose taken is biotransformed in the intestinal wall by decarboxylation (first-pass effect), the involvement of the liver in this process is practically minimal. The level of decarboxylation in the intestine of levodopa decreases with increasing dose. The substance does not bind to blood plasma proteins. Aromatic L-amino acid decarboxylase is found in large quantities in the intestines, liver and kidneys. Decarboxylation of levodopa is the main pathway for dopamine formation. The second metabolic pathway is methoxylation under the influence of catechol-O-methyltransferase, which results in the formation of 3-O-methyldopa. This metabolite accumulates during long-term treatment. An additional pathway of metabolism of levodopa is transamination, its end products are vanilpyruvate, vanilla acetate, 2,4,5-trihydroxyphenylacetic acid. Apart from transamination, all pathways of levodopa metabolism are irreversible;
excretion: the half-life of levodopa (T _1/2) when combined with carbidopa increases to 3 hours. Up to 69% of the substance in the form of dopamine and its metabolites (norepinephrine, homovanillic acid, vinyl mandelic acid, dihydrophenylacetic acid) can be found in urine.

Pharmacokinetic characteristics of carbidopa: the maximum concentration (Cmax) in the blood is reached 2–4 hours after administration; in therapeutic doses, carbidopa does not penetrate the blood-brain barrier; approximately 50% of the substance is excreted through the kidneys and intestines, including 35% unchanged in the urine.

Indications for use

Parkinson's disease;
Parkinson's syndrome, including post-encephalitis parkinsonism, parkinsonism, which is a consequence of intoxication with manganese or carbon monoxide.

Contraindications

Absolute:

secondary parkinsonism, which is a consequence of the use of antipsychotics (neuroleptics);
essential tremor;
angle-closure glaucoma;
severe psychosis / neurosis;
melanoma, including suspicion of it;
Huntington's disease;
skin diseases of unknown etiology;
concomitant therapy with non-selective monoamine oxidase (MAO) inhibitors;
breast-feeding;
age up to 18 years;
hypersensitivity to the components of the drug.

Tidomet Forte tablets should be prescribed with caution if the patient has erosive and ulcerative lesions of the stomach and / or duodenum, severe liver and / or kidney dysfunction, a history of epileptic seizures, heart failure, myocardial infarction with a history of heart rhythm disturbances, endocrine diseases system (including diabetes mellitus), bronchial asthma, mental disorders.

During gestation, Tidomet Forte can be used only in cases where the expected clinical effect of therapy for the mother, according to the doctor, exceeds the potential threat to the fetus.

Tidomet Forte, instructions for use: method and dosage

Tidomet Forte tablets are taken orally with a small amount of food or immediately after a meal, swallowing whole (without chewing) and drinking water.

During the period of use of the drug, the patient should be prescribed a diet low in protein.

The recommended dosage (number of tablets): initial dose - ¹ / ₂ units. 2 times a day, if necessary, the dose can be gradually increased. At the beginning of replacement therapy for severe cases of parkinsonism - 1 pc. 3 times a day. For most patients, the maintenance dose is 3–6 pcs. in a day.

If necessary, the appointment of Tidomet Forte in an amount of more than 6 pcs. per day, caution and monitoring of the patient's condition is required. The maximum daily dose is 8 pcs.

It should be borne in mind that to suppress the peripheral transformation of levodopa, the daily dose of carbidopa should be on average 70-100 mg.

Receiving levodopa should be discontinued for ¹ / ₂ days before initiation of therapy Tidometom Forte depot medicaments containing levodopa and carbidopa, - for 1 day. During the transition, the dose of the drug should not exceed 20% of the previous dose of levodopa.

Side effects

Dyskinesias, including choreiform, dystonic and other involuntary movements, as well as nausea, were noted as the most frequent adverse reactions in patients using Tidomet Forte. The decision to discontinue the drug can be made in case of early signs of extrapyramidal hyperkinesis, such as blepharospasm and / or muscle twitching.

Adverse reactions from systems and organs recorded during therapy with Tidomet Forte:

from the nervous system: drowsiness, sleep disturbance (including insomnia, nightmares), psychotic reactions (including hallucinations, delirium, paranoid thinking), agitation, neuroleptic malignant syndrome, paresthesias, episodes of bradykinesia (on-off syndrome), headache, dizziness, pathological addictions, confusion, increased libido, depression (including suicidal intentions), dementia, seizures;
from the digestive system: dry mouth, change in taste, darkening of saliva, vomiting, diarrhea, constipation, duodenal ulcer, bleeding from the gastrointestinal tract;
on the part of the hematopoietic system: thrombocytopenia, agranulocytosis, leukopenia, anemia, hemolytic anemia;
on the part of the cardiovascular system: palpitations, arrhythmia, decrease or increase in blood pressure (BP) and other orthostatic reactions fainting, phlebitis;
from the respiratory system: upper respiratory tract infections, shortness of breath;
on the part of the immune system: pruritus, urticaria, bullous rashes (including pemphigus-like reactions), hemorrhagic vasculitis (Schönlein's purpura - Henoch), angioedema;
dermatological reactions: skin rash, darkening of sweat, excessive sweating, alopecia;
from the genitourinary system: dark urine, frequent urination, urinary tract infections;
laboratory parameters: a decrease in the level of hemoglobin and hematocrit, hyperbilirubinemia, an increase in the activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and / or lactate dehydrogenase, an increase in urea nitrogen, hyperglycemia, positive Coombs' test, leukocyturia, hematuria, bacteriuria;
other reactions: asthenia, chest pain.

In addition, one should take into account the likelihood of developing the following adverse reactions, which are established against the background of the use of levodopa as monotherapy:

from the nervous system: anxiety, ataxia, nervousness, extrapyramidal disorders, memory loss, falls, increased tremor, gait disturbance, decreased thinking acuity, numbness, disorientation, euphoria, muscle twitching, blepharospasm, trismus, peripheral neuropathy, activation of Horner's latent syndrome;
from the digestive system: salivation, dysphagia, heartburn, flatulence, hiccups, burning sensation of the tongue, gastrointestinal pain, bruxism;
on the part of the cardiovascular system: myocardial infarction;
from the side of metabolism: edema, increase or decrease in body weight;
from the senses: visual impairment, oculogyric crisis, mydriasis;
from the respiratory system: cough, pain in the throat;
dermatological reactions: hot flushes, malignant melanoma;
from the genitourinary system: urinary incontinence, urinary retention, priapism;
laboratory parameters: hypokalemia, leukopenia, hyperuricemia, hypercreatininemia, glucosuria, proteinuria;
others: malaise, fatigue, weakness, hoarseness, abdominal pain, shortness of breath, pain in the lower extremities, agitation.

Overdose

For the treatment of an overdose when taking a high dose of Tidomet Forte, immediate gastric lavage is indicated. Then it is necessary to periodically conduct electrocardiography in order to timely diagnose arrhythmias, careful monitoring of the patient's condition, as well as the appointment of antiarrhythmic therapy according to clinical indications.

special instructions

If the patient develops muscle twitching or blepharospasm, consider discontinuing the drug.

Discontinue treatment with Tidomet Forte should be by gradually reducing the daily dose of the drug. A sudden interruption of therapy can contribute to the development of muscle rigidity, an increase in body temperature and serum creatine phosphokinase activity. The complex symptomatology of the condition is similar to neuroleptic malignant syndrome, therefore, if it is necessary to suddenly reduce the dose of Tidomet Forte or interrupt its intake, patients need careful monitoring.

Close medical monitoring is necessary, including in the treatment of patients with comorbidities such as erosive and ulcerative lesions of the stomach and / or duodenum, heart failure, diabetes mellitus, bronchial asthma, endocrine system diseases, mental illness, severe renal failure and / or liver, as well as if there is an indication in the patient's history of epileptic seizures or myocardial infarction with rhythm disturbances.

Due to the fact that Tidomet Forte can cause mental illness, during the period of its use it is recommended to carefully monitor the patient's condition for the development of a depressive state, including suicidal tendencies. If the patient has had psychoses, then the selection of therapy requires special care.

The appointment of Tidomet Forte to patients with atrial, nodular and ventricular arrhythmias, or who have had myocardial infarction, should be done only after a thorough preliminary examination. It is necessary to monitor cardiac activity in this category of patients both when taking the first dose and during the titration period.

Due to the increased risk of developing melanoma, patients with Parkinson's disease are advised to have their skin examined periodically by a dermatologist.

It should be borne in mind that when determining ketones in urine using the litmus test against the background of the use of Tidomet Forte, this research method can give a false-positive result, the reaction does not change when urine is boiled. In addition, a false negative result can be in the determination of glucose in urine by a method based on the enzymatic reaction of glucose oxidase.

Long-term treatment with the drug must be accompanied by periodic monitoring of the hematopoietic system, liver, kidney, cardiovascular system, mental status of the patient.

When carrying out surgical operations with general anesthesia, the dose of Tidomet Forte is not reduced. In the case of planning the use of cyclopropane or halothane, the combined antiparkinsonian drug should be discontinued no later than 8 hours before general anesthesia. After surgery, it is recommended to continue treatment at the same dose.

With open-angle glaucoma, it is necessary to regularly monitor intraocular pressure.

Patients should be informed about the property of Tidomet Forte to induce drowsiness and sudden falling asleep.

Influence on the ability to drive vehicles and complex mechanisms

After the appointment of Tidomet Forte, patients are advised to give up driving and other types of work, the performance of which requires increased attention and speed of psychomotor reactions.

Application during pregnancy and lactation

During gestation, Tidomet Forte can be used only in cases where the expected clinical effect of therapy for the mother, according to the doctor, exceeds the potential threat to the fetus.

The appointment of Tidomet Forte during breastfeeding is contraindicated. During lactation, the decision to stop breastfeeding or discontinue the drug should be made taking into account the importance of therapy for the mother.

Pediatric use

The use of Tidomet Forte for the treatment of patients under the age of 18 years is contraindicated due to the lack of information on the effectiveness and safety.

With impaired renal function

Tidomet Forte should be used with caution to treat patients with severe renal impairment.

For violations of liver function

Tidomet Forte should be used with caution to treat patients with severely impaired liver function.

Use in the elderly

It should be borne in mind that the absorption of levodopa in elderly patients is higher than in younger patients.

Drug interactions

When used simultaneously with Tidomet Forte:

monoamine oxidase (MAO) inhibitors, except for MAO-B inhibitors: circulatory disorders (flushing of the face, increased blood pressure, agitation, tachycardia, dizziness) due to the presence of levodopa, therefore, taking MAO inhibitors should be discontinued 14 days before starting the drug;
antihypertensive drugs: their combination with Tidomet Forte increases the risk of postural hypotension;
tricyclic antidepressants: while taking tricyclic antidepressants, the bioavailability of levodopa decreases, in addition, the likelihood of developing arterial hypertension and dyskinesia increases;
isoniazid, phenothiazine and butyrophenone derivatives: D ₂ -dopamine receptor agonists can reduce the therapeutic effect of levodopa;
adrenomimetics: levodopa can cause a significant increase in the activity of adrenergic agonists, requiring a decrease in their dose. The combination with beta-adrenomimetics, drugs for inhalation anesthesia increases the risk of cardiac arrhythmias;
amantadine: there is a potentiating effect of levodopa and amantadine;
methyldopa, levodopa: the likelihood of side effects increases when they are combined with Tidomet Forte;
pyridoxine: being a cofactor of the enzyme responsible for the peripheral decarboxylation of levodopa with the formation of dopamine (decarboxylase of aromatic L-amino acids), pyridoxine, when administered without inhibitors of aromatic L-amino acid decarboxylase simultaneously with levodopa, potentiates its peripheral metabolism, reducing the level of passage through the blood-brain barrier … As a result, pyridoxine reduces the therapeutic effect of levodopa, unless drugs that inhibit the peripheral decarboxylase of aromatic L-amino acids are additionally prescribed. With their additional appointment, the daily dose of levodopa can be reduced by 70-80%, provided that the same clinical result is maintained;
phenytoin, clonidine, diazepam, thioxanthene derivatives, m-anticholinergics, papaverine, reserpine: these drugs can cause a decrease in the antiparkinsonian effect;
lithium preparations: the incidence of dyskinesia and hallucinations increases with concomitant therapy with lithium preparations;
metoclopramide: by increasing the bioavailability of levodopa, metoclopramide may adversely affect disease control;
iron salts: it is possible to reduce the bioavailability of the active substances of the drug when combined with iron salts.

Analogs

Analogs of Tidomet Forte are: Madopar, Stalevo, Nakom, Sinemet, Tremonorm, Levodopa, Sindopa, Duodopa, Carbidopa and others.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 30 ° C, protected from moisture and light.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Tidomet Forte

Reviews of Tidomet Forte are rare. In them, patients diagnosed with Parkinson's disease, along with reports of an improvement in their condition with the use of the drug, complain of the occurrence of such undesirable phenomena as nausea, muscle pain, diarrhea, increase / decrease in blood pressure, insomnia, and in rare cases, the progression of the disease. At the same time, experts often recommend continuing therapy for a longer time, referring some of the described adverse reactions to transient.

Price for Tidomet Forte in pharmacies

The price of Tidomet Forte for a pack containing 100 tablets can range from 615 rubles.

Tidomet Forte: prices in online pharmacies

Drug name

Price

Pharmacy

Tidomet forte 250 mg + 25 mg tablets 100 pcs.

549 r

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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!