Zeptol - Instructions For Use, Price, Reviews, Analogs Of Tablets

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

Zeptol

Zeptol: 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. Price in pharmacies

Latin name: Zeptol

ATX code: N03AF01

Active ingredient: carbamazepine (Carbamazepine)

Manufacturer: San Pharmaceuticals Industries Ltd. (Sun Pharmaceutical Industries Ltd.) (India)

Description and photo update: 2019-05-07

Prices in pharmacies: from 83 rubles.

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Zeptol is an antiepileptic drug.

Release form and composition

• tablets: flat, round, white, on one side marked "ZEPTOL 200" and a chamfer, on the other - with a dividing line (10 pieces in a strip of aluminum foil, in a cardboard box 10 strips);
• tablets of prolonged action, film-coated: biconvex, round, light brown, with a line on one side (10 pcs. in a strip of aluminum foil, in a cardboard box 3 strips).

Each pack also contains instructions for using Zeptol.

1 tablet contains:

• active substance: carbamazepine - 200 mg;
• additional components: hypromellose 2910 (Metocel E5), colloidal silicon dioxide, microcrystalline cellulose, corn starch, povidone K 30, sodium propyl parahydroxybenzoate (sodium propylparaben), bronopol, magnesium stearate, purified talc, sodium lauryl sulfate A, sodium carboxymethyl

1 tablet of prolonged action, film-coated, contains:

• active substance: carbamazepine - 200 or 400 mg;
• additional components: hypromellose 2208 (Metocel K4M) - for a dosage of 400 mg, microcrystalline cellulose, ethylcellulose M50, corn starch, colloidal silicon dioxide, purified talc, magnesium stearate, croscarmellose sodium;
• film shell: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate (1: 2: 1) (Eudragit E-100), macrogol 6000 (polyethylene glycol 6000), purified talc, magnesium stearate, titanium dioxide, iron dye red oxide and yellow oxide.

Pharmacological properties

Pharmacodynamics

Carbamazepine is an iminostilbene derivative that exhibits a pronounced anticonvulsant (antiepileptic) effect and antidepressant (thymoanaleptic), antipsychotic and normotimic effect in a moderate degree. Also, the drug demonstrates analgesic properties, especially in patients with trigeminal neuralgia.

The mechanism of action of the active substance is not fully understood. It is assumed that its anticonvulsant effect is due to a decrease in the ability of neurons to provide a high frequency of occurrence of repeated action potentials as a result of inhibition of the activity of sodium channels. In addition, blocking the release of neurotransmitters by inhibiting presynaptic sodium channels and the emergence of action potentials, which leads to a decrease in synaptic transmission, also appears to be important.

The mechanism of action of carbamazepine probably involves receptors of gamma-aminobutyric acid (GABA), which may have a connection with calcium channels. Presumably, the influence exerted by the active substance on the systems of modulators of neurotransmission is of no small importance. The antidiuretic effect of carbamazepine may be associated with a hypothalamic effect on osmoreceptors, carried out by influencing the secretion of antidiuretic hormone (ADH), and also caused by a direct effect on the renal tubules.

The effectiveness of an antiepileptic drug has been noted in the treatment of generalized tonic-clonic seizures, focal (partial) epileptic seizures, which are accompanied or not accompanied by secondary generalization, as well as with a combination of the above types of seizures. As a rule, the use of Zeptol is ineffective for small seizures - petit mal, myoclonic seizures and absences.

Against the background of carbamazepine therapy in patients with epilepsy (especially in children and adolescents), a decrease in the severity of symptoms of anxiety and depression was recorded, and the drug also contributed to a decrease in irritability and aggressiveness. The degree of influence of the active substance on psychomotor indicators and cognitive function depends on its dose. The anticonvulsant effect may begin to appear after a few hours or after a few days (sometimes almost after 1 month due to autoinduction of metabolism).

Against the background of essential and secondary trigeminal neuralgia, in the overwhelming majority of cases, carbamazepine counteracts the occurrence of pain attacks. Relief of pain in trigeminal neuralgia is observed after 8–72 hours.

Zeptol provides an increase in the threshold of convulsive readiness for alcohol withdrawal syndrome, which, as a rule, is lowered in this condition, and reduces the severity of the symptoms of this syndrome (tremor, increased excitability, gait disturbances).

Antimanic (antipsychotic activity) is recorded after 7-10 days and may be due to suppression of the metabolism of norepinephrine and dopamine.

Maintenance of a more stable level of carbamazepine in the blood is ensured by using the prolonged form of the drug 1-2 times a day.

Pharmacokinetics

The absorption of the drug can vary from 72 to 96%, food intake does not affect the rate and extent of its absorption. The maximum concentration of carbamazepine (C _max) in plasma after a single dose of tablets can be observed after 12 hours, when taking the prolonged form of the drug - after 6-24 hours. Plasma protein binding of carbamazepine in adults is 70–80%, in children - 55–59%. Stationary concentrations of the active substance in the blood plasma are observed on average after 1–2 weeks, the speed of their achievement is influenced by the individual characteristics of metabolism, the duration of therapy, the dose of Zeptol and the patient's condition. Half-life (T _½) a single dose on average is approximately 36 hours (from 25 to 65 hours), after repeated administration, depending on the duration of treatment - from 12 to 24 hours. When using the prolonged form of Zeptol, T _½ is equal to 30-40 hours.

Metabolic transformation is carried out in the liver, mainly through the epoxy pathway with the formation of the main metabolites: active - carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. The isoenzyme mainly responsible for the conversion of carbamazepine to its active metabolite is cytochrome CYP3A4. In the course of biotransformation, an inactive metabolite, 9-hydroxymethyl-10 carbamoylacridane, is also formed. The content of carbamazepine-10,11-epoxide reaches 30% of the level of carbamazepine.

In the cerebrospinal fluid (CSF) and saliva, there are concentrations proportional to the amount of the active substance not bound to proteins - 20-30%. Carbamazepine crosses the placental barrier, the level of the substance in breast milk is 25-60% of that in plasma.

Excreted in the form of inactive metabolites: with urine - about 70-72% (of which in the form of unchanged carbamazepine - about 2%, in the form of an active metabolite carbamazepine-10,11-epoxide - about 1%), with feces - 28-30% …

In children, due to the higher rate of elimination, it may be necessary to prescribe higher doses of the drug (based on 1 kg of body weight) than in adults.

There are no data on changes in pharmacokinetics in patients with impaired renal / hepatic function and in elderly patients.

Indications for use

Pills

• epilepsy (excluding absences, myoclonic or flaccid seizures): simple / complex partial epileptic seizures, primary and secondary generalized tonic-clonic epileptic seizures, mixed forms of seizures - monotherapy or in combination with other anticonvulsants;
• trigeminal neuralgia;
• idiopathic glossopharyngeal neuralgia;
• facial muscle spasms in trigeminal neuralgia, epileptiform seizures in multiple sclerosis, tonic convulsions, paroxysmal movement and speech disorders (paroxysmal ataxia and dysarthria), pain attacks and paroxysmal paresthesias;
• pain in diabetic neuropathy, pain in peripheral nerve lesions in the presence of diabetes mellitus, polyuria and polydipsia of a neurohormonal nature against the background of diabetes insipidus of central genesis;
• alcohol withdrawal syndrome (convulsions, excessive excitability, anxiety, sleep disturbances);
• psychotic disorders (psychoses, affective and schizoaffective disorders, disorders of the limbic system).

Extended-release tablets

• epilepsy: simple / complex partial epileptic seizures (with or without loss of consciousness) with or without secondary generalization, generalized tonic-clonic epileptic seizures, mixed forms of convulsive seizures;
• neurogenic pain syndrome and trigeminal neuralgia;
• idiopathic glossopharyngeal neuralgia, typical and atypical trigeminal neuralgia in multiple sclerosis and idiopathic trigeminal neuralgia;
• pain in diabetic neuropathy, pain in peripheral nerve lesions in the presence of diabetes mellitus, polyuria and polydipsia of a neurohormonal nature against the background of diabetes insipidus of central genesis;
• alcohol withdrawal syndrome (convulsions, excessive excitability, anxiety, sleep disturbances);
• acute manic conditions and supportive treatment of bipolar affective disorders in order to prevent exacerbations or to reduce the severity of their clinical manifestations.

Contraindications

Absolute for both dosage forms:

• disorders of bone marrow hematopoiesis (anemia, leukopenia);
• atrioventricular block (AV block);
• combined administration with lithium preparations and monoamine oxidase inhibitors (MAO);
• hypersensitivity to any of the constituents of Zeptol, as well as to substances with a structure similar to carbamazepine, for example, to tricyclic antidepressants.

Additional contraindications for extended-release tablets:

• indications in the anamnesis of episodes of suppression of bone marrow hematopoiesis or any kind of porphyria;
• age up to 4 years.

An additional contraindication for Zeptol in tablet form is acute intermittent porphyria (including history).

Relative (use antiepileptic drugs with caution):

• decompensated chronic heart failure (CHF);
• disorders of the kidneys and / or liver;
• dilutional hyponatremia: insufficiency of the adrenal cortex, ADH hypersecretion syndrome, hypothyroidism, hypopituitarism;
• hyperplasia of the prostate;
• suppression of bone marrow hematopoiesis, concomitant with taking medications (in history);
• increased intraocular pressure;
• active alcoholism, since due to the aggravation of the depression of the central nervous system (CNS), the biotransformation of carbamazepine is enhanced;
• elderly age;
• combined use with sedative-hypnotics.

Zeptol, instructions for use: method and dosage

Zeptol tablets are taken orally with a small amount of liquid, during, after a meal, or in between meals. The drug can be prescribed both as monotherapy and as part of a complex treatment.

Extended-release tablets must be swallowed 1 whole or, if prescribed by a doctor, ½ without chewing. Since the active substance from the prolonged-release tablets is released gradually and slowly, Zeptol should be taken 2 times a day, the doctor determines the optimal treatment regimen. If it is necessary to switch from using conventional tablets to taking a prolonged form, according to clinical experience, in some patients it may be necessary to increase the previously taken dose of the drug.

When treating epilepsy, it is advisable to prescribe Zeptol tablets as monotherapy. It is necessary to start using the drug by taking a small daily dose, which should then be gradually increased until the desired effect is achieved. When selecting the optimal dose, it is recommended to determine the level of carbamazepine in the blood plasma. In the case of the appointment of Zeptol to a previously conducted antiepileptic therapy, its addition is carried out gradually, while the doses of already received drugs are not changed, but if necessary, an appropriate correction is made. If the patient forgot to take the next dose of carbamazepine on time, it should be taken as soon as this omission is discovered, but a double dose of Zeptol cannot be used.

Recommended dosage regimen depending on indications:

• epilepsy: adults take Zeptol 1-2 times a day at an initial dose of 100-200 mg, then the dose is slowly increased to 400-600 mg twice a day, the maximum daily dose should not exceed 1600-2000 mg; in children over 4 years of age, the intake can be started with a daily dose of 100 mg, then every week the dose can be increased by 100 mg; children aged 4 years and under are prescribed Zeptol (tablets) at an initial daily dose of 20-60 mg and then increase it every other day by 20-60 mg; maintenance daily doses for children are set at the rate of 10–20 mg / kg, divided into several doses; recommended maintenance daily doses in children for tablets (depending on age): under 1 year old - 100-200 mg in 1 dose, 1-5 years old - 200-400 mg in 1-2 doses, 6-10 years old - 400-600 mg in 2-3 doses, 11-15 years old - 600-1000 mg in 2-3 doses;recommended maintenance daily doses in children for extended-release tablets (in several doses): 4-5 years - 200-400 mg, 6-10 years - 400-600 mg, 11-15 years - 600-1000 mg;
• neuralgia of the trigeminal nerve and neurogenic pain syndrome: 2 times a day, 100-200 mg, then the daily dose can be increased by no more than 200 mg (up to about 600-800 mg) until pain relief, then the dose is reduced to the lowest effective; after the start of the course, a positive result is usually noted after 1–3 days; long-term therapy, in case of premature withdrawal of carbamazepine, pain may resume; in elderly patients, the initial dose should be 100 mg 2 times a day;
• diabetic neuropathy, accompanied by pain: 2-4 times a day, 200 mg (tablets); 2 times a day, 200-300 mg (extended-release tablets);
• diabetes insipidus (tablets): for adults, on average 2-3 times a day, 200 mg;
• pain sensations with lesions of peripheral nerves against the background of diabetes mellitus: 2 times a day, 200-300 mg;
• idiopathic glossopharyngeal neuralgia, trigeminal neuralgia in the presence of multiple sclerosis and idiopathic trigeminal neuralgia (prolonged-release tablets): 200-400 mg twice a day;
• polyuria and polydipsia of a neurohormonal nature with diabetes insipidus of central origin (prolonged-release tablets): for adults, the average dose is 200 mg 2 times a day; for children, the dose is reduced taking into account age and body weight;
• alcohol withdrawal syndrome: average dose - 200 mg 2 times a day; in severe cases, during the first days of the course, it is allowed to increase the dose to 600 mg 2 times a day; at the beginning of therapy with severe manifestations of alcohol withdrawal, Zeptol is used in combination with detoxification treatment and sedative-hypnotics (chlordiazepoxide, clomethiazole); after the end of the acute phase, the drug can be used as monotherapy;
• affective disorders - treatment and prevention (tablets); bipolar affective disorders - supportive therapy, acute manic states (prolonged-release tablets): prescribed in a daily dose of 200-400 mg during the first week of the course, then the dose is increased every week by 200 mg, bringing to 1000 mg per day, evenly divided into 2 receptions.

The duration of therapy is set by the attending physician; treatment should be completed gradually. Switching to Zeptol is required slowly, with a gradual decrease in the dose of the previous drug.

Side effects

When assessing the frequency of occurrence of adverse events, the following gradations were used: very often - 10% or more; often - from 1% to 10%; infrequently - from 0.1% to 1%; rarely - from 0.01% to 0.1%; extremely rare - less than 0.01%:

• CNS: very often - a feeling of fatigue, dizziness, drowsiness, ataxia; often - diplopia, visual accommodation disturbances (including blurred vision), headache; infrequently - nystagmus, abnormal involuntary movements (tics, tremors, fluttering tremors - asterixis, dystonia); rarely - oculomotor disorders, orofacial dyskinesia, speech disorders (dysarthria), paresthesia, peripheral neuropathy, paresis, choreoathetosis; extremely rarely - disturbances in taste, neuroleptic malignant syndrome;
• cardiovascular system (CVS): rarely - decrease / increase in blood pressure (BP), intracardiac conduction disorders; extremely rarely - arrhythmias, bradycardia, AV block with fainting, CHF, thromboembolism (including pulmonary artery), thrombophlebitis, collapse, exacerbation of coronary heart disease (IHD);
• mental disorders: rarely - anxiety, agitation, aggression, anorexia, visual / auditory hallucinations, depression, disorientation; extremely rare - activation of psychosis;
• hypersensitivity reactions (with the development of the following reactions, treatment with Zeptol should be discontinued): rarely - delayed-type multiple organ hypersensitivity with skin rashes, fever, leukopenia, arthralgia, eosinophilia, lymphadenopathy, vasculitis, signs resembling lymphoma, altered liver function and hepatosplenomegaly (disorders are observed in various combinations), involvement of other organs is possible (including the myocardium, pancreas, lungs, kidneys, colon); extremely rarely - aseptic meningitis with peripheral eosinophilia and myoclonus, angioedema, anaphylactic reaction;
• allergic reactions: very often - urticaria (including significantly expressed), allergic dermatitis; infrequently - erythroderma, exfoliative dermatitis; rarely - itching, systemic lupus erythematosus; extremely rare - hair loss, sweating, acne, purpura, skin pigmentation disorders, photosensitivity reactions, erythema multiforme and nodosum, toxic epidermal necrolysis, Stevens-Johnson syndrome; isolated cases of hirsutism were recorded (the causal relationship of the appearance of this complication with the use of Zeptol has not been established);
• hepatobiliary system: very often - an increase in the activity of gamma-glutamyl transferase (GGT) as a result of the induction of the enzyme in the liver (as a rule, it has no clinical significance); often - an increase in the activity of alkaline phosphatase (ALP) in the blood; infrequently - an increase in the level of transaminases; rarely - the destruction of the intrahepatic bile ducts, leading to a decrease in their number, jaundice, hepatitis of the parenchymal (hepatocellular), cholestatic or mixed type; extremely rare - liver failure, granulomatous hepatitis;
• digestive system: very often - vomiting, nausea; often - dry mouth; infrequently - constipation / diarrhea; rarely - abdominal pain; extremely rare - stomatitis, glossitis, pancreatitis;
• hematopoietic organs: very often - leukopenia; often - eosinophilia, thrombocytopenia; rarely - folic acid deficiency, lymphadenopathy, leukocytosis; extremely rare - anemia, true erythrocytic aplasia, aplastic / megaloblastic / hemolytic anemia, pancytopenia, agranulocytosis, late cutaneous / variegated / acute intermittent porphyria, reticulocytosis;
• genitourinary system: extremely rarely - urinary retention, frequent urination, interstitial nephritis, impaired renal function (oliguria, hematuria, albuminuria, increased urea / azotemia), renal failure, decreased sperm count and motility, sexual dysfunction / impotence;
• endocrine system and metabolism: often - weight gain, fluid retention, edema, decreased blood osmolarity and hyponatremia due to an effect similar to that of ADH, which rarely leads to dilution hyponatremia (water intoxication), proceeding with headache, vomiting, lethargy, neurological disorders and disorientation; extremely rarely - an increase in the level of blood prolactin with galactorrhea, gynecomastia or without them, changes in the parameters of the thyroid gland - a decrease in the content of L-thyroxine (thyroxine, free thyroxine, triiodothyronine) and an increase in the level of thyroid-stimulating hormone (TSH) (usually not accompanied by clinical manifestations), violations of bone metabolism (decrease in blood levels of 25-hydroxycholecalciferol and calcium), which causes osteomalacia / osteoporosis; increased cholesterol content, incl.including high density lipoprotein cholesterol and triglycerides;
• sense organs: extremely rarely - conjunctivitis, lens opacity, increased intraocular pressure, hearing impairment, including tinnitus, changes in the perception of pitch, hypoacusia, hyperacusis;
• musculoskeletal system: rarely - muscle weakness; extremely rarely - muscle pain or cramps, arthralgia.

Overdose

Symptoms of a Zeptol overdose are usually disorders of the CVS, central nervous system and respiratory system.

• CVS: decrease / increase in blood pressure, tachycardia, fainting, intraventricular conduction disturbances with expansion of the QRS complex, cardiac arrest;
• Central nervous system and sense organs: agitation, drowsiness, depression of central nervous system functions, hallucinations, disorientation, coma; slurred speech, blurred vision, ataxia, dyskinesia, dysarthria, nystagmus, hyperreflexia (at the beginning of intoxication), hyporeflexia (later); hypothermia, mydriasis, myoclonus, psychomotor disorders, convulsions;
• digestive system: nausea, vomiting, delayed evacuation of food from the stomach, decreased motility of the colon;
• urinary system: fluid retention, urinary retention, oliguria / anuria, hyponatremia;
• respiratory organs: pulmonary edema, respiratory depression;
• laboratory parameters: hyponatremia, leukopenia / leukocytosis, metabolic acidosis, hyperglycemia and glucosuria may appear, increased activity of the muscle fraction of creatine phosphokinase.

If an overdose is detected, therapy is prescribed based on the clinical condition of the patient; hospitalization is indicated. There is no specific antidote. Determination of the plasma level of carbamazepine is recommended (in order to confirm poisoning with this substance and assess the degree of overdose). Gastric lavage is performed, activated charcoal is prescribed, late evacuation of stomach contents can cause delayed absorption on days 2 and 3 and reappearance of intoxication symptoms during recovery. Hemodialysis, peritoneal dialysis, and forced diuresis are ineffective (dialysis is useful in the presence of concomitant renal failure and severe poisoning). In the intensive care unit, symptomatic supportive treatment, correction of electrolyte disorders, monitoring of body temperature,functions of the heart, kidney and urinary bladder activity, corneal reflexes.

Against the background of a decrease in blood pressure, the use of plasma substitutes is recommended, intravenous (IV) infusion of dopamine / dobutamine; against the background of heart rhythm disturbances, treatment should be selected individually; when seizures occur, benzodiazepines (for example, diazepam) are administered and, with caution, due to the aggravation of the threat of respiratory depression, other anticonvulsants (phenobarbital) are administered. With the development of water intoxication, the introduction of fluids is limited and a slow infusion of 0.9% sodium chloride solution is carried out intravenously, which can be useful to prevent the development of cerebral edema. It is recommended to conduct blood purification on carbon sorbents.

special instructions

Zeptol is usually ineffective in minor epileptic seizures (absences) and myoclonic seizures. In the presence of mixed forms of epileptic seizures, the drug should be used with caution and subject to regular medical supervision due to the possible risk of their intensification. Reception of Zeptol must be canceled if there is an aggravation of epileptic seizures.

During the period of therapy, there may be a transient / persistent decrease in the number of leukocytes or platelets, in most cases it is temporary and does not indicate the occurrence of agranulocytosis or aplastic anemia. Before the start of the course, as well as during treatment, it is required to conduct clinical blood tests, including counting the number of platelets and, possibly, reticulocytes, and determine the level of hemoglobin.

Patients should be informed about early signs of toxicity and symptoms inherent in possible hematological disorders, as well as symptoms of the skin and liver. It is necessary to urgently consult a doctor with the development of such undesirable phenomena as sore throat, fever, rash, ulceration of the oral mucosa, unreasonable appearance of hemorrhages and hemorrhages. If signs of pronounced bone marrow suppression are detected, Zeptol should be canceled.

Before starting the course of treatment and periodically during its course, it is recommended to carry out a study of the activity of the liver, especially in elderly patients and patients with a history of indications of its damage. If there is an increase in previously existing functional liver disorders or the occurrence of active liver disease, treatment with the drug should be stopped immediately.

Therapy with antiepileptic drugs in some cases can proceed with the appearance of suicidal attempts / suicidal thoughts. Since the mechanism of the occurrence of suicidal behavior when using these drugs has not been established, its development cannot be ruled out when taking Zeptol. Patients and their caregivers should be warned about the need to immediately seek medical attention if signs of suicidal thoughts / tendencies appear.

Elderly patients during the course of treatment need observation due to the possible exacerbation of latent mental disorders, manifested by confusion and psychomotor agitation.

Abrupt discontinuation of carbamazepine therapy can cause epileptic seizures. If an urgent withdrawal of Zeptol is necessary, the patient should be transferred to another antiepileptic drug while being treated with an appropriate drug for such cases (for example, phenytoin, administered intravenously, or diazepam, used intravenously or rectally).

During treatment, the development of severe dermatological reactions (including Stevens-Johnson syndrome, Lyell's syndrome) was extremely rare. The use of Zeptol should be discontinued immediately when signs and symptoms appear, presumably indicating the occurrence of these complications. With the development of severe life-threatening skin reactions, the patient should be taken to a hospital. As a rule, the appearance of such disorders was noted in the first months of the course of therapy.

According to a retrospective analysis of Zeptol use, in Chinese patients, there is a correlation between the incidence of severe skin reactions associated with carbamazepine and the presence of the HLA-B * 1502 allele of the human leukocyte antigen (HLA) gene in the genome of these patients. When treating patients with carbamazepine in the countries of the Asian region (Philippines, Malaysia, Thailand), where the prevalence of this allele was recorded, an increase in the incidence of severe dermatological side effects was noted (from an estimate of the frequency of "very rare" to "rare").

Patients who are possible carriers of the HLA-B * 1502 allele (for example, people of Chinese nationality) should be tested for its presence in the genotype. Carrying out drug therapy in carriers of this allele is recommended only if the expected benefit from treatment far outweighs the risk of complications. In representatives of the Caucasian, Negroid and American races, an insignificant prevalence of the above allele was revealed.

Before starting therapy with Zeptol, you should stop taking MAO inhibitors at least 14 days or even earlier, if the clinical situation allows.

Influence on the ability to drive vehicles and complex mechanisms

During treatment, especially at the beginning of the course or when titrating the dose, dizziness and drowsiness may occur. As a result, patients who drive a car or other complex machinery need to be careful.

Application during pregnancy and lactation

Therapy of epilepsy with Zeptol during pregnancy should be carried out with extreme caution.

Women of reproductive age should, if possible, use Zeptol in monotherapy mode, in the lowest effective dose, since it has been established that the incidence of congenital anomalies in newborns whose mothers received combined antiepileptic treatment is higher than when these women receive monotherapy. It is recommended to regularly monitor the plasma level of carbamazepine in the blood.

If it is necessary to take Zeptol during pregnancy or when pregnancy occurs during the period of therapy, it is necessary to carefully compare the expected benefits of treatment and its possible complications, especially in the first trimester of pregnancy.

In children born to mothers with epilepsy, a tendency to intrauterine development disorders, including malformations, was revealed. Zeptol may exacerbate the risk of such disorders, however, in the course of controlled studies of the use of the drug in monotherapy, no convincing evidence of this was obtained. While pregnant women were taking the drug, isolated cases of congenital diseases and malformations were recorded, for example, non-closure of the arches of the vertebrae (spina bifida) and other congenital anomalies (including CVS and craniofacial defects).

Antiepileptic drugs increase the lack of folic acid, which is often noted in pregnant women, which may contribute to an increase in the frequency of birth defects in children whose mothers have taken antiepileptic drugs. As a result, it is recommended to take folic acid before the onset of the planned pregnancy and during its course. To prevent the development of increased bleeding in newborns, mothers in the last weeks of pregnancy, as well as newborns, should take vitamin K ₁.

Carbamazepine is excreted in breast milk (25-60% of plasma levels), therefore, in the context of continued treatment with Zeptol, its benefits and the likelihood of side effects in the infant must be carefully evaluated. If you continue to breastfeed while using the product, you need to monitor the baby because of the risk of possible adverse events (allergic skin reactions, excessive drowsiness, etc.). It is recommended to regularly monitor the level of carbamazepine in breast milk.

Patients of childbearing age during treatment with Zeptol should resort to the use of non-hormonal contraception.

Pediatric use

Children under 4 years of age should not take extended-release tablets. Because of the difficulties in taking solid dosage forms, patients of this age group are recommended to prescribe carbamazepine in the form of a syrup.

With impaired renal function

In the presence of functional disorders of the kidneys, therapy with Zeptol should be carried out with caution.

For violations of liver function

In the presence of functional disorders of the liver, treatment with an antiepileptic agent is recommended with caution.

Use in the elderly

Zeptol should be used with caution in elderly patients.

Drug interactions

• inhibitors of the isoenzyme CYP3A4: the level of carbamazepine in plasma increases and the risk of side effects is aggravated;
• inducers of the CYP3A4 isoenzyme: the metabolism of carbamazepine is accelerated, which leads to a decrease in its content in plasma and a weakening of its therapeutic effect;
• antiepileptic drugs (vigabatrin, styripentol), antidepressants (fluvoxamine, trazodone, desipramine, nefazodone, fluoxetine, viloxazine, paroxetine), antipsychotics (olanzapine), muscle relaxants (dantrolene, oxybutyninamide) (adults, vaputinamide), antidote high doses), azole derivatives (ketoconazole, voriconazole, fluconazole, itraconazole), HIV protease inhibitors (for example, ritonavir), antiulcer drugs (cimetidine, omeprazole), calcium antagonists (diltiazem, verapamil), antiglaucoma drugs) (acetazolamide antibiotics) (clarithromycin, erythromycin, troleandomycin, josamycin), antihistamines (loratadine, terfenadine), antiplatelet agents (ticlopidine), analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, dextropropoxyphenase), androgens:the plasma concentration of carbamazepine increases, which can provoke the appearance of side reactions (drowsiness, dizziness, ataxia); it is required to regularly monitor and correct the level of carbamazepine in the blood;
• loxapine, primidone, quetiapine, valproic acid, progabid, valpromide, valnoctamide: the plasma content of carbamazepine-10,11-epoxide increases, the development of undesirable reactions is possible; need to control the level of this substance in the blood and adjust the doses of Zeptol;
• antiepileptic drugs (mezuximide, oxcarbazepine, fosfenytoin, fensuximide, felbamate, phenytoin, primidone, phenobarbital, possibly also clonazepam), anti-tuberculosis drugs (rifampicin), antineoplastic agents (doxinoretinospillin), bronchodilatine, aminospilinospiline, preparations of St. John's wort (Hypericum perforatum): the level of carbamazepine in the blood plasma decreases, it may be necessary to change its doses;
• antibiotics (doxycycline), NSAIDs, analgesics (paracetamol, buprenorphine, tramadol, methadone, phenazone), antiepileptic drugs (topiramate, clonazepam, felbamate, clobazam, ethosuximide, lamotrigine, valproic acid, neparidazone, thiagidazine) dicumarol, warfarin, acenocoumarol, fenprocoumon), antidepressants (mianserin, bupropion, trazodone, citalopram, sertraline, nefazodone), tricyclic antidepressants (amitriptyline, imipramine, clomipramine, nortripaztyline drugs) (itraconium pills) (imatinib), antipsychotics (risperidone, clozapine, bromperidol, quetiapine, ziprasidone, haloperidol, olanzapine), immunosuppressants (everolimus, cyclosporine), cardiac glycosides (digoxin), thyroid drugs (levothyroxine)glucocorticosteroids (dexamethasone, prednisolone), anxiolytics (midazolam, alprazolam), HIV protease inhibitors (saquinavir, ritonavir, indinavir), bronchodilators (theophylline), hormonal contraceptives, drugs that lower blood pressure) or felodipine and felodipine progesterone: a decrease in the plasma level of these drugs is possible, a correction of their doses may be required
• phenytoin, mefenytoin: the level of phenytoin may increase / decrease, the level of mephenytoin may increase.

Reactions of interaction of carbamazepine with other drugs / substances that should be taken into account:

• isoniazid: the hepatotoxicity caused by this substance may increase;
• diuretics (furosemide, hydrochlorothiazide): symptomatic hyponatremia may appear;
• levetiracetam: possible aggravation of the toxic effects of carbamazepine;
• antipsychotics (thioridazine, haloperidol), lithium preparations or metoclopramide: the frequency of undesirable neurological effects may increase (when combined with antipsychotics - even in the presence of therapeutic plasma levels of active substances);
• non-depolarizing muscle relaxants (pancuronium bromide): it is possible for carbamazepine to antagonize the action of these drugs; with this combination, it may be necessary to increase the doses of these muscle relaxants, it is necessary to carefully monitor the condition of the patients in view of the possible faster than expected completion of the neuromuscular blockade;
• hormonal contraceptives: the therapeutic effect of these drugs may decrease as a result of the induction of microsomal enzymes, there are reports of bleeding between periods; you need to resort to alternative methods of contraception;
• ethanol: there may be a decrease in its tolerance; during therapy, you must refrain from drinking alcohol.

Analogs

Zeptol analogs are: Carbamazepine, Carbalepsin retard, Carbamazepin retard-Akrikhin, Carbamazepin-Ferein, Carbamazepin-Acri, Finlepsin, Tegretol, Finlepsin retard, etc.

Terms and conditions of storage

Keep out of the reach of children, protected from moisture and light, at a temperature up to 30 ° C (for tablets) or up to 25 ° C (for extended-release tablets).

Shelf life of tablets - 5 years, prolonged-release tablets - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Zeptol

The few reviews about Zeptol are mostly positive. Many patients note that the drug effectively reduces the risk of epileptic seizures, demonstrates a positive effect on the symptoms of depression, reduces irritability, and also relieves neurogenic pain syndrome and reduces the intensity of seizures in trigeminal neuralgia. The disadvantages of Zeptol include a large number of side effects.

Price for Zeptol in pharmacies

The price of Zeptol, tablets of prolonged action, film-coated, can be (30 pieces per pack): dosage 200 mg - 70-85 rubles, dosage 400 mg - 110-160 rubles.

Zeptol: prices in online pharmacies

Drug name Price Pharmacy

Zeptol tablets prolonged action p.p. 200mg 30 pcs. 83 rbl. Buy

Zeptol 200 mg film-coated tablets of prolonged action 30 pcs. 83 rbl. Buy

Zeptol 400 mg film-coated tablets of prolonged action 30 pcs. RUB 98 Buy

Zeptol tablets prolonged action p.p. 400mg 30 pcs. RUB 100 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!