Carbamazepine in Latin. When and how much? Indications for use of Carbamazepine

Thank you

Most often, patients tolerate treatment with carbamazepine well if they carefully follow all the doctor’s instructions regarding the amount of the drug taken and the treatment regimen. But sometimes a number of side effects are still observed. Often their appearance is associated with an increase in the required dosage, while such effects disappear two to three days after the dosage is normalized. The appearance of side effects from the central nervous system are also most often associated with overdoses or with individual drug metabolism. During such a course of treatment, it is necessary to monitor the level of the drug in the blood.

• The drug affects the functioning of the central nervous system. In ten percent of cases, there is a craving for sleep, dizziness, asthenia, from one to ten percent of patients suffer from migraine-like pain, disturbance of accommodation, less than one percent suffer from trembling of the limbs, nystagmus, tics, disturbances in the functioning of the organs of vision and speech, myasthenia, paresthesia.

• The drug affects the patient's psyche: from one to ten percent of patients suffer from visions or auditory hallucinations, aversion to food, nervousness, disorientation in space, and in isolated cases reactive psychoses were recorded.
• The drug may cause allergic manifestations. Most often these are rashes on the body, in isolated cases itching, lupus-like symptoms, Steven-Johnson syndrome, photosensitivity.
• In isolated cases, combined reactions of individual drug intolerance were observed, occurring with chills, vasculitis, rash on the body, swelling lymph nodes, joint pain, blood disorders and liver dysfunction. In addition, there is likely to be disruption of the kidneys, respiratory organs, myocardium, pancreas, and intestines.

• The drug affects blood production, ten percent of patients develop leukopenia, slightly less often thrombocytopenia, the level of eosinophils increases, even less often the level of leukocytes increases, the number of folic acid. In isolated cases, aplastic anemia, agranulocytosis, aplasia, porphyria, and reticulocytosis are observed.
• The drug can affect the functioning of the digestive system, quite often causing vomiting, drying of the oral mucosa, less often, defecation disorders, epigastric pain, in isolated cases pancreatitis, ulceration of the oral mucosa.
• The drug can affect the functioning of the cardiovascular system, in isolated cases causing changes in intracardiac conduction, blood pressure, and exacerbation of coronary heart disease.
• Treatment with carbamazepine may affect the functioning of the glands internal secretion and metabolism, causing weight gain, swelling, disruption of the production of prolactin, thyroxine, thyroid-stimulating hormone.
• The drug may also affect work genitourinary system, causing in isolated cases kidney dysfunction, nephritis, frequent urge to urination, impaired potency.

Reviews

And my neurologist insistently continues to prescribe carbamazepine, although I have symptomatic epi and it doesn’t help me at all, only there are more side effects, I even left work, constant dizziness and disorientation. I told her about this, but she says that this cannot be!

Hello, my boyfriend is sick. He has epilepsy. The doctor prescribed us carbamazepine in an increasing dosage (the first two days, one tablet in the evening, the third and fourth days, one in the morning and evening, the fifth and sixth day, one in the morning and two in the evening, and on the seventh, two in the morning and two in the evening) yesterday he I drank for 4 days (1 in the morning and one in the evening) and today I need to drink for 5 days (1 in the morning and 2 in the evening). But this morning he called me and said that since yesterday he has been dizzy (“if I look far away, for example, at my feet, I feel dizzy”) yesterday and this morning he was dizzy. I worry. Is it worth drinking them further?. I just changed the pressure and it was 150 to 100..

Hello! My son took carbamazepine from February 17, 2017 to April 5 of this year. Epilepsy is questionable, but the first seizures were on February 28, 2016, then on February 17, from that moment he was prescribed carbamazepine. On April 2, my son developed a high temperature of 39 degrees. Then, on April 5, a rash appeared, and the hospital diagnosed hemorrhagic vasculitis, bilateral pneumonia, and swollen lymph node. They refused to take the drug. On April 12, another attack occurred, she again gave carbamazepine, but the son became red and his body itched for two days, they again refused the drug. The allergic reaction went away. We were discharged from the hospital on April 19 and we still cannot get an appointment with a neurologist, either they don’t answer the phone, or there is no appointment with the doctor at all, and finally only on May 23 we can see a doctor. I hope that they will prescribe another medicine that does not have such side effects.

Name:
Carbamazepine
INN:
Carbamazepine
ATX code: N03AF01.

Analogues: Finlepsin

Pharmacotherapeutic group:

Antiepileptic drug.

Compound

One tablet contains

active substance:

carbamazepine - 200 mg,

Excipients: microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium lauryl sulfate.

pharmachologic effect

Anticonvulsant, tricyclic iminostilbene derivative. The anticonvulsant effect is associated with a decrease in the ability of neurons to maintain high frequency development of repeated action potentials through inactivation sodium channels. Carbamazepine also has a moderate antimanic, antipsychotic effect, as well as an analgesic effect for neurogenic pain. The mechanisms of action may involve gamma-aminobutyric acid receptors, which may be coupled to calcium channels; The effect of carbamazepine on neurotransmission modulator systems also appears to be important. The antidiuretic effect of Carbamazepine is associated with a hypothalamic effect on osmoreceptors, which is mediated through the secretion of antidiuretic hormone, as well as a direct effect on the renal tubules. Prevents attacks of trigeminal neuralgia, reduces the severity of clinical manifestations of alcohol withdrawal and reduces seizure activity. If not diabetes mellitus reduces diuresis and thirst.

Pharmacokinetics

Absorbed slowly from the gastrointestinal tract. Almost completely metabolized. Maximum plasma concentration occurs after 8-12 hours. Binds to blood proteins by 70-80%. IN cerebrospinal fluid and saliva, concentrations are created in proportion to the proportion of non-protein bound active substance(20-30%). The half-life is 30-40 hours, with long-term use decreases to 10-20 hours. Penetrates into breast milk (25-60% of plasma levels) and through the placental barrier. Biotransforms in the liver with the formation of several metabolites. Excreted in small quantities from breast milk. The onset of anticonvulsant action varies from several hours to several days (sometimes up to 1 month). The antineuralgic effect develops after 8-72 hours, the antimanic effect - after 7-10 days.

Indications for use

epilepsy: partial seizures with elementary symptoms (focal seizures); partial seizures with complex symptoms (psychomotor seizures); grand mal seizures, mainly of focal origin (grand mal seizures during sleep, diffuse grand mal seizures); mixed forms epilepsy;

trigeminal neuralgia;

paroxysmal pain of unknown cause, arising on one side of the root of the tongue, pharynx and soft palate(genuine glossopharyngeal neuralgia);

pain with lesions peripheral nerves with diabetes mellitus (pain with diabetic neuropathy);

epileptiform seizures with multiple sclerosis, such as, for example, spasms of the facial muscles with trigeminal neuralgia, tonic convulsions, paroxysmal speech and movement disorders (paroxysmal dysarthria and ataxia), discomfort(paroxysmal paresthesias) and attacks of pain;

development prevention seizures with alcohol withdrawal syndrome;

psychoses (mainly in manic-depressive states, hypochondriacal depression). Secondary prevention affective and schizoaffective psychoses.

Directions for use and doses

Inside, during or after meals, with a drink a small amount liquids

Contraindications

• Atrioventricular block;
• Treatment with MAO inhibitors for 14 days before starting treatment with carbamazepine;
• Liver failure;
• Acute recurrent porphyria.

Side effect

Carbamazepine is an antiepileptic drug that causes the fewest side effects. However, in some cases, ataxia, dizziness, accommodation disorders, drowsiness, dry mouth, and diarrhea develop.

Allergic reactions (rash, Stevens-Johnson syndrome), hair loss, leukopenia are possible. Rarely, especially in older people, cardiac conduction disorders, hematological changes, cholestatic hepatitis, edema and weight gain may occur, including in some cases increased frequency of seizures is possible. All these reactions are indications for discontinuation of the drug. In the elderly, especially at the beginning of treatment, confusion may occur, which usually resolves spontaneously after 1-2 weeks or after reducing the dose.

Pregnancy and breastfeeding

There is some evidence of a teratogenic effect on the fetus. The use of the drug during pregnancy requires especially careful monitoring.

Side effects that occur in a child during breastfeeding: lethargy (rarely) and decreased appetite.

Precautionary measures

Before starting and during therapy, regular blood (cellular elements) and urine tests and monitoring of liver function indicators are recommended. Prescribe with caution if there is a history of heart, liver, kidney diseases, hematological disorders, increased intraocular pressure, latent psychosis, agitation, diseases characterized by seizures, in old age, transport drivers and people working with machinery. Women are advised to take additional folic acid (before or during pregnancy); in order to prevent increased bleeding in last weeks During pregnancy and in newborns, vitamin K can be used.

Interaction with other drugs

Carbamazepine stimulates the metabolism of cyclosporine, ethosuximide, felodipine and warfarin, which leads to a reduction in the duration of action of these drugs. Danazol, dextropropoxyphene, erythromycin, isoniazid and verapamil inhibit the metabolism of carbamazepine, which may result in unexpected strong effect or side effects of carbamazepine. In some patients, diltiazem reduces the metabolism of carbamazepine, which leads to an increase in its concentration in the blood plasma. Barbiturates accelerate the elimination of carbamazepine. Cisplatin and doxorubicin reduce the absorption of carbamazepine and reduce its plasma levels.

Overdose

Symptoms:

disorientation, drowsiness, agitation, hallucinations, blurred vision, nystagmus, ataxia, convulsions, myoclonus, respiratory depression, pulmonary edema, tachycardia, cardiac arrest accompanied by loss of consciousness, decreased colonic motility, hyponatremia, hyperglycemia, possible metabolic acidosis.

Treatment:

gastric lavage, appointment activated carbon and saline laxative, forced diuresis. To maintain patency respiratory tract- artificial respiration and (or) use of oxygen. It is necessary to anticipate a re-intensification of symptomatic overdose on the 2nd and 3rd day after its onset, which is associated with the slow absorption of the drug.

Package

30 or 50 tablets in plastic cases or in polymer jars for packaging medicines.

10 tablets in a blister pack.

Pencil case, jar, 3 or 5 blisters along with an insert in secondary packaging.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25ºС.

Keep out of the reach of children.

Best before date - 3 years.

Manufacturer:

LLC "Farmland"

The page contains instructions for use Carbamazepine. It is available in various dosage forms of the drug (200 mg tablets), and also has a number of analogues. This abstract has been verified by experts. Leave your feedback on the use of Carbamazepine, which will help other site visitors. The drug is used for various diseases (epilepsy, neuralgia, psychosis, affective disorders). The product has a number of side effects and interactions with other substances. Doses of the drug differ for adults and children. There are restrictions on the use of the medicine during pregnancy and breastfeeding. Treatment with Carbamazepine should only be prescribed by a qualified physician. The duration of therapy may vary and depends on the specific disease. Composition and interaction of the drug with alcohol.

Instructions for use and dosage

Inside, regardless of food intake, along with a small amount of liquid.

Epilepsy. Where possible, carbamazepine should be prescribed as monotherapy. Treatment begins with a small daily dose, which is subsequently slowly increased until the optimal effect is achieved.

The addition of carbamazepine to existing antiepileptic therapy should be carried out gradually, while the doses of the drugs used are not changed or, if necessary, adjusted.

For adults, the initial dose is 100-200 mg 1-2 times a day. Then the dose is slowly increased until the optimal therapeutic effect is achieved (usually 400 mg 2-3 times a day, maximum 1.6-2 g per day).

Children over 3 years old - an initial dose of 20-60 mg per day, gradually increasing by 20-60 mg every other day.

In children over 3 years old, the initial dose is 100 mg per day, the dose is increased gradually, every week by 100 mg. Maintenance doses: 10-20 mg/kg per day (in several doses): for 4-5 years - 200-400 mg (in 1-2 doses), 6-10 years - 400-600 mg (in 2-3 doses ), for 11-15 years - 600-1000 mg (in 2-3 doses).

For trigeminal neuralgia, 200-400 mg per day is prescribed on the first day, gradually increased by no more than 200 mg per day until the pain stops (on average 400-800 mg per day), and then reduced to the minimum effective dose.

For pain syndrome of neurogenic origin, the initial dose is 100 mg 2 times a day on the first day, then the dose is increased by no more than 200 mg per day, if necessary increasing it by 100 mg every 12 hours until the pain subsides. Maintenance dose - 200-1200 mg per day in several doses.

When treating elderly patients and patients with hypersensitivity, the initial dose is 100 mg 2 times a day.

Alcohol withdrawal syndrome: average dose - 200 mg 3 times a day; in severe cases, the dose can be increased to 400 mg 3 times a day during the first few days. At the beginning of treatment for severe withdrawal symptoms, it is recommended to prescribe in combination with sedative-hypnotics medicines(clomethiazole, chlordiazepoxide).

Diabetes insipidus: the average dose for adults is 200 mg 2-3 times a day. In children, the dose should be reduced according to the age and body weight of the child.

Diabetic neuropathy accompanied by pain: average dose - 200 mg 2-4 times a day. For the prevention of relapses of affective and schizoaffective psychoses - 600 mg per day in 3-4 doses.

For acute manic states and affective (bipolar) disorders, daily doses are 400-1600 mg. The average daily dose is 400-600 mg (in 2-3 doses). In acute manic states, the dose is increased quickly; for maintenance treatment of affective disorders, the dose is increased gradually (to improve tolerability).

Compound

Carbamazepine + excipients.

Release forms

Tablets 200 mg.

Carbamazepine- an antiepileptic drug (dibenzazepine derivative), which also has a normothimic, antimanic, antidiuretic effect (in patients with diabetes insipidus) and analgesic (in patients with neuralgia) effect.

The mechanism of action is associated with the blockade of voltage-gated Na channels, which leads to stabilization of the neuronal membrane, inhibition of the occurrence of serial neuronal discharges and a decrease in synaptic conduction of impulses. Prevents the re-formation of Na-dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases the reduced seizure threshold, etc. reduces the risk of developing an epileptic attack. Increases conductivity for K, modulates voltage-gated Ca channels, which can also determine the anticonvulsant effect of the drug. Corrects epileptic personality changes and, ultimately, increases the sociability of patients and promotes their social rehabilitation. It can be prescribed as the main therapeutic drug and in combination with other anticonvulsants. Effective for focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, for generalized tonic-clonic epileptic seizures, as well as a combination of these types (usually ineffective for small seizures - petit mal, absence seizures and myoclonic seizures) .

In patients with epilepsy (especially children and adolescents), it has been noted positive influence on symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness. The effect on cognitive function and psychomotor performance is dose dependent and highly variable.

The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism). In case of essential and secondary neuralgia of the trigeminal nerve, in most cases it prevents the occurrence of painful attacks. Effective for relieving neurogenic pain from tabes spinal cord, post-traumatic paresthesia and postherpetic neuralgia. Relief of pain in trigeminal neuralgia is observed after 8-72 hours. In case of alcohol withdrawal syndrome, it increases the threshold convulsive readiness(which at this state usually reduced) and reduces the severity of clinical manifestations of the syndrome ( increased excitability, tremor, gait disturbances).

In patients with diabetes insipidus, it leads to rapid compensation of water balance, reduces diuresis and the feeling of thirst.

The antipsychotic (antimanic) effect develops after 7-10 days and may be due to inhibition of the metabolism of dopamine and norepinephrine.

Pharmacokinetics

Absorption is slow, but quite complete (food intake does not affect the speed and extent of absorption). In the cerebrospinal fluid (hereinafter referred to as CSF) and saliva, concentrations are created in proportion to the amount of active substance not bound to proteins (20-30%). Penetrates through the placental barrier. The concentration in breast milk is 25-60% of that in plasma. Metabolized in the liver, mainly along the epoxide pathway with the formation of the main metabolites: active - carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. A low-active metabolite, 9-hydroxy-methyl-10-carbamoylacridan, is also formed. Can induce its own metabolism. The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine.

Excreted in the form of inactive metabolites in urine (70%) and feces (30%). There is no evidence that the pharmacokinetics of carbamazepine changes in elderly patients. Data on the pharmacokinetics of carbamazepine in patients with impaired renal or hepatic function are not yet available.

Indications

• epilepsy (excluding absence seizures, myoclonic or flaccid seizures) - partial seizures with complex and simple symptoms, primary and secondary generalized forms of seizures with tonic-clonic seizures, mixed forms of seizures (monotherapy or in combination with other anticonvulsants);
• idiopathic trigeminal neuralgia;
• trigeminal neuralgia in multiple sclerosis;
• idiopathic glossopharyngeal neuralgia;
• alcohol withdrawal syndrome;
• treatment of affective disorders;
• polydipsia and polyuria in diabetes insipidus;
• pain syndrome in diabetic polyneuropathy;
• prevention of phasic affective disorders (manic-depressive psychosis, schizoaffective disorders, etc.).

Contraindications

• hypersensitivity to carbamazepine and chemically similar drugs (tricyclic antidepressants) or to any other component of the drug;
• acute intermittent porphyria (including history);
• simultaneous use of monoamine oxidase inhibitors (hereinafter referred to as MAO inhibitors) and for 2 weeks after their discontinuation;
• violation of bone marrow hematopoiesis;
• atrioventricular block;
• pregnancy;
• lactation period.

special instructions

Before starting treatment, it is necessary to conduct a general blood test (including platelet and reticulocyte counts), a general urinalysis, and determine the level of iron, concentrations of electrolytes and urea in the blood serum. Subsequently, these indicators should be monitored weekly during the first month of treatment and then monthly. When prescribed to patients with increased intraocular pressure, periodic monitoring is necessary. Non-progressive asymptomatic leukopenia does not require discontinuation, however, treatment should be discontinued if progressive leukopenia or leukopenia accompanied by clinical symptoms infectious disease.

Information about the possible effect of a medicinal product for medical use on the ability to drive vehicles and machinery. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Side effect

• dizziness;
• ataxia;
• drowsiness;
• general weakness;
• headache;
• tics;
• nystagmus;
• oculomotor disorders;
• peripheral neuritis;
• paresthesia;
• muscle weakness and paresis;
• hallucinations;
• depression;
• loss of appetite;
• anxiety;
• aggressive behavior;
• excitation;
• disorientation;
• activation of psychosis;
• hives;
• exfoliative dermatitis;
• erythroderma;
• lupus-like syndrome;
• Stevens-Johnson syndrome;
• photosensitivity;
• multiform and erythema nodosum;
• aseptic meningitis with myoclonus;
• anaphylactic reaction;
• angioedema;
• pulmonary hypersensitivity reactions characterized by fever, shortness of breath, pneumonitis or pneumonia;
• leukopenia, thrombocytopenia, eosinophilia, leukocytosis, lymphadenopathy, agranulocytosis, aplastic anemia;
• nausea, vomiting;
• dry mouth;
• diarrhea or constipation;
• abdominal pain;
• glossitis;
• stomatitis;
• pancreatitis;
• intracardiac conduction disorders;
• decrease or increase in blood pressure;
• bradycardia;
• arrhythmias;
• atrioventricular block with fainting;
• collapse;
• worsening or development of congestive heart failure;
• exacerbation of coronary heart disease (including the appearance or increase in frequency of angina attacks);
• thrombophlebitis;
• thromboembolic syndrome;
• swelling;
• weight gain;
• increased prolactin levels (may be accompanied by galactorrhea and gynecomastia);
• hypercholesterolemia and hypertriglyceridemia;
• interstitial nephritis;
• renal failure;
• impaired renal function (albuminuria, hematuria, oliguria, increased urea/azotemia);
• frequent urination;
• urinary retention;
• sexual dysfunction/impotence;
• arthralgia;
• violations taste sensations;
• cataract;
• conjunctivitis;
• changes in the perception of pitch;
• skin pigmentation disorders;
• purpura;
• acne;
• sweating;
• alopecia.

Drug interactions

Carbamazepine increases the activity of microsomal liver enzymes and may reduce the effectiveness of drugs metabolized in the liver. Co-administration of carbamazepine with CYP3A4 inhibitors may lead to an increase in its concentration in the blood plasma. Combined use with CYP3A4 inducers can lead to an acceleration of the metabolism of carbamazepine and a decrease in its concentration in the blood plasma; on the contrary, their cancellation can reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

Increase the concentration of carbamazepine in plasma: verapamil, diltiazem, felodipine, dextropropoxyphene, viloxazine, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazol, desipramine, nicotinamide (in adults, only in high doses); macrolides (erythromycin, josamycin, clarithromycin, troleandomycin); azoles (itraconazole, ketoconazole, fluconazole), terfenadine, loratadine, isoniazid, propoxyphene, grapefruit juice, viral protease inhibitors used in HIV therapy. Felbamate reduces the plasma concentration of carbamazepine and increases the concentration of carbamazepine-10,11-epoxide, and a simultaneous decrease in the serum concentration of felbamate is possible. The concentration of carbamazepine is reduced by phenobarbital, phenytoin, primidone, methsuximide, fensuximide, theophylline, rifampicin, cisplastin, doxirubicin, possibly: clonazepam, valpromide, valproic acid, oxcarbazepine and herbal preparations, containing St. John's wort (Hypericum perforatum). There are reports of the possibility of valproic acid and primidone displacing carbamazepine from binding to plasma proteins and increasing the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). Isotretinoin alters the bioavailability and/or clearance of carbamazepine and carbamazepine-10,11-epoxide (monitoring of carbamazepine plasma concentrations is necessary). Carbamazepine may reduce plasma concentrations (reduce or even completely eliminate effects) and require dose adjustment the following drugs: clobazam, clonazepam, ethosuximide, primidone, valproic acid, alprazolam, glucocorticosteroids (prednisolone, dexamethasone), cyclosporine, doxycycline, haloperidol, methadone, oral medications containing estrogens and/or progesterone (selection required alternative methods contraception), theophylline, oral anticoagulants (warfarin, phenprocoumon, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors used in the treatment of HIV infection (indinavir , ritonavir, saquinovir), calcium channel blockers (dihydropyridone group, for example, felodipine), itraconazole, levothyroxine, midazolam, olazapine, praziquantel, risperidone, tramadol, ciprasidone. There are reports that while taking carbamazepine, the level of phenytoin in the blood plasma may either increase or decrease, and the level of mephenytoin may increase (in rare cases). Carbamazepine for joint use with paracetamol increases the risk of its toxic effect on the liver and reduces therapeutic effectiveness (acceleration of paracetamol metabolism). The simultaneous administration of carbamazepine with phenothiazine, pimozide, thioxanthenes, molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to an increased inhibitory effect on the central nervous system and a weakening of the anticonvulsant effect of carbamazepine. Concomitant administration with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied clinical manifestations. Reduces the effects of non-depolarizing muscle relaxants (pancuronium). Reduces ethanol (alcohol) tolerance. Speeds up metabolism indirect anticoagulants, hormonal contraceptives, folic acid; praziquantel may enhance the elimination of thyroid hormones. Accelerates the metabolism of general anesthesia agents (enflurane, halothane, fluorothane) with an increased risk of hepatotoxic effects; enhances the formation of nephrotoxic metabolites of methoxyflurane. Strengthens the hepatotoxic effect of isoniazid.

Analogues of the drug Carbamazepine

Structural analogues of the active substance:

• Actinerval;
• Apo Carbamazepine;
• Zagretol;
• Zeptol;
• Carbalepsin retard;
• Carbamazepine Nycomed;
• Carbamazepine Acri;
• Carbamazepine Ferein;
• Carbapin;
• Karbasan retard;
• Mazepin;
• Stazepin;
• Storilat;
• Tegretol;
• Tegretol CR;
• Finlepsin;
• Finlepsin retard;
• Epial.

Use in children

Use is possible in children over 3 years of age according to the dosage regimen.

Use during pregnancy and breastfeeding

When pregnancy occurs (when deciding whether to prescribe carbamazepine during pregnancy), it is necessary to carefully compare the expected benefits of therapy and its possible complications, especially in the first 3 months of pregnancy. It is known that children born to mothers with epilepsy are predisposed to disorders of intrauterine development, including malformations.

Carbamazepine, like all other antiepileptic drugs, may increase the risk of these disorders. There are isolated cases reported congenital diseases and developmental defects, including spina bifida and hypospadias. Patients should be provided with information about the possibility of an increased risk of malformations and the opportunity to undergo antenatal diagnosis.

Antiepileptic drugs increase folic acid deficiency, which is often observed during pregnancy, which may contribute to an increase in the incidence of birth defects in children (before and during pregnancy, supplemental folic acid is recommended). In order to prevent increased bleeding in newborns, it is recommended that women in the last weeks of pregnancy, as well as newborns, be prescribed vitamin K1.

Carbamazepine passes into breast milk; the benefits should be weighed against the possible undesirable consequences breastfeeding during ongoing therapy. Mothers taking carbamazepine may breastfeed their infants, provided that the infant is monitored for possible developmental adverse reactions(for example, severe drowsiness, allergic skin reactions).

Self-medication can be harmful to your health.
You should consult your doctor and read the instructions before use.

Carbamazepine: instructions for use

Description: The tablets are white or white with a yellowish tint, flat-cylindrical, chamfered, with a score on one side.

What is CARBAMAZEPINE and what does it contain?

CARBAMAZEPINE belongs to the pharmacotherapeutic group of antiepileptic drugs. ATC code N03AF01.

Each CARBAMAZEPINE tablet contains: active substance - carbamazepine 200 mg, excipients: microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium lauryl sulfate.

How CARBAMAZEPINE interacts with the body

CARBAMAZEPINE is a broad-spectrum antiepileptic drug with central muscle relaxant and sedative properties. Improves the mental state and mood of patients. The drug acts primarily on the central nervous system, providing antiepileptic activity in various types of epilepsy (generalized and focal forms).

Indications for use

epilepsy: partial seizures with elementary symptoms (focal seizures); partial seizures with complex symptoms (psychomotor seizures); grand mal seizures, mainly of focal origin (grand mal seizures during sleep, diffuse grand mal seizures); mixed forms of epilepsy;

trigeminal neuralgia;

paroxysmal pain of unknown cause arising on one side of the root of the tongue, pharynx and soft palate (genuine glossopharyngeal neuralgia);

pain due to damage to peripheral nerves due to diabetes mellitus (pain due to diabetic neuropathy);

epileptiform convulsions in multiple sclerosis, such as spasms of the facial muscles in trigeminal neuralgia, tonic convulsions, paroxysmal speech and movement disorders (paroxysmal dysarthria and ataxia), discomfort (paroxysmal paresthesia) and attacks of pain;

prevention of the development of convulsive seizures during alcohol withdrawal syndrome;

psychoses (mainly in manic-depressive states, hypochondriacal depression). Secondary prevention of affective and schizoaffective psychoses.

Inside, during or after meals, with a small amount of liquid

For epilepsy, where possible, carbamazepine should be prescribed as monotherapy.

In the case when carbamazepine is added to existing antiepileptic therapy, this should be done gradually, while the doses of the drugs used are not changed or, if necessary, adjusted.

CARBAMAZEPINE is contraindicated in the following pathology

Atrioventricular block.

Treatment with MAO inhibitors for 14 days before starting treatment with carbamazepine.

Liver failure.

Acute recurrent porphyria.

Hypersensitivity to carbamazepine or chemically similar drugs (for example, tricyclic antidepressants) or to other components of the drug.

Possible side effects

CARBAMAZEPINE is an antiepileptic drug that causes the fewest side effects. However, in some cases, ataxia, dizziness, accommodation disorders, drowsiness, dry mouth, and diarrhea develop. Allergic reactions (rash, Stevens-Johnson syndrome), hair loss, leukopenia are possible. Rarely, especially in older people, cardiac conduction disorders, hematological changes, cholestatic hepatitis, edema and weight gain may occur, and in some cases an increase in seizures may occur. All these reactions are indications for discontinuation of the drug. In the elderly, especially at the beginning of treatment, confusion may occur, which usually resolves spontaneously after 1-2 weeks or after reducing the dose.

Interaction with other drugs

CARBAMAZEPINE should not be prescribed simultaneously with irreversible monoamine oxidase inhibitors (nialamide, etc., furazolidone) due to the possibility of increased side effects. Phenobarbital and hexamidine weaken the antiepileptic activity of carbamazepine. Increases the hepatotoxicity of isoniazid. Reduces the effects of anticoagulants, anticonvulsants (hydantoin derivatives or succinimides), barbiturates, clonazepam, primidone, valproic acid. Phenothiazines, pimozide, thioxanthenes increase central nervous system depression (convulsive threshold decreases), cimetidine, clarithromycin, diltiazem, verapamil, erythromycin, propoxyphene reduce metabolism (increases the risk toxic effect). Reduces the activity of corticosteroids, estrogens and estrogen-containing drugs oral contraceptives, quinidine, cardiac glycosides (induction of metabolism).

Overdose

Symptoms: disorientation, drowsiness, agitation, hallucinations and coma, blurred vision, dysarthria, nystagmus, ataxia, dyskinesia, hyper-/hyporeflexia, convulsions, myoclonus, hypothermia; respiratory depression, pulmonary edema; tachycardia, hypo-/hypertension, cardiac arrest accompanied by loss of consciousness; vomiting, decreased colonic motility; fluid retention in the body.

Treatment: consult a doctor immediately, induce vomiting or gastric lavage, prescribe activated charcoal and saline laxative, forced diuresis.

Precautionary measures

Before starting and during therapy, regular blood (cellular elements) and urine tests and monitoring of liver function indicators are recommended. Prescribe with caution if there is a history of heart, liver, kidney diseases, hematological disorders, increased intraocular pressure, latent psychosis, agitation, diseases characterized by seizures, in old age, transport drivers and people working with machinery. Women are advised to take additional folic acid (before or during pregnancy); in order to prevent increased bleeding in the last weeks of pregnancy and in newborns, it is possible to use vitamin

During treatment with antiepileptic drugs, depression may develop and mood changes. If you feel you are developing depression or have thoughts of suicide, contact your doctor immediately. Tell your relatives or close friends that you are starting to feel depressed and have fears.

Release form Tablets 200 mg.

Standard commercial packaging

30 or 50 tablets in a polymer jar. 1 can along with package insert in secondary packaging.

10 tablets in a blister pack. 3 or 5 blister packs along with an insert in secondary packaging.