Description of the drug CARBAMAZEPINE PHARMLAND
With simultaneous use of inhibitors of the CYP3A4 isoenzyme, an increase in the concentration of carbamazepine in the blood plasma is possible.
With the simultaneous use of inducers of the CYP3A4 isoenzyme system, it is possible to accelerate the metabolism of carbamazepine, reduce its concentration in the blood plasma, and reduce the therapeutic effect.
With simultaneous use, carbamazepine stimulates the metabolism of anticoagulants and folic acid.
When used simultaneously with valproic acid, a decrease in the concentration of carbamazepine and a significant decrease in the concentration of valproic acid in the blood plasma is possible. At the same time, the concentration of carbamazepine metabolite, carbamazepine epoxide, increases (probably due to inhibition of its conversion to carbamazepine-10,11-trans-diol), which also has anticonvulsant activity, so the effects of this interaction can be neutralized, but more often adverse reactions occur - blurred vision, dizziness, vomiting, weakness, nystagmus. With the simultaneous use of valproic acid and carbamazepine, a hepatotoxic effect may develop (apparently due to the formation of a minor metabolite of valproic acid, which has a hepatotoxic effect).
With simultaneous use, valpromide reduces the metabolism in the liver of carbamazepine and its metabolite carbamazepine-epoxide due to inhibition of the enzyme epoxide hydrolase. This metabolite has anticonvulsant activity, but with a significant increase in plasma concentration it can have a toxic effect.
When used simultaneously with verapamil, diltiazem, isoniazid, dextropropoxyphene, viloxazine, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazol, desipramine, nicotinamide (in adults, only in high doses), erythromycin, troleandomycin, josamycin, clarithromycin; with azoles (including itraconazole, ketoconazole, fluconazole), terfenadine, loratadine, it is possible to increase the concentration of carbamazepine in the blood plasma with the risk of side effects (dizziness, drowsiness, ataxia, diplopia).
When used simultaneously with hexamidine, the anticonvulsant effect of carbamazepine is weakened; with hydrochlorothiazide, furosemide - a decrease in sodium content in the blood is possible; with hormonal contraceptives - the effect of contraceptives may weaken and acyclic bleeding may develop.
When used simultaneously with thyroid hormones, it is possible to increase the elimination of thyroid hormones; with clonazepam - it is possible to increase the clearance of clonazepam and decrease the clearance of carbamazepine; with lithium preparations - a mutual enhancement of the neurotoxic effect is possible.
When used simultaneously with primidone, a decrease in the concentration of carbamazepine in the blood plasma is possible. There are reports that primidone may increase plasma concentrations of the pharmacologically active metabolite, carbamazepine 10,11-epoxide.
When used simultaneously with ritonavir, the side effects of carbamazepine may increase; with sertraline - a decrease in the concentration of sertraline is possible; with theophylline, rifampicin, cisplatin, doxorubicin - a decrease in the concentration of carbamazepine in the blood plasma is possible; with tetracycline - the effects of carbamazepine may be weakened.
With simultaneous use with felbamate, a decrease in the concentration of carbamazepine in the blood plasma is possible, but an increase in the concentration of the active metabolite of carbamazepine-epoxide, while a decrease in the plasma concentration of felbamate is possible.
When used simultaneously with phenytoin and phenobarbital, the concentration of carbamazepine in the blood plasma decreases. A mutual weakening of the anticonvulsant effect is possible, and in rare cases, its strengthening.
Possible side effects
Carbamazepine tablets usually do not cause unwanted reactions, however, like all medicines, they can sometimes cause side effects.
Some side effects may be serious
If any of the following adverse reactions develop after taking the drug, you should immediately stop taking them and consult a doctor:
- Serious skin reactions: rash, redness of the skin, blistering of the lips, eyes or mouth, peeling skin accompanied by fever. These adverse reactions are most likely to occur in people of Han (Chinese) and Thai descent.
- Mouth ulcers or unexplained bruising or bruising
- Sore throat and/or high fever
- Yellowing of the skin or whites of the eyes
- Swelling of the ankles, feet, or legs
- Any signs of nervous disorders or confusion
- Joint and muscle pain, rash on the bridge of the nose and cheeks, and breathing problems (these may be a sign of a rare side effect called lupus erythematosus)
- Fever, skin rash, joint pain, abnormal blood tests and liver function (these phenomena may be a sign of hypersensitivity with multiple organ damage)
- Bronchospasm with wheezing and cough, difficulty breathing, weakness, rash, itching or swelling of the face (these reactions may be a sign of a severe allergic reaction)
- Pain in the stomach
The following adverse reactions have also been reported
Very common: (≥1/10)
Leukopenia (decreased number of white blood cells, which are necessary to protect the body from infections); dizziness and increased fatigue; feeling unsteady or having difficulty controlling movements; nausea or vomiting; changes in liver enzyme levels (usually without any symptoms); skin reactions, which can be quite serious).
Frequent: (from ≥1/100 to <1/10)
changes in your blood, including an increased tendency to bruise or bleed; fluid retention and swelling; weight gain; decreased sodium levels in the blood, which may cause confusion; headache; double vision or blurred vision; dry mouth.
Uncommon (≥1/1000 to <1/100)
Abnormal involuntary movements, including tremors or tics; abnormal eye movements; diarrhea; constipation
Rare (≥1/10000 to <1/1000)
Damage to the lymph glands; folic acid deficiency; generalized allergic reactions, including rash, joint pain, fever, problems with the kidneys and other organs; hallucinations, depression; loss of appetite; anxiety; aggression; agitation; confusion; speech disorder; numbness or tingling in the arms and legs; muscle weakness; high blood pressure (which can cause dizziness and facial flushing, headaches, fatigue and nervousness); low blood pressure (symptoms: feeling weak, light-headed, dizzy, confused, blurred vision); heart rhythm disturbances; stomach ache; liver damage, including jaundice; lupus symptoms.
Very rare (≥1/100,000 to <1/10,000)
Changes in blood composition, including anemia; porphyria; meningitis; swelling of the mammary glands and milk production, which occurs in both men and women; abnormalities in thyroid analysis; osteomalacia (pain when walking and curvature of the long bones of the legs); osteoporosis; increased levels of lipids in the blood; taste disturbances; conjunctivitis; glaucoma; cataract; hearing impairment; cardiovascular problems, including deep vein thrombosis (DVT), the symptoms of which may include fatigue, pain, swelling, fever, changes in skin color and visibility of superficial veins; pulmonary and respiratory problems; serious skin reactions, including Stevens-Johnson syndrome (these reactions may occur more frequently in patients of Thai or Chinese descent); ulcers in the mouth and tongue; liver failure; increased skin sensitivity to sunlight; changes in skin pigmentation; acne; increased sweating; hair loss; excess hair growth on the face and body; muscle pain or cramps; sexual problems that may further affect male fertility, loss of libido or impotence; renal failure; drops of blood in the urine, frequent/infrequent or difficult urination.
The following symptoms have also been reported, but their frequency cannot be estimated from the available data:
Serious skin reactions accompanied by feeling unwell and changes in blood test results. Diarrhea, abdominal pain and fever (signs of colon inflammation), recurrence of herpes infection (may be important if the immune system is weakened), complete loss of nails, fractures, decreased bone density, drowsiness, memory loss, purple or red purple bumps that may cause itching.
There is no need to worry about these side effects. Most people taking carbamazepine do not experience the reactions described.
If any of the symptoms bother you or you notice a side effect not listed in this leaflet, please consult your doctor.
Your doctor will choose the most optimal treatment for you and may prescribe a different drug.
Symptoms of bone disorders have also been reported, including osteomalacia and osteoporosis (thinning of the bones) and fractures. Check with your doctor or pharmacist if you are on long-term treatment with antiepileptic drugs, have had symptoms of osteoporosis, or have taken steroid medications.
Side Effect Reporting:
Tell your doctor or pharmacist if you notice any side effects, including any side effects not listed in this leaflet. You can also report side effects to , by going to the website www.arpimed.com and filling out the appropriate form “Report a side effect or ineffectiveness of a drug” or directly to the Scientific Center for Expertise of Medicines and Medical Technologies named after Academician E. Gabrielyan, going to website: www.pharm.am to the section “Report a side effect of a drug” and fill out the form “Card for reporting a side effect of a drug” Hotline phone: +37410237665; +37498773368. By reporting side effects, you can help provide more information about the safety of this drug.
How to store Carbamazepine
- Store out of reach of children, protected from moisture and light at a temperature of 15-250C
- Do not take Carbamazepine after the expiration date indicated on the drug package. When indicating the expiration date, we mean the last day of the specified month
- Shelf life - 3 years
Medicines should not be disposed of in wastewater or sewer systems. Ask your pharmacist how to dispose of any medicine you no longer need. These measures are aimed at protecting the environment.
Package contents and additional information
What Carbamazepine contains
Active substance: carbamazepine – 200 mg per tablet;
Other components: microcrystalline cellulose, sodium carmellose, magnesium stearate, Aerosil 200
What Carbamazepine looks like and contents of the pack
Round biconvex tablets of white or almost white color with a score on one side; without smell
Description of packaging
Cardboard packaging containing 50 tablets in strip packaging (PVC/aluminium)
5 blister packs of 10 tablets each, together with an insert, are placed in a cardboard package.
Cardboard packaging containing 40 tablets in a blister pack (PVC/aluminum).
4 blister packs of 10 tablets each, together with the package insert, are placed in a cardboard package.
Vacation conditions
Dispensed by prescription.
Cautions and contraindications
- You need to watch for bleeding, bruising, mouth ulcers, infections, and fever. Taking carbamazepine increases the risk of aplastic anemia and agranulocytosis by 5-8 times.
- Use cautiously with MAOIs.
- May cause exacerbation of angle-closure glaucoma.
- Reduces the effectiveness of hormonal contraceptives.
- Restriction of fluid intake may be necessary due to the risk of interfering with antidiuretic hormone production.
- Cannot be used if the patient has a history of bone marrow suppression.
- Do not use if the patient is allergic to any tricyclic compounds.
Indications
Ministry of Health of Russia
- E23.2 Diabetes insipidus
- F10.3 Withdrawal state
- F30 Manic episode
- F31 Bipolar affective disorder
- G35 Multiple sclerosis
- G40 Epilepsy
- G40.1 Localized (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
- G40.2 Localized (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
- G40.3 Generalized idiopathic epilepsy and epileptic syndromes
- G50.0 Trigeminal neuralgia
- G52.1 Lesions of the glossopharyngeal nerve
- G63.2 Diabetic polyneuropathy (E10-E14+ with common fourth character .4)
- R35 Polyuria
- R52.9 Pain, unspecified
- R63.1 Polydipsia
FDA recommendations
- Partial seizures with complex symptoms
- Generalized tonic-clonic seizures (grand mal)
- Mixed seizures
- Trigeminal neuralgia pain
- Acute episode of mania/mixed mania
UK Medicines and Healthcare Products Regulatory Agency guidelines
- Generalized tonic-clonic and partial seizures
- Trigeminal neuralgia pain
- Prevention of manic-depressive psychosis in patients not responding to lithium treatment
Treatment regimen
Dosage and dose selection
- 400-1200 mg/day
- Children under 6 years: 10-20 mg/kg per day
Bipolar disorder, seizures (adults, children over 13): Start with 200 mg twice daily; increase every week by 200 mg/day in several doses; maximum for adults 1200 mg/day; maximum for children 13-15 years old – 1000 mg/day; some patients may require doses up to 1600 mg/day.
Trigeminal neuralgia pain: start with 100 mg twice daily; increase every week by 200 mg/day in divided doses.
- Best taken with food
- Slowly increasing the dose delays the onset of the therapeutic effect, but increases tolerance to sedative side effects
- If other sedatives are being taken, increase the dose slowly
- Over time, after several weeks of treatment, dose adjustment is required
How quickly does it work?
Response to acute mania may occur within a few weeks.
It may take several months for your mood to stabilize.
Cramps should stop after 2 weeks.
Expected Result
Disappearance of symptoms.
Treatment can be continued indefinitely to prevent mania or seizures.
If it doesn't work
(for bipolar disorder)
Increase the dose;
Switch to another drug or add another drug;
Connect psychotherapy;
Determine if there is a comorbid condition
How to stop taking it
Reduce the dose gradually. Abruptly stopping use increases the risk of bipolar disorder relapse. In epilepsy, abrupt cessation can trigger seizures [1].
Treatment combinations
- Lithium
- Valproic acid
- Atypical antipsychotics
- Lamotrigine
- Antidepressants (with caution, as there is a risk of mood destabilization) [1].
Side effects and other risks
Mechanism of side effects
The causes of side effects of carbamazepine are theoretically associated with excessive effects on voltage-gated sodium channels.
Major metabolites may cause side effects.
Side effects
- Sedation, dizziness, confusion, unsteadiness, headache.
- Diarrhea, nausea, vomiting
- Leukopenia
- Rash
- Dangerous side effects: aplastic anemia, agranulocytosis, purpura, Stevens-Johnson syndrome, Parhon syndrome with hyponatremia.
- Weight gain: yes, but infrequently
- Sedation: yes, and may be significant and, for some patients, excessively strong
What to do about side effects
- Wait;
- Take in the evening to avoid sedation;
- To avoid irritation to the stomach, take with food;
- Switch to another drug [1].
Long term use
Reduces libido;
Monitoring the functioning of the liver, kidneys, and thyroid gland is required, as well as regular general blood tests and sodium level measurements.
addictive
No.
Overdose
May be fatal; nausea, vomiting, involuntary movements, cardiac arrhythmias, difficulty breathing, sedation, coma.
Special patient groups
Patients with kidney problems
The dose needs to be reduced [1].
Patients with liver disease
Use with caution [1].
Patients with heart disease
Use with caution [1].
Elderly patients
In older people, side effects are more pronounced.
Children and teenagers
- Approved for use in epilepsy.
- Children 6-12 years: initial dose 100 mg twice daily; increase every week by 100 mg/day in several doses; maximum dose 1000 mg/day; maintenance dose 400-800 mg/day.
- Children 5 years and younger: initial dose 10-20 mg/kg per day 2-3 times daily; increase every week if there is a need; maximum dose 35 mg/kg/day.
Pregnant
- In the first trimester, it increases the risk of fetal developmental abnormalities. If treatment continues, tests should be performed to identify pregnancy pathologies. To reduce the risk, you should start taking folic acid (1 mg/day) earlier than usual.
- For bipolar disorder, carbamazepine should be discontinued until pregnancy occurs. During pregnancy, atypical antipsychotics are preferred.
Breast-feeding
- It is recommended that you stop taking carbamazepine or stop breastfeeding.
Carbamazepine
Carbamazepine
Registration number: P N001134/01-110908
Trade name : CARBAMAZEPINE
International nonproprietary name : carbamazepine
Dosage form : tablets
Composition : one tablet contains 200 mg of carbamazepine as an active substance; excipients - ludipress (lactose monohydrate, povidone, crospovidone), magnesium stearate, calcium monohydrate, potato starch.
Description : tablets of white or white with a yellowish tint, flat-cylindrical in shape with a chamfer and a score.
Pharmacotherapeutic group : antiepileptic drug.
ATX code [NO3AF01].
Pharmacological properties:
Armacodynamics :
An antiepileptic drug, a derivative of dibenzazepine, which has normothimic, antimanic and analgesic effects. Activates the central inhibitory GABAergic system. Blocks voltage-dependent sodium channels of nerve cell membranes, which leads to functional stabilization of neurons, reduces the activity of excitatory neurotransmitter acids (glutamate, aspartate), interacts with central adenosine receptors (suppression of adenylate cyclase activation). Increases the seizure threshold, corrects epileptic personality changes. In diabetes insipidus, it reduces diuresis and thirst (due to the antidiuretic effect).
Pharmacokinetics:
Absorption is slow, but quite complete (food intake does not affect the speed and extent of absorption). After a single dose, the maximum concentration (Cmax) is reached after 12 hours. Equilibrium concentrations of the drug in plasma are achieved after 1-2 weeks. Concentrations of carbamazepine - 10,11 - epoxide (pharmacologically active metabolite) are about 30% of the concentration of carbamazepine. The connection with plasma proteins in children is 55 - 59%, in adults - 70 - 80%. 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. The half-life (T1/2) of a single dose is 25-65 hours (on average about 36 hours), after repeated doses - 12-24 hours. In patients receiving additional other anticonvulsants, T1/2 is on average 9-10 hours. It is 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 antiepileptic drugs); 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), concomitant use of monoamine oxidase inhibitors (hereinafter referred to as MAO inhibitors) and within 2 weeks after their withdrawal, disorders of bone marrow hematopoiesis, atrioventricular block, pregnancy and lactation.
With caution - dilution hyponatremia, old age, alcohol intake, suppression of bone marrow hematopoiesis while taking medications (history); prostatic hyperplasia, increased intraocular pressure, severe heart failure, liver failure, chronic renal failure.
Directions for use and doses:
Orally, regardless of food intake, with a small amount of liquid.
For epilepsy: whenever 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.
For adults, the initial dose is 100-200 mg 1-2 times a day. Then the dose is slowly increased to 400 mg 2-3 times a day. The maximum daily dose is 1600 – 2000 mg.
For children, the average daily dose is determined at the rate of 10-20 mg/kg body weight per day and is: for children aged 4 months to 1 year - 100-200 mg per day, from 1 year to 5 years - 200-400 mg (in 1-2 doses), from 6 to 10 years – 400-600 mg (in 2-3 doses), for 11-15 years – 600-1000 mg (in 2-3 doses).
For trigeminal neuralgia and neurogenic pain syndrome: 100-200 mg 2 times a day, then the dose is gradually increased by no more than 200 mg per day until the pain stops (on average, up to 600-800 mg), then reduced to the minimum effective doses. The effect usually occurs 1 to 3 days after the start of treatment.
The drug is prescribed for a long time: if the drug is discontinued prematurely, the pain may recur. When treating elderly patients, the initial dose is 100 mg 2 times a day.
Alcohol withdrawal syndrome: average dose – 200 mg 3 times a day. In severe cases, in the first days the dose can be increased to 400 mg 3 times a day. At the beginning of treatment for severe withdrawal symptoms, it is prescribed in combination with detoxification therapy and sedative-hypnotics.
Diabetes insipidus: average dose for adults – 200 mg 2 – 3 times a day. Diabetic neuropathy accompanied by pain: 200 mg 2 – 4 times a day.
For the prevention of affective disorders: in the first week, the daily dose is 200 – 400 mg. Subsequently, the dose is increased by 200 mg per week, bringing it to 1 g/day. The daily dose is evenly divided into 3-4 doses.
The transition to carbamazepine treatment should be gradual, with a reduction in the dose of the previous drug. Treatment should be stopped gradually. The duration of treatment is determined by the doctor.
Side effect:
From the central nervous system: dizziness, ataxia, drowsiness, general weakness, headache, accommodation paresis, tremor, tics, nystagmus, orofacial dyskinesia, oculomotor disorders, dysarthria, choreoathetoid disorders, peripheral neuritis, paresthesia, muscle weakness and paresis.
From the mental sphere: hallucinations, depression, loss of appetite, anxiety, aggressive behavior, agitation, disorientation, activation of psychosis.
Allergic reactions: urticaria, exfoliative dermatitis, erythroderma, lupus-like syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, erythema multiforme and erythema nodosum. Multiorgan delayed-type hypersensitivity reactions with fever, skin rash, vasculitis, lymphadenopathy, lymphoma-like features, arthralgias, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function tests (these manifestations occur in various combinations) are possible. Other organs may also be involved (eg, lungs, kidneys, pancreas, myocardium, colon). Very rarely - aseptic meningitis with myoclonus, anaphylactic reaction, angioedema, pulmonary hypersensitivity reactions characterized by fever, shortness of breath, pneumonitis or pneumonia.
From the hematopoietic organs: leukopenia, thrombocytopenia, eosinophilia, leukocytosis, lymphadenopathy; agranulocytosis, aplastic anemia, true erythrocyte aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia.
From the digestive system (hereinafter referred to as the gastrointestinal tract): nausea, vomiting, dry mouth, diarrhea or constipation, abdominal pain, glossitis, stomatitis, pancreatitis.
From the liver: increased activity of gamma-glutamyltransferase (usually has no clinical significance), increased activity of alkaline phosphatase and “liver” transaminases, hepatitis (granulomatous, cholestatic, parenchymal (hepatocellular) or mixed type); liver failure.
From the cardiovascular system (hereinafter referred to as CVS): 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 increased frequency of angina attacks), thrombophlebitis, thromboembolic syndrome.
From the endocrine system and metabolism: edema, weight gain, hyponatremia, increased prolactin levels (may be accompanied by galactorrhea and gynecomastia); a decrease in the level of L-thyroxine (free T4, T3) and an increase in the level of thyroid-stimulating hormone (TSH) (usually not accompanied by clinical manifestations), disorders of calcium-phosphorus metabolism in bone tissue (decrease in the concentration of Ca2+ and 25-OH-cholecalciferol in the blood plasma); osteomalacia; hypercholesterolemia and hypertriglyceridemia.
From the genitourinary system: interstitial nephritis, renal failure, renal dysfunction (albuminuria, hematuria, oliguria, increased urea/azotemia), frequent urination, urinary retention, sexual dysfunction/impotence.
From the musculoskeletal system: arthralgia, myalgia or convulsions.
From the senses: disturbances of taste, clouding of the lens, conjunctivitis; hyper- or hypoacusia, changes in the perception of pitch.
Other: skin pigmentation disorders, purpura, acne, sweating, alopecia.
Overdose:
Symptoms: usually reflect disorders of the central nervous system, cardiovascular system and respiratory system.
From the central nervous system and sensory organs: depression of central nervous system functions, disorientation, drowsiness, agitation, hallucinations, fainting, coma; visual disturbances (“fog” before the eyes), dysarthria, nystagmus, ataxia, dyskinesia; convulsions, psychomotor disorders, myoclonus, mydriasis.
From the cardiovascular system: tachycardia, decreased blood pressure, sometimes increased blood pressure, intraventricular conduction disturbances with widening of the QRS complex; heart failure.
From the respiratory system: pulmonary edema.
From the digestive system: nausea and vomiting, delayed evacuation of food from the stomach.
From the urinary system: urinary retention, oliguria or anuria; fluid retention; dilution hyponatremia.
Laboratory indicators: leukocytosis or leukopenia, hyponatremia, metabolic acidosis, hyperglycemia and glycosuria, increased CPK muscle fraction.
Treatment: there is no specific antidote. Gastric lavage, administration of activated charcoal (late evacuation of gastric contents can lead to delayed absorption for 2-3 days and reappearance of intoxication symptoms), symptomatic therapy. Forced diuresis, hemodialysis and peritoneal dialysis are ineffective (dialysis is indicated for a combination of severe poisoning and renal failure). Children may require exchange transfusions. It is recommended to carry out hemosorption on carbon sorbents.
Interaction with other drugs:
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, cisplastine, 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 the effects) and require dose adjustment of the following drugs: clobazam, clonazepam, ethosuximide, primidone, valproic acid, alprazolam, glucocorticosteroids (prednisolone, dexamethasone), cyclosporine, doxycycline, haloperidol, methadone, oral drugs containing estrogens and/or progesterone (selection of alternative methods of contraception is necessary), 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, when used together 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 by clinical manifestations. Reduces the effects of non-depolarizing muscle relaxants (pancuronium). Reduces ethanol tolerance. Accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid; praziquantel may enhance the elimination of thyroid hormones. Accelerates the metabolism of general anesthesia agents (enflurane, halothane, ftorotan) with an increased risk of hepatoxic effects; enhances the formation of nephrotoxic metabolites of methoxyflurane. Strengthens the hepatotoxic effect of isoniazid.
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 of an infectious disease occurs. Sudden cessation of carbamazepine may trigger epileptic seizures. Before prescribing carbamazepine and during treatment, liver function testing is necessary. If existing liver dysfunction worsens or active liver disease develops, the drug should be discontinued immediately. The possibility of activation of latent psychoses should be taken into account, and in elderly patients, the possibility of developing disorientation or agitation.
During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. It is recommended to stop drinking alcohol.
Release form : tablets 200 mg. 10 tablets in a blister pack or 40 tablets in a glass jar or 50 tablets in a polymer jar.
5 contour blister packs or one jar made of glass or polymer material along with instructions for use in a cardboard pack.
Conditions for dispensing from pharmacies: by prescription.
Storage conditions:
List B. In a dry place, protected from light, at a temperature not exceeding 25°C.
Best before date:
2 years. Do not use after the expiration date.
Units:
pack
