Composition, form of production and packaging
Tablets of prolonged action, covered with a film coat of light brown color, round, biconcave, with a risk on one side.
1 tab.
carbamazepine 200 mg
Excipients: ethyl cellulose M50 - 11.5 mg, cellulose microcrystalline - 33.75 mg, corn starch - 1.8 mg, talc purified - 10.5 mg, silicon dioxide colloid - 2.5 mg, croscarmellose sodium 2.5 mg, magnesium stearate 2.5 mg.
Composition of the shell: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate [1: 2: 1] (Eudragit E-100) 2.5 mg, talc purified 2.15 mg, macrogol 6000 (0.51 g polyethylene glycol) 0.5 mg titanium dioxide 2 mg magnesium stearate - 1 mg, iron oxide red oxide - 0.1 mg, ferric oxide yellow oxide - 0.25 mg.
10 pieces. - Strips of aluminum foil (3) - packs of cardboard.
Tablets of prolonged action, covered with a film coat of light brown color, round, biconcave, with a risk on one side.
1 tab.
carbamazepine 400 mg
Auxiliary substances: ethylcellulose M50 - 45 mg, microcrystalline cellulose 27.5 mg, hypromellose 2208 (Methocel K4M) 25 mg, corn starch 10 mg, talc purified 20 mg, silicon dioxide colloid 5 mg, croscarmellose sodium 10 mg, magnesium stearate - 5 mg.
Sheath composition: copolymer of butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate [1: 2: 1] (Eudragit E-100) -3 mg, talc purified 4.3 mg, macrogol 6000 (polyethylene glycol 6000) 1 mg, titanium dioxide 4 mg, magnesium stearate - 2 mg, iron oxide red oxide - 0.2 mg, ferric oxide yellow oxide - 0.5 mg.
10 pieces. - Strips of aluminum foil (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The derivative of iminostilbene, which has a pronounced anticonvulsant (antiepileptic) effect, and also to a moderate degree antipsychotic, antidepressant (timoanaleptic) and normotimicheskim action. In addition, it has an analgesic effect, especially in trigeminal neuralgia. The mechanism of action has been studied in part.
Presumably, anticonvulsant action is associated with a decrease in the ability of neurons, maintain a high frequency of development of repeated action potentials through inactivation of sodium channels. In addition, it seems that inhibition of the release of neurotransmitters by blocking the presynaptic sodium channels and the development of action potentials, which in turn reduces the synaptic transmission, is important.
The mechanisms of action may involve gamma-aminobutyric acid (GABA) receptors, which can be linked to calcium channels; Also, apparently, the effect of carbamazepine on the systems of neurotransmitter modulators is important. The antidiuretic effect of carbamazepine may be related to the hypothalamic effect on osmoreceptors, which is mediated through the secretion of the antidiuretic hormone, and is also due to direct action on the renal tubules.
Effective in focal (partial) epileptic attacks (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, and also with a combination of these types of seizures (usually ineffective in small attacks - petit mal, absences and myoclonic seizures ).
Patients with epilepsy (especially in children and adolescents) have a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness. Influence on cognitive function and psychomotor parameters depends on the dose. The onset of an anticonvulsant effect varies from a few hours to several days (sometimes up to 1 month due to autoinduction of metabolism).
In the case of essential and secondary neuralgia of the trigeminal nerve, in most cases it prevents the occurrence of painful attacks. Relaxation of pain in trigeminal neuralgia is noted after 8-72 hours.
With alcohol withdrawal syndrome, it increases the threshold of convulsive readiness, which is usually reduced in this condition, and reduces the severity of clinical manifestations of the syndrome (increased excitability, tremor, gait disturbance). Antipsychotic (antimanic) action develops after 7-10 days, may be due to the inhibition of the metabolism of dopamine and norepinephrine. The prolonged dosage form ensures the maintenance of a more stable concentration of carbamazepine in the blood when taken 1-2 times / day.
PHARMACOKINETICS
Absorption is 72-96%. C max in blood plasma is achieved after 6-24 hours. Binding to plasma proteins is about 75%. T 1/2 from 30 to 40 hours. It is metabolized in the liver, mainly along the epoxide route, with the formation of the main metabolites: active carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. A low-active metabolite of 9-hydroxy-methyl-10 carbamoylacridan is also formed. The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine. In the cerebrospinal fluid (further CSF) and saliva, concentrations are created in proportion to the amount of the active substance unbound with proteins (20-30%). Penetrates through the placental barrier. Concentration in breast milk is 25-60% of that in plasma. It is excreted as inactive metabolites with urine (70%) and feces (30%).
It is an inducer of hepatic enzymes and stimulates its own metabolism. There is no evidence that the pharmacokinetics of carbamazepine change in elderly patients.
Data on the pharmacokinetics of carbamazepine in patients with impaired renal or hepatic function are not yet sufficient.
INDICATIONS
- Epilepsy: complex or simple partial epileptic seizures (with or without loss of production) with secondary generalization or without it; generalized tonic-clonic epileptic seizures; mixed forms of epileptic seizures;
- trigeminal neuralgia and neurogenic pain syndrome;
- Pain in the defeat of peripheral nerves in diabetes mellitus, pain in diabetic neuropathy, polyuria and polydipsia of neurohormonal nature in diabetes insipidus of central genesis;
- idiopathic neuralgia of the trigeminal nerve and trigeminal neuralgia in multiple sclerosis (typical and atypical); idiopathic neuralgia of the glossopharyngeal nerve;
- alcohol withdrawal syndrome;
- acute manic conditions and maintenance therapy of bipolar affective disorders with the purpose of preventing exacerbations or alleviating clinical manifestations of exacerbation.
DOSING MODE
Inside. The drug can be taken during, after meals or in between meals with a small amount of liquid.
The drug can be used as a monotherapy or as part of a combination therapy.
Tablets of prolonged action (whole tablet or half if prescribed by a doctor) should be swallowed whole, without chewing, squeezed with a small amount of liquid, tk.the active substance is released from the tablets of prolonged action slowly and gradually, they are prescribed 2 times / day. Given that Zeptol is prescribed 2 times / day, the optimal scheme of therapy is determined by the doctor on the basis of the recommendations given.
When transferring a patient from taking conventional tablets to taking prolonged-action tablets, clinical experience shows that in some patients with the use of long-acting tablets, it may be necessary to increase the dose of the drug.
Epilepsy: complex or simple partial epileptic seizures (with or without loss of consciousness) with secondary generalization or without it; generalized tonic-clonic epileptic seizures; mixed forms of epileptic seizures: whenever possible, Zeptol should be given as monotherapy. Treatment begins with a small daily dose, which is then slowly increased until an optimal effect is achieved. To determine the optimal dose of the drug, it is recommended to determine the concentration of the active substance in the blood plasma. Joining Zepthol to already conducted antiepileptic therapy should be carried out gradually, while the doses of the drugs used do not change or, if necessary, carry out appropriate correction of the doses of the drugs taken. If the patient forgot to take the next dose of the drug in a timely manner, you should take the missed dose immediately, as soon as this omission became noticed while not taking a double dose of the drug.
For adults, the initial dose of 100-200 mg 1-2 times / day. Then the dose is slowly increased to 400-600 mg 2 times / day. The maximum daily dose is 1600-2000 mg.
For children over the age of 4, treatment can be started with the use of the drug at a dose of 100 mg / day; The dose is increased gradually - every week by 100 mg.
For children under 4 years of age, carbamazepine is preferably administered in the form of a syrup due to the difficulty of using solid dosage forms in this age group.
Supportive doses for children are 10-20 mg / kg / day (in several steps):
Age of the child
4-5 years 200-400 mg
6-10 years 400-600 mg
11-15 years 600-1000 mg
With neuralgia of the trigeminal nerve and neurogenic pain syndrome: 100-200 mg 2 times / day, then gradually increase the dose by no more than 200 mg / day until the pain ceases (on average, up to 600-800 mg), then reduced to a minimal effective dose. The effect usually occurs 1-3 days after the start of treatment. Assign the drug for a long time; with the premature cancellation of the drug pain can resume. In the treatment of elderly patients, the initial dose of 100 mg 2 times / day.
Pain with peripheral nerve damage in diabetes mellitus, pain with diabetic neuropathy: 200-300 mg 2 times / day.
Polyuria and polydipsia of neurohormonal nature in diabetes insipidus of central genesis: the average dose for adults is 200 mg 2 times / day. In children, the dose of the drug should be reduced in accordance with the age and body weight of the child.
Idiopathic neuralgia of the trigeminal nerve and trigeminal neuralgia in multiple sclerosis; idiopathic neuralgia of the glossopharyngeal nerve: the average daily dose is 200-400 mg 2 times / day.
Alcohol abstinence syndrome: the average dose is 200 mg 2 times / day. In severe cases, in the first days the dose can be increased to 600 mg 2 times / day. At the beginning of treatment, severe abstinence is prescribed in combination with detoxification therapy and sedative-hypnotic drugs (for example, clomethiazole, chlordiazepoxide). After resolving the acute phase, Zeptol treatment can be continued as a monotherapy.
Acute manic conditions and maintenance therapy of bipolar affective disorders: in the first week the daily dose of 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 2 doses.
The transition to treatment with carbamazepine should be gradual, reducing the dose of the previous drug. Stop treatment should be gradual. The duration of treatment is determined by the doctor.
SIDE EFFECT
When assessing the frequency of occurrence of various adverse reactions, the following grades were used: very often 10% or more; often - 1-10%; infrequently - 0.1-1%; rarely - 0.01-0.1%; very rarely - less than 0.01%.
Dose-dependent adverse reactions usually occur within a few days, both spontaneously and after a temporary dose reduction. The development of adverse reactions from the CNS may be a consequence of a relative overdose of the drug or significant fluctuations in the concentrations of the active substance in the plasma. In such cases it is recommended to monitor the concentration of the drug in the plasma.
From the side of the central nervous system: very often - dizziness, ataxia, drowsiness, a sense of fatigue; often - headache, diplopia, impaired vision accommodation (eg, blurred vision); infrequent - abnormal involuntary movements (eg, tremor, "fluttering" tremor - asterixis, dystonia, tics); nystagmus; rarely - orofacial dyskinesia, oculomotor disorders, speech disorders (eg, dysarthria), choreoathetosis, peripheral neuropathy, paresthesia, paresis; very rarely - taste disorders, malignant neuroleptic syndrome. The role of carbamazepine as a drug that causes or contributes to the development of malignant neuroleptic syndrome, especially when it is prescribed in conjunction with neuroleptics, remains unclear.
From the psychic sphere: rarely - hallucinations (visual or auditory), depression, anorexia, anxiety, aggression, agitation, disorientation; very rarely, the activation of psychosis.
Allergic reactions: very often - allergic dermatitis, hives, which can be very pronounced; infrequently - exfoliative dermatitis, erythroderma; rarely - systemic lupus erythematosus, itching; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity reactions, erythema multiforme and nodosum, skin pigmentation disorders, purpura, acne, sweating, hair loss. There have been reports of rare cases of hirsutism, but the cause-and-effect relationship of this complication with taking the drug remains unclear.
Reactions of hypersensitivity: rarely - multi-organ hypersensitivity of delayed type with fever, skin rashes, vasculitis, lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function and destruction of intrahepatic bile ducts with a decrease in their number (these manifestations occur in various combinations). Other organs may also be involved (eg, lungs, kidneys, pancreas, myocardium, large intestine). Very rarely, aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactic reaction, angioedema. If the above-mentioned allergic reactions occur, the drug should be discontinued.
On the part of the organs of hematopoiesis: very often - leukopenia; often - thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy, deficiency of folic acid; very rarely - agranulocytosis, aplastic anemia, pancytopenia, anemia, true erythrocyte aplasia, megaloblastic anemia, variegate porphyria, late cutaneous porphyria, acute "intermittent" porphyria, reticulocytosis, hemolytic anemia.
From the digestive tract: very often - nausea, vomiting; often - dry mouth; infrequently - diarrhea, constipation; rarely - abdominal pain; very rarely - glossitis, stomatitis, pancreatitis.
On the part of the liver: very often - increased activity of gamma-glutamyltransferase (due to the induction of this enzyme in the liver), which usually has no clinical significance; often - increased activity of alkaline phosphatase of the blood; infrequently - increased activity of transaminases; rarely - hepatitis of cholestatic, parenchymal (hepatocellular) or mixed type, destruction of intrahepatic bile ducts with a decrease in their number, jaundice; very rarely - granulomatous hepatitis, hepatic insufficiency.
From the cardiovascular system: rarely - violations of intracardiac conduction; decrease or increase in blood pressure; very rarely - bradycardia, arrhythmias, atrio-ventricular blockade with syncope, collapse, chronic heart failure, exacerbation of coronary heart disease, thrombophlebitis, thromboembolism (eg, pulmonary embolism).
On the part of the endocrine system and metabolism: often - swelling, fluid retention, weight gain, hyponatremia and decreased blood osmolarity due to an effect similar to the action of antidiuretic hormone, which in rare cases leads to water intoxication (hyponatremia of dilution), accompanied by lethargy, vomiting , headache, disorientation and neurologic disorders; very rarely - an increase in the concentration of blood prolactin, accompanied or not accompanied by such manifestations as galactorrhea, gynecomastia; changes in the indices of thyroid function - a decrease in the concentration of L-thyroxine (free thyroxine, thyroxine, triiodothyronine) and an increase in the thyroid-stimulating hormone (TSH) concentration, which is usually not accompanied by clinical manifestations; metabolic disorders of bone tissue (decrease in calcium and 25-hydroxycholecalciferol in the blood), which leads to osteomalacia / osteoporosis; increased cholesterol concentrations, including high-density lipoprotein cholesterol, and triglycerides.
On the part of the genitourinary system: very rarely - interstitial nephritis, renal failure, renal dysfunction (eg albuminuria, hematuria, oliguria, urea / azotemia increase), frequent urination, urinary retention, impaired sexual function / impotence, spermatogenesis (decrease in sperm count and their mobility).
From the side of the musculoskeletal system: rarely - muscle weakness; very rarely - arthralgia, muscle pain or cramps.
From the sense organs: very rarely - a violation of taste, clouding of the lens, conjunctivitis, increased intraocular pressure; Hearing impairment, incl. noise in the ears, hyperacusia, hypoacusia, changes in perception of the height of sound.
CONTRAINDICATIONS
- Hypersensitivity to carbamazepine and other components of the drug, as well as to substances with a carbamazepine-like structure (eg, tricyclic antidepressants);
- children up to 4 years (up to 4 years carbamazepine preferably used in the form of syrup due to the difficulty of application of solid dosage forms in this age group);
- violation of medullary hematopoiesis (anemia, leukopenia);
- presence in the history of episodes of suppression of bone marrow hematopoiesis, or all varieties of porphyria;
- atrioventricular block;
- co-administration of drugs lithium and MAO inhibitors.
PREGNANCY AND LACTATION
Zeptolom treatment of epilepsy during pregnancy should be undertaken with extreme caution.
In women of childbearing age Zeptol should, whenever possible, be used as a monotherapy, as the incidence of congenital anomalies in fetuses born to women who were treated with a combination of antiepileptic drugs is greater than in those who received each of these agents as monotherapy. Should be given the minimum effective dose Zeptola.
Recommended regular monitoring of carbamazepine plasma concentrations.
If pregnancy occurs in a woman receiving Zeptol, or if there is a question on the appointment of Zeptola during pregnancy, you need to carefully compare the expected benefits of therapy and its possible complications, especially in the I trimester of pregnancy.
We know that children born to mothers with epilepsy are more likely prone to violations of fetal development, including malformations. It has been reported that carbamazepine, like all major antiepileptic drugs, can increase the risk of these disorders, although the final confirmation, which would have been obtained as a result of controlled studies using Zeptola as monotherapy, to date not available. There have been reports of cases of congenital diseases and malformations, including spina bifida (spina bifida) and other congenital anomalies (including craniofacial and cardiovascular system) have been observed in patients taking Zeptol.Patients should be given information about the possibility of an increased risk of malformations and the possibility to pass antenatal diagnosis. It is known that during pregnancy folic acid deficiency develops. It has been reported that antiepileptic drugs increase the deficit. This may contribute to increased incidence of birth defects in children born to women taking antiepileptic drugs. Therefore, prior to and during pregnancy recommended supplementation of folic acid.Therefore, prior to and during pregnancy recommended supplementation of folic acid.Therefore, prior to and during pregnancy recommended supplementation of folic acid.
In order to prevent excessive bleeding in newborns of women in the last weeks of pregnancy and the newborn is recommended to prescribe vitamin K 1 .
Carbamazepine is excreted in breast milk, concentration therein constitute 25-60% of the level in the blood plasma. Therefore, you should weigh the benefits and possible adverse effects of breastfeeding in the face of continued therapy Zeptolom. Mother taking Zeptol may continue breast feeding, but with the proviso that the child will be placed under surveillance in respect of possible side effects (e.g., drowsiness expressed, allergic skin reactions). Recommended regular monitoring of carbamazepine concentrations in breast milk.
Described several cases of seizures and / or respiratory depression in newborns whose mothers took the drug along with other anticonvulsants. In addition, also reported several cases of vomiting, diarrhea and / or malnutrition in infants whose mothers received Zeptol. Perhaps these reactions are manifestations of neonatal withdrawal syndrome.
Women of childbearing age during treatment with carbamazepine is recommended to use non-hormonal contraception.
APPLICATION FOR CHILDREN
In children aged 4 carbamazepine preferably used in the form of syrup due to the difficulty of application of solid dosage forms in this age group.
SPECIAL INSTRUCTIONS
The drug is usually ineffective in absence seizures (petit mal) and myoclonic seizures. In patients with mixed seizures the drug should be used with caution and only on condition that the regular medical follow-up (due to the possible increase in attacks). In the event the application attacks Zeptol preparation should be discontinued.
During use of the drug at different rates observed transient or sustained reduction in the number of platelets or leukocytes. However, in most cases, these effects are transient and usually are not a harbinger of the beginning of aplastic anemia or agranulocytosis. Before treatment, and periodically during the treatment process should be carried out clinical analyzes of blood, including counting the number of platelets and possibly reticulocytes and also to determine the concentration of iron in the serum.
Should be brought to the attention of patients about the early signs of toxicity inherent probable hematological disorders, as well as the symptoms of the skin and liver. The patient is informed of the need to immediately contact a physician) in the case of occurrence of adverse reactions such as fever, sore throat, rash, ulceration of the oral mucosa, wanton occurrence of hemorrhage, hemorrhage of petechiae or purpura.
In those cases when, during treatment was low content of platelets or leukocytes (or their tendency to reduction) should carefully watch the condition of the patient and expanded clinical blood indices analysis. If revealed signs of significant bone marrow suppression, Zeptol the drug should be discontinued.
In applying Zeptola rarely observed severe dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome). Zeptol drug should be lifted immediately in the event that there are signs and symptoms of supposedly proving the development of severe dermatological reactions - eg, Stevens-Johnson syndrome or Lyell's syndrome. With the development of the heavy (in some cases life-threatening patient's) skin reactions, the patient should be admitted to the hospital. In most cases, Stevens-Johnson syndrome and Lyell's syndrome developed in the first months of drug therapy.
The effect of factors such as the dosage of anticonvulsant drugs, compliance of patients, simultaneous therapy other drugs comorbidities or level of control of dermatological reactions, the incidence of severe skin reactions (and mortality in patients with Stevens-Johnson syndrome and toxic epidermal necrolysis) is not established.
Mild skin reactions (isolated makuleznaya or maculopapular rash) in most cases are not severe iobychno transient and disappear within a few days or weeks, even with continued treatment or after reduction of the dose.
However, since the differential diagnosis between early signs of severe skin reactions and mild transient skin rash may be difficult, in the development of any skin reactions, the patient should be under medical supervision (with a view to the timely termination of drug therapy in case of deterioration of the patient's condition).
According to a retrospective analysis of the drug in patients Hoa there is a correlation between the frequency of severe dermatological reactions and by the presence in the genome of a patient allele HLA-B * 1502 gene of human leukocyte antigen (HLA).
In the application of carbamazepine in patients in the countries of Asia (Thailand, Malaysia, the Philippines), where there is a preferential distribution of the allele HLA-B * 1502 was found an increase in the incidence (from gradation "very rarely" to "rarely") severe dermatological reactions, including Stevens-Johnson syndrome and Lyell's syndrome. Distribution frequency allele HLA-B * 1502 is as follows: in the Philippines, Thailand, Hong Kong and Malaysia - more than 15%, in Taiwan - 10%, in North China - 4% in South Asia, including India - 2-4% in Japan and Korea - less than 1%. The prevalence of this allele in evropeidnoy persons, Negroid and Americanoid (Hispanics and Indians) races is negligible.
In the appointment of carbamazepine possible carriers of the allele HLA-B * I502 (for example, persons of Chinese nationality) recommended genotyping on the allele. Prescribed the drug carriers of the allele to be only in the case if the benefits of therapy outweighs the potential risk. The person Caucasoid, Negroid and Americanoid races conducting genotyping of allele HLA-B * 1502 before the appointment Zeptola optional.
Patients already receiving therapy Zeptolom not recommended to perform the genotyping on the allele, since severe skin reactions were observed in most cases during the first months of the drug (regardless of the presence of HLA-B * 1502 alleles).
However, the results of genotyping of allele HLA-B * 1502 should not affect the degree of control over the condition of the patient and the physician vigilance regarding serious skin reactions. Development of Stevens-Johnson syndrome and toxic epidermal necrolysis in patients perhaps negative for the allele HLA-B * 1502. Also, in many cases, persons of Chinese nationality positive for the allele HLA-B * 1502 in the application are not mentioned Zeptola of Stevens-Johnson syndrome and toxic epidermal necrolysis.
The influence of other factors such as the dosage of anticonvulsant drugs, compliance of patients, simultaneous therapy other drugs comorbidities or level of control of dermatological reactions, the incidence of severe skin reactions (and mortality in patients with Stevens-Johnson syndrome and toxic epidermal necrolysis) not established .
Mild skin reactions (isolated macular or maculopapular rash) in most cases are transient and not severe and usually disappear within a few days or weeks, even with continued treatment or after reduction of the dose.
However, since the differential diagnosis between early signs of severe skin reactions and mild transient skin rash may be difficult, in the development of any skin reactions, the patient should be under medical supervision (with a view to the timely termination of drug therapy in case of deterioration of the patient's condition).
The relationship between the presence in the genome allele HLA-B * 1502 and the development of mild skin Reaction (such as hypersensitivity reaction, or isolated makuleznaya maculopapular rash) is not installed.
With the development of hypersensitivity to Zeptolu patients may be observed as separate skin lesions, liver (including intrahepatic bile duct disease), blood and lymphatic system, or other organs, and a combination thereof that should be considered as a systemic reaction. In the case of signs and symptoms of hypersensitivity to the drug Zeptol drug should be discontinued immediately.
Patients with known hypersensitivity to carbamazepine should be informed of the possibility of hypersensitivity reactions to oxcarbazepine approximately 25-30% of cases.
Cross-hypersensitivity reactions may also occur between carbamazepine and phenytoin.
Before the start of drug treatment and periodically during therapy to study the total urine analysis and determination of blood urea concentration. Before the appointment of carbamazepine in the treatment process to be a study of liver function, especially in patients with a history of which there is evidence of liver disease and in elderly patients. In the case of amplification of already existing liver dysfunction or when the active liver disease medication should be discontinued immediately.
Before treatment, it is recommended to conduct an eye examination, including a study of the fundus and intraocular pressure measurement. In the case of destination patients preparation with increased intraocular pressure requires continuous monitoring of this parameter.
There are currently registered anecdotal reports of male fertility disorders and / or disorders of spermatogenesis (the relationship of these disorders with carbamazepine has not been proved).
The drug may reduce the effectiveness of drugs containing estrogen and / or progesterone, so that women of childbearing age during drug treatment should apply alternative methods of contraception.
Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very small, however, the regular determination of carbamazepine concentrations may be useful in the following situations: when a sharp increase in seizure frequency; in order to check whether the patient is taking medication properly; during pregnancy; when treating children or adolescents; suspected impaired absorption of the drug; in cases of suspected development of toxic reactions if the patient is taking several medications.
As the background of the drug may increase the latent mental disorders, should ensure monitoring of elderly patients to identify symptoms like confusion, and psychomotor agitation. In some cases, treatment with antiepileptic drugs accompanied by the emergence of suicidal attempt / suicidal intentions. This was also confirmed by conducting a meta-analysis of randomized placebo-controlled trials with antiepileptics.
Since the mechanism of suicidal attempts at application antiepileptic drugs are not known, it is impossible to exclude them from occurring in the treatment of patients Zeptolom. Patients and staff need to warn about the need to monitor the emergence of suicidal ideation / suicidal behavior and, in case of symptoms, seek immediate medical attention.
Sudden discontinuation of carbamazepine can cause epileptic seizures. If necessary abruptly interrupt treatment, the patient should be transferred to another antiepileptic agent undercover shown in such cases the drug (e.g., diazepam, administered in / or rectally, or phenytoin administered in / in).
Before the appointment of the drug MAO inhibitors should be discontinued at least 2 weeks, or if the clinical situation allows, even for a longer period. During the treatment period, do not drink alcohol.
The effect on the ability to drive vehicles and work mechanisms
ability patient receiving Zeptol to fast reaction, particularly at the beginning of therapy or during the selection of the dose may be impaired due to the occurrence of drowsiness and dizziness. Therefore, when driving or operating machinery, patients should exercise caution.
OVERDOSE
Symptoms usually reflect disorders of the central nervous system, cardiovascular and respiratory systems.
On the part of the central nervous system and sensory organs: central nervous system depression functions, disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (first), hyporeflexia (later); convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis).
From the CCC: tachycardia, decreased blood pressure
