Active material: Carbamazepine
When ATH: N03AF01
CCF: Anticonvulsants
When CSF: 02.05.04
Manufacturer: ALSI Pharma Company Inc. (Russia)
Pills white or white with a yellowish tint, ploskotsilindricheskoy form, a facet and Valium.
| 1 tab. | |
| Carbamazepine | 200 mg |
Excipients: potato starch, colloidal silicon dioxide (aэrosyl), magnesium stearate, talc, povidone, Tween-80.
10 PC. – упаковки ячейковые контурные (1) – пачки картонные.
10 PC. – упаковки ячейковые контурные (2) – пачки картонные.
10 PC. – упаковки ячейковые контурные (3) – пачки картонные.
10 PC. – упаковки ячейковые контурные (4) – пачки картонные.
10 PC. – упаковки ячейковые контурные (5) – пачки картонные.
Antiepileptics, tricyclic derivative iminostilbene. It is believed, that the anticonvulsive action associated with lowering the ability of neurons to maintain a high incidence of repetitive action potentials by inactivating sodium channel. Besides, apparently, It has a value of inhibition of neurotransmitter release by blocking presynaptic sodium channels and development of action potentials, which in turn reduces the synaptic transmission.
It has moderate antimanic, antipsihoticheskoe action, as well as the analgesic effect in neurogenic pain. The mechanisms of action, perhaps, GABA receptors are involved, that may be associated with calcium channel; also, apparently, It has a value of carbamazepine effect on neurotransmission modulators system.
Antidiuretic action of carbamazepine may be due to effects on hypothalamic osmoreceptors, which is mediated through the secretion of ADH, and also due to the direct effect on the renal tubules.
After oral carbamazepine almost completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 75%. An inducer of hepatic enzymes and stimulates its own metabolism.
T1/2 is 12-29 no. 70% excreted in the urine (active metabolites) and 30% – с калом.
Epilepsy: big, Focal, hybrid (including large and focal) seizures. Neurogenic pain syndrome mainly genesis, incl. эssentsialynaya neuralgia nerve troynichnogo, trigeminal neuralgia in multiple sclerosis, эssentsialynaya glossofaringealynaya neuralgia. Prevention of seizures in alcohol withdrawal syndrome. Affective and schizoaffective psychosis (as a means of preventing). Diabetic neuropathy pain syndrome. Central diabetes insipidus, polyuria and polydipsia of neurohormonal nature.
Establish individually. When administered to adults and adolescents 15 years old and older starting dose is 100-400 mg. If necessary, and taking into account the clinical effect of the dosage is increased by no more than 200 mg/day with an interval 1 Sun. Частота приема – 1-4 times / day. The maintenance dose is usually 600-1200 mg / day in divided doses. The duration of treatment depends on the indication, the effectiveness of treatment, the patient's response to therapy.
Children under the age of 6 years of use 10-20 mg / kg / day 2-3 divided doses; if necessary, taking into account the tolerance dose is increased by no more than 100 mg/day with an interval 1 Sun.; maintenance dose is usually 250-350 mg / day and does not exceed 400 mg / day. For children 6-12 years - by 100 mg 2 times / day for the first day, next dose 100 mg/day with an interval 1 Sun. until the optimum effect; maintenance dose is usually 400-800 mg / day.
The maximum dose: when administered to adults and adolescents 15 лет и старше – 1.2 g / day, детям – 1 g / day.
From the central and peripheral nervous system: often - dizziness, ataxia, drowsiness; possible headache, diplopia, accommodation disturbances; редко – непроизвольные движения, nistagmo; в отдельных случаях – окуломоторные нарушения, dysarthria, peripheral neuritis, paresthesia, muscular weakness, symptoms of paresis, hallucinations, depression, feeling tired, violent behavior, ažitaciâ, disturbances of consciousness, activation of psychosis, dysgeusia, conjunctivitis, noise in ears, hyperacusis.
From the digestive system: nausea, GGT increase, increased activity of alkaline phosphatase, vomiting, dry mouth; редко – повышение активности трансаминаз, jaundice, cholestatic hepatitis, diarrhea or constipation; в отдельных случаях – снижение аппетита, stomach ache, glossitis, stomatitis.
Cardio-vascular system: редко – нарушения проводимости миокарда; in certain cases, bradycardia, Arrhythmia, AV-blockade with syncope, collapse, heart failure, manifestations of coronary insufficiency, thrombophlebitis, thromboembolism.
From the hematopoietic system: leukopenia, eozinofilija, thrombocytopenia; редко – лейкоцитоз; в отдельных случаях – агранулоцитоз, aplasticheskaya anemia, red cell aplasia, megaloblastnaya anemia, reticulocytosis, gemoliticheskaya anemia, granulomatous hepatitis.
Metabolism: giponatriemiya, fluid retention, swelling, weight gain, decrease in plasma osmolality; в отдельных случаях – острая перемежающаяся порфирия, folic acid deficiency; disorders of calcium metabolism, high cholesterol and triglycerides.
On the part of the endocrine system: gynecomastia or galactorrhea; редко – нарушения функции щитовидной железы.
From the urinary system: редко – нарушения функции почек, interstitial nephritis and renal insufficiency.
The respiratory system: в отдельных случаях – диспноэ, pneumonitis or pneumonia.
Allergic reactions: skin rash, itch; seldom-Lymphadenopathy, fever, hepatosplenomegaly, artralgii.
AV блокада, previous mielodeprescia, intermittent porphyria history, simultaneous MAO inhibitors and drugs lithium, hypersensitivity to carbamazepine.
If necessary, use in pregnancy (especially in the I trimester) and during lactation should carefully weigh the potential benefits of treatment for the mother and the risk to the fetus or child. Thus carbamazepine are only recommended as monotherapy in the minimum effective doses.
Women of childbearing age during treatment with carbamazepine is recommended to use non-hormonal contraception.
Carbamazepine is not used in atypical or small generalized seizures, myoclonic or atonic seizures. should not be used to relieve common pains; as a prophylactic agent during prolonged periods of remission trigeminal neuralgia.
To use caution in concomitant diseases of the cardiovascular system, function expressed by human liver and / or kidney, for patients with diabetes, increased intraocular pressure, When specifying a history of hematologic response to application of other preparations, giponatriemii, urinary retention, hypersensitivity to tricyclic antidepressants, When specifying a history of interrupted treatment with carbamazepine, as well as children and elderly patients.
Treatment should be under the supervision of a physician. Prolonged treatment is necessary to control blood picture, the functional state of the liver and kidneys, the concentration of electrolytes in the blood plasma, conduct eye examination. Recommended periodic determination of plasma levels of carbamazepine to monitor the efficacy and safety of treatment.
Not less than 2 weeks prior to the initiation of therapy with carbamazepine should be discontinued treatment MAO inhibitors.
During treatment, avoid alcohol.
Effects on ability to drive vehicles and management mechanisms
During treatment should refrain from activities potentially hazardous activities, require attention, psychomotor speed reactions.
With simultaneous use of isozyme inhibitors of CYP3A4 may increase the concentration of carbamazepine in plasma.
With simultaneous use of isozyme CYP3A4 inducers system may accelerate metabolism of carbamazepine, reducing its concentration in blood plasma, reduction of the therapeutic effect.
With simultaneous use of carbamazepine stimulates the metabolism of anticoagulants, folic acid.
While the use of valproic acid may decrease the concentration of carbamazepine and significant decrease in the concentration of valproic acid in blood plasma. При этом повышается концентрация метаболита карбамазепина – карбамазепин-эпоксида (probably by inhibiting its conversion into carbamazepine-10,11-trans-diol), which also possesses anticonvulsant activity, therefore, the effects of interaction can be offset, но чаще возникают побочные реакции – нечеткость зрения, dizziness, vomiting, weakness, nistagmo. With simultaneous application of valproic acid, carbamazepine may develop hepatotoxicity (apparently, due to formation of a secondary metabolite of valproic acid, which has hepatotoxic).
With simultaneous application valpromid reduces hepatic metabolism of carbamazepine and its metabolite carbamazepine-epoxide due to inhibition of the enzyme epoxide hydrolase. Said metabolite possesses anticonvulsant activity, but with a significant increase in plasma concentrations may be toxic.
While the use of verapamil, diltiazemom, izoniazidom, dekstropropoksifenom, viloksazinom, fluoxetine, fluvoksaminom; possible - with cimetidine, acetazolamide, danazolom, desipramine, nicotinamide (adult, Only high doses); Erythromycin, troleandomycin, dzhozamytsynom, clarithromycin; with azolami (incl. with itrakonazolom, ketoconazole, fluconazole), terfenadine, loratadine may increase carbamazepine plasma concentrations with the risk of side effects (dizziness, drowsiness, ataxia, diplopia).
While the use of attenuated geksamidinom anticonvulsant effect of carbamazepine; hydrochlorothiazide, фуросемидом – возможно уменьшение содержания натрия в крови; с гормональными контрацептивами – возможно ослабление действия контрацептивов и развитие ациклических кровотечений.
While the use of thyroid hormones may increase the elimination of thyroid hormones; с клоназепамом – возможно повышение клиренса клоназепама и уменьшение клиренса карбамазепина; с препаратами лития – возможно взаимное усиление нейротоксического действия.
While the use of primidone may decrease carbamazepine plasma levels. There are reports, что примидон может повышать концентрацию в плазме фармакологически активного метаболита – карбамазепина-10,11-эпоксида.
While the use of ritonavir possibly increased side effects of carbamazepine; с сертралином – возможно уменьшение концентрации сертралина; theophylline, rifampicin, cisplatin, доксорубицином – возможно уменьшение концентрации карбамазепина в плазме крови; с тетрациклином – возможно ослабление эффектов карбамазепина.
In an application with carbamazepine felbamate may decrease plasma concentrations of, but the increase in the concentration of the active metabolite carbamazepine-epoxide, with the possible decrease in plasma concentration of felbamate.
In an application with phenytoin, phenobarbital carbamazepine reduced plasma concentration. Perhaps the relative weakening of anticonvulsant action, а в редких случаях – его усиление.
This site uses cookies and services to collect technical data from visitors to ensure performance and improve the quality of service.. By continuing to use our site, you automatically agree to the use of these technologies.
Read More