Finlepsin
Use during pregnancy and breastfeeding
For women of reproductive age, Finlepsin® is prescribed, if possible, as monotherapy, in the minimum effective dose, because
the incidence of congenital anomalies in newborns from mothers taking combined antiepileptic treatment is higher than with monotherapy. When pregnancy occurs, it is necessary to compare the expected benefits of therapy and possible complications, especially in the first trimester of pregnancy. It is known that children of mothers with epilepsy are predisposed to disorders of intrauterine development, including malformations. Finlepsin® may increase the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including spina bifida. Antiepileptic drugs increase folic acid deficiency, which is often observed during pregnancy, which may increase the incidence of birth defects in children, so folic acid supplementation is recommended before and during pregnancy.
In order to prevent hemorrhagic complications in newborns, it is recommended that women in the last weeks of pregnancy, as well as newborns, be prescribed vitamin K.
Carbamazepine passes into breast milk, so the benefits and possible undesirable effects of breastfeeding should be weighed against ongoing therapy. If breastfeeding is continued while taking Finlepsin, the child should be monitored due to the possibility of adverse reactions (for example, severe drowsiness, allergic skin reactions).
Use for liver dysfunction
The drug should be used with caution in cases of liver dysfunction.
Use for renal impairment
The drug should be used with caution in cases of impaired renal function.
Use in children
Can be used in children according to indications.
special instructions
Monotherapy for epilepsy begins with a low initial dose, gradually increasing it until the desired therapeutic effect is achieved.
When selecting the optimal dose, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially during combination therapy. In some cases, the optimal dose may deviate significantly from the recommended initial maintenance dose, for example, due to induction of microsomal liver enzymes or due to interactions during combination therapy.
In some cases, treatment with antiepileptic drugs was accompanied by the occurrence of suicide attempts/suicidal intentions. This was also confirmed in a meta-analysis of randomized clinical trials using antiepileptic drugs. Since the mechanism of suicide attempts when using antiepileptic drugs is not known, their occurrence cannot be excluded during treatment with Finlepsin®. Patients and staff should be warned to monitor for suicidal thoughts/behavior and to seek immediate medical attention if symptoms occur.
Finlepsin® should not be combined with sedative-hypnotics. If necessary, it can be combined with other substances used to treat alcohol withdrawal. During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma. Due to the development of side effects from the central nervous system and the autonomic nervous system, patients are closely monitored in a hospital setting.
When transferring a patient to carbamazepine, the dose of the previously prescribed antiepileptic drug should be gradually reduced until it is completely discontinued. Sudden cessation of carbamazepine may trigger epileptic seizures. If it is necessary to abruptly interrupt treatment, the patient should be transferred to another antiepileptic drug under the cover of the drug indicated in such cases (for example, diazepam administered intravenously or rectally, or phenytoin administered intravenously).
Several cases of vomiting, diarrhea and/or decreased nutrition, convulsions and/or respiratory depression have been described in newborns whose mothers took carbamazepine concomitantly with other anticonvulsants (these reactions may represent neonatal withdrawal syndrome).
Before prescribing carbamazepine and during treatment, liver function testing is necessary, especially in patients with a history of liver disease, as well as in elderly patients. If existing liver dysfunction worsens or active liver disease develops, the drug should be discontinued immediately.
Before starting treatment, it is necessary to conduct a study of the blood picture (including counting platelets, reticulocytes), iron level in the blood serum, general urine analysis, urea level in the blood, electroencephalogram, determination of the concentration of electrolytes in the blood serum (and periodically during treatment, because hyponatremia may develop). Subsequently, these indicators should be monitored weekly during the first month of treatment and then monthly.
In most cases, a transient or persistent decrease in the number of platelets and/or leukocytes is not a precursor to the onset of aplastic anemia or agranulocytosis. However, before starting treatment, and periodically during treatment, clinical blood tests should be performed, including platelet counts and possibly reticulocyte counts, and serum iron levels should be determined. Non-progressive asymptomatic leukopenia does not require discontinuation, but treatment should be discontinued if hypersensitivity reactions or symptoms appear that suggest the development of Stevens-Johnson syndrome or Lyell's syndrome. Mild skin reactions (isolated macular or maculopapular exanthema) usually disappear within a few days or weeks, even with continued treatment or after reducing the dose of the drug (the patient should be under close medical supervision at this time).
The possibility of activation of latent psychoses should be taken into account, and in elderly patients, the possibility of developing disorientation or psychomotor agitation.
Male fertility and/or spermatogenesis disorders are possible, but the relationship between these disorders and carbamazepine has not yet been established.
Intermenstrual bleeding may occur with simultaneous use of oral contraceptives. Carbamazepine may adversely affect the reliability of oral contraceptives, so women of reproductive age should use alternative methods of birth control during treatment. Carbamazepine should only be used under medical supervision.
Patients should be informed of early signs of toxicity, as well as skin and liver symptoms. The patient is informed of the need to immediately consult a doctor in case of adverse reactions such as fever, sore throat, rash, ulceration of the oral mucosa, causeless bruising, hemorrhages in the form of petechiae or purpura.
Before starting treatment, it is recommended to conduct an ophthalmological examination, including slit lamp examination of the fundus and measurement of intraocular pressure. If the drug is prescribed to patients with increased intraocular pressure, constant monitoring of this indicator is required.
Patients with severe cardiovascular diseases, liver and kidney damage, as well as elderly people are prescribed lower doses of the drug.
Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very small, regular determination of carbamazepine levels may be useful in the following situations: with a sharp increase in the frequency of attacks; to check whether the patient is taking the drug properly; during pregnancy; when treating children or adolescents; if there is a suspicion of impaired absorption of the drug; if toxic reactions are suspected if the patient is taking several medications.
During treatment with Finlepsin, it is recommended to refrain from drinking alcohol.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Description of the drug FINLEPSIN® 200 RETARD (FINLEPSIN® 200 RETARD)
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.
