Description
Latin name
FINLEPSIN
Release form
White tablets, round, with a bevel, convex on one side and with a risk in the form of a wedge-shaped recess on the other.
Packing
10 pcs – blisters (5) – packs of cardboard.
Pharmacological action
Farmgroup: antiepileptic.
Pharmacological action:
Finlepsin, an antiepileptic drug (dibenzazepine derivative), which also has an antidepressant, antipsychotic and antidiuretic effect, has an analgesic effect in patients with neuralgia.up to 1 month due to auto-induction of metabolism).
With essential and secondary trigeminal neuralgia, carbamazepine in most cases prevents the onset of pain attacks. Relief of pain in trigeminal neuralgia is noted after 8-72 hours.
With alcohol withdrawal syndrome, it increases the seizure threshold, which in this state is usually reduced and reduces the severity of the clinical manifestations of the syndrome (increased irritability, tremor, gait disorders).
Antipsychotic (antimaniac) effect develops after 7-10 days, may be due to inhibition of dopamine and norepinephrine metabolism.
Indications
Epilepsy: partial seizures with elementary symptoms (focal seizures), partial seizures with complex symptoms, psychomotor seizures, large convulsive seizures of mainly focal origin (large seizures during sleep, diffuse large seizures) mixed forms of epilepsy
trigeminal neuralgia
idiopathic glossopharyngeal neuralgia
pain in diabetic polyneuropathy
epileptiform seizures in multiple sclerosis, facial muscle spasms in trigeminal neuralgia, paroxysmal syndromes and paroxysm pain anxiety, convulsions, hyperactivity, sleep disturbances)
psychotic disorders (affective and schizoaffective disorders, psychoses, n impaired function of the limbic system).
Contraindications
Disorders of bone marrow hematopoiesis (anemia, leukopenia)
acute intermittent porphyria (including a history)
AV blockade
simultaneous administration of lithium and anti-anxiety drugs sensitivity to srd
With caution, the drug should be used in decompensated chronic heart failure, in case of impaired liver and / or kidney function, in elderly patients, in patients with chronic alcoholism (CNS depression intensifies, carbamazepine metabolism intensifies), with dilution hyponatremia (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, adrenal cortex insufficiency), with suppression of bone marrow hematopoiesis against the background of taking medications (with a history of prostate gland), increased intraocular pressure with simultaneous use with sedative and hypnotic drugs.
Use during pregnancy and lactation
For women of reproductive age, Finlepsin ® is, if possible, prescribed as monotherapy, in a minimally effective dose, because the frequency of congenital malformations of newborns from mothers who took combined antiepileptic treatment is higher than with monotherapy.
When pregnancy occurs, it is necessary to compare the expected benefit of therapy and possible complications, especially in the first trimester of pregnancy.
It is known that children of mothers with epilepsy are predisposed to intrauterine developmental disorders, including malformations. Finlepsin ® can increase the risk of these disorders.
There are isolated reports of cases of congenital diseases and malformations, including non-closure of the vertebral arches (spina bifida). Antiepileptic drugs increase folic acid deficiency, often observed during pregnancy, which can increase the incidence of birth defects in children. therefore, before the planned pregnancy and during pregnancy, folic acid intake is recommended.
In order to prevent hemorrhagic complications in newborns, women in the last weeks of pregnancy, as well as newborns, are recommended to prescribe vitamin K.
Carbamazepine passes into breast milk, so the benefits and possible undesirable consequences of breastfeeding should be compared in the context of ongoing therapy. With continued breastfeeding while taking Finlepsin, monitoring of the child should be established in connection with the possibility of developing adverse reactions (for example, severe drowsiness, allergic skin reactions).
Composition
One tablet contains:
active ingredients 200 mg carbamazepine
excipients: gelatin, magnesium stearate, microcrystalline cellulose, croscarmellose sodium.
Dosage and administration
The drug is administered orally, during or after meals, with plenty of fluids.
Epilepsy
Whenever possible, Finlepsin ® should be prescribed as monotherapy.
Accession of Finlepsin to the ongoing antiepileptic therapy should be carried out gradually, while the doses of the drugs used are corrected if necessary.
If the patient has forgotten to take the next dose of the drug in a timely manner, the missed dose should be taken as soon as this omission has been noticed, and you should not take a double dose of the drug.
Adults
The initial dose is 200-400 mg (1-2 tablets) / day, then the dose is gradually increased until the optimal effect is achieved. The maintenance dose is 800-1200 mg / day, which are distributed in 1-3 doses per day.
The maximum daily dose is 1.6-2 g.
Children
If the child is not able to swallow the tablet whole, you can chew, crush or shake it in a small amount of water.
The initial dose for children aged 1 year to 5 years is 100-200 mg / day, then the dose is gradually increased by 100 mg / day until the optimal effect for children from 6 to 10 years old is 200 mg / day, then the dose is gradually increase by 100 mg / day to achieve the optimal effect for children from 11 to 15 years old – 100-300 mg / day, then the dose is gradually increased by 100 mg / day to achieve the optimal effect.
Maintenance doses: for children aged 1-5 years – 200-400 mg / day (in several doses), 6-10 years – 400-600 mg / day (in 2-3 doses) 11-15 years – 600-1000 mg / day (in 2-3 doses).
The recommended dosage schedule is presented in the table.
Age Initial dose Maintenance dose
Adults 1 tab. 1 time / day 1-2 tab. 3 times / day
Children from 1 year to 5 years 1/2 tab. 1-2 times a day 1 tab. 1-2 times a day
Children from 6 to 10 years 1/2 tab. 2 times / day 1 tab. 3 times / day
Children from 11 to 15 years 1/2 tab. 2-3 times / day 1 tab. 3-5 times / day
Duration of use depends on the indications and individual response of the patient to the drug. The decision to transfer the patient to Finlepsin ®, the duration of its use and the abolition of treatment is taken individually by the doctor. The possibility of reducing the dose of the drug or stopping treatment is considered after a 2-3-year period of complete absence of seizures.
Treatment is stopped, gradually reducing the dose for 1-2 years, under the supervision of an EEG. In children, with a decrease in the daily dose of the drug, weight gain with age should be considered.
Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia
The initial dose is 200-400 mg (1-2 tablets), which is increased to 400-800 mg (2-4 tablets) in 1-2 doses, until the pain disappears completely . In a certain part of patients, treatment can be continued with a lower maintenance dose of 200 mg (1 tab.) 2 times / day (corresponding to 400 mg / day).
Senior patients and patients with hypersensitivity Finlepsin ® are prescribed in an initial dose of 100 mg (1/2 tab.) 2 times / day (corresponding to 200 mg / day).
Treatment of alcohol withdrawal in a hospital setting
Average daily dose – 200 mg (1 tab.) 3 times / day (corresponding to 600 mg / day). In severe cases, in the first days, the dose can be increased to 400 mg (2 tablets) 3 times / day (corresponding to 1200 mg / day).
If necessary, Finlepsin ® can be combined with other substances used to treat alcohol withdrawal.
Treatment of alcohol withdrawal syndrome with Finlepsin is discontinued, gradually reducing the dose for 7-10 days.
During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.
Due to the possible development of adverse reactions from the central and autonomic nervous system, patients are carefully monitored in a hospital setting.
Pain in diabetic neuropathy
Average daily dose – 200 mg (1 tab.) 3 times / day (corresponding to 600 mg / day). In exceptional cases, Finlepsin ® can be prescribed 400 mg (2 tablets) 3 times / day (corresponding to 1200 mg / day).
Epileptiform seizures in multiple sclerosis
Average dose – 200 mg (1 tab.) 3 times / day (corresponding to 600 mg / day).
Treatment and prevention of psychosis
The initial dose and maintenance dose are usually the same: 200-400 mg (1-2 tablets) / day. If necessary, the dose can be increased to 400 mg (2 tablets) 2 times / day (corresponding to 800 mg / day).
Side effects of the
From the central nervous system and peripheral nervous system:
often – dizziness, ataxia, drowsiness, general weakness, headache, paresis (e.g. tremor, fluttering tremor – asterixis, dystonia, tics),
nystagmus rarely – hallucinations (visual or auditory), depression, decreased appetite, anxiety, aggressive behavior, psychomotor agitation, disorientation, psychosis activation, orofacial dyskinesia, oculomotor disturbances, speech disorders (eg dysarthria or slurred speech), horeoatetoidnye disorders, peripheral neuritis, paresthesia, muscle weakness and paresis symptoms.
The role of the drug in the development of central nervous system, especially in combination with antipsychotics, remains unclear.
The development of adverse reactions from the central nervous system may be due to a relative overdose of the drug or significant fluctuations in plasma concentrations of carbamazepine.
Allergic reactions: often – urticaria
sometimes – erythroderma, multi-organ delayed-type hypersensitivity reactions with fever, skin rashes, vasculitis (including erythema nodosum, as a manifestation of skin vasculitis), lymphadenopathy, signs reminiscent of lymphoma, l arrhythmias, arrhythmias, eosinophilia, hepatosplenomegaly and altered indicators of liver function (these manifestations are found in various combinations).
Other organs (e.g. lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis or eosinophilic pneumonia.
If the above allergic reactions occur, the drug should be discontinued.
Rarely – lupus-like syndrome, skin itching, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), photosensitivity.
From the hemopoietic organs:
often – leukopenia, thrombocytopenia, eosinophilia
rarely – leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocyte anemia, retinal hemorrhagic fibrosis, megaloblastic anemia, pyloric fibrosis
From the digestive system:
often – nausea, vomiting, dry mouth, increased GGT activity (due to the induction of this enzyme in the liver), which usually does not have clinical significance, increased activity of alkaline phosphatase, sometimes – increased activity of hepatic transaminases, diarrhea or constipation , abdominal pain
rarely – glossitis, gingivitis, stomatitis, pancreatitis, hepatitis of cholestatic, parenchymal (hepatocellular) or mixed type, jaundice, granulomatous hepatitis, liver failure.
From the cardiovascular system:
rarely – cardiac conduction disturbances, decreased or increased blood pressure, bradycardia, arrhythmias, AV block with fainting, collapse, worsening or development of chronic heart failure, exacerbation of coronary heart disease (including the appearance or frequency of angina attacks), thrombophlebitis, thromboembolic syndrome.
From the endocrine system and metabolism:
often – edema, fluid retention, weight gain, hyponatremia (decreased plasma osmolarity due to an effect similar to ADH, which in rare cases leads to dilution hyponatremia, accompanied by lethargy, vomiting, headache disorientation and neurological disorders)
rare – increased prolactin levels (may be accompanied by galactorrhea and gynecomastia), decreased L-thyroxine concentration and increased thyroid-stimulating hormone concentration (usually not accompanied by clinical manifestations), disorders of calcium-phosphorus metabolism in bone tissue (decrease in plasma concentration of Ca2 + and 25-OH-colecalciferol), osteomalacia, hypercholesterolemia (including HDL cholesterol), hypertriglyceridemia and swollen lymph nodes, hirsutism. genitourinary system:
rarely – interstitial nephritis, renal failure, impaired renal function (e.g., albuminuria, hematuria, oliguria, increased urea / azotemia), rapid urination, urinary retention, decreased potency.
From the musculoskeletal system:
rarely – arthralgia, myalgia or cramps.
On the part of the sensory organs:
rarely – disturbances in taste, clouding of the lens, conjunctivitis, hearing impairment, including tinnitus, hyperacusia, hypoacusia, changes in perception of pitch.
Other: disorders of skin pigmentation, purpura, acne, sweating, alopecia.
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life
3 years.
Active ingredient
Carbamazepine
dosage form
tablets
Possible product names
FINLEPSIN 0.2 N50 TABL
Finlepsin 0.2g 50tb
Finlepsin 200mg Tab. X50 (R)
FINLEPSIN 200MG. No. 50 TAB.
FINLEPSIN TAB. 200MG No. 50
