Finlepsin retard pills with prolonged action 400mg N50
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Active ingredients
Carbamazepine
Release form
Pills
Composition
Tablets of prolonged action, composition (1 tab.): Active substance: carbamazepine - 400 mg; excipients: Eudragit RS30D (ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate copolymer (0.1) - 22 mg; triacetin - 4.4 mg; talc - 31.2 mg; Eudragit L30D-55 (methacrylic acid and ethyl acrylate copolymer) - 70 mg; MCC - 43.6 mg; crospovidone - 24.8 mg; colloidal silicon dioxide - 2.66 mg; magnesium stearate - 1.34 mg
Pharmacological effect
Pharmacokinetics
Indications
analgesic, antipsychotic, antiepileptic
Contraindications
Inside, during or after a meal, drinking plenty of fluids. For ease of use, the tablet (as well as its half or a quarter) can be pre-dissolved in water or juice, since the property of prolonged release of the active substance after the dissolution of the tablet in the liquid is preserved. The range of doses used is 400–1200 mg / day, which is divided into 1-2 doses per day. The maximum daily dose should not exceed 1600 mg. Epilepsy; Whenever possible, Finlepsin Retard should be administered as a monotherapy. Treatment begins with the use of a small daily dose, which is subsequently slowly increased to achieve the optimal effect. The addition of Finlepsin Retard to the already ongoing antiepileptic therapy should be carried out gradually, while the doses of the drugs used do not change or, if necessary, be corrected. If the patient forgot to take the next dose of the drug in a timely manner, you should take the missed dose as soon as this omission is noticed, and you should not take a double dose of the drug .; Adults. The initial dose is 200-400 mg / day, then the dose is gradually increased until the optimum effect is achieved. Maintenance dose - 800–1200 mg / day, which is divided into 1-2 doses per day. Children. The initial dose for children from 6 to 15 years old is 200 mg / day, then the dose is gradually increased by 100 mg / day to achieve the optimal effect. Maintenance doses for children 6-10 years old - 400-600 mg / day (in 2 doses); for children 11–15 years old - 600–1000 mg / day (in 2 doses) .; The following dosing regimen is recommended: Age categories Initial dose Support dose; Adults 200–300 mg in the evening, 200–600 mg in the morning; 400–600 mg in the evening; Children from 6 to 10 years old, 200 mg in the evening, 200 mg in the morning; 200-400 mg in the evening; Children from 11 to 15 years old, 200 mg in the evening, 200-400 mg in the morning; 400–600 mg in the evening; The duration of application depends on the indications and the individual reaction of the patient to treatment.The decision to transfer the patient to Finlepsin retard, the duration of its use and the cancellation of treatment is made by the doctor individually. 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 of the drug within 1–2 years, under the control of EEG. In children with a decrease in the daily dose of the drug should take into account the increase in body weight with age .; Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia; The initial dose is 200-400 mg / day, which is divided into 2 doses. The initial dose is increased up to the complete disappearance of pain, on average up to 400–800 mg / day. After that, in a certain part of the patients, treatment can be continued with a lower maintenance dose of 400 mg. Elderly patients and patients sensitive to Karabamazepine, Finlepsin retard is prescribed in an initial dose of 200 mg 1 time per day .; Pain in diabetic neuropathy; The average daily dose is 200 mg in the morning and 400 mg in the evening. In exceptional cases, Finlepsin Retard can be administered in a dose of 600 mg 2 times a day .; Treatment of alcohol withdrawal in the hospital; The average daily dose is 600 mg (200 mg in the morning and 400 mg in the evening). In severe cases, in the first days, the dose can be increased to 1200 mg / day, which is divided into 2 doses .; If necessary, Finlepsin Retard can be combined with other substances used to treat alcohol withdrawal, except for sedative-hypnotic drugs .; During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma .; In connection with the possible development of side effects from the central and autonomic nervous system, patients are carefully monitored in the inpatient setting .; Epileptiform convulsions in multiple sclerosis; The average daily dose is 200-400 mg 2 times a day .; Treatment and prevention of psychosis; The initial and maintenance doses, as a rule, are the same - 200-400 mg / day. If necessary, the dose can be increased to 400 mg 2 times a day.
Use during pregnancy and lactation
From the blood and lymphatic system: leukocytosis, eosinophilia, leukopenia, thrombocytopenia, folic acid deficiency, agranulocytosis, aplastic anemia,pancytopenia, erythrocyte aplasia, anemia, megaloblastic anemia, acute intermittent porphyria, variegated porphyria, late skin porphyria, reticulocytosis, possible hemolytic anemia, bone marrow failure .; Immune system disorders: drug eruptions with eosinophilia and systemic symptoms (DRESS), multiorgan delayed-type hypersensitivity with fever, skin rashes, vasculitis, lymphadenopathy; signs resembling lymphoma; arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and abnormal liver function tests that occur in various combinations, bile duct syndrome (destruction and disappearance of intrahepatic bile ducts); aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactic reaction, angioedema, hypogammaglobulinemia. Other organs may also be involved (for example, liver, lungs, kidneys, pancreas, myocardium, large intestine) .; On the part of the endocrine system: edema, fluid retention, weight gain, hyponatremia and decrease in plasma osmolarity through the effect of carbamazepine, similar to the action of antidiuretic hormone, which sometimes leads to hyperhydration, which is accompanied by lethargy, vomiting, headache, confusion and neurological disorders, increased prolactin levels with or without clinical symptoms such as galactorrhea and gynecomastia; abnormal results of thyroid function tests: a decrease in the level of L-thyroxine (FT4, T4, T3) and an increase in TSH, which usually passes without clinical manifestations, a violation of bone metabolism indicators (a decrease in plasma calcium levels and 25-hydroxycolcalciferol in blood plasma, which osteomalacia / osteoporosis, elevated cholesterol levels, including HDL cholesterol and TG. Carbamazepine can lower blood plasma levels of folic acid, plasma levels of vitamin B12 have been reported to decrease and homocysteine level; metabolic and nutritional disorders: folate deficiency, decreased appetite, acute porphyria, chronic porphyria; Mentally: hallucinations (visual or auditory), depression, lack of appetite, anxiety,aggressive behavior, agitation, nervous agitation, confusion, activation of latent psychosis, mood changes, such as depressive or manic mood swings, phobias, lack of motivation, involuntary movements, such as asterixis .; Nervous system disorders: general weakness, dizziness, ataxia, drowsiness, sedation, fatigue, headache, abnormal reflex movements (for example, tremor, large-scale tremor, dystonia, tic), nystagmus, orofacial dyskinesia, delayed thinking, speech disorders (for example, dysrhythmia or slurred speech), choreoathetosis, peripheral neuropathy, paresthesias, muscle weakness and paresis, taste disturbance, neuroleptic malignant syndrome, memory impairment, ataxic and cerebellar disorders, which hen accompanied by headache .; On the part of the organ of vision: conjunctivitis, disturbance of accommodation (diplopia, blurred vision), increased intraocular pressure, clouding of the lens, retinotoxicity, oculomotor disturbances .; On the part of the organ of hearing and the vestibular apparatus: hearing loss, tinnitus, tinnitus, hyperacussion, hypoacusia, impaired pitch perception .; Cardiovascular: intracardiac conduction disorders, bradycardia, arrhythmia, worsening of coronary heart disease, congestive heart failure, circulatory collapse, AV blockade with syncope, hypertension or hypotension, vasculitis, thrombophlebitis, thromboembolism (eg pulmonary embolism). ; On the part of the respiratory system: increased sensitivity to the lungs, which is characterized by fever, shortness of breath, pulmonitis or pneumonia. In the event of such hypersensitivity reactions, the drug should be discontinued .; On the part of the digestive system: loss of appetite, dry mouth, nausea, vomiting, diarrhea, constipation, abdominal pain, stomatitis, gingivitis, glossitis, pancreatitis, colitis .; Hepatobiliary disorders: changes in liver function tests (increased gamma-glutamyltransferase, increased alkaline phosphatase, transaminases), jaundice, various forms of hepatitis (cholestatic, hepatocellular, granulomatous, mixed), life-threatening acute hepatitis,liver failure.; On the part of the skin and subcutaneous fat: allergic dermatitis, urticaria, pruritus, exfoliative dermatitis, erythroderma, necrosis of superficial areas of the skin with blistering (Lyell's syndrome), photosensitization, redness of the skin with polymorphous spots in the form of spots and the formation of nodes, with hemorrhages ( exudative erythema multiforme, erythema nodosum multiforme, Stevens-Johnson syndrome), petechial hemorrhages in the skin and lupus erythematosus (red disseminated lupus, alopecia), diaphoresis, changes in skin igmentation, acne, hirsutism, vasculitis, purpura, increased sweating, acute generalized exantomous pustus (AGEP), lichenoid keratosis, onychomadesis .; On the part of the musculoskeletal system: arthralgia, myalgia, muscle cramps, muscle pain, fractures, decrease in bone mineral density .; On the part of the kidneys and urinary tract: proteinuria, hematuria, oliguria, dysuria, pollakiuria, urinary retention, tubulointerstitial nephritis, renal failure, increased blood urea / azotemia, frequent urination .; On the part of the reproductive system and mammary glands: impaired spermatogenesis (with a decrease in the number and / or motility of spermatozoa), erectile dysfunction, impotence, decreased sexual desire .; Infections and invasions: reactivation of the human herpes virus type VI .; The deviation of the results of laboratory tests: hypogammaglobulinemia.
Dosage and administration
epilepsy: complex or simple partial convulsive seizures (with loss or without loss of consciousness) with or without secondary generalization; generalized tonic-clonic seizures; mixed forms of convulsive seizures .; Finlepsin retard can be used both as monotherapy and as part of combination therapy .; Acute manic states; supportive therapy for bipolar affective disorders in order to prevent exacerbations or to reduce the severity of clinical manifestations of exacerbation .; Alcohol withdrawal syndrome .; Idiopathic trigeminal neuralgia and trigeminal neuralgia in multiple sclerosis (typical and atypical) .; Idiopathic neuralgia of the glossopharyngeal nerve.
Side effects
Precautionary measures
Interaction with other drugs
Finlepsin Retard should not be prescribed: if there is an established hypersensitivity to carbamazepine or chemically similar drugs (tricyclic antidepressants), or other components of the drug; with AV blockade; ; patients with a history of bone marrow suppression; ; patients with hepatic porphyria (for example, acute intermittent porphyria, mixed porphyria, late skin porphyria) in history; in combination with MAO inhibitors; in combination with voriconazole, since treatment may be ineffective.
special instructions
Cytochrome P450 ZA4 (CYP ZA4) is the main enzyme that catalyzes the formation of the active metabolite of carbamazepine-10, 11-epoxide. The simultaneous use of inhibitors of CYP ZA4 can cause an increase in the concentration of carbamazepine in the blood plasma, which, in turn, can lead to the development of adverse reactions. The simultaneous use of CYP ZA4 inducers may enhance the metabolism of carbamazepine, which leads to a potential decrease in the concentration of carbamazepine in the blood plasma and its therapeutic effect. Similarly, stopping the intake of the CYP ZA4 inducer may decrease the rate of metabolism of carbamazepine, which leads to an increase in the level of carbamazepine in the blood plasma. Carbamazepine is a powerful inducer of CYP ZA4, therefore, it can decrease the concentration of other drugs in the blood plasma, which are mainly metabolized by the induction of their metabolism .; Human microsomal epoxide hydrolase is an enzyme responsible for the formation of 10,11-transdiol derivatives of carbamazepine. The simultaneous administration of human microsomal epoxide hydrolase inhibitors can lead to an increase in plasma concentrations of carbamazepine-10,11-epoxide .; Drugs that can increase the level of carbamazepine and / or carbamazepine-10,11-epoxide in blood plasma. Since an increase in the level of carbamasenin in the blood plasma can lead to the appearance of side reactions (such as dizziness, drowsiness, ataxia, diplopia), the dose of the drug should be adjusted accordingly and / or controlled in plasma with simultaneous use of such drugsanti-inflammatory drugs: dextropropoxyphene, ibuprofen; androgens: danazol; antibiotics: macrolide antibiotics (for example, erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin); ; antidepressants: desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, viloxazine, trazodone; ; antiepileptic drugs: stiripentol, vigabatrin; ; antifungal agents: azoles (for example, itraconazole, ketoconazole, fluconazole, voriconazole). Alternative antiepileptic drugs may be recommended for patients who receive treatment with voriconazole or itraconazole; antihistamine drugs: terfenadine, loratadine; antipsychotic drugs: olanzalin, loxapine, quetiapine; anti-tuberculosis drugs: isoniazid; ; antiviral drugs: protease inhibitors for the treatment of HIV (eg ritonavir); ; carbonic anhydrase inhibitors: acetazolamide; cardiovascular drugs: verapamil, diltiazem; drugs for the treatment of gastrointestinal diseases: cimetidine, omeprazole; muscle relaxants: oxybutynin, dantrolen; antiplatelet drugs: ticlopidine; ; other substances: nicotinamide (in adults, only in high doses), grapefruit juice.