Epilepsy (except absence seizures, myoclonic seizures, or lingering) – partial seizures with complex symptomatology and simple; generalized epilepsy, epilepsy with small seizures; in the complex therapy in the treatment of trigeminal neuralgia, glossopharyngeal neuralgia, alcohol withdrawal syndrome, affective disorders, polydipsia and trenbolone hex polyuria with diabetes insipidus, diabetic polyneuropathy.
Hypersensitivity to carbamazepine or components of the drug. Atrio-ventricular block; disorders of bone marrow hematopoiesis; intermittent porphyria (including history); concomitant use of monoamine oxidase inhibitors.
Be wary – hyponatremia dilution (hypersecretion syndrome of antidiuretic hormone (hereinafter ADH), hypopituitarism, hypothyroidism, adrenal insufficiency), advanced age, alcohol intake (increases CNS depression, increases carbamazepine metabolism), inhibition of bone marrow hematopoiesis in patients receiving medications (history) ; prostatic hyperplasia, increased intraocular pressure, severe heart failure, liver failure, chronic renal failure.
It is not recommended to use during pregnancy and lactation.
Dosage and administration :
Assign the inside, regardless of the meal with a small amount of liquid.
Monotherapy: treatment begins with the application of a small daily dose, which subsequently slowly increased until the optimum effect.
Joining carbamazepine to the already ongoing antiepileptic therapy should be gradual, with the dose of the drugs do not change or, if necessary, carry out their correction.
dosage is determined by your doctor.
For adults, the initial dose is 100-200 mg 1-2 times a day. Then slowly increase the dose to achieve optimal therapeutic effect (as much as possible – 1600-2000 mg / day).
For children from 4 months to 4 years, the average daily dose is 10-20 mg / kg body weight: from 4 months to 1 year – 100-200 mg per day, from 1 to 5 years – 200-400 mg (1-2 doses), from 6 to 10 years – 400-600 mg (2-3 doses) for 11-15 years – 600-1000 mg (2-3 hours).
Maintenance dose: 10-20 mg / kg per day (in stages).
For trigeminal neuralgia and neurogenic pain syndrome: Carbamazepine appointed from 100-200 mg 2 times a day, gradually increasing the dose no more than 200 mg a day until the end of pain on average up to 600-800 mg, then reduced to the minimum effective dose. The effect is usually 1-3 days after the start of treatment. Prescribe medication for a long time; with premature drug discontinuation pain may return. In the treatment of elderly patients the initial dose should be 100 mg 2 times a day.
Alcohol withdrawal syndrome: the average dose – 200 mg 3 times a day. In severe cases, the dose during the first days can be increased (up to 400 mg three times a day).
Diabetes insipidus: the average dose for adults – 200 mg 2-3 times a day. Diabetic neuropathy, accompanied by pain: the average dose – 200 mg 2-4 times a day.
For the prevention of affective disorders: the first week of daily dose of 200-400 mg (2 tablets). Subsequently the dose increased to 200 mg per week, bringing it to about 1 g daily dose divided evenly 3-4 Hour. Daylight carbamazepine treatment should be gradual, with decreasing doses previous preparation. Discontinuation of therapy with carbamazepine should be also gradually. Duration of treatment is determined by the doctor individually.
Side effects :
On the part of the central nervous system: very often – dizziness, ataxia, drowsiness, weakness, often – headache, diplopia, accommodation disturbances, oculomotor, speech and hyperkinetic disorders, peripheral neuritis, paresthesia, muscle weakness, paresis symptoms. From the mental sphere : rarely – hallucinations (visual or auditory), depression, loss of appetite, restlessness, trenbolone hex aggressive behavior, agitation, disorientation; very rarely – activation of psychosis. Allergic reactions: from urticaria to angioedema and anaphylaxis. In the event of hypersensitivity reactions, use of the drug should be discontinued. From the side of hematopoiesis: very often – leukopenia; often – thrombocytopenia, eosinophilia; rarely – leukocytosis, lymphadenopathy; very rarely – agranulocytosis, aplastic anemia, pure red cell aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia. From the digestive system (hereinafter GI) tract: often – nausea, vomiting; often – dry mouth; sometimes – diarrhea or constipation, abdominal pain; very rarely – glossitis, stomatitis, pancreatitis. Liver: very often – increasing the activity of gamma-glutamyl transpeptidase; often – alkaline phosphatase; sometimes – increased activity of “liver” transaminases; rarely – hepatitis cholestatic, parenchymal (hepatocellular) or mixed type, jaundice, very rarely – granulomatous hepatitis, hepatic failure. On the part of the cardiovascular system (hereafter CAS): rarely – a violation of intracardiac conduction; increase or decrease in blood pressure; very rarely – bradycardia, collapse, worsening or development of congestive heart failure, aggravation of coronary artery disease, thrombophlebitis, thromboembolic syndrome. On the part of the endocrine system and metabolism: often – edema, fluid retention, weight gain, hyponatremia, very rare – raising prolactin (may be accompanied by galactorrhea and gynecomastia); reduction of L-thyroxine and increased thyroid stimulating hormone (TSH) (usually not accompanied by clinical signs);disorders of calcium-phosphorus metabolism in bone tissue; osteomalacia; hypercholesterolemia and hypertriglyceridemia. From the urogenital system: very rarely – interstitial nephritis, renal failure, renal failure, urinary frequency, urinary retention, sexual dysfunction / impotence. From the musculoskeletal system: very rarely – arthralgia, myalgia or cramps. From the sensory organs: rarely – a violation of taste sensations, cataract, conjunctivitis; hearing disorders: tinnitus, hyperacusis, Gipoakuzija, changes in the perception of pitch. Other: disorders of skin pigmentation, purpura, acne, sweating, alopecia. In rare cases – hirsutism.
Symptoms : Central nervous system: depression of the central nervous system functions, disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (in the beginning), hyporeflexia (later); convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis; Cardiovascular system: tachycardia, decreased or increased blood pressure, conduction disorder, fainting, cardiac arrest, respiratory system: respiratory depression, pulmonary edema Gastrointestinal: nausea and vomiting, delay the passage of food from the stomach, decreased motility of the colon. The urinary system: urinary retention, oliguria or anuria; fluid retention; . hyponatremia breeding laboratory and instrumental data: leukocytosis or leukopenia, hyponatremia, may be metabolic acidosis, hyperglycemia and glucosuria, increased muscle creatine phosphokinase fraction.
Treatment : the specific antidote is available. It is recommended gastric lavage, reception activated carbon, conducting hemosorption on coal sorbents, symptomatic therapy. If necessary – hospitalization.
Interaction with other drugs :
Not less than 2 weeks prior to initiating therapy with carbamazepine should be discontinued treatment monoamine oxidase inhibitors.
Phenobarbital and hexamidine weaken the anticonvulsant effect of carbamazepine.
When oral contraceptives due to weakening of the action of hormonal contraceptives may be sudden acyclic bleeding. During treatment with carbamazepine is recommended to use non-hormonal methods of contraception.
Co-administration of carbamazepine and neuroleptics or metoclopramide may contribute to symptoms of side effects to the central nervous system, the psyche.
When concomitant trenbolone hex administration of carbamazepine with lithium preparations enhanced the neurotoxic effect of both drugs.
Carbamazepine enhances the hepatotoxic effects of isoniazid.
Concomitant use carbamazepine diuretics can lead to a reduction in the sodium content in the blood serum.
carbamazepine stimulates anticoagulants metabolism, hormonal contraceptive drugs, folic acid.
carbamazepine may enhance the elimination of thyroid hormones.
The concentration of carbamazepine in plasma while appointing reduce: phenobarbital, phenytoin, primidone, valproic acid, theophylline.
The concentration of carbamazepine in plasma while the appointment of increase: antibiotics macrolide, isoniazid, calcium antagonists, acetazolamide, dextropropoxyphene / propoxyphene, viloksazin, danazol, nicotinamide (at high doses in adults), cimetidine and desipramine.
Special instructions :
Treatment should be under medical supervision. The drug is prescribed with caution in concomitant diseases of the cardiovascular system, expressed violations of the liver and / or kidney disease, diabetes mellitus, increased intraocular pressure, when specifying a history of haematological reactions to the use of other drugs, hyponatremia, urinary retention, increased sensitivity to tricyclic antidepressants, when specifying a history of interrupted treatment with carbamazepine, as well as children and elderly patients. Prolonged treatment is necessary to control blood picture, liver function, renal, electrolyte concentration in blood plasma, to carry out an eye examination. Recommended periodic determination of plasma levels of carbamazepine to monitor the effectiveness and safety of treatment.
During the treatment should refrain from activities potentially hazardous activities that require attention, psychomotor speed of reaction; contraindicated the use of alcoholic beverages.
Product form :
200 mg tablets. 10 tablets in blisters. According to 1,2,3,4 or 5 contour cell packages with instructions for use in paper cartons. 500, 600, 1000, 1200 tablets in a jar polymer (for hospitals).
Storage : List B. In dry, dark place at a temperature no higher than 25 ° C. Keep out of the reach of children.
Shelf life : 3 years. Do not use after the expiration date.
Conditions of supply of pharmacies : Prescription.