Medication

Tegretol

Structure

  • The composition of one tablet of the drug Tegretol may include 200 mg or 400 mg carbamazepine. Additional substances: sodium carmellose, microcrystalline cellulose, silicon dioxide, magnesium stearate.
  • 5 ml of tegretol drug syrup contains 100 mg carbamazepine. Additional substances: sodium saccharinate, polyethylene glycol 400, hydroxyethyl cellulose 300, propylene glycol, microcrystalline cellulose, sorbitol, sodium carmellose, methyl parahydroxybenzoate, sorbic acid, propyl parahydroxybenzoate, water, aromatic caramel.

Release form

Round white flat tablets with a chamfer, engraved with “CG” (or “CG / CG”) on one surface and “G / K” (or “LR / LR”) and risk on the other surface.

  • 10 tablets of 200 mg per blister; 5 blisters in a cardboard bundle.
  • 10 tablets of 400 mg per blister; 3 blisters in a cardboard bundle.
  • 100 ml of syrup in a dark glass bottle; 1 bottle with a measuring spoon in a cardboard bundle.

Pharmachologic effect

Anticonvulsantact.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Dibenzodiazepine antiepileptic drug. Also possesses psychotropicand neurotropic effects.

Tegretol is effective in the event of focal seizures with or without secondary generalization, tonic-clonic generalized seizures, and a combination of the above seizures.

When using the drug as monotherapy in individuals with epilepsy revealed the psychotropic effect of the drug, which manifested itself by stopping the symptoms of anxiety and depression, lowering the level of irritability and aggressiveness.
Tegretol is effective in certain neurological diseases: prevents attacks of pain in secondary and cryptogenic trigeminal neuralgia. The drug is also used to relieve pain of the neurogenic type in various conditions, for example, post-traumatic paresthesias, postherpetic neuralgia. At alcohol withdrawal increases the seizure threshold and weakens the severity of withdrawal symptoms (tremorirritability, gait disturbance). In persons with diabetes insipidus the drug reduces diuresis and thirst.

As a psychotropic agent used in manic conditions, for maintenance therapy of bipolar disorders, with schizoaffective and manic psychosesat acute schizophrenia polymorphic nature.
The mechanism of action of the drug is associated with a blockage of sodium channels, leading to stabilization of the membranes of overexcited neurons, inhibition of the development of multiple discharges in nerve cells. Anticonvulsant effect due to stabilization of the walls of neurons and decreased secretion glutamatedecreased activity glutamate. Increases a low seizure threshold and the risk of an epileptic seizure. It stops epileptic changes in personality structure and ultimately increases the sociability of patients and improves their social rehabilitation.

Pharmacokinetics

After ingestion, it is absorbed slowly and in full. After a single use of the pill, the highest concentration is reached after 12 hours. There are no clinically important differences in the degree of absorption of the active substance after taking various oral forms of release of the drug.

Eating does not affect the rate and level of absorption of the active substance.

Binding carbamazepine with proteins blood reaches 80%. It crosses the histohematological barriers and into breast milk.

Metabolized in the liver along the epoxy pathway to form 10,11-transdiol metaboliteand glucuronic conjugate.Biotransformation carbamazepine provides isoenzyme CYP3A4. Inactive derivative is also highlighted. 9-hydroxymethyl-10-carbamoylacridane.

After taking the drug, the half-life carbamazepine is approximately 36 hours.

About 71% of the dose is excreted by the kidneys and 29% by the intestines.

Indications for use

  • Manic statesacute type and supportive therapy of affective bipolar disorder to prevent exacerbations or reduce the severity of clinical manifestations.
  • Alcohol withdrawal.
  • Epilepsy: partial seizures (with or without loss of consciousness) with or without secondary generalization; generalized tonic-clonic seizures; mixed forms of seizures.
  • Diabetic neuropathy with the presence of pain.
  • Trigeminal neuralgia including cryptogenic and against the background of multiple sclerosis; cryptogenic neuralgia of the glossopharyngeal nerve.
  • Diabetes insipidus central; neurohormonal polyuria and polydipsia.

Contraindications

  • The presence of episodes of inhibition of hematopoiesis in the bone marrow or information about intermittent porphyria acute in history.
  • AV blockade.
  • Combination with MAO blockers. Before prescribing MAO blockersadvised to cancel at least 14 days in advance.
  • Hypersensitivity to the active substance, chemically related drugs or other components of the drug.

Side effects

  • Reactions from the nervous activity: ataxia, dizziness, diplopia, drowsiness, headache, general weakness, disturbances of accommodation, nystagmusoculomotor disturbances, orofacial dyskinesiaspeech impairment peripheral neuritis, choreoathetoid disordersmuscle weakness paresthesia, symptoms of paresis.
  • Reactions from the psyche: depressionvisual or auditory hallucinationsanxiety loss appetite, aggressive behavior, disorientation, arousal, activation of psychosis.
  • Allergic reactions: hivesallergic skin reactions uhxfoliative dermatitis, erythroderma, lupus-like syndrome, Stevens-Johnson syndrome, itching, epidermal toxic necrolysis.
  • Dermatological reactions: knobby and erythema multiformephotosensitivity purpuraskin pigmentation changes acne, hair loss, increased sweating.
  • Reactions from the hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, lymphadenopathy, leukocytosis,deficit folic acid, red blood cell aplasia, aplastic anemia,intermittent acute porphyria, megaloblastic anemia, hemolytic anemia, reticulocytosis.
  • Digestive reactions: nausea, increased content gamma glutamyl transferaseincreasing content alkaline phosphataseor transaminase jaundice, liver failure, glossitisdry mouth, vomiting, diarrhea, hepatitis, stomach ache, constipation, stomatitis, pancreatitis.
  • Hypersensitivity Reactions: Multi-Organ delayed hypersensitivity from fever, vasculitis,skin rashes, lymphadenopathylymphoma-like symptoms leukopenia, arthralgia, eosinophilia, hepatosplenomegaly; aseptic meningitis, angioedema, anaphylactic reaction.
  • Circulatory Reactions: arrhythmiascardiac conduction disorders, arterial hypertension, arterial hypotension, bradycardia, AV blockcongestive heart failure, thrombophlebitis, collapse, thromboembolic syndrome.
  • Hormonal reactions: fluid retention, swelling, hyponatremia, decrease in plasma osmolarity, weight gain, increase in content prolactin, galactorrhea, gynecomastialevel reduction thyroxineincrease in content thyroid stimulating hormone, metabolic disorders in bone tissue, increased levels cholesterol.
  • Reactions from the genitourinary sphere: renal failure, interstitial nephritis, impaired renal function, urinary retention, rapid urination, sexual dysfunction.
  • Reactions from the sensory organs: clouding of the lens, change in taste, conjunctivitis, tinnitus, hearing impairment, hypoacusia, hyperacusis, disturbance of sound perception.
  • Respiratory reactions: dyspnea, pneumonia.
  • Reactions from the musculoskeletal system: arthralgia, cramps, muscle pain.

Instructions for use Tegretol (Method and dosage)

Instructions for use Tegretol allows you to take tablets during or after a meal simultaneously with a small amount of liquid. At epilepsyif possible, the drug should be taken as monotherapy.

Therapy begins with the use of a small daily dose, which is then slowly increased to the optimal level. To select the optimal dosage, it is recommended that the content of the active substance in the blood be determined.

When the drug is added to the already selected antiepileptic therapy, this must be done gradually, and the doses of the drugs used usually do not change or correct.

The initial dose for adults is 100-200 mg 1-2 times a day. Then the dosage is slowly increased until the optimal therapeutic effect; as a rule, it is achieved with 400 mg per day. Some patients may need to take 1.6 grams or 2 grams of the drug per day.

Children 4 years of age and younger should begin treatment with 20-60 mg of the drug per day and increase the dosage by 20-60 mg in one day.

In children over 4 years of age, therapy is allowed to start with 100 mg per day; the dosage is increased slowly, by 100 mg once a week.

Supporting dosages for children are 10-20 mg / kg per day.

During therapy trigeminal neuralgia the initial dose is 200-400 mg per day. It is gradually increased until the pain is relieved (200 mg to 4 times a day), then it is slowly lowered to the lowest support level. The recommended initial dose for the elderly is 100 mg twice in laziness.

At alcohol withdrawal the standard dose is 200 mg three times a day. In especially severe cases, in the first few days, the dosage may be increased. In severe manifestations of alcohol withdrawal, therapy begins with the use of a combination of tegretol with sedative-hypnotic drugs. After stopping the acute phase, Tegretol monotherapy can be performed.

At diabetes insipidusthe average adult dose is 200 mg of the drug up to 3 times a day. In children, the dosage should be reduced in accordance with the age and weight of the child.

In the treatment diabetic neuropathy with the presence of pain, the usual dose of the drug is 200 mg up to four times a day.

At manic states acute type and with maintenance therapy of bipolar disorders, daily doses are 400-1600 mg. The standard daily dose is 400-600 mg.

Overdose

Signs of an overdose: agitation, depression of the nervous system, drowsiness, disorientation, hallucinations,blurred vision coma, dysarthriaslurred speech ataxia, nystagmus, dyskinesia, hyporeflexia, hyperreflexia, hypothermia, convulsions, myoclonus, psychomotor disorders mydriasis, pulmonary edemarespiratory depression tachycardia, hypertension, arterial hypotension, cardiac arrest, fainting, vomiting, decreased bowel motility, oliguria, urinary retention, fluid retention, anuria, hyponatremia, hyperglycemia, metabolic acidosis,level up creatinine phosphokinase.

Overdose treatment: hospitalization, level determination carbamazepinein the blood to assess the severity of an overdose. Removing the contents of the stomach, application enterosorben, symptomatic therapy, monitoring of the heart, correction of electrolyte disturbances. Specific antidote does not exist.

Interaction

The combined use of tegretol with CYP3A4 inhibitors able to increase concentration carbamazepine in the blood and cause side effects. Sharing inducers CYP3A4 can lead to activation metabolism Tegretol and a decrease in the concentration of the active component in the plasma, as well as a possible decrease in the severity of the therapeutic effect.

Level carbamazepine in the blood can increase Diltiazem, Verapamil, Dextropropoxyphene, Fluoxetine, Viloxazine, Fluvoxamine, Acetazolamide, Cimetidine, Danazole, Nicotinamide, Desipramine, Nefazodon, Azoles, Macrolide Antibiotics, Terfenadine, Grapefruit Juice, Loratazidin, Inhibitor, Viratazidin, Inhibit.

Level carbamazepine in the blood can reduce phenytoin, phenobarbital, primidone, theophylline, progabid, valproic acid, metsuximide, rifampicin, fensuximide, cisplatin, clonazepam, doxorubicin, oxcarbazepine.

With simultaneous use with Felbamate decrease in level is not excluded carbamazepine in serum.

Carbamazepine able to reduce the concentration or even completely level the effects of certain drugs. It may be necessary to change the doses of a number of drugs: Clonazepam, clobazam, corticosteroids, ethosuximide, valproic acid, primidone, alprazolam, cyclosporin, felodipine, digoxin, haloperidol, doxycycline, methadone, imipramine, oral contraceptives, oral anticoagulants, Theophylline, Felbamate, Topiramate, Lamotrigine, Tiagabin, Zonisamide, tricyclic antidepressants, Oxcarbazepine, Clozapine, protease inhibitors, calcium channel blockers, Itraconazole, Levothyroxine, Praziquantel, Midazolam, Olanzapine, estrogen-containing drugs, Tramadol, Risperidone, Cyprasidone.

While using carbamazepineand Paracetamol a decrease in the bioavailability of the latter is not excluded.

Combined use carbamazepine from lithium metoclopramideor antipsychotic drugs can lead to an increase in the frequency of adverse reactions.

Concomitant use of the drug with some diuretic drugs (hydrochlorothiazide, furosemide) capable of leading to hyponatremia.

Carbamazepine reduces effects muscle non-depolarizing relaxants.

Terms of sale

On prescription.

Storage conditions

Store in a dark, dry place at room temperature. Keep out of the reach of children.

Shelf life

5 years.

Special instructions

During the period of taking Tegretol, the occurrence of agranulocytosis and aplastic anemia.

During use of the product with a different frequency, a temporary or persistent decrease in the amount is detected platelet count or white blood cells. But in the vast majority of cases, these adverse reactions are transient.

Tegretol should be immediately canceled if symptoms are detected that indicate the appearance of severe dermatological disorders.

Caution must be exercised when using the drug in patients with mixed epileptic seizures. In these cases, the tool can cause a worsening of the course of seizures.

Prior to the appointment of Tegretol and during treatment, monitoring of liver functional parameters is necessary, especially in patients with liver diseases and in the elderly.

Before prescribing the drug and regularly during treatment, it is recommended that a urinalysis and level urea in plasma.

Tegretol has a weak anticholinergic activity. When using the drug in patients with increased intraocular pressure, constant monitoring of this indicator is needed.

Tegretol is able to significantly reduce the effect oral contraceptives due to microsomal activation enzymes, because of this, non-drug methods of prevention should be used by childbearing women during the treatment period pregnancy.

Sudden withdrawal of Tegretol can trigger seizures epilepsy. If it is still necessary to abruptly stop treatment with the drug, then in this case, the patient with epilepsy needs to switch to another antiepileptic drugs (with reception Diazepam).

The appearance of cross hypersensitivity reactions from Oxcarbazepine and Phenytoin.

During treatment, care should be taken when driving.

Analogs

Matches for ATX Level 4 code:FinlepsinCarbamazepine

Apo-Carbamazepine, Actinval, Zagretol, Carbamazepine, Zeptol, Mazepin, Storilat, Stazepin, Finlepsin, Epial.

For children

Children 4 years of age and younger should begin treatment with 20-60 mg of the drug per day and increase the dosage by 20-60 mg in one day.

In children over 4 years of age, therapy is allowed to start with 100 mg per day; the dosage is increased slowly, by 100 mg once a week.

Supporting dosages for children are 10-20 mg / kg per day.

With alcohol

It is forbidden to take alcohol during the period of use of the drug.

During pregnancy and lactation

It is allowed to use the drug in these periods under the close supervision of a doctor and in the presence of strict indications.

Reviews on Tegretol

Reviews on Tegretol indicate that this drug has established itself as an effective treatment epileptic seizures. Reports of side effects are rare.

Price Tegretol where to buy

The price of Tegretol 200 mg No. 50 in Russia is 357-406 rubles. In Ukraine, such packaging costs an average of 228 hryvnia.

  • Online Pharmacies in Russia
  • Online pharmacies in UkraineUkraine

Pharmacy Dialog

  • Tegretol CR retard (tab. N / a 200mg No. 50) 284 rub.order
  • Tegretol (tab. 200mg No. 50) 355 rub.order
  • Tegretol CR retard (tab. PO 400mg No. 30) 296 rub.order

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  • Tegretol tsr 400 mg No. 30 tab.Novartis Pharma S.p.A. 317 rub.order
  • Tegretol 200 mg n50 tablet Novartis Pharma S.p.A. 395 rub.order
  • Tegretol tsr 200 mg No. 50 tab.Novartis Pharma S.p.A. 320 rub.order
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Pharmacy24

  • Tegretol 200 mg N50 tablets Novartis Pharma S.p.A., Italy 252 UAH.order

Pani Pharmacy

  • Tegretol tablets Tegretol tablets 200mg No. 50 Italy, Novartis Pharma 257 UAH order
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Watch the video: CARBAMAZEPINE TEGRETOL - PHARMACIST REVIEW - #114 (February 2020).

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