Tegretol (Carbamazepine)

Tegretol (carbamazepine) is an anticonvulsant used to treat neurological conditions including epilepsy, nerve pain, and the manic symptoms of bipolar disorder.

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  1. Indications
  2. Dosage and instructions for use
  3. Overdose
  4. Contraindications
  5. Side Effects
  6. Drug Interactions
  7. Special Precautions
  8. Storage

Product info

Indications

Tegretol is prescribed for:

  • epilepsy (not effective in small and monoclonal seizures);
  • manic states of an acute nature;
  • the need for maintenance therapy in bipolar affective disorders to prevent the development of exacerbations, reduce the symptoms of exacerbations;
  • alcohol withdrawal syndrome;
  • trigeminal neuralgia of idiopathic nature;
  • neuralgia of the trigeminal nerve associated with multiple sclerosis;
  • idiopathic neuralgia of the glossopharyngeal region;
  • neuropathy in the background of diabetes with pain syndrome;
  • insulin-dependent diabetes, associated with cerebral disorders, with polyuria and polydipsia associated with neurohormonal shifts.

Dosage and instructions for use

The drug can be taken during, after meals or in between meals with a small amount of water.

The retard tablets (whole pill or half if prescribed by a doctor) should be swallowed without chewing, with a small amount of liquid. Because the active substance is released from the tablets slowly and gradually, they are prescribed 2 times/day.

Transfer of a patient from taking conventional tablets to taking retard tablets: Clinical experience shows that in some patients with the use of retard tablets, it may be necessary to increase the dose of the drug.

Considering the drug interaction and the different pharmacokinetics of antiepileptic drugs, Tegretol dose for elderly patients should be selected with caution.

In epilepsy, whenever possible, Tegretol should be given as monotherapy.

Treatment begins with a small daily dose, which is then slowly increased until an optimal effect is achieved.

To select the optimal dose of the drug, it is recommended to determine the level of the active substance in the blood plasma.

In the event that the drug is added to the existing antiepileptic therapy, it should be done gradually, while the doses of the drugs used do not change or, if necessary, be corrected.

For adults, the initial dose of Tegretol is 100-200 mg 1 or 2 times/day. Then the dose is slowly increased until the optimal therapeutic effect is achieved; it is usually achieved at a dose of 400 mg/day, given in 2-3 doses. Some patients may require a dose of 1.6 g / day or 2 g / day.

In children aged 4 years and under, it is recommended to start treatment with 20-60 mg/day and increase the dose by 20-60 mg every other day.

In children over the age of 4, treatment can be initiated with a dose of 100 mg/day; The dose is increased gradually – every week by 100 mg.

Supportive doses for children are 10-20 mg / kg / day (in several steps):

Age of a child Daily Dose
Less than 1 year 100-200 mg (1 time a day)
1-5 years 200-400 mg (divided in 1-2 doses)
6-10 years 400-600 mg (divided into 2-3 doses)
11-15 years 600-1000 mg (divided into 2-3 doses)

The recommended initial dose for elderly patients is 100 mg 2 times/day.

Overdose

Symptoms

  • Central nervous system: depression of CNS functions; disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia, hyporeflexia; convulsions, psychomotor disorders, myoclonus, hypothermia, mydriasis;
  • Respiratory system: respiratory depression, pulmonary edema;
  • Cardiovascular system: tachycardia, arterial hypotension; sometimes – hypertension, conduction disorders with QRS complex expansion; cardiac arrest, syncope;
  • Gastrointestinal tract: vomiting, delaying passage of food from the stomach, decreased motility of the colon;
  • Urinary system: urinary retention, oliguria or anuria; fluid retention; hyponatremia of dilution due to the effect of carbamazepine, similar to the action of antidiuretic hormone;
  • Changes in laboratory indicators: hyponatremia, metabolic acidosis is possible, hyperglycemia is possible, muscle fraction of creatinine phosphokinase is increased.

Treatment

  • Initially, overdose treatment should be based on the clinical condition of the patient; hospitalization is indicated. The concentration of carbamazepine in the plasma is determined to confirm the poisoning of this agent and to assess the degree of overdose;
  • Evacuation of the stomach contents, gastric lavage, the use of activated charcoal are carried out. Late evacuation of gastric contents can lead to delayed absorption and re-emergence of symptoms of intoxication during recovery. Symptomatic maintenance therapy is used in the intensive care unit, monitoring of heart function, careful correction of electrolyte disorders. There is no specific antidote for Tegretol.

Contraindications

Tegretol is not used in the following cases:

  • children younger than 12 months;
  • prostate adenoma;
  • leukopenia;
  • violations of AV-conduction;
  • myocardial insufficiency;
  • hypersensitivity to carbamazepine;
  • thrombocytopenia;
  • hypersensitivity to additive components;
  • the depressed state of bone marrow hematopoiesis;
  • intermittent porphyria (including in the anamnesis);
  • evidence in gerontology;
  • hypothyroidism;
  • lactation;
  • therapy with MAO inhibitors;
  • glaucoma;
  • renal failure.

Side Effects

Tegretol may cause the following side effects:

  • a violation of taste perception;
  • paralysis;
  • urticaria;
  • arrhythmia;
  • disorientation;
  • depression;
  • asthenic condition;
  • erythroderma;
  • epigastric pain;
  • dizziness;
  • peripheral neuropathy;
  • hyperhidrosis;
  • constipations;
  • thrombophlebitis;
  • aggression;
  • auditory hallucinations;
  • headache;
  • ataxia;
  • acute intermittent porphyria;
  • drowsiness;
  • agranulocytosis;
  • violation of intramyocardial conductivity;
  • oculomotor disorders;
  • nystagmus;
  • visual hallucinations;
  • orofacial dyskinesia;
  • paresthesia;
  • late porphyria of the skin;
  • deterioration of spermatogenesis;
  • megaloblastic anemia;
  • increased intraocular pressure;
  • renal insufficiency;
  • impaired kidney function;
  • hypo- or hypertension;
  • dryness of the oral mucosa;
  • stomatitis;
  • tremor;
  • increased body weight;
  • deficiency of folic acid;
  • syndrome of extinction of bile ducts;
  • choreoathetoid disorders;
  • seizures of nausea;
  • hypogammaglobulinemia;
  • allergic dermatitis;
  • aplastic anemia;
  • edema;
  • lymphadenopathy;
  • vasculitis;
  • toxic epidermal necrolysis;
  • angioedema;
  • thromboembolism;
  • diarrhea;
  • pancreatitis;
  • hepatosplenomegaly;
  • arthralgia;
  • pneumonitis;
  • true erythrocyte aplasia;
  • anuria;
  • muscular spasm;
  • septic meningitis;
  • hyperprolactinemia;
  • impotence;
  • disorder of sexual function;
  • multi-organ hypersensitivity;
  • anaphylaxis;
  • noise in the ears;
  • hepatic insufficiency;
  • exfoliative dermatitis;
  • glossitis;
  • SLE;
  • hypercholesterolemia;
  • Stevens-Johnson syndrome;
  • photosensitivity;
  • hematuria;
  • leukemia.

With excess dosages, the severity of side effects increases.

Drug Interactions

  • Verapamil – increased plasma concentrations of carbamazepine;
  • Calcium antagonists – increased plasma concentrations of carbamazepine with a risk of toxic effects. Dose adjustment is required;
  • Acetazolamide – the risk of violations of osteogenesis;
  • Diltiazem – the risk of side effects due to increased plasma concentrations of carbamazepine;
  • Benzodiazepines – potentiation of Tegretol;
  • Glucocorticoids – decreased efficiency of glucocorticoids;
  • Dextropropoxyphene – the risk of side effects due to increased plasma concentrations of carbamazepine;
  • Diltiazem – decreased metabolism of carbamazepine with an increased risk of toxic effects;
  • Hormonal contraceptives – decrease in the effectiveness of contraceptives;
  • MAO inhibitors – development of severe hyperstimulation;
  • Clonazepam – decreased efficacy of clonazepam-containing agents;
  • Primidone – decrease in the efficacy of primidone;
  • Quinidine – decrease in the effectiveness of quinidine;
  • Desmopressin – increased desmopressin effectiveness;
  • Erythromycin – decreased metabolic processes in the conversion of carbamazepine with an increase in plasma concentrations of carbamazepine;
  • Antiepileptic drugs – mutual reduction in effectiveness;
  • Doxycycline – decreased efficacy of doxycycline-containing agents;
  • Cortisone – decreased cortisone efficacy;
  • Isoniazid – increased risk of damage to liver tissue;
  • Nizatidine – enhanced effects, the risk of toxic effects of carbamazepine;
  • Cardiac glycosides – induction of the metabolism of cardiac glycosides with a decrease in their effectiveness;
  • Clarithromycin – decreased metabolism of carbamazepine with the possible development of adverse symptoms;
  • Mebendazole – decreased effectiveness of mebendazole;
  • Sertraline – increased depressive effects;
  • Estrogens – decreased estrogen effectiveness;
  • Loratadin – decreased metabolism of carbamazepine with the possible development of adverse symptoms;
  • Cisapride – decreased efficiency of carbamazepine;
  • Itraconazole – the effects of itraconazole decrease;
  • Nicardipine – enhanced effects (including toxic) of carbamazepine;
  • Felbamate – potentiation of secondary symptoms;
  • Nefazodone – increased efficacy and increased adverse symptoms of carbamazepine;
  • Nimodipine – increased efficacy and increased adverse symptoms of carbamazepine;
  • Non-selective inhibitors of a reverse neuronal capture of monoamine molecules – possible development of psychosis, confusion;
  • Phenobarbital – decreased antiepileptic efficacy of carbamazepine;
  • Pimozide – potentiation of CNS depression, lowering the threshold of convulsive readiness;
  • Phenytoin – reducing the concentration of carbamazepine;
  • Doxorubicin – weakening the effectiveness of carbamazepine;
  • Theophylline – decreased plasma concentrations of carbamazepine;
  • Pancuronium – decreased effectiveness of pancuronium;
  • Viral protease inhibitors – potentiation of the effects of carbamazepine;
  • Ethosuximide – weakening the effectiveness of carbamazepine;
  • Paracetamol – decreased bioavailability of paracetamol;
  • Lithium preparations – increased side neurologic symptoms;
  • Metoclopramide – the risk of developing unwanted reactions from the nervous system;
  • Diuretics – the risk of hyponatremia;
  • Haloperidol – increased adverse neurologic symptoms.

Special Precautions

  • Caution is necessary when prescribing Tegretol during pregnancy because of the possibility of teratogenic effects of the active ingredient;
  • The drug is prescribed only under medical supervision, so as not to miss the serious consequences of side symptoms;
  • During the start of therapy and periodically during the treatment, clinical tests are performed to detect changes in the urea nitrogen level, to determine the condition of the blood picture;
  • Due to the anticholinergic effect of Tegretol, intraocular pressure may increase;
  • The drug can activate latent psychosis;
  • When there are symptoms of oppression of bone marrow hematopoiesis when serious dermatological reactions are suspected, the drug is canceled;
  • With mixed seizures, there can sometimes be a paradoxical provocation of seizure syndrome. It is recommended that the drug is discontinued immediately;
  • Those who take contraceptives against the background of therapy with Tegretol should use additional barrier methods of contraceptive protection;
  • Abrupt withdrawal of the medication is dangerous because of the risk of provocation of seizures;
  • The preparation significantly reduces the rate of psychomotor response. This is an obstacle to the adequate management of the vehicle and performing work associated with a potential hazard.

Storage

Tegretol tablets should be stored at a temperature of up to 77 degrees Fahrenheit. The product must not be exposed to moisture.

Do not store the remedy in places that are potentially available to children, mentally unhealthy family members, animals. Using an expired product may damage your health.