Grandaxin pills 50mg №60

Pills

Composition

1 pill contains:
Active ingredients: tofizopam 50 mg.

Excipients: stearic acid, Magnesium stearate, gelatin, talc, potato starch, lactose monohydrate, microcrystalline cellulose.

Packing

60 pieces

Mechanism of action

GRANDAKSIN - tranquilizer.

A drug from the group of benzodiazepine derivatives (an atypical benzodiazepine derivative). It has anxiolytic effect, not accompanied by a sedative, muscle relaxant, anticonvulsant effect. It is a psycho-vegetative regulator, eliminates various forms of autonomic disorders. It has moderate stimulating activity.

Due to the lack of muscle relaxant effect, the drug can be used in patients with myopathy and myasthenia.

Due to the atypical nature of the chemical structure, in contrast to the classical benzodiazepine derivatives, Grandaxin in therapeutic doses does not potentiate the effect of alcohol and practically does not cause the development of physical, psychological dependence and withdrawal syndrome.

Grandaxine refers to daytime tranquilizers.

Indications and usage

Neurosis and neurosis-like states - conditions that are accompanied by:
Emotional stress.
Vegetative disorders.
Moderate anxiety.
Apathy.
Decreased activity.
Obsessive experiences.
Reactive depression with mild psychopathological symptoms.
Mental adaptation disorder (post-traumatic stress disorder).
Climacteric syndrome (as an independent tool, as well as in combination with hormonal drugs).
Premenstrual tension syndrome.
Cardialgia (as monotherapy or in combination with other drugs).
Alcohol withdrawal syndrome.
Myasthenia gravis, myopathies, neurogenic muscular atrophies and other pathological conditions with secondary neurotic symptoms in cases where anxiolytics are contraindicated with a pronounced muscle relaxant effect.

Contraindications

Conditions accompanied by pronounced psychomotor agitation, aggressiveness, or deep depression.
Respiratory failure in the stage of decompensation.
Syndrome stop breathing in a dream (in history).
Simultaneous use with tacrolimus, sirolimus, cyclosporine.
I trimester of pregnancy.
Lactation period (breastfeeding).
Hypersensitivity to the components of the drug or any other benzodiazepines.

Precautions should be prescribed the drug in the following cases:
Decompensated chronic respiratory distress syndrome.
Acute respiratory failure in history.
Closed angle glaucoma.
Epilepsy.
Organic brain damage (eg, atherosclerosis).

Pregnancy and Breastfeeding

Grandaksin is contraindicated for use in the first trimester of pregnancy and during lactation (breastfeeding).

Dosage and administration

Set individually, taking into account the patient's condition, the clinical form of the disease and individual sensitivity to the drug.

Adults appoint 50-100 mg (1-2 tab.) 1-3 times / day. With irregular use, you can take 1-2 tab. The maximum daily dose is 300 mg.
Use in special clinical situations

Elderly patients and patients with renal insufficiency reduce the daily dose by about 2 times.

Adverse reactions

From the side of the central nervous system: headache, insomnia, irritability, psychomotor agitation, confusion, convulsive seizures in patients with epilepsy.

On the part of the digestive system: loss of appetite, constipation, flatulence, nausea, dry mouth; in some cases - cholestatic jaundice.

Allergic reactions: possible pruritus, rash (including scarlet-like rash).

On the part of the musculoskeletal system: muscle tension, muscle pain.

Special notes

It should be borne in mind that in patients with mental retardation, elderly patients, patients with impaired renal and / or liver function more often than other patients, side effects may occur.

Tofizopam is not recommended for chronic psychosis, phobias or obsessive-compulsive disorders. In these cases, the risk of suicidal attempts and aggressive behavior increases. Therefore, Grandaxine is not recommended as monotherapy for depression or depression accompanied by anxiety.

Care must be taken in treating patients with depersonalization, as well as with organic brain damage (for example, with atherosclerosis).

In patients with epilepsy, tofisopam may increase the threshold of convulsive readiness.

Each Grandaxine pill contains 92 mg of lactose, which should be considered in patients with lactose intolerance.
Application for violations of the liver

Patients with impaired liver function more often than other patients may experience side effects.

Application for violations of kidney function

Patients with renal insufficiency reduce the daily dose by about 2 times.

Influence on ability to drive motor transport and control mechanisms

Grandaxine does not cause a significant decrease in the ability to concentrate. The question of the possibility of driving vehicles and driving mechanisms should be solved only after evaluating the patient's individual response to the drug.

Drug Interactions

Simultaneous use of tacrolimus, sirolimus, cyclosporine and Grandaxin is contraindicated. Plasma concentrations of drugs that are metabolized with the participation of the CYP3A4 isoenzyme may increase when taken concomitantly with tofisopam.

The use of Grandaxine with drugs that suppress the functions of the central nervous system (analgesics, general anesthetics, antidepressants, histamine H 1 receptor blockers, sedatives, hypnotics, antipsychotics), enhances their effects (for example, sedation or respiratory depression).

Hepatic enzyme inducers (ethanol, nicotine, barbiturates, antiepileptic drugs) can increase the metabolism of tofisopam, which can lead to a decrease in its concentration in blood plasma and a weakening of the therapeutic effect.

Some antifungal drugs (ketoconazole, itraconazole) can slow down the hepatic metabolism of tofisopam, which leads to an increase in its concentration in blood plasma.

Some antihypertensive drugs (clonidine, Calcium channel blockers) may enhance the effects of Grandaxine.

Beta-blockers may slow down the metabolism of tofisopam, but this effect has no clinical significance.

Tofizopam with simultaneous use may increase the level of Digoxin in the blood plasma.

Benzodiazepines, incl. tofizopam, may affect the anticoagulant effect of Warfarin.

Long-term simultaneous use of disulfiram may inhibit the metabolism of tofisopam.

Antacids may affect the absorption of tofisopam.

Cimetidine and Omeprazole with simultaneous use inhibit the metabolism of tofisopam.

Oral contraceptives can reduce the intensity of the metabolism of tofisopam.

Tofizopam weakens the inhibitory effect of ethanol on the central nervous system.

Overdosage

After taking the drug in a dose of 50-120 mg / kg of body weight, vomiting, confusion, coma, respiratory depression and / or epileptic seizures may occur.
Treatment: in case of marked suppression of the functions of the central nervous system, it is not recommended to induce vomiting, the stomach should be flushed. The introduction of Activated carbon helps to reduce the absorption of the drug. It is necessary to constantly monitor the basic physiological parameters and apply appropriate symptomatic therapy. When respiratory depression can be performed artificial respiration. The introduction of CNS stimulants is not recommended. Hypotension is best eliminated in / in the introduction of fluids and transfer the patient to the Trendelenburg position. If these measures do not restore normal blood pressure, you can enter dopamine or norepinephrine (norepinephrine). Dialysis and forced diuresis are not effective. In case of emergency, it is possible to use a specific benzodiazepine antagonist, flumazenil, but its use in overdose with tofisopam has not been clinically tested.

The drug should be stored at a temperature of 15 ° to 25 ° C.

5 years