Grandaxinum

Grandaxinum – drug with anxiolytic action.

Form of release and structure

Grandaxinum is released in the form of tablets: grayish-white or white color, round, flat, with a facet, inodorous or almost inodorous, with a text of "GRANDAX" on one of the parties and with risky on another (on 10 pieces in blisters, on 2 or 6 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: Tofizopamum – 50 mg;
• Auxiliary components: stearic acid – 1 mg; magnesium stearate – 1 mg; gelatin – 3,5 mg; talc – 2 mg; potato starch – 20,5 mg; monohydrate of lactose – 92 mg; microcrystallic cellulose – 10 mg.

Indications to use

• Neurosis-like states (the state which are followed by vegetative frustration, emotional pressure, the apathy which is moderately expressed by concern, persuasive experiences, hypoactivity) and neurosises;
• Cardialgias (as monotherapy or along with other drugs);
• Situational depression with moderately expressed psychopathological symptoms;
• Posttraumatic stressful frustration (disorder of mental adaptation);
• Syndrome of premenstrual tension;
• Menopausal syndrome (as monotherapy or along with hormonal medicines);
• Myopathies, neurogenic muscular atrophies, myasthenia and other morbid conditions with secondary neurotic symptoms in cases when it is contraindicated to use anxiolytic drugs of the expressed myorelaxation action;
• Syndrome of alcoholic abstinence.

Contraindications

• Respiratory insufficiency in a decompensation stage;
• States which are followed by the expressed psychomotor excitement, a deep depression or aggression;
• Apnoea syndrome in a dream (in the anamnesis);
• Simultaneous use with sirolimusy, takrolimusy, cyclosporine;
• Inborn insufficiency of lactase, intolerance of a galactose, sprue of glucose and galactose (monohydrate of lactose is a part of Grandaxinum);
• First trimester of pregnancy and period of a lactation (breastfeeding);
• Hypersensitivity to components of drug or any other benzodiazepines.

Grandaxinum should be taken with caution the patient with acute respiratory insufficiency in the anamnesis, dekompensirovanny chronic respiratory a distress syndrome, epilepsy, closed-angle glaucoma, organic lesions of a brain (for example, with atherosclerosis).

Route of administration and dosage

The mode of dosing is set individually taking into account a clinical form of a disease, a condition of the patient and individual sensitivity to effect of drug.

The adult Grandaksin appoint 1-3 times a day on 1-2 tablet (50-100 mg). The maximum daily dose – 300 mg. At irregular use of drug it is possible to take 1-2 pill.

At a renal failure and the patient of advanced age the daily dose should be lowered approximately twice.

Side effects

During therapy development of disturbances from some systems of an organism is possible:

• Alimentary system: dryness in a mouth, nausea, a lock, a loss of appetite, a meteorism; in some cases – cholestatic jaundice;
• Central nervous system: confusion of consciousness, sleeplessness, a headache, psychomotor excitement, an acrimony, convulsive attacks at patients with epilepsy;
• Respiratory system: respiratory depression;
• Musculoskeletal system: muscle pain, muscle tension;
• Allergic reactions: a dieback (including a scarlatiniform dieback), a skin itch.

Special instructions

At elderly patients, and also at patients with abnormal liver functions and/or kidneys, a delay of mental development side effects can be observed more often than at others.

Grandaxinum is not recommended to be accepted as monotherapy of depressions or the depressions which are followed by alarm (because of high risk of suicide attempts and an agressive behavior).

It is necessary to be careful during use of Grandaxinum by the patient with depersonalization, and also with organic lesions of a brain (for example, with atherosclerosis).

At patients with epilepsy Tofizopamum can raise a threshold of convulsive readiness.

92 mg of lactose are a part of each tablet that patients need to consider with a lactose intolerance.

And ability to concentrate Grandaxinum has no significant effect on attention.

Medicinal interaction

Simultaneous use of Grandaxinum with takrolimusy, sirolimusy and cyclosporine contraindicated.

Tofizopamum reduces the oppressing impact of ethanol on the central nervous system.

At simultaneous use of Grandaxinum with some medicines the following undesirable effects can be shown:

• The drugs suppressing functions of the central nervous system (analgetics, antidepressants, means for the general anesthesia, blockers histamine H1 receptors, somnolent, sedative and antipsychotic drugs) – strengthening of their effects;
• Some antifungal drugs (итраконазол, кетоконазол) – delay of hepatic metabolism of Tofizopamum is possible that leads to increase in its concentration in a blood plasma;
• Inductors of liver enzymes (barbiturates, ethanol, antiepileptic means, nicotine) – strengthening of metabolism of Tofizopamum is possible that can lead to easing of its therapeutic effect;
• Beta adrenoblockers – delay of metabolism of Tofizopamum is possible (clinical value has no);
• Peroral contraceptive means – decrease in intensity of metabolism of Tofizopamum is possible;
• Some anti-hypertensive drugs (blockers of calcium channels, clonidine) – strengthening of effects of Grandaxinum is possible;
• Benzodiazepines, including Tofizopamum – influence on anticoagulating effect of warfarin is possible;
• Digoxin – increase in its level in a blood plasma is possible;
• Antiacid means – change of absorption of Tofizopamum is possible;
• Disulfiramum (long simultaneous use) – oppression of metabolism of Tofizopamum is possible;
• Omeprazol and Cimetidinum – oppression of metabolism of Tofizopamum.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 5 years.