Tofisopam

Pharmacotherapeutic group:

anxiolytics diabetes
Field of application:

neurology
Dosage form:

Light-yellow film-coated tablets light-yellow color.
Dosage:

50 mg
Quantity per pack:

20 60
Dispensing conditions:

Prescription only

Instructions for use

Neuroses, psychopathies, and other conditions accompanied by feelings of emotional tension, restlessness, anxiety, and fear; reactive depression with moderately pronounced psychopathic symptoms; premenstrual syndrome, menopausal syndrome; cardiac pain (as monotherapy or in combination with other medications); myasthenia gravis, myopathies, neurogenic muscular atrophies, and other pathological conditions with secondary neurotic symptoms, when anxiolytics with pronounced muscle-relaxing effects are contraindicated; alcohol withdrawal syndrome.

Method of administration and dosage

The dosing regimen for tofisopam is determined on an individual basis, taking into account the patient’s condition, the clinical presentation of the disease, and individual sensitivity to the drug. Adults are prescribed 50–100 mg (1–2 tablets) 1–3 times a day. If used occasionally, you may take 1–2 tablets. The maximum daily dose is 300 mg. For elderly patients and patients with renal insufficiency, the daily dose should be reduced by approximately half. Take the medication by mouth with a sufficient amount of liquid (such as a glass of water). The duration of treatment is determined by the attending physician.

Special instructions and precautions for use

With long-term use, especially at high doses, drug dependence may develop. A course of medication is recommended for NMT 4–12 weeks, including a period of gradual tapering off of tofisopam. Tofisopam is not recommended for use in cases of chronic psychosis, phobias, or obsessive-compulsive disorders. In these cases, the risk of suicide attempts and aggressive behavior increases. In patients with epilepsy, tofisopam may increase the seizure threshold. Do not drink alcohol during treatment. Effects on the ability to drive and operate machinery During treatment, patients must not drive any vehicles or engage in other activities that require high levels of concentration and rapid psychomotor reactions.

Contraindications

Hypersensitivity to tofisopam or other benzodiazepine derivatives; conditions accompanied by severe psychomotor agitation, aggression, or severe depression; decompensated respiratory failure; obstructive sleep apnea syndrome; coma; concomitant use with tacrolimus, sirolimus, or cyclosporine; pregnancy, lactation (breastfeeding); children and adolescents under 18 years of age. Use with caution Decompensated chronic respiratory distress, history of acute respiratory failure, angle-closure glaucoma, epilepsy, organic brain disorders (e.g., atherosclerosis).

Shelf life

2 years

Drug
Safety

In accordance with Russian law, international standards, and the company’s quality policy, Pharmproject monitors the safety and quality of the medicinal products it manufactures throughout their entire lifecycle.

If you experience an adverse reaction while taking any of Pharmproject’s products, be sure to report it to a pharmacovigilance specialist

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