Spitomin (buspirone) tablets 10 mg. №60

Description

Spitomin (buspirone) tablets 10 mg. №60

Composition

active substance: buspirone;

1 tablet contains buspirone hydrochloride 5 mg or 10 mg;

Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silica.

Dosage form

Tablets.

Basic physical and chemical properties:

• 5 mg tablets: white or almost white, round, flat, bevelled tablets, engraved with the stylistic letter E and the number 151 on the one hand and a dash on the other hand, odorless or with a faint characteristic odor;
• 10 mg tablets: White or almost white, round, flat, bevelled tablets, engraved with stylistic letter E and the number 152 on the one hand and a dash on the other hand, odorless or with a faint characteristic odor.

The risk is only for breaking the tablet to facilitate swallowing, not for dose distribution.

Pharmacotherapeutic group

Drugs that affect the nervous system. Anxiolytics.
ATX code N05B E01.

Pharmacological properties

Buspirone is an anxiolytic and is used to treat anxiety of various origins, especially neuroses, accompanied by feelings of anxiety, restlessness, tension, irritability. The mechanism of the anxiolytic effect of buspirone and other azaspirodecanedione derivatives differs from the mechanism of action of benzodiazepines. They do not act on benzodiazepine-GABA-chloride-ionophore receptor complex; however, because they are partial agonists of 5-HT1A receptors, they act by modulating the serotonergic system. This effect suppresses 5-HT renewal and reduces the incidence of inflammation of 5-HT neurons in the dorsal nuclei of the suture. Buspirone is highly related to presynaptic 5-HT1A receptors and is a partial agonist of postsynaptic 5-HT1A receptors in the central nervous system. Buspirone has been shown to have properties typical of anxiolytics and antidepressants.

Buspirone does not show significant activity against benzodiazepine receptors and does not affect the binding of GABA. Unlike benzodiazepines, buspirone does not exhibit muscle relaxant or anticonvulsant properties. Unlike benzodiazepines, buspirone does not cause tolerance or dependence, and no withdrawal symptoms develop upon completion of treatment. The action of buspirone develops gradually. The therapeutic effect begins between 7 and 14 days of therapy, and the maximum effect is achieved only after 4 weeks of treatment.

Indications

Spitomin tablets is used in the treatment of:

• panic disorder;
• generalized anxiety disorders (GAD);
• autonomic dysfunction syndrome;
• depressive disorders (as part of complex treatment);
• alcohol withdrawal syndrome.

Contraindications

The use of Spitomin tablets is impossible with increased sensitivity to buspirone hydrochloride, severe renal failure, severe hepatic failure, glaucoma, pregnancy, myasthenia gravis. The drug is used in pediatric practice, as it is not intended for the treatment of patients under 18 years of age.
In addition, Spitomin is not prescribed to patients who receive therapy with MAO inhibitors or within 14 days after stopping them.
Spitomin is prescribed with caution to patients with liver cirrhosis and renal failure.

Application during pregnancy and lactation

Due to the fact that there have been no controlled clinical studies regarding the use of buspirone hydrochloride during pregnancy, the appointment of Spitomin during this period is possible only in extreme cases. During therapy with Spitomin, a woman of childbearing age should use reliable methods of contraception, since the safety of the drug for the fetus has not been confirmed.
Buspirone penetrates into breast milk, therefore, if it is necessary to prescribe Spitomin to a lactating woman, it is necessary to refuse feeding.

Method of administration and dosage

Spitomin tablets must be taken orally, preferably after meals at the same time.
The drug is not intended for the episodic elimination of feelings of anxiety, since the maximum therapeutic effect can be obtained only with repeated use of the drug.
The dose of the drug is selected individually. The starting dose of the drug is 15 mg, however, if necessary, it may be increased by 5 mg every knock every 2 or 3 days. To obtain the maximum therapeutic effect, the daily dose is divided into 2 or 3 doses. The highest single dose is 30 mg, the daily dose is 60 mg.

Overdose

When taking Spitomin in high doses, the patient develops gastrointestinal disorders, dizziness, increased drowsiness, depression of consciousness.
In case of drug poisoning, the patient is rinsed with the stomach and prescribed appropriate treatment.

Side effects

When taking Spitomin, the patient may develop fainting, cerebrovascular accident, decompensated heart failure, myocardial infarction, headaches, sleep disturbances, depersonalization, euphoria, fear, hallucinations, suicidal thoughts, epileptic seizures, cold intolerance, stuttering, extrapyramidal disorders ears, swelling of the nasal mucosa, blurred vision, redness of the eyes, impaired taste and smell, eye pain, thyroid damage, flatulence, increased appetite, and diarrhea.