Instructions for use of the drug Spitomin and reviews about it

Prohibited during pregnancy

Prohibited during breastfeeding

Prohibited for children

Allowed for older people

Has limitations for liver problems

Has limitations for kidney problems

Spitomin is a modern non-benzodiazepine anxiolytic that has a thymoleptic effect. It has been used in psychiatry since 1980 for the treatment of panic and generalized anxiety disorders. According to the information specified in the instructions for use, the medication is used both in monotherapy and in combination with other psychotropic drugs.

Composition and release form

Spitomin is produced by a Hungarian pharmaceutical company in the form of white round flat tablets. According to the instructions for use, the drug contains the following substances:

Pharmacological profile

The drug is a tranquilizing drug, but can also have an antidepressant effect on the body. Its main difference from similar ones in

Buspirone hydrochloride formula

that it is not a sedative and hypnotic. The drug does not have a negative effect on psychomotor functions.

The effect of using the drug appears after only 7–14 days, the maximum effect is recorded in the patient only after four weeks.

The drug has a relaxing effect on the body, but taking it does not cause drowsiness. In addition, it is an excellent sedative aimed at reducing the development of an antidepressant state.

Pharmacodynamics and pharmacokinetics

Buspirone hydrochloride belongs to the group of anxiolytics - psychotropic drugs that reduce fear, anxiety, irritability, and emotional tension. The mechanism of action of the drug differs from the effect on the body of drugs from the group of benzodiazepines, which are characterized by sedative, hypnotic, anticonvulsant, and sedative properties.

Buspirone is a partial 5-HT (serotonin) receptor agonist. Its action is directly related to the neurotransmitter serotonin, through which signals are transmitted between nerve cells (neurons) through the synaptic space. The more popular name for serotonin is the “happiness hormone”, since it affects mood and eliminates depression. In addition, the neurotransmitter reduces pain, eliminates inflammation, allergies, and regulates the functioning of the digestive system.

The functioning of many organs and systems depends on serotonin, so its deviation from the norm causes various pathologies, including changes in the emotional background. A lack of neurotransmitter leads to depression, obsessive disorders, and migraines. An increased amount causes serotonin syndrome - hallucinations, schizophrenia, mania, increases anxiety, and causes insomnia.

Spitomin acts by modulating (changing) the serotonergic system. Under its influence, serotonin renewal is inhibited and the frequency of inflammation of 5-HT neurons in the dorsal raphe nuclei is reduced. The result is a decrease in anxiety and depression.

Unlike benzodiazepines, it does not have an anticonvulsant effect, does not reduce the tone of skeletal muscles, and most importantly, does not cause addiction. Buspirone does not have an immediate effect, so it cannot be used once. The medicine manifests itself gradually, so the first signs of the drug's effect appear between the first and second weeks. The maximum effect is observed after a month.

After absorption into the blood, 95% of the active substance binds to plasma proteins: 86% to albumin, the rest to acidic α1-glycoprotein. Buspirone undergoes major transformation in the liver almost immediately. The main metabolite, 5-OH-buspirone, is not active. The action is exerted by the dealkylated metabolite 1-(2-pyrimidinyl)-piperazine, 1-PP.

The maximum concentration of the drug is observed an hour and a half after taking the drug, the required therapeutic level in plasma is two days after repeated use. From 30 to 65% of the substance leaves the body in urine during the day, 20–40% is excreted in feces. If the patient has problems with the liver or kidneys, the period of elimination of buspirone from the body slows down.

Analogues of the drug

Drug analogues include drugs that have a similar effect, for example, benzodiazepine tranquilizers and other anxiolytics:

1. 
   Phenazepam pilyule_nervi-386 is a benzodiazepine tranquilizer. Available in the form of tablets and ampoules. It has an antidepressant, sedative, hypnotic and muscle-relaxing effect. The cost of 50 tablets with a dosage of 0.5 mg is about 90 rubles.

2. Phenibut pilyule_nervi-387 – tablets containing 250 mg of aminophenylbutyric acid. The drug has a nootropic effect, eliminates anxiety, fear, insomnia, and autonomic disorders. The cost of 20 tablets is about 217 rubles.
3. Atarax is a non-benzodiazepine anxiolytic, a derivative of diphenylmethane. It is used for anxiety disorders, unreasonable fear, acute mental illnesses, phobias, and itchy skin. At the same time, the medication does not have a hypnotic effect and does not cause muscle relaxation, and does not have anticonvulsant activity. The drug costs approximately 297 rubles (25 tablets with a dosage of 25 mg).
4. Divaza is an anti-neurotic drug, the anti-anxiety effect of which is to improve the flow of oxygen and nutrients to the brain, normalize the function of cell membranes of neurons and the condition of the vascular wall.

   
   Properties of the drug

   Indications for the use of this remedy are conditions accompanied by increased anxiety, fear, emotional instability, and irritability. The average cost of Divaz tablets is 295-305 rubles.

These medications are anxiolytics and have a nootropic effect. However, you cannot independently replace the medication with analogues, since their effect on the body, dosage and method of administration may differ.

How to take Spitomin

According to the instructions for use, the tablets should be taken at the same time with a small amount of water. While using the drug, you should avoid grapefruits and juice made from them. The fruit increases the level of buspirone in the blood, so it can cause side effects and the severity of their manifestation. The tablets can be taken without regard to meals, but if the drug is taken with food, the absorption of buspirone will slow down.

Food increases the bioavailability of the drug, so the instructions recommend taking the medicine after meals.

The dosage is selected individually. First, the neurologist prescribes 5 mg of Spitomin 2-3 times a day. Then the daily dosage is gradually increased to 20–30 mg, which are distributed over several doses. You can take no more than 30 mg at a time. The maximum daily dose is 60 mg.

Similar drugs:

• Miaser Oral tablets
• Life 900 (LIFE 900) Oral tablets
• Heptral Lyophilisate for the preparation of a solution for intramuscular, subconjunctival administration and for instillation into the eye
• Lenuksin Oral tablets
• Heptor (Heptor) Lyophilisate for the preparation of solution for injection
• Prodep Capsule
• Citalopram Oral tablets
• Paroxetine Oral tablets
• Deprim forte Capsule
• Trittico Oral tablets

** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Spitomin, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Spitomin is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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special instructions

The drug is not prescribed for children. Elderly patients need to be careful due to deterioration of kidney and liver function and an increased risk of side effects. For this reason, the instructions for use recommend prescribing the minimum effective dose. If it is necessary to increase the dosage, the physician should constantly monitor the condition of such patients.

During pregnancy, the drug Spitomin is prescribed only in extreme cases, since its effect on the fetus has not been studied. The active ingredient of the drug passes into breast milk and can negatively affect the baby's health. For this reason, the medicine is not used during lactation, and if this cannot be avoided, stop breastfeeding.

Spitomin affects brain function, reduces concentration and reaction speed. For this reason, while taking the drug, you should refrain from driving vehicles and other activities that require high precision.

Indications and contraindications for taking Spitomin

Spitomin is a psychotropic medication that is used for various anxiety disorders, such as:

• anxiety neurosis;
• spontaneous panic attacks;
• violation of autonomic regulation of internal organs.

In addition, the drug is used as part of complex therapy for vegetative, somatic, neurological and mental disorders associated with prolonged use of alcoholic beverages. Also, in combination with other medications, Spitomin is used to treat various depressive disorders.

Depressive neurosis

The drug has certain contraindications for use:

• hypersensitivity to the components of the drug;
• various kidney pathologies;
• liver dysfunction;
• constant or periodic increase in eye pressure;
• damage to neuromuscular synapses.

In addition, the simultaneous use of the drug with substances that inhibit the activity of monoamine oxidase enzymes is prohibited.

The effect of the drug on the condition of the fetus during pregnancy has not been fully studied. The drug is prescribed to pregnant women only in extreme cases. If treatment is necessary during lactation, breastfeeding should be stopped. The medication is not prescribed to patients under 18 years of age, since there is no information about its safety for this group of patients.

Drug interactions

Before you start taking Spitomin, you must inform your neurologist about all medications you have been taking recently. According to the instructions for use, when prescribing the drug, the following points should be taken into account:

• Buspirone does not relieve withdrawal symptoms from benzodiazepines. For this reason, it is impossible to abruptly transfer a patient to Spitomin after long-term therapy with drugs of this group. The first step is to gradually stop taking benzodiazepines. The same applies to drugs that depress the central nervous system and other hypnotics/sedatives.
• Due to the risk of hypertensive crisis, it is not recommended to combine the drug with MAO inhibitors. The latter suppress the enzyme monoamine oxidase, which is found in nerve endings, in order to prevent the destruction of serotonin, dopamine and other neurotransmitters.
• Inhibitors of cytochrome P450, which is actively involved in the transformation of buspirone, can increase the bioavailability of Spitomin.
• Ritonavir and Ketonazole inhibit the metabolism of buspirone, which leads to an increase in its plasma level. If it is necessary to use these medications with Spitomin, reduce the dose of the latter.
• Phenytoin, Dexamethasone, Phenobarbital, Carbamazepine increase the rate of metabolism of buspirone. To maintain the effectiveness of Spitomin, its dose must be increased.
• The combination of Spitomin with Haloperidol and Trazodone increases their concentration in the blood and causes side effects, including migraine, dizziness, and nausea.
• Simultaneous use with Rifampicin reduces the maximum concentration of Spitomin in the blood by 83.9%.

Simultaneous use with certain medications increases the maximum concentration of buspirone in the blood; for this reason, the dosage of Spitomin should be reduced. The instructions indicate that the severity of the therapeutic effect increases and the toxicity of buspirone increases when combined with the following drugs:

• Verapamil – 3–4 times;
• Diltiazem – 4 times;
• Itraconazole – 13 times;
• Nefezadone – 20 times;
• Cimetidine – by 40%;
• Erythromycin – 5 times.

There is a lack of clinical data on how the combination of Spitomin with antihypertensive, hypoglycemic drugs, antipsychotics, antidepressants, oral contraceptives, and cardiac glycosides affects the body. For this reason, the instructions for use advise the use of these drugs simultaneously with buspirone under close medical supervision.

From application practice

Having studied the reviews, we can draw the main conclusion that most often Spitomin is not addictive, but in some people it may become addictive.

Among the advantages of the drug are: quick assistance in treatment, effectiveness in the fight against anxiety and panic. Among the disadvantages of the medicine, it is noted that it acts slowly on the human body, its price and a large number of negative effects on the human body.

Doctors' opinions vary, but more often they are positive. Most agree that the drug is well tolerated by patients, inexpensive and effective. Next is direct speech.

I would like to say right away that the drug is quite strong and serious and you simply cannot prescribe it to yourself. This drug is a tranquilizer and was prescribed to me to reduce the symptoms of anxiety.

Despite the fact that Spitomin really helps get rid of anxiety quite well, it caused unbearable nausea and dizziness for me. After a few days, these side effects disappeared.

Alexey Valerievich, 42

I was prescribed to take Spitomin tablets. The doctor immediately explained that the medicine was quite serious and needed to be taken at the same time. After using the drug a few days later, I felt that my nervous tension had really disappeared and I felt better.

The only negative that I would like to note is its price - a little expensive.

Alina

What do they recommend?

If you again read all the same forums, then patients who have previously used the drug say that it should be used at the same time.

Do not change the dosage yourself; it is better to consult a doctor who will actually prescribe it correctly. Also, if it is necessary to increase the dosage, this should be done gradually.

Side effects of Spitomin

In most cases, side effects occur early in treatment. Over time, the strength of their manifestations decreases, or they disappear altogether:

• dizziness;
• nervousness, hostility, anger, confusion,
• insomnia;
• nightmares;
• drowsiness, apathy;
• semi-fainting state;
• decreased concentration;
• nausea, diarrhea;
• noise in ears;
• nasal congestion, sore throat;
• increased fatigue.

Conditions such as impaired coordination, tremors, increased perception of sounds, euphoria, epilepsy, thoughts of suicide, and fear are less commonly observed. Also among the side effects:

• blurred vision, redness of the eyes, conjunctivitis, photophobia, increased intraocular pressure, narrowed field of vision;
• slurred speech;
• pain in bones and muscles;
• arthralgia (joint pain);
• paresthesia - a sensitivity disorder in the form of spontaneously occurring burning, tingling, goosebumps;
• numbness;
• skin rash, dry mouth, flatulence;
• anorexia;
• lack of appetite or gluttony;
• weakness, powerlessness;
• increased sweating;
• claustrophobia, sudden changes in mood, stupor, slow reaction.

Sometimes nonspecific chest pain, temporary loss of consciousness, tachycardia, bradycardia, hypertension or hypotension, a feeling of shortness of breath, and amenorrhea may appear. There may be a decrease in platelets and leukocytes in the blood, an increase in liver enzymes - alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Very rarely, but nosebleeds, frequent urination, menstrual irregularities, decreased or increased libido, decreased ejaculation, and impotence may occur.

Overdose

During treatment, you must strictly follow the doctor's instructions, and in no case exceed the dose. Otherwise the following are possible:

• dizziness;
• nausea;
• vomit;
• increased fatigue;
• constriction of the pupils (miosis);
• loss of consciousness;
• problems in the digestive system.

If these symptoms appear, call a doctor immediately. As a treatment, the instructions for the drug recommend gastric lavage. There is no specific antidote. During this period, you need to monitor your blood pressure, breathing, and pulse.

Reviews about the use of Spitomin

Reviews from patients and doctors confirm the effectiveness of Spitomin. Negative comments are rare.

Doctors

Neurologists use Spitomin in their practice. They often prescribe this medication, noting its effectiveness and immediate action:

Kovalchuk Z.P.: “I often prescribe Spitomin as part of complex therapy, since the drug alone cannot always cope with serious disorders. I would like to note that the side effects indicated in the instructions for the medication occur rarely, which is undoubtedly a plus.”

Oleynikov E.V.: “When used and prescribed correctly, the medication is effective and easily tolerated, with the exception, of course, of individual intolerance. Most often, side effects are a consequence of self-medication.”

Contraindications

Do not use Spitomin if you are allergic to buspirone or other components of the drug. In addition, the instructions for use indicate the following contraindications:

• acute attack of glaucoma;
• myasthenia gravis is a neuromuscular disease that manifests itself as increased fatigue;
• serious problems with the liver (with cirrhosis it is possible, but under the strict supervision of a doctor);
• renal failure, in which the glomerular filtration rate is below 10 ml/min.;
• epilepsy;
• alcoholism;
• severe poisoning with alcohol, sleeping pills, antipsychotics or analgesics;
• treatment with MAO inhibitors (monoamine oxidase) during this period;
• two weeks after stopping taking an irreversible MAO inhibitor;
• one day after taking the last tablet of a reversible MAO inhibitor.

Buying medicine and its analogues

The price of Spitomin is quite reasonable, but the amount varies by region. On average, the cost of 60 tablets, which at a certain dosage will last for 30 days, is 565 rubles.

The drug must be stored, like almost all others, in a dark place out of reach of children. In this case, the storage temperature should not exceed 30 degrees. The drug can be sold in a pharmacy if the buyer presents a prescription.

There are numerous analogues of Spitomin, and the main and most often used is Buspirone. But, unfortunately, in Russia it cannot be purchased in pharmacies. The drug is actively sold in Ukraine.

Alternatively, the drug can be replaced with other tranquilizers, but they will not contain Buspirone. But again, only a doctor can do this, since the selection of drugs is individual.

There is no need to self-medicate, prescribe or discontinue certain medications; this can be done by a doctor who has all the necessary information.