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Spitomin

Travellers familiar with Spitomin from Central and Eastern Europe are unlikely to encounter the same brand elsewhere — it is registered in only six countries. Its active ingredient is buspirone, classified as an anxiolytic within the broader psycholeptic group, with adjacent positioning in the antidepressant and antianxiety categories described on this page.

Buspirone is prescribed in the management of generalised anxiety disorder and related anxiety presentations. The registered indication list for Spitomin also includes several somatic symptoms that often accompany anxiety states — among them stress-related complaints, sweating, paresthesia, and gastrointestinal symptoms such as dyspepsia and diarrhoea. The structured indication section below this introduction reflects exactly how the product has been registered with national regulators.

The country footprint clusters tightly: Hungary, Romania, Russia, Lithuania, Slovakia, and Latvia. A reader who has been prescribed Spitomin in one of these markets and is now travelling or relocating will generally not see the brand on pharmacy shelves further west or further east, but buspirone itself is widely available internationally under different brand names. The local-pharmacist-as-translator role matters here — confirming that a locally available product contains the same active ingredient is a routine pharmacy counter conversation.

Other medications used in anxiety management exist worldwide across several pharmacological categories, and these are not freely interchangeable with buspirone — molecules positioned for similar indications can have meaningfully different profiles. Any patient managing an anxiety disorder across borders should treat substitution as a clinical conversation: the prescribing healthcare provider, ideally one familiar with the patient's history, is the appropriate person to lead any change in therapy.

Countries
Hungary Latvia Lithuania Romania Russia Slovakia
Diseases
Dyspepsia Diarrhea Cold Generalized Anxiety Disorder Anxiety&Panic Attacks Paresthesia Sweating Stress Lightheadedness,Dizzy Schizophrenia Insomnia Dry mouth
Ingredients
Buspirone
Drug Actions
Anxiolytic Psycholeptics Antidepressant Antianxiety

Drugs with the same active ingredients

Ansitec Buspar Nadrifor Pacific buspirone Qibite Dalpas Buspar dividose Buspirone Buspirone hcl actavis Buspirone hydrochloride mylan Buspirone hydrochloride par Vanspar Vanspar (oral) Buspirone actavis Buspon спитомин Ansiten Ansiten 10 Ansiten 5 Busansil

Overdose

No information provided.

Contraindications

Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride.

Pharmaceutical form

Pills

Therapeutic indications

Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:

Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:

Motor Tension

Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.

Autonomic Hyperactivity

Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.

Apprehensive Expectation

Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.

Vigilance and Scanning

Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.

The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.

The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of longterm use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.

Name of the medicinal product

Spitomin

Qualitative and quantitative composition

Buspirone

Special warnings and precautions for use

WARNINGS

The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride tablets have been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets not be used concomitantly with an MAOI.

Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.

PRECAUTIONS General Interference With Cognitive And Motor Performance

Studies indicate that buspirone hydrochloride tablets are less sedating than other anxiolytics and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable. Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that buspirone treatment does not affect them adversely.

While formal studies of the interaction of buspirone hydrochloride with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone.

Potential For Withdrawal Reactions In Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients

Because buspirone hydrochloride tablets do not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs. Therefore, before starting therapy with buspirone hydrochloride tablets, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment. Rebound or withdrawal symptoms may occur over varying time periods, depending in part on the type of drug, and its effective half-life of elimination.

The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures.

Possible Concerns Related To Buspirone’s Binding To Dopamine Receptors

Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudoparkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients. The syndrome may be explained in several ways. For example, buspirone may increase central noradrenergic activity; alternatively, the effect may be attributable to dopaminergic effects (i.e., represent akathisia). See ADVERSE REACTIONS: Postmarketing Experience.

Information For Patients

To assure safe and effective use of buspirone hydrochloride tablets, the following information and instructions should be given to patients:

Inform your physician about any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with buspirone hydrochloride tablets.

Inform your physician if you are pregnant, or if you are planning to become pregnant, or if you become pregnant while you are taking buspirone hydrochloride tablets.

Inform your physician if you are breastfeeding an infant.

Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery.

You should take buspirone hydrochloride consistently, either always with or always without food.

During your treatment with buspirone hydrochloride tablets, avoid drinking large amounts of grapefruit juice.

Laboratory Tests

There are no specific laboratory tests recommended.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No evidence of carcinogenic potential was observed in rats during a 24 month study at approximately 133 times the maximum recommended human oral dose; or in mice, during an 18 month study at approximately 167 times the maximum recommended human oral dose.

With or without metabolic activation, buspirone did not induce point mutations in five strains of Salmonella typhimurium (Ames Test) or mouse lymphoma L5178YTK+ cell cultures, nor was DNA damage observed with buspirone in Wi-38 human cells. Chromosomal aberrations or abnormalities did not occur in bone marrow cells of mice given one or five daily doses of buspirone.

Pregnancy Teratogenic Effects

Pregnancy Category B

No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at buspirone doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate and well-controlled studies during pregnancy have not been performed. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor And Delivery

The effect of buspirone hydrochloride on labor and delivery in women is unknown. No adverse effects were noted in reproduction studies in rats.

Nursing Mothers

The extent of the excretion in human milk of buspirone or its metabolites is not known. In rats, however, buspirone and its metabolites are excreted in milk. Buspirone hydrochloride tablets administration to nursing women should be avoided if clinically possible.

Pediatric Use

The safety and effectiveness of buspirone were evaluated in two placebo-controlled 6 week trials involving a total of 559 pediatric patients (ranging from 6 to 17 years of age) with GAD. Doses studied were 7.5 mg to 30 mg b.i.d. (15 to 60 mg/day). There were no significant differences between buspirone and placebo with regard to the symptoms of GAD following doses recommended for the treatment of GAD in adults. Pharmacokinetic studies have shown that, for identical doses, plasma exposure to buspirone and its active metabolite, 1-PP, are equal to or higher in pediatric patients than adults. No unexpected safety findings were associated with buspirone in these trials. There are no longterm safety or efficacy data in this population.

Geriatric Use

In one study of 6632 patients who received buspirone for the treatment of anxiety, 605 patients were ≥ 65 years old and 41 were ≥ 75 years old; the safety and efficacy profiles for these 605 elderly patients (mean age =70.8 years) were similar to those in the younger population (mean age = 43.3 years). Review of spontaneously reported adverse clinical events has not identified differences between elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out.

There were no effects of age on the pharmacokinetics of buspirone (see CLINICAL PHARMACOLOGY, Special Populations).

Use In Patients With Impaired Hepatic Or Renal Function

Buspirone is metabolized by the liver and excreted by the kidneys. A pharmacokinetic study in patients with impaired hepatic or renal function demonstrated increased plasma levels and a lengthened half-life of buspirone. Therefore, the administration of buspirone hydrochloride tablets to patients with severe hepatic or renal impairment cannot be recommended (see CLINICAL PHARMACOLOGY).

Dosage (Posology) and method of administration

The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed.

The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.

When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the DRUG INTERACTIONS section should be followed.

Frequently asked questions

What conditions does Spitomin treat?

Spitomin is prescribed in the management of generalised anxiety disorder and related anxiety presentations, including panic-type symptoms and stress-related complaints. The structured indication list further down this page reflects the registered uses recognised by regulators in the markets where Spitomin is sold, and includes several somatic symptoms that frequently accompany anxiety states. The active ingredient sits within the anxiolytic category of psycholeptic medications.

Which active substance is in Spitomin?

Spitomin contains buspirone, an anxiolytic agent within the broader psycholeptic group. Buspirone is distinct in profile from several other classes used in anxiety management and is the same molecule whether dispensed under the Spitomin brand or under other commercial names. The same active ingredient circulates internationally under various brand names, particularly in markets where the original patent has long expired.

In how many countries is Spitomin available?

Spitomin is registered in six countries, clustered across Central and Eastern Europe and the post-Soviet space: Hungary, Romania, Russia, Lithuania, Slovakia, and Latvia. Outside this regional footprint the specific brand is unlikely to be encountered, although buspirone itself is available in many other markets under different brand names. If your country is not on this list, a local pharmacist can confirm what is available.

Are there other medications with the same active ingredient as Spitomin?

Buspirone is sold under several brand names worldwide and is widely available as a generic in many markets. Other medications used in anxiety management — including agents in adjacent anxiolytic and antidepressant categories — also exist, although they are not interchangeable without medical guidance, since their pharmacological profiles differ meaningfully. To identify a local buspirone-containing product, search the active ingredient on Pill2Trip or ask a pharmacist.

Should I consult a doctor before taking Spitomin?

Yes. Spitomin is a prescription medication, and treatment of anxiety disorders is calibrated to an individual's history, concurrent medications, and clinical picture. Prescription pathways, available brands, and regulatory classifications differ between countries, which is particularly relevant for travellers and people relocating across borders. Any decision to start, stop, switch, or substitute buspirone should sit with a healthcare provider familiar with the patient.

Spitomin

Available in 6 countries