Instruction for use: Zolomaks

Trade name of the drug – Zolomaks

Active substance: Alprazolam (Alprazolamum)

Dosage Form: Tablets
Composition:
Pills. 1 tablet contains 250 mg of alprazolam. The blisters of 30 tablets. Packaged in a cardboard box. Tablets, 1 mg. The package of 30 pieces.
Pharmacotherapeutic group:

Anxiolytic (tranquilizer)

ATX Code

N05BA12 Alprazolam

The nosological classification (ICD-10)

F32 Depressive episode: adynamic subdepression; Astheno-adynamic state subdepressive; Asthenic-depressive disorder; Asthenic-depressive state; Asthenic-depressive disorder; Asthenic-depressive state; Major depressive disorder; Sluggish-apathetic depression with inhibition; Double depression; depressive pseudodementia; Depressive disorder; Depressed mood disorder; Depressive disorder; mood Depressive disorder; the doldrums; Depressive disorders; Depressive syndrome; Depressive syndrome larvirovanny; Depressive syndrome with psychosis; masked Depression; Depression; exhaustion Depression; Depression with symptoms of lethargy within cyclothymia; Depression smiling; involutionary depression; involutionary melancholy; involutional depression; Manic-depressive disorder; masked depression; Melancholic attack; Neurotic depression; Neurotic depression; Shallow depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression is a moderately severe; psychopathological symptoms; Reactive depression; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Senesto-pathic depression; senile depression; Symptomatic depression; somatogenic depression; cyclothymic depression; Exogenous depression; lypothymia; Endogenous depression; The endogenous depressive syndrome.
F41 Other anxiety disorders: anxiety Relief; Nonpsychotic anxiety disorders; An alarm condition;
Anxiety; Disturbingly suspicious condition; Chronic anxiety; Sense of anxiety

Pharmacological PropertiesPharmachologic effect
Anxiolytic (tranquilizer) from the group of benzodiazepines intermediate-acting, also has a sedative-hypnotic effect. It increases the braking action of endogenous GABA (neurotransmitter pre-and post-synaptic inhibition in the central nervous system). It stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors ascending activating reticular formation of the brain stem and lateral horn neurons of the spinal cord; reduces the excitability of the subcortical structures of the brain (the limbic system, thalamus, hypothalamus), polysynaptic inhibits spinal reflexes. The anxiolytic effect is to reduce the emotional stress, anxiety, weakening, fear, anxiety.
Sedative-hypnotic effect is a decrease in symptoms of neurotic origin (anxiety, fear). Pronounced anxiolytic activity combined with a mild sedative effect; shortens the period of sleep, increases sleep duration, reduces the number of nighttime awakenings. The mechanism of hypnotic action is inhibition of the cells of the reticular formation of the brain. It reduces the impact of emotional, autonomic and motor stimuli that disturb sleep.

Pharmacokinetics
After oral administration, Alprazolam is rapidly and completely absorbed from the gastrointestinal tract. Cmax plasma levels reached within 2.1 hours. Binding to plasma proteins is 80%. It is metabolized in the liver. T1 / 2 is an average of 12-15 hours. Alprazolam and its metabolites are excreted primarily by the kidneys.

Indications for Zolomaks

Anxiety, neuroses, accompanied by a sense of anxiety, danger, anxiety, stress, sleep disturbance, irritability, and somatic disorders; mixed anxiety and depression; neurotic reactive depression accompanied by depressed mood, loss of interest in surroundings, anxiety, loss of sleep, loss of appetite, somatic disorders; anxiety and neurotic depression, developed on the background of somatic diseases; panic disorder without combined phobia symptoms.

Contraindications for Zolomaks

Coma, shock, myasthenia gravis, angle-closure glaucoma (acute onset or predisposition), acute alcohol poisoning (with the weakening of vital functions), opioid analgesics, sleeping pills and psychotropic drugs, chronic obstructive airway disease with early signs of respiratory failure, acute respiratory failure, severe depression (suicidal tendencies may occur), pregnancy (especially I trimester), lactation, childhood and adolescence to 18 years, increased sensitivity to benzodiazepines.

Zolomaks Dosage and Administration
Individual. It is recommended to use the minimum effective dose. Correcting dose during treatment, depending on the achieved effect and tolerability. If necessary increase dose should be increased gradually, beginning in the evening and then daily intake. The initial dose is 250-500 mg 3 times / day, if necessary, may gradually increase to 4.5 mg / day. For elderly or infirm patients the initial dose of 250 mg 2-3 times / day maintenance dose - 500-750 mg / day, taking into account the tolerance dose can be increased if necessary. The abolition or reduction of the dose of Alprazolam should be done gradually by reducing the daily dose of no more than 500 mg every 3 days; sometimes you may need to further slow the cancellation.

Side effect of Zolomaks

CNS: at the beginning of treatment (particularly in elderly patients), somnolence, fatigue, dizziness, decreased ability to concentrate, ataxia, disorientation, unsteady gait, mental retardation and motor responses; rarely - headache, euphoria, depression, tremors, memory loss, impaired coordination of movements, depressed mood, confusion, dystonic extrapyramidal reactions (uncontrolled movements, including eye), weakness, myasthenia gravis, dysarthria; in some cases - paradoxical reactions (aggressive outbursts, confusion, agitation, anxiety, suicidal tendencies, muscle spasms, hallucinations, agitation, irritability, anxiety, insomnia).

From the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, loss of appetite, constipation or diarrhea, abnormal liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.

From hemopoiesis system: leucopenia, neutropenia, agranulocytosis (chills, pyrexia, sore throat, extreme tiredness or weakness), anemia, thrombocytopenia.

From the urinary system: possible urinary incontinence, urinary retention, renal dysfunction, decreased or increased libido, dysmenorrhea.

From endocrine system: the change in body weight, libido disorders, menstrual irregularities on the part of the cardiovascular system: possible decrease in blood pressure, tachycardia.

Allergic reactions: possible skin rash, itching.

Zolomaksat Pregnancy and breast-feeding
Alprazolam has a toxic effect on the fetus and increase the risk of birth defects when used in the I trimester of pregnancy. The constant use during pregnancy may lead to physical dependence with the development of withdrawal symptoms in the newborn. Reception at therapeutic doses in later stages of pregnancy can cause depression of the central nervous system of the newborn. Application just before birth or during labor may cause neonatal respiratory depression, decreased muscle tone, hypotension, hypothermia and a weak act of sucking (suckling newborn flaccid syndrome).

Perhaps the selection of benzodiazepines in breast milk, which can cause drowsiness in the newborn and hamper feeding.In experimental studies have shown that alprazolam and its metabolites are excreted in breast milk.

Application of Zolomaks at violations of liver function
Caution should be used alprazolam in patients with impaired hepatic function.
Application of Zolomaks at violations of renal function
Caution should be used alprazolam in patients with impaired renal function.

Use of the drug in children
Contraindications: children and teens up to 18 years.

Use in elderly patients
For elderly or infirm patients the initial dose of 250 mg 2-3 times / day maintenance dose - 500-750 mg / day, taking into account the tolerance dose can be increased if necessary.

Cautions when taking the drug Zolomaks
When endogenous depression alprazolam can be used in combination with antidepressants. In the application of alprazolam in patients with depression marked cases of hypomania and mania.

Caution should be used alprazolam in patients with impaired liver and / or kidneys.

In patients previously treated with drugs that affect the central nervous system, alprazolam is effective at lower doses, compared with patients who received antidepressants, anxiolytics or suffering from chronic alcoholism.

With prolonged use at high doses may develop addiction and the formation of drug dependence, particularly in patients who are prone to abuse drugs. With the rapid dose decrease or abrupt cancellation observed alprazolam withdrawal syndrome, the symptoms of which can range from a small dysphoria and insomnia to a severe syndrome with cramps in the stomach and skeletal muscles, vomiting, sweating, tremors and convulsions. Withdrawal syndrome is more common in persons, long-term (more than 8-12 weeks. treated with alprazolam).

It should not be used in conjunction with other tranquilizers alprazolam.

The safety of alprazolam in children and adolescents under the age of 18 years have not been established.

Children, especially at a younger age, it is very sensitive to the inhibitory effect of benzodiazepines on the central nervous system. during treatment, avoid alcohol.

Effects on ability to drive vehicles and management mechanisms In the period of treatment should refrain from activities potentially hazardous activities that require increased attention and psychomotor speed reactions (driving vehicles or work with mechanisms).

Overdose
Symptoms: drowsiness, confusion, decreased coordination, decreased reflexes, coma.
Treatment: No specific antidote is recommended gastric lavage and supportive therapy.

Interaction
With simultaneous use of psychotropic, anticonvulsant drugs and ethanol observed alprazolam increased inhibitory action on CNS.
With simultaneous use of blockers of histamine H2-receptor reduce the clearance of alprazolam and enhance the inhibitory effect of alprazolam on the CNS; macrolide antibiotics - reduce the clearance of alprazolam.
With simultaneous use of hormonal contraceptives for intake increases T1 / 2 of alprazolam.
With simultaneous use of alprazolam with dextropropoxyphene observed more pronounced CNS depression than in combination with other benzodiazepines, because alprazolam may increase the concentration in plasma.
Simultaneous treatment with digoxin increases the risk of cardiac glycoside intoxication.
Alprazolam imipramine increases the concentration in plasma.
With simultaneous use of itraconazole, ketoconazole increase the effects of alprazolam.
With simultaneous use of paroxetine may increase the effects of alprazolam due to inhibition of its metabolism.
Fluvoxamine alprazolam increases the concentration in plasma and the risk of its side effects.
With simultaneous use of fluoxetine may increase the alprazolam concentration in plasma due to the reduction of its metabolism and clearance under the influence of fluoxetine, which is accompanied by psychomotor impairment.
We can not exclude the possibility of strengthening the action of alprazolam while the use of erythromycin.

SPECIAL INSTRUCTIONS
The reception should be stopped gradually, slowly reducing the dose: abrupt withdrawal may be accompanied by withdrawal symptoms (anxiety and fear). Be wary appoint people who work with machines or drivers of vehicles (slows down the reaction rate and reduces the concentration of attention). It is recommended to refrain from drinking alcohol. Nursing mothers at the time of treatment should stop breastfeeding.

Storage conditions
In a dry place at room temperature.
Keep out of the reach of children.

Shelf life
3 years. Do not use beyond the expiration date printed on the package.
Conditions of supply of pharmacies
On prescription.