Zolomax - Instructions For The Use Of Tablets, Reviews, Analogs, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Zolomax

Zolomax: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Zolomaks

ATX code: N05BA12

Active ingredient: Alprazolam (Alprazolam)

Producer: GRINDEX AO (Latvia)

Description and photo update: 18.10.2018

Zolomax is a psychotropic drug; anxiolytic tranquilizer.

Release form and composition

Dosage form of the drug - tablets: oval, with a chamfer and a risk on one side; in a dosage of 0.25 mg - white, with the inscription "APZM 0.25", in a dosage of 1 mg - blue, with the inscription "APZM 1" (10 pcs. in blisters, 3 or 5 packages in a cardboard box sealed self-adhesive transparent sticker of light green color to control the first opening).

1 tablet contains:

• active substance: alprazolam - 0.25 or 1 mg;
• auxiliary ingredients: sodium benzoate, sodium docusate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, lactose monohydrate; for a dosage of 1 mg - indigo carmine (EEC E132).

Pharmacological properties

Pharmacodynamics

Alprazolam has anxiolytic, central muscle relaxant, anticonvulsant, sedative-hypnotic and anti-panic effect. The depressing effect of the drug on the central nervous system (CNS) is mainly realized in the hypothalamus, thalamus and limbic system. Alprazolam enhances the inhibitory effect of GABA (gamma-aminobutyric acid), one of the main mediators of pre- and postsynaptic inhibition of the transmission of nerve impulses in the central nervous system.

The determining factor in the mechanism of action of alprazolam is the stimulation of the benzodiazepine receptors of the supramolecular GABA-benzodiazepine-chlorionophore receptor complex, leading to the activation of the GABA receptor, decreasing the excitability of the subcortical structures of the brain and inhibiting polysynaptic spinal reflexes.

The anxiolytic effect of alprazolam is manifested by a decrease in emotional stress, weakening of the symptoms of anxiety and fear. The pronounced anxiolytic effect is combined with a moderate hypnotic effect, shortening the period of falling asleep, increasing the duration of sleep, and reducing the number of nighttime waking up. The mechanism of the hypnotic effect is based on the inhibition of cells of the reticular formation of the brain stem. The influence of vegetative, emotional and motor stimuli that disturb the process of falling asleep decreases.

Alprazolam has practically no effect on the respiratory and cardiovascular systems.

Pharmacokinetics

The maximum concentration of alprazolam in plasma when taken orally is achieved after ~ 1-2 hours with an absorption level of about 80% of the dose taken. As a result of a single oral administration of 0.5 mg, an average maximum concentration of 7.1 ng / ml is achieved. The relationship between the taken dose of alprazolam and its plasma concentration is linear. ~ 80% of the drug binds to plasma proteins.

Alprazolam is able to penetrate the placental and blood-brain barriers (BBB), enter breast milk; the equilibrium plasma concentration usually reaches within 2–3 days.

The drug is extensively metabolized in the liver to form a biologically active alpha-hydroxyl metabolite. Isoenzymes CYP3A7, CYP3A5 and CYP3A4 are involved in metabolic processes with alprazolam. The substance is excreted from the body in the form of compounds with glucuronic acid, mainly by the kidneys. The half-life (T _½) is 11-16 hours. In the case of repeated administration, the accumulation is minimal, since alprazolam is a benzodiazepine with a short or medium half-life, and its elimination after completion of therapy is rapid.

Indications for use

• anxious states and neuroses, accompanied by a feeling of anxiety, anxiety, danger, tension, irritability, sleep impairment, somatic disorders;
• anxiety and neurotic depression developing against the background of somatic diseases;
• neurotic reactive-depressive states, accompanied by a decrease in mood, loss of interest in the environment, anxiety, loss of sleep, loss of appetite, somatic disorders;
• mixed anxiety and depressive disorders;
• panic disorder with and without phobic symptoms.

Contraindications

Absolute:

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• angle-closure glaucoma;
• asthenic bulbar paralysis (myasthenia gravis);
• acute poisoning with narcotic, alcoholic, hypnotic and psychotropic substances;
• COPD (chronic obstructive pulmonary disease) of severe course;
• severe depression with suicide attempts;
• shock, coma;
• sleep apnea;
• severe renal / liver dysfunction;
• the period of pregnancy (especially the first trimester) and breastfeeding;
• children and adolescents up to 18 years old;
• hypersensitivity to alprazolam, other benzodiazepines and other components of the drug.

Relative contraindications: Zolomax is taken with caution in case of cerebral and spinal ataxia, a history of drug dependence, propensity to abuse psychotropic drugs, hyperkinesis, organic brain diseases, psychosis (paradoxical reactions are possible), hypoproteinemia, liver failure, chronic renal failure in old age.

Instructions for the use of Zolomax: method and dosage

The tablets are taken orally, 2-3 times a day, regardless of the diet. The dose is selected and adjusted in the course of treatment individually, depending on the effectiveness of therapy and the individual tolerance of the drug. It is recommended that the minimum effective dose be used.

Recommended dosage:

• anxiety: the initial dose is 0.25–0.5 mg three times a day; this dose, if necessary, can be increased to 4 mg / day, divided into several doses;
• panic disorder: 0.5 mg three times a day; the daily dose can be increased to 3–6 mg, the maximum daily dose is 10 mg;
• anxiety conditions associated with depression: the initial dose is 0.5 mg three times a day; this dose, if necessary, can be increased to 4.5 mg / day; the initial daily dose may be taken at bedtime to minimize daytime sleepiness.

The duration of therapy is 4-12 weeks.

To end taking the drug should be done with great care, for a long time, in order to avoid the development of withdrawal syndrome. For example, a patient taking 0.5 mg in the morning and afternoon, and 1 mg in the evening (only 2 mg of alprazolam), the daily dose should be reduced by no more than 0.25 mg 1 every 3 days.

For most patients, a dose of 4–6 mg / day is sufficient for 4–12 weeks. If necessary, sometimes the dose is increased to 10 mg / day (1 mg once every 3-4 days, no more), and the duration of therapy is up to 8 months.

For the treatment of elderly and debilitated patients, smaller doses are used: the initial dose is 0.25 mg 2-3 times a day, in case of good tolerance and, if necessary, it can be gradually increased to 0.5-0.75 mg / day.

Side effects

Side effects, as a rule, are recorded at the beginning of therapy and disappear gradually with further use of the drug or a dose reduction.

Reactions from organs and systems to taking alprazolam:

• central nervous system: at the beginning of therapy (especially in elderly patients) - a feeling of fatigue, drowsiness, dizziness, disorientation, impaired concentration, slowing down of motor and mental reactions; rarely - euphoria, headache, decreased mood, memory impairment, impaired coordination of movements, tremor, confusion, dystonic extrapyramidal reactions (uncontrollable movements, including the eyes), dysarthria, myasthenia gravis; extremely rarely - paradoxical reactions (anxiety, irritability, insomnia, confusion, aggressive outbursts, psychomotor agitation, suicidal tendencies, fear, muscle spasm, hallucinations);
• hematopoietic organs: anemia, neutropenia, leukopenia, agranulocytosis (hyperthermia, chills, sore throat, unusual weakness / fatigue), thrombocytopenia;
• digestive system: drooling / dry mouth, heartburn, nausea / vomiting, anorexia, constipation / diarrhea, liver dysfunction, jaundice and increased activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP);
• genitourinary system: urinary retention / incontinence, decreased / increased libido, impaired renal function, dysmenorrhea;
• hypersensitivity reactions: skin rash, itching;
• effect on the fetus: teratogenicity (especially in the first trimester); in newborns whose mothers took the drug - depression of the central nervous system, respiratory failure and suppression of the sucking reflex;
• other reactions: addiction and drug dependence, lowering blood pressure (blood pressure); rarely - visual impairment (diplopia), weight loss, tachycardia; as a result of a sharp dose reduction or discontinuation of the intake, withdrawal syndrome may develop - nausea / vomiting, sleep disturbances, increased irritability, depersonalization, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, tremor, hyperhidrosis, depression, perceptual disorders (incl. hyperacusis, paresthesia, photophobia), convulsions, tachycardia, in rare cases - acute psychosis.

Overdose

An overdose is observed when taking 500-600 mg of the drug. Its symptoms are: confusion, drowsiness, decreased reflexes, tremor, nystagmus, bradycardia, decreased blood pressure, shortness of breath or shortness of breath, coma.

For the treatment of the condition, it is recommended to flush the stomach, give the patient activated charcoal, then carry out symptomatic therapy: maintain breathing and blood pressure, in a hospital setting, inject flumazenil. Hemodialysis for the elimination of alprazolam is ineffective.

special instructions

During therapy, patients are strictly prohibited from drinking alcoholic beverages (ethanol).

In the case of long-term treatment for renal / hepatic insufficiency, it is necessary to monitor the peripheral blood picture and liver enzyme parameters.

If patients have not previously taken psychotropic drugs, they respond to lower doses of the drug, in comparison with patients who have already taken anxiolytics and antidepressants, or suffering from alcoholism.

For the treatment of endogenous depression, alprazolam can be used in combination with antidepressants. The use of alprazolam in patients with depression can lead to the development of manic and hypomanic states. Patients with depressive disorders receiving Zolomax treatment should be kept under observation, especially at the beginning of therapy, in order to avoid suicide attempts.

Like other benzodiazepines, alprazolam can cause drug dependence, especially with prolonged use of high doses (more than 4 mg / day).

Treatment should be stopped immediately if patients experience such unusual reactions as acute states of excitement, increased aggressiveness, fear, hallucinations, suicidal thoughts, increased muscle cramps, difficulty falling asleep, interrupted superficial sleep.

Influence on the ability to drive vehicles and complex mechanisms

Zolomax should be taken with caution by patients who require an increased speed of psychomotor reactions and increased concentration of attention, driving potentially dangerous mechanisms, vehicles performing other types of complex work, for work and life.

Application during pregnancy and lactation

During pregnancy, Zolomax is used in exceptional cases, only for health reasons. The drug has a toxic effect on the fetus, increases the likelihood of developing congenital defects, especially when used in the first trimester. Alprazolam in therapeutic doses in later stages of pregnancy can cause central nervous system depression in the newborn. Continuous use during pregnancy can lead to physical dependence in the fetus, with the development of withdrawal syndrome in the newborn.

The use of Zolomax immediately before childbirth or during labor can cause a flaccid baby syndrome in a newborn, accompanied by respiratory depression, decreased muscle tone, hypotension, hypothermia and weak sucking.

According to the results of experimental studies, it was established that alprazolam and its metabolites are excreted in breast milk, due to their ingestion into the newborn's body, an increase in drowsiness and difficulty in feeding is possible.

Pediatric use

According to the instructions, Zolomax is contraindicated for use in children and adolescents under 18 years of age due to insufficient data on the effectiveness and safety of the drug in this age group of patients.

With impaired renal function

The drug is prohibited for use in patients with severe renal impairment.

For violations of liver function

The drug is prohibited for use in patients with severe liver dysfunction.

Use in the elderly

Elderly or weakened patients should start taking the drug with a dose of 250 mcg 2-3 times / day, gradually bringing it to a maintenance dose of 500-750 mcg / day. If necessary, the dose can be increased, only taking into account the individual tolerance of alprazolam.

Drug interactions

• inhibitors of microsomal oxidation: increase the risk of developing toxic effects;
• inducers of liver microsomal enzymes: reduce the effectiveness of alprazolam;
• antihypertensive drugs: may aggravate the severity of the decrease in blood pressure;
• other psychotropic drugs, anticonvulsants and antihistamines, ethanol and substances that have a depressing effect on the central nervous system: alprazolam enhances their effect;
• clozapine: respiratory depression may increase;
• levodopa: alprazolam reduces its effectiveness in patients with parkinsonism;
• zidovudine: its toxicity may increase;
• imipramine and desipramine: when taken simultaneously with alprazolam at a dose of 4 mg / day, their concentration in plasma increases;
• cimetidine, macrolides, nefazodone, fluvoxamine, fluoxetine, dextropropoxyphene, sertraline, diltiazem, digoxin, and oral contraceptives: may inhibit the metabolism of alprazolam in the liver, increasing its effect.

Analogs

Zolomax analogs are: Alzolam, Alprazolam, Helex, Helex SR, Neurol.

Terms and conditions of storage

Zolomax is included in list III of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

The drug should be stored at a temperature not exceeding 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Zolomax

Reviews about Zolomax are few, but rather contradictory. For some patients, the drug helped to cope with the underlying disease; as disadvantages, they indicate only the presence of a large number of side effects and the high cost of the drug. Other patients who took Zolomax emphasize its lower effectiveness in comparison with less expensive counterparts made in Russia, and note the presence of a large number of negative side reactions (severe headaches, hypertension, etc.).

Zolomax price in pharmacies

There is no data on the availability and price of Zolomax in pharmacies, as well as its direct analogues.

There are drugs on sale - group analogues, the possibility of using which instead of Zolomax should be personally agreed with the attending physician: Afobazol ~ 344 rubles, Phenorelaxan ~ 61 rubles, Hydroxyzin Canon ~ 208 rubles, Strezam ~ 247 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!