Universal reference book for medicines
Product name: ALZOLAM (ALZOLAM)

Active substance: alprazolam

Type: Tranquilizer (anxiolytic)

Manufacturer: Sun Pharmaceutical Industries (India)
Composition, form of production and packaging
Tablets are
round, flat, oblique to the edges, orange, with a dividing risk on one side and engraving "Alzolam" on the other.

1 tab.

alprazolam 1 mg

Excipients: lactose, microcrystalline cellulose, starch, magnesium stearate, silicon dioxide colloid, dyes (quinoline yellow, brilliant blue, crimson 4R, sunset yellow).

10 pieces.
- packings cellular planimetric (10) - packs cardboard.
Tablets are round, flat-cylindrical, green, with a dividing risk on one side and engraving "Alzolam" on the other.

1 tab.

alprazolam 250 Ојg

Excipients: lactose, microcrystalline cellulose, starch, magnesium stearate, silicon dioxide colloidal anhydrous, dyes (quinoline yellow, brilliant blue).

10 pieces.
- packings cellular planimetric (10) - packs cardboard.
Tablets are round, flat-cylindrical, pink in color, with a dividing risk on one side and engraving "Alzolam" on the other.

1 tab.

alprazolam 500 Ојg

Excipients: lactose, microcrystalline cellulose, starch, magnesium stearate, silicon dioxide colloidal anhydrous, dye 4R.

10 pieces.
- packings cellular planimetric (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Anxiolytic agent (tranquilizer).
Strong substance (approved at the meeting of the Standing Committee on Drug Control on April 17, 2002, Protocol No. 1 / 84-2002).
Alzolam has an anxiolytic, central muscle relaxant, anticonvulsant, sedative-hypnotic and anti-panic effect.
Has a depressing effect on the central nervous system, which is realized mainly in the thalamus, hypothalamus and limbic system. Enhances the inhibitory effect of gamma-aminobutyric acid (GABA), which is one of the main mediators of pre- and postsynaptic inhibition of nerve impulse transmission in the central nervous system. It also has anxiolytic, sedative, miorelaxing and anticonvulsant action.
The mechanism of action of Alzolam is determined by the stimulation of the benzodiazepine receptors of supramolecular GABA-benzodiazepine-chloro-formof the formulation complex leading to activation of the GABA receptor, which causes a decrease in the excitability of the subcortical structures of the brain, inhibition of polysynaptic spinal reflexes.

Anxiolytic effect is manifested in the reduction of emotional tension, alleviation of symptoms of anxiety, fear.

The pronounced anxiolytic activity is combined with a mild hypnotic effect;
shortens the period of falling asleep, prolongs the duration of sleep, reduces the number of nocturnal awakenings. The mechanism of hypnotic action is the inhibition of cells of the reticular formation of the brain stem. Reduces the impact of emotional, vegetative and motor stimuli, which break the mechanism of falling asleep. Virtually no effect on the cardiovascular and respiratory systems.
PHARMACOKINETICS

When oral intake of C max in plasma is achieved after about 1-2 hours. After a single oral dose of 0.5 mg, the mean C max was 7.1 ng / ml.
There is a linear relationship between the dose of alzolam and the concentration in the plasma. At oral intake about 80% of the dose is absorbed. About 80% of the drug binds to plasma proteins. Can pass through the placenta, GEB, penetrate into breast milk. A stable concentration in the plasma is usually achieved within a few (2-3) days.Alzolam is actively metabolized in the liver, the main metabolite is the alpha-hydroxyl metabolite, which has biological activity. Removal of the drug from the body occurs mainly through the kidneys in the form of compounds with glucuronic acid. T 1/2 - 11-16 hours Accumulation on repeated appointment is minimal (refers to benzodiazepines with short or medium T 1/2 ), excretion after cessation of treatment is rapid.
INDICATIONS

- treatment of neurotic and neurosis-like disorders with anxiety, incl.
associated with depression;
- panic disorder.

DOSING MODE

Inside, 2-3 times / day, regardless of food intake.

The dose of the drug is selected individually and corrected during the treatment, depending on the effect and individual tolerability.

The use of minimum effective doses is recommended.

In case of anxiety, the initial dose is 0.25-0.5 mg 3 times / day.
If necessary, this dose can be increased to 4 mg / day (divided into several receptions).
In the elderly, the initial dose is 0.25 mg 2-3 times / day.

In anxiety conditions associated with depression, the initial dose is 0.5 mg 3 times / day.
If necessary, the dose is increased to 4.5 mg / day. The initial dose can be administered before bedtime to minimize daytime sleepiness. Duration of treatment is 4-12 weeks.
Stopping the drug should be done with great care.
The dose should be reduced gradually and slowly, no more than 0.5-1 mg at bedtime or 0.5 mg 3 times / day.
For most patients, a sufficient dose is 4-6 mg / day for 4-12 weeks.
In some cases, if necessary, the dose can be increased to 10 mg / day (but not more than 1 mg every 3-4 days), and the duration of treatment - up to 8 months.
At treatment of elderly and weakened patients it is necessary to use smaller doses: initial - 0.25 mg 2-3 times / day, if necessary and good tolerance it gradually increase to 0.5-0.75 mg / day.

SIDE EFFECT

Side effects usually occur at the beginning of the treatment and gradually disappear as the drug is used or the dose is lowered.

From the side of the central nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, fatigue, dizziness, impaired concentration, ataxia, disorientation, slowing of mental and motor reactions;
rarely - headache, euphoria, decreased mood, tremor, memory loss, movement coordination disorder, frightened consciousness, dystonic extrapyramidal reactions (uncontrolled movements, including the eye), muscle weakness, blurred speech; extremely rarely - paradoxical reactions (aggressive outbursts, confusion, psychomotor agitation, fear, suicidal tendencies, muscle spasm, hallucinations, anxiety, insomnia).
From the hematopoiesis: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.

On the part of the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, anorexia, constipation, diarrhea, impaired liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.

On the part of the genitourinary system: urinary incontinence, urinary retention, impaired renal function, decreased or increased libido, dysmenorrhea.

Allergic reactions: skin rash, itching.

Influence on the fetus: teratogenicity (especially I trimester), CNS depression, respiratory failure and suppression of sucking reflex in newborns whose mothers used the drug.

Other: addiction, drug dependence, lowering blood pressure;
rarely - visual impairment (diplopia), weight loss, tachycardia. With a sharp decrease in dose or discontinuation of reception - withdrawal syndrome (increased irritability, sleep disturbance, dysphoria, spasm of smooth muscles of the internal organs and skeletal muscles, depersonalization, increased sweating, decreased mood, nausea, vomiting, tremor, perception disorders, incl. hyperaemia, paresthesia, photophobia, tachycardia, convulsions, rarely - acute psychosis).
CONTRAINDICATIONS

- coma;

- shock;

- an angle-closure glaucoma;

- Myasthenia gravis;

- Acute poisoning with alcohol, narcotic, hypnotics and psychotropic drugs;

- severe course of chronic obstructive pulmonary diseases;

- severe depression (suicidal attempts);

- sleep apnea syndrome;

- pronounced impairment of kidney and liver function;

- Pregnancy (especially the first trimester);

- lactation period;

- hypersensitivity to alprazolam or other benzodiazepines.

With caution: cerebral and spinal ataxia, drug addiction in medical history, addiction to psychotropic drugs, hyperkinesis, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia, advanced age, safety of Alzolam in children and adolescents (under 18) not installed.

PREGNANCY AND LACTATION

When pregnancy is used only in exceptional cases and only for life indications.
Has a toxic effect on the fetus and increases the risk of developing congenital malformations when used in the first trimester of pregnancy. Taking therapeutic doses at a later time of pregnancy can cause depression of the newborn's central nervous system. Continuous use during pregnancy can lead to physical dependence with the development of withdrawal syndrome in a newborn. The use directly before childbirth or during labor can cause a respiratory depression in the newborn, a reduction in muscle tone, hypotension, hypothermia, and a weak act of sucking (the so-called "sluggish child syndrome").
APPLICATION FOR FUNCTIONS OF THE LIVER

With renal failure and long-term treatment, control over the picture of peripheral blood and hepatic enzymes is necessary.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With hepatic insufficiency and long-term treatment, control over the pattern of peripheral blood and hepatic enzymes is necessary.

APPLICATION FOR CHILDREN

The safety of Alzolam in children and adolescents (under 18 years of age) has not been established.

APPLICATION IN ELDERLY PATIENTS

In the treatment of elderly patients , smaller doses should be used: initial dose 0.25 mg 2-3 times / day, if necessary and good tolerability it is gradually increased to 0.5-0.75 mg / day.

SPECIAL INSTRUCTIONS

In the process of Alzolam treatment, patients are strictly prohibited from drinking alcohol (ethanol).

In renal / hepatic insufficiency and long-term treatment, control over the picture of peripheral blood and hepatic enzymes is necessary.

Patients who did not previously take psychotropic drugs respond to the drug in lower doses, compared with patients who previously took antidepressants, anxiolytics or who suffer from alcoholism.

With endogenous depression, Alzolam can be used in combination with antidepressants.
When Alzolam was used, patients with depression experienced cases of hypomanic and manic state development.
Like other benzodiazepines, Alzolam has the ability to induce drug dependence during long-term admission in large doses (more than 4 mg / day).

When patients develop such unusual reactions as increased aggressiveness, acute excitement, feelings of fear, thoughts of suicide, hallucinations, increased muscle cramps, difficult sleep, superficial sleep, treatment should be discontinued.

Children, especially at a young age, are very sensitive to the CNS depressing action of benzodiazepines.

OVERDOSE

Overdose of the drug (taking 500-600 mg).

Symptoms: drowsiness, confusion, decreased reflexes, nystagmus, tremor, bradycardia, shortness of breath or shortness of breath, lowering blood pressure, coma.

Treatment: gastric lavage, reception of activated charcoal.
Symptomatic therapy (maintenance of respiration and blood pressure), administration of flumazenil (in hospital settings). Hemodialysis is ineffective.
DRUG INTERACTION

Alzolam enhances the effect of other psychotropic drugs, anticonvulsant and antihistamines, ethanol and drugs that exert a depressing effect on the central nervous system.

Inhibitors of microsomal oxidation - increase the risk of toxic effects.
Inductors of microsomal liver enzymes - reduce efficacy.
Hypotensive drugs can increase the severity of blood pressure lowering.

Clozapine - may increase respiratory depression.

Reduces the effectiveness of levodopa in patients with Parkinsonism.

It is possible to increase the toxicity of zidovudine.

Alzolam in a dose of 4 mg / day increases plasma concentrations of iminramine and desipramine (by 31% and 20%, respectively) with simultaneous admission.

The metabolic clearance of alzolam decreases with the simultaneous administration of conventional therapeutic doses of cimetidine and antibiotics from the macrolide group.

Caution should be exercised and thought should be given to reducing doses of alzolam when taken with cimetidine, macrolides, nefazodone, fluvoxamine, fluoxetine, propoxyphene, sertraline, diltiazem, digoxin and oral contraceptives.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

Strong substance (approved at the meeting of the Standing Committee on Drug Control on April 17, 2002, Protocol No. 1 / 84-2002).

TERMS AND CONDITIONS OF STORAGE

Store in a dry, dark place at a temperature of no higher than 30 В° C.
Keep out of the reach of children. Shelf life - 3 years.

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