Helex

The drug Helex acts on the central nervous system and is a psychotropic sedative and tranquilizer.

Helex is on the list No. 1 of potent substances, therefore it is sold only with a prescription.

Indications Helex

The following conditions are considered as indications requiring the use of Helex:

• pronounced restless behavior with or without signs of a depressive state;
• signs of increasing, sometimes unmotivated, anxiety, stress, phobia;
• impaired concentration, bouts of irritability, sleep disturbances, possibly combined with increased motor activity of the patient, which may subsequently result in various physical disorders;
• signs of impending or deep depression, possibly against the background of restless behavior, which are manifested by apathy and depression, loss of interest and loss of the ability to receive satisfaction from anything, lack of energy potential and psychomotor activity;
• anxiety against the background of combined disorders, intermittent attacks of excitement and depression, which may accompany diseases of certain organs and systems, or a chronic form of withdrawal syndrome (syndrome of cessation of consumption of alcoholic beverages and other stimulants of the nervous system);
• state of panic.

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Release form

The drug Helex is a tablet form of a drug whose international and chemical term is Alprazolam.

The tablets can be produced in various dosages:

• 0.25 mg – round, white, slightly convex on both sides. The edges are slightly beveled, one side of the tablet has a dividing strip;
• 0.5 mg – round, pinkish in colour, slightly convex on both sides. They have white dotted elements on the surface, slightly bevelled edges and a dividing strip on one side;
• 1 mg – round, bluish in colour with white dots on the surface, with a dividing strip on one side.

Each tablet contains 0.25 mg, 0.5 mg or 1 mg of the active ingredient alprazolam, respectively. Additional substances include lactose, dye, polysorbate, povidone, corn starch, magnesium stearate.

The tablets are packed in 15 pieces in cell packs placed in cardboard boxes.

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Pharmacodynamics

Helex is a psychotropic drug that also has some antidepressant, hypnotic and anticonvulsant effects. The active substance of this drug activates the inhibitory effect of γ-aminobutyric acid in the brain, increases the reaction rate of GABA receptors to this neurotransmitter by stimulating the receptors of benzodiazepine receptors of the supramolecular biological regulatory complex chlorine-ionophore GABA.

Taking Helex can cause muscle relaxation. The drug also has a slight anticonvulsant effect.

Helex can also be used as a mild hypnotic drug that makes the process of falling asleep easier, prolongs sleep time and reduces the frequency of awakenings at night. The hypnotic effect of the drug is explained by its properties to affect the neurons of the reticular formation in the brain and reduce the reaction to vegetative, emotional and motor stimuli that interfere with the process of normal sleep.

When using Helex, patients experience a disappearance of signs of anxiety and phobia, as well as a reduction in psychological stress.

Helex has a minor effect on the heart, blood vessels and respiratory organs of a healthy person.

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Pharmacokinetics

After oral administration, the active substance alprazolam is well absorbed in the digestive system and reaches its maximum level in the blood serum within 60-120 minutes. The biological availability of the drug is about 80%. The concentration of the active component in the blood can increase simultaneously with an increase in the dosage of the drug. About ¾ of the dose consumed is bound to plasma proteins.

The active substance of the drug is able to penetrate the placental and encephalitic barrier, and is also found in breast milk. The concentration equilibrium of the active component in the blood serum is determined on the II-III day from the beginning of treatment.

Metabolism occurs in the liver with the formation of a biologically active component (α-hydroxy metabolite).

The drug is excreted mainly by the kidneys, in the form of glucuronic compounds. The half-life of the active substance is up to 11-16 hours.

Alprazolam is almost incapable of accumulating in the body.

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Dosing and administration

Helex is an oral medication. It can be taken regardless of food intake.

Usually the drug is taken 2-3 times a day. The duration of the course of treatment and dosage are selected individually.

When determining the treatment regimen, it is necessary to carefully assess the patient's condition, adjusting the amount and frequency of drug administration if necessary.

Adult patients may be prescribed Helex for the treatment of panic attacks and depressive states, starting with minimal dosages of 0.25-0.5 mg/day. Then the dosage is increased, first increasing the intake of the drug in the evening, then during the day. A gradual increase in dosage reduces the likelihood of side effects.

Further treatment is carried out according to the following scheme:

Symptoms	Start of therapy	Supportive care
A state of anxiety and/or depression	Adults: 0.25-0.5 mg three times daily. Elderly: 0.25 mg twice or three times daily.	Adults: 0.5-4 mg/day, divided into three doses. For the elderly: 0.5-0.75 mg/day, divided into three doses, or 4 to 10 mg/day, divided into a greater number of doses.
Panic attacks	0.5-1 mg three times a day.	From 4 to 10 mg/day, divided into several doses.

If side effects already appear at the initial stage of treatment, the dosage of the drug is reduced.

Treatment with Helex is discontinued gradually, as sudden withdrawal of the drug may lead to undesirable consequences. Gradual withdrawal from the drug should be carried out over a long period of time. For example, if a patient takes 0.5 mg of Helex three times a day, then such a dosage should be reduced by no more than 0.25 mg every three days.

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Use Helex during pregnancy

Helex is prohibited for use during pregnancy and lactation.

Moreover, immediately before the course of treatment, patients must be examined for the absence of pregnancy, and a reliable contraceptive drug must be prescribed. If pregnancy does occur during Helex therapy, it is imperative to immediately inform the doctor: he will reconsider the possibility of canceling the drug, which can harm the developing fetus.

If it is necessary to take the drug during lactation, breastfeeding should be discontinued.

Contraindications

Helex is not recommended for patients who are prone to allergies to the active or auxiliary substance of the drug.

Helex is not recommended for the treatment of individuals with lactose intolerance.

The drug is not used to treat patients suffering from respiratory failure, serious disorders of the functional capacity of the liver and urinary system, myasthenic syndrome, acute increase in intraocular pressure, acute alcohol or drug intoxication, overdose of barbiturates and psychotropic substances.

Helex is not used during pregnancy or for the treatment of pediatric patients.

It is not recommended to prescribe Helex to patients with alcoholism, since during the entire course of treatment with the drug, alcoholic beverages, as well as drugs based on ethyl alcohol, are prohibited.

During the treatment period, it is not recommended to engage in activities that require increased attention and quick reactions.

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Side effects Helex

At the initial stage of treatment with Helex, patients may note the appearance of a feeling of unmotivated fatigue, drowsiness, and inability to concentrate. Dizziness and psychomotor inhibition are possible. Side effects of Helex most often occur in elderly patients.

Regardless of age category and duration of therapy, the following side effects may occur:

• trembling hands;
• depressive states;
• headaches;
• confusion of consciousness, forgetfulness;
• speech disorder;
• aggressiveness, hallucinations;
• deterioration of vision;
• taste disturbances;
• emaciation, anorexia;
• dyspeptic disorders;
• menstrual dysfunction;
• decreased sexual desire;
• urinary retention.

If the drug is suddenly discontinued, a characteristic syndrome may appear, which is expressed in muscle spasms, vomiting, convulsions and increased sweating.

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Overdose

Signs of overdose may develop when taking excessively large doses of Helex. The typical symptoms of overdose are as follows:

• motor coordination disorders;
• disturbances of consciousness;
• drop in blood pressure;
• In case of a large overdose – comatose state, respiratory failure and cardiac arrest.

What measures should be taken in case of an overdose of Helex:

• a patient who has not lost consciousness must have a gag reflex induced;
• An unconscious patient should be intubated and have his stomach washed.

After cleansing the stomach, the patient can be given activated charcoal and mineral laxatives.

A patient with an overdose should be observed by a doctor in a hospital. In case of a severe overdose, a drug with an effect opposite to alprazolam, flumazenil, can be used.

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Interactions with other drugs

The combined use of Helex and antidepressants is acceptable in patients with endogenous depressive states.

When used together with Helex and neuroleptics, barbiturates, anticonvulsants, narcotic painkillers, ethanol and central muscle relaxants, an increase in each other's activity is observed.

The combined use of Helex with omeprazole may provoke the occurrence of toxic effects of alprazolam.

A decrease in the effect of Helex may be observed when taken simultaneously with a drug that induces microsomal oxidation.

The active substance Helex may increase the level of imipramine in the blood serum when taken together.

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Storage conditions

The medicinal product Helex must be stored and transported in its original container at a temperature of 15°-30°C.

The product should be protected from direct sunlight. Keep children away from storage areas of medicines.

Shelf life

The shelf life of Helex is up to 5 years.

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