Helex - instructions for use, dose, side effects, contraindications

Active substanceAlprazolamAlprazolam

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KRKA, dd, Novo mesto, AO

Dosage form: & nbsppills

Composition:

1 tablet contains: active substance alprazolam 0.25 mg

Excipients: lactose monohydrate, corn starch, povidone, polysorbate 80, crospovidone, magnesium stearate.

1 tablet contains: active substance alprazolam 0.5 mg

Excipients: lactose monohydrate, corn starch, povidone, polysorbate 80, crospovidone, quinoline yellow dye, E 104, magnesium stearate.

1 tablet contains: active substance alprazolam 1 mg

Excipients: lactose monohydrate, corn starch, povidone, polysorbate 80, crospovidone, dye blue (dye patented blue E 131 + dye diamond black E151), magnesium stearate.

Description:

Tablets 0.25 mg: Round, slightly biconvex white tablets with a bevelled edge and a notch on one side.

Tablets 0.5 mg: Round, slightly biconvex tablets of light yellow color, white inclusions are allowed, with a bevelled edge and a notch on one side.

Tablets 1 mg: Round, slightly biconvex tablets of light blue color, white and blue inclusions are allowed, with a bevelled edge and a notch on one side.

Pharmacotherapeutic group:Anxiolytic agent (tranquilizer). List III of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

ATX: & nbsp

N.05.B.A Benzodiazepine derivatives

N.05.B.A.12 Alprazolam

Pharmacodynamics:

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

Alprazolam - a drug from the group of benzodiazepine derivatives of medium duration, also has a sedative-hypnotic effect. Stimulates the benzodiazepine receptors, supramolecular GABA-benzodiazepine-chloro-formophore complex, which leads 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, reduces the excitability of the subcortical structures of the brain (limbic system, thalamus, hypothalamus).Has anxiolytic (eliminates feelings of anxiety and fear), sedative, antidepressant, hypnotic, anticonvulsant, central muscle relaxant effect. Anxiolytic action is manifested in a decrease in emotional tension, easing anxiety, fear, anxiety.

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.

Pharmacokinetics:Absorption after ingestion is rapid and complete. The maximum concentration in blood plasma is reached after 1-2 hours. The connection with plasma proteins is 80%. Penetrates through the placental and blood-brain barrier, penetrates into breast milk. Equilibrium concentration in blood plasma is achieved within 2-3 days. Metabolised in the liver. The half-life is 11-16 hours (refers to benzodiazepines with an average half-life). It is excreted mainly by kidneys in the form of compounds with glucuronic acid.

Indications:

The drug is used strictly according to the doctor's prescription:

- Anxiety disorders (without symptoms of depression), accompanied by a sense of anxiety,danger, tension, agitation, irritability, insomnia.

- Alarming conditions associated with depression.

- Anxiety disorders and mixed anxiety-depressive conditions, against the background of somatic diseases, withdrawal syndrome in the phase of chronic alcoholism.

- Panic disorders.

Contraindications:

Helex® is contraindicated in patients with hypersensitivity to alprazolam or other ingredients of the drug, as well as other benzodiazepines.

Acute attack of angle-closure glaucoma, shock, myasthenia gravis, acute alcohol poisoning (with impaired vital functions), narcotic analgesics, hypnotics, acute respiratory failure, nocturnal sleep apnea, chronic obstructive pulmonary disease, severe liver and kidney dysfunction, epilepsy. Pregnancy (especially I trimester) and lactation period, age under 18 years (safety and efficacy not established).

The drug is not recommended for the treatment of patients with severe depression and suicidal tendencies.

Carefully:Hepatic failure, chronic renal failure, cerebral and spinal ataxia, drug dependence in history, hyperkinesia, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia, elderly age.

Pregnancy and lactation:

During pregnancy are 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 of the drug during pregnancy can cause depression of the newborn's CNS and lead to physical dependence with the development of the "cancellation" syndrome in the newborn. The use of the drug immediately before childbirth or during childbirth can cause a respiratory depression in the newborn, a decrease in muscle tone, hypotension, hypothermia, and a weak act of sucking ("sluggish child syndrome").

Dosing and Administration:

The optimal dose of Hleksa® is determined individually based on the severity of the symptoms and the individual response of the patient. The table shows the use of the drug, which meets the needs of most patients.If patients are required to prescribe higher doses, they should be increased with caution in order to avoid side effects. First increase the evening dose of the drug, and then the day.

Indication

Initial therapy

Supportive therapy

Feeling anxious or feeling anxious with symptoms of depression

Adults:

0.25-0.5 mg 3 times in

day

Elderly:

0.25 mg 2-3 times a day

Adults:

0.5-4 mg per day, divided by

2- 3 admission

Elderly:

0,5-0,75 mg 2-3 times a day, divided into 2-3 doses

Panic

disorders

0.5 - 2 mg 3 times a day (do not increase more than 1 mg for 3-4 days)

4-10 mg per day, divided into several doses

The initial dose should be reduced if side effects are observed with their appointment. Cancellation of Hleksa® should be carried out gradually, as a sharp interruption of the course can cause withdrawal syndrome. Gradual cancellation should take an extended period of time, i.e. if the patient takes 0.5 mg in the morning, 0.5 mg in the afternoon and 1 mg in the evening, then he should reduce the daily dose by no more than 0.25 mg every three days.

Side effects:

From the nervous system: at the beginning of treatment (especially in elderly patients), drowsiness, fatigue, dizziness, decreased ability to concentrate, ataxia,instability of gait, slowing of mental and motor reactions; rarely - headache, euphoria, depression, tremor, memory loss, coordination of movements, confusion, diastolic extrapyramidal reactions, weakness, myasthenia gravis, dysarthria; extremely rarely - paradoxical reactions (outbreaks of aggression, psychomotor agitation, fear, suicidal tendencies, muscle spasm, hallucinations, agitation, irritability, anxiety, insomnia).

On the part of the hematopoiesis: leukopenia, neutropenia, agranulocytosis, anemia, thrombocytopenia.

On the part of the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, decreased appetite, constipation, or diarrhea, impaired liver function, increased activity of "liver" 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.

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 (irritability, nervousness, sleep disturbances, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, increased sweating, depression, nausea, vomiting, tremor, perception disorders, hyperacusia, paresthesia, photophobia , tachycardia, convulsions, rarely - acute psychosis).

Influence on the fetus: teratogenicity, CNS depression, respiratory failure and suppressing the sucking reflex in newborns, if the mother takes the drug during pregnancy.

Overdose:

Symptoms: when taking 500-600 mg of alprazolam and more - drowsiness, confusion, decreased reflexes, nystagmus, tremor, bradycardia, shortness of breath or shortness of breath, lowering of blood pressure, coma.

Treatment: gastric lavage, reception of activated charcoal. Symptomatic therapy (maintenance of breathing and arterial pressure, administration of flumazenil (in a hospital) .Hemodialysis is ineffective.

Interaction:

With the simultaneous administration of HELEX® (as well as all benzodiazepines) with other antipsychotic drugs (antipsychotics, antidepressants, anesthetics,anticonvulsant and antihistamine), the inhibitory effect on the central nervous system can increase.

Alprazolam reduces the effectiveness of levodopa in patients with Parkinsonism.

Helex® can enhance the effects of alcohol, so patients should refrain from drinking alcohol during treatment.

With the simultaneous administration of alprazolam in doses up to 4 mg with imipramine and clomipramine, stable concentrations of the latter in the blood plasma can increase by 30% and 20%, respectively.

Hypotensive drugs can increase the severity of lowering blood pressure. Simultaneous administration of alprazolam and fluvoxamine causes an increase in plasma concentration of alprazolam by approximately 30%.

Inductors of microsomal liver enzymes - reduce the effectiveness of alprazolam. Simultaneous administration of alprazolam with ketoconazole, itraconazole and other antifungal agents of the azole group, antibiotics - macrolides (erythromycin, oleandomycin, etc.), cimetidine, oral contraceptives, fluoxetine, sertraline, deltiazem, nefazodone can reduce the metabolism of alprazolam in the liver and enhance its effect.

Special instructions:

Alprazolam is not recommended for patients with primary signs of depression with psychomotor retardation, as well as for bipolar depression and psychotic symptoms. Because of the increased risk of suicidal behavior, all patients with depressive disorders should be monitored, especially at the beginning of treatment.

Long-term treatment should be discontinued gradually (see section "route of administration and dose").

If the drug is suddenly discontinued, there may be a "cancellation" syndrome, especially if you take longer than 8-12 weeks.

Elderly patients should be given a minimum effective dose, because they may develop ataxia or the sedation will be too strong.

Effect on the ability to drive transp. cf. and fur:

The drug has an effect on psychophysical abilities, especially if it is taken with alcohol or tranquilizers. During the treatment period, care must be taken when dealing with potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 0.25, 0.5 and 1 mg.

Packaging:

15 tablets in a blister pack.2 blisters per cardboard pack together with instructions for use.

Storage conditions:

List 1 of the strong BACC.

Store in a dry place, at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013561 / 01

Date of registration:07.08.2007

Date of cancellation:2016-10-27

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA KRKA Slovenia

Information update date: & nbsp27.10.2016

Illustrated instructions

Instructions

Helex® (Helex®)