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Structure

active substance: Diazepam;

2 ml of solution (1 ampoule) Mistere 10 mg diazepama,

Excipients: benzoic acid (E 210), sodium benzoate (E 211), propylene glycol, alcohol benzyl, ethyl alcohol 96%, water for injection

Dosage form

Injection.

Basic physico-chemical properties: Transparent liquid, color from transparent to light yellow with a green tint.

Pharmacological group

Anxiolitics. Benzodiazepine derivatives. ATH code N05B A01.

Pharmacological properties

Pharmacological.

Diazepam - a psychotropic drug class benzodiazepine with a pronounced soothing, anti-tesry, anticonvulsant and myorial action is also inherent in the hypnotic effect.

In the central nervous system (CNS), diazepams act on specific benzodiazepine receptors, which are functionally closely related to gamma-amine oil acid receptors (GABS) - the main brake mediator of the CNS, therefore, as a result of the operation of the diazepam, the braking action of the GABA on the central nervous system is enhanced.

Diazepam acts on the receptors of the limbic system and the cortex of the brain, showing sedative and anxiolytic effects. The myarlaxing and anticonvulsant diazepama associated with its property reduce the activity of epileptogenic media of all parts of the brain, as well as with its braking effect on the spinal cord reflexes. Diazepams practically does not act on the receptors of the peripheral vegetative nervous system and does not cause extrapyramidal disorders.

Pharmacokinetics.

absorption

The absorption of diazepam depends on the path of its administration. When administered, the drug is absorbed completely, but not always diazepams are absorbed faster than when oral administration.

distribution

The level of binding diazepam and its metabolites with blood plasma proteins is high (diazepam - 98%). It is known that diazepam is well soluble in lipids. Diazepams and its metabolites penetrate the hematorecephalic and placental barriers, and also penetrate into breast milk (approximately 1/10 concentration in the plasma of the mother's blood).

metabolism

Diazepam is metabolized mainly in the liver with the formation of pharmacologically active metabolites - N-dismemteraldiazepam, Tekezepama, Oxazepama.

output

Diazepam removal consists of two phases. The first phase indicates its soon distribution in the body, the second phase - about long-term output, which lasts 1-2 days.

The half-life of the drug may continue 2-5 days, since the body circulates its active metabolite - dismemteraldiazepam (Nordiazepam).

With repeated reception of diazepam, the accumulation of diazepama and the dismelthydiazepam is observed. Until the equilibrium state, 2 weeks can be achieved, and the metabolite concentration may even exceed the level of diazepam.

Diazepams and its metabolites are derived from the body with urine, mainly in the form of conjugates.

Clearance diazepam is 20-30 ml / min.

Pharmacokinetics in special clinical cases

The half-life of diazepam and its metabolites increases in newborns, older people and patients with liver diseases. In renal failure, the half-life practically does not change.

Intramuscular injections can cause an increase in the activity of the plasma CFC when the maximum level is achieved after 12-24 hours after administration. This must be taken into account with the differential diagnosis of myocardial infarction.

Absorption with the introduction of a variable (especially jagical muscles). This introduction method should be used if oral or intravenous administration is impossible or not recommended.

The relationship between the concentration of diazepam and its metabolites in the blood plasma and the therapeutic effect of vines.

Indications

The states of anxiety and fear or their symptoms.

Alcohol abstine syndrome.

Convulsions of various etiologies, epileptic status, febrile cramps.

The drug is also used during premedication before surgical operations.

Contraindications

• Increased sensitivity to benzodiazepines in history.
• The acute attack of the closedian glaucoma or an open-angle glaucoma if the patient does not receive proper therapy.
• Miasthenia gravis. .
• Respiratory depression, acute respiratory failure.
• Night apnea.
• Heavy liver failure.
• Intoxication by drugs or psychotropic substances.
• Inxication of alcohol, acute intoxication by substances inhibiting CNS.
• The first 30 days of the life of newborns due to lack of liver function.
• I and III trimesters of pregnancy.
• Breastfeeding period.

It is not intended for the treatment of phobias, obsession and chronic psychosis.

It is impossible to apply in the form of monotherapy for the treatment of depression or depression, which is accompanied by anxiety, fear, since such patients may have suicidal inclinations.

Interaction with other medicines and other types of interactions

The simultaneous use of diazepam and antihistamine drugs of central action, antipsychotic drugs, muscle relaxants (ballopen, tizanidine), nubyl, lumbercidine, phenothiazine or barbituric acid derivatives, narcotic drugs, antidepressants (inhibitors of Mao et al.), As well as cimetidine, disulfirama and alcoholic beverages can Increase sedative effect on the central nervous system. The risk of apnea increases, hypotension and weakness of muscles are possible.

With the simultaneous use of diazepam with opiates, an inhibitory effect on respiration can be enhanced. When applied with other Miorolaksanta, the consequences are unpredictable, there is a risk of stopping breathing.

With simultaneous use with antihypertensive agents, their hypotensive effect is enhanced; α-adrenoblays can enhance the sedative diazepam effect. Elderly patients need special supervision.

Isoniazide, Ritonavir, Amprenavir increase the concentration of benzodiazepines in the blood plasma.

If diazepams are administered simultaneously with any narcotic anesthetic (for example, in dentistry), the drug is recommended to be administered after administration of an anesthetic agent, the dose should be thoroughly corrected according to the needs of the patient.

In pharmacokinetic studies, conflicting data on the interaction of diazepam with antiepileptic means was obtained.

Inhibitors of liver enzymes (for example, cimetidine, fluvoxamine, fluoxetine, omeprazole) have the ability to reduce benzodiazepine clearance, thus enhancing their action. In turn, the inductors of the liver enzymes (rifampicin) can increase benzodiazepine clearance.

There are reports that benzodiazepines affect the elimination of phenytoin.

With simultaneous use with the levodopa, the effect of Levodopa decreases.

With simultaneous use with digoxin diazepams, it may reduce its renal excretion, thus increasing the toxicity of digoxin.

Isoniazide, disulfers, antihistamine agents and contraceptive means containing estrogens are reinforced, while rifampicin weakens the bonding of diazepam and desmethylthydiazepam with blood plasma proteins, thus increasing the concentration of the fraction of unbound diazepam in the blood plasma.

With simultaneous use with alcohol, pathological reactions are possible. The pathological effect of the interaction of diazepam and alcohol does not depend on the amount and type of drinking alcohol.

Alcohol can be taken no earlier than 36 hours after applying diazepam.

Antifungal preparations (ketoconazole) also increase the concentration of benzodiazepines in the blood plasma.

Features of application

Parenteral diazepam should not be used to patients with organic changes in the brain (especially atherosclerosis) or with chronic pulmonary failure. However, in exceptional cases or in the treatment of the patient in the hospital, diazepam can be administered parenterally in smaller doses. Intravenously drug is injected slowly, not exceeding the speed of 1 ml (5 mg) / min. It is necessary to avoid the solution of the drug in artery or the occasional space. When administered, the drug should be introduced deep into the muscle. To the drug, is in the syringe or in the infusion system, other solutions or medicines cannot be added! After intravenous administration, the drug operates quickly, but briefly, it is not recommended to be used for supporting therapy.

It is necessary to thoroughly weigh the expediency of using diazepam patients with respiratory impairment and reduced attention due to the danger of respiratory oppression.

For patients with chronic pulmonary failure or chronic liver diseases, a dose decrease can be necessary to apply with caution as early as renal failure, although the semi-period of the diazepam elimination does not change.

When applying diazepam, amnesia is possible. Typically, this condition appears a few hours after applying the drug, therefore, to reduce the risk, patients should provide 7-8 hour continuous sleep.

When using benzodiazepines, paradoxical reactions may occur, such as anxiety, excitation, nervousness, aggressiveness, paranoia, anger, nightmares, hallucinations, psychosis, inadequate behavior and other negative behavioral behavior. When these symptoms appear, the drug should be canceled. These symptoms are most often manifested in children and elderly patients.

When using benzodiazepines, dependence is possible. The risk is increased in patients, the drug is long used or used in large doses in patients with a tendency to the excessive use of alcohol and medication in history. If physical dependence on benzodiazepines arose, with the termination of therapy, the symptoms of cancellation arise. They include headache, muscle pain, increased anxiety, tension, confusion of consciousness, nervousness. In severe cases, such symptoms may appear: the loss of reality, depersonalization, the numbness of the limbs, increased sensitivity to light, noise and physical contacts, hallucinations, or epilepsy attacks. In case of termination of long intravenous therapy, a gradual decrease in the dose is necessary.

Special caution should be observed, applying the injecting form of diazepam to the elderly patients, very weakened patients and patients with cardiorespiratory failure, since there is a risk of apnea and / or heart stop. The simultaneous use of barbiturates, alcohol and other CNS depressants increases the depressing effect of the cardiorespiratory function, increases the risk of apnea.

The benzyl alcohol contained in solution can cause irreparable harm to the newborn, especially premature. In such cases, the injection solution is used only when there is no therapeutic alternative.

With long-term therapy, it is advisable to regularly check blood and liver indicators.

Benzodiazepines are prescribed to children only after a thorough assessment of the need for their use; The duration of treatment should be minimal.

In pediatric practice, minimal doses are used to avoid dangerous side effects (apnea or long-term drowsiness).

It should be used with caution during porphyria.

Do not apply diazepam in obstetrics.

Application during pregnancy or breastfeeding.

No data on the safety of the drug during pregnancy. Some studies indicate the congenital risk of anomalies associated with the use of benzodiazepines in the first trimester of pregnancy, so their use is contraindicated. The drug cannot be applied in the last trimension of pregnancy.

If diazepams are prescribed to a woman, it should be aware of the need to consult a doctor about the cessation of the drug when planning pregnancy or suspected pregnancy.

Diazepams stand out in breast milk, so during the lactation period is prohibited.

The ability to influence the reaction rate when managing motor vehicles or other mechanisms.

Patients should be informed that diazepams, like other drugs of this group, may worsen the patient's ability to perform tasks that require special skills. The sedative effect of the drug, amnesia, disrupted the ability to concentrate and excited muscle functions adversely affect the ability to control vehicles and maintain mechanisms. During the application of diazepam, it should be avoided by risk-related (work with technical devices, vehicle management). In case of insufficient sleep, attention is even more weakened. Patients should be informed that alcohol can strengthen side effects, so during treatment it should be refused.

Method of application and dose

The dose is established individually depending on the indications for the use and severity of the disease.

Under the introduction, the drug is absorbed slowly. The recommended administration rate is 0.5-1 ml / min or 2.5-5 mg / min.

In case of severe fear Diazepam is injected intramuscularly or intravenously at a dose of up to 10 mg, repeating the introduction every 4:00, if necessary.

To ensure a sedative effect In front of small surgical or medical procedures, the drug is injected into large veins of 10-20 mg for 2-4 minutes for premedication - intravenously 100-200 μg / kg body weight.

To prevent convulsion in adults Diazepams are administered intravenously at 10-20 mg at a speed of 5 mg / min. If necessary, the injection can be repeated in 30-60 minutes. Another application scheme provides for more frequent administration of smaller doses or intramuscular administration.

Doses for children with intravenous or intramuscular administration of the drug are 200-300 μg / kg of body weight or 1 mg for each year of life. The maximum daily dose for children should not exceed 3 mg / kg.

With muscular spasms Diazepams are injected intramuscularly or slowly intravenously at 10 mg every 4:00.

Large doses are needed for elimination of Tetania . In this case, adults and children are prescribed intravenously at 100-300 μg / kg body weight every 1-4 hours.

With severe alcohol abstinence syndrome Intramuscularly introduced or intravenously 10 mg of diazepam, in some cases the dose can be increased.

Children.

Apply children from 30 days of life.

Overdose

The overdose of benzodiazepines is usually expressed in the oppression of the CNS, from drowsiness to coma. In light cases, symptoms include drowsiness, confusion of consciousness, oppression of reflexes and apathy. In more severe cases, symptoms may include hypotension, arterial hypotension, oppression of respiratory function, or (rarely) and death (very rarely).

If an overdose occurred orally, the stomach washed without delay, respiratory stimulation, the introduction of infusion solutions.

The possibilities of applying dialysis are limited. Treatment is symptomatic, breathing should be monitored, changes in the pulse of and pressure. Arterial hypotension is eliminated by metraminine or norepinefrin. To reduce the depression of the central nervous system, a specific antagonist of benzodiazepine receptors - fluumazenil can be used. Patients who need such interference should be carefully observed in hospital conditions. Care should be taken when using fluumazenyl patients with epilepsy, which are treated benzodiazepines.

Medical Instructions

medicinal preparation

Diazpex ®.

Tradename

Diazpex ®.

International non-proprietary title

Diazepam

Dosage form

Tablets 5 mg

Structure

One tablet contains

active substance - diazepam 5 mg,

excipients: Lactoses of monohydrate, starch hydroxypropyl, cellulose Microcrystalline, silicon colloid dioxide, talc, magnesium stearate.

Description

Round white tablets with flat surfaces with faceted and risky.

Pharmacotherapeutic group

Anxiolitics. Benzodiazepine derivatives.

N05BA01 PBX code

Pharmacological properties

Pharmacokinetics

With oral administration, about 75% of the drug is absorbed, the maximum level in the blood plasma occurs after 1-2 hours. 98% of the prepared drug binds to blood plasma proteins. In the liver 98-99% diazepama metabolized.

Main metabolites - Nordiazepam (in blood plasma), oxazepam (in the urine) and tempozapam. In the form of glucuronides, metabolites are highlighted mainly with urine, 10% - with a fee, 0.5-2% - with urine unchanged.

The period of half-life in the plasma of the blood of adults - 1-3 days, in the elder age - 100 hours, in newborns - 31 hours, in infants - 8-14 hours.

With acute hepatitis, half-life in adults is lengthened to 2-4 days, and during the cirrhosis, the liver is doubled.

Pharmacodynamics

Diazpex contains diazepams - an anxiolytic means of a benzodiazepine group. It has an anxiolytic, central minelaxing, anticonvulsant, sedative and moderate sleeping pills. Enhances the effect of sleeping pills, narcotic, neuroleptic, analgesic drugs, alcohol.

The mechanism of action of the drug is associated with gamma-amine oil acid (gamc), which is a brake mediator in the central nervous system (CNS). It is known that GAMK-Yergic neurons brake the activity of neurons of other types. The drug reduces the activity of the enzyme gamke transaminase, thereby increasing the content of GABC in the brain. On the other hand, the sensitivity of the receptors to the gamke increases. All this enhances the inhibitory effect of GAMK-Ergic neurons on neurons of other types. With braking of noradreengic and dopaminergic neurons, sedative and sleeping effects of diazepam and other benzodiazepines are associated. The anticonvulsant and the miorlaxing effect is due to the braking of the corresponding neurons of cortical centers and the spinal cord. The braking of the excitation processes in the ascending reticular system leads to the development of an anxiolytic effect.

Indications for use

Various neuropsychiatric diseases: neurosis, psychopathy, as well as neurosis and psychopath-like states in schizophrenia

Organic brain lesions, including cerebrovascular diseases, somatic diseases, accompanied by signs of emotional stress, anxiety, fear, increased irritability, senthenechondria, obsessive and phobic disorders, sleep disorders

In children's psychoneurological practice, Diazpex is prescribed with neurotic and neurosis-like states that are accompanied by the phenomena listed above, as well as headaches, enuresis, mood and behavior disorders

Diazpex is used in epilepsy for the treatment of convulsive paroxysms, mental equivalents

Due to the Mioroxizing effect, the drug is also used for different spastic conditions.

In a complex with other drugs, diazepex is prescribed to treat abstinence syndrome during alcoholism

Diazpex is used for premium and atalagesia in combination with analgesics and other neurotropic drugs

In dermatological practice, it is used at itchy dermatoses

The drug reduces the night secretion of the gastric juice, which can play an important role when appointing it as a soothing and sleeping remedy with patients with ulcerative stomach disease

Also has an antiarrhythmic effect

Method of application and dose

Diazpex is used inside. Doses are selected individually for each patient.

Adultsit is recommended to prescribe the drug, starting with a dose of 2.5-5 mg (½-1 tablet) 1-2 times a day, then gradually increasing it. Typically, a single dose for adults is 5-10 mg (1-2 tablets). In some cases (with increased excitation, fear, alarm), a one-time dose can be increased to 20 mg. The daily medicinal dose is given in 2-3 receptions. The maximum daily dose is 60 mg.

In case of sleep disorders, adults are prescribed 5-10 mg before bedtime.

Weakened and elderly patients, as well as patients with impaired liver and kidney functions Treatment should be started with a half of the usual dose for adults, gradually increasing it, depending on the effect achieved and tolerance.

Children From 7 years and older prescribe at 2.5-5 mg. The daily dose is 5-10 mg.

The duration of the continuous course of treatment should not exceed 1 month. Before the re-course of treatment, the break should be at least 3 weeks.

Side effects

Sleepiness (especially strong in the first days), light dizziness, sometimes unsure gait. The concentration of attention is reduced; neuromuscular reaction slowed down

Seldom - Ataxia, skin itching, nausea, constipation

During long-term use, drug addiction is possible, memory breakdown, menstrual cycle, reduced sexual entry

In some cases, initiation may be observed at the beginning of treatment.

Hypoprotecrimeia

In elderly and childhood, there is an increase in the frequency of manifestation of sedative side effects

Contraindications

Individual intolerance to benzodiazepine derivatives

Pronounced violations of liver and kidney function

Pregnancy (1st trimester) and lactation period

Heavy Miastion

Medicinal interactions

When applying diazepx, together with other drugs, the following interactions may be observed: monoaminoxidase inhibitors, Strychnine and cozols are antagonists of diazep; Substances depressing the central nervous system (alcohol, sleeping pills, anticonvulsant, painful, etc.), sharply enhance the effect of diazepx; Antacid tools can delay, but do not lower the absorption of diazepam; Premedication using diazepx can reduce the dose of fentanyl required to cause introductory anesthesia, and reduce the time of loss of consciousness; Isoniazide can slow down the deseparation, which leads to an increase in its plasma concentration; Rifampicin can enhance the removal of diazepam and as a result of its concentration in the blood plasma.

special instructions

Risk of development

If patients take the benzodiazepine group tranquilizers for a long or in excessively high doses, a physical or mental dependence on the drug can sometimes develop. With a rapid reduction in the dose or sudden cessation of the reception of diazepx, the abstinence syndrome may develop for which the following symptoms are characterized: anxiety, trembling, insomnia, and in severe cases - nausea, delirium, seizures. To prevent the development of abstinence, the reception should be discontinued by a gradual decline in the dose.

To ensure the effective and safe use of diazepx, patients should be prevented about the inadmissibility of a unauthorized increase in the dose or the discontinuation of the drug without the permission of the doctor.

Precautions

To prevent the development of addiction, Diazpex is recommended only for short-term treatment.

The drug should be cautious to assign patients with violations of liver or kidney activities, since in these cases it is possible to reduce its elimination and increased action.

With caution to assign patients with glaucoma!

Elderly patients, children, as well as in patients with organic brain lesions, the inhibitory effect of diazepx on the CNS is expressed more.

Care should be taken when appointing diazepx patients with severe depression and a likely suicide proposal.

Tablets Diazpex contain lactose. Patients with rare innate intolerance to galactose, deficit Lapplactase or Malabsorption glucose-galactose can not be prescribed this medicine.

Pregnancy

During pregnancy, Diazpex should be prescribed only in the presence of urgent indications if the expected therapeutic effect justifies the risk of a possible toxic effect on the fetus.

In clinical studies, it was found that the diazepam overcomes the placental barrier. The results of individual studies indicate that the use of so-called "small tranquilizers" (chloridiazepoxide, diazepams, meproamat) in the first trimester of pregnancy increases the risk of organogenesis disorders. Regular use of benzodiazepines during pregnancy can lead to the development of abstinal syndrome in newborns (anxiety, tremor, an increase in muscle tone), and the application in the last weeks of pregnancy - the oppression of the CNS.

Features of the influence of the medicinal product on the ability to control the vehicle or potentially hazardous mechanisms

In the process of treatment with the drug, alcohol use is categorically prohibited.

Overdose

Symptoms: long-lasting confusion, reduced reflexes, pronounced drowsiness, tremor, slow heartbeat, shortness of breath, or difficulty breathing, long-term lubricated speech, maliciousness, pronounced weakness.

Treatmentit consists in supporting therapy and includes the calling of vomiting and the appointment of the activated carbon, washing the stomach, the purpose of oxygen, the introduction of infusion solutions with the appointment of effective diuretics (forced diuresis), intravenous introduction of vasoconstrictor agents (dopamine, norepinerenaline), fluumazenyl administration (benzodiazepine antagonist).

Release form and packaging

Tablets 5 mg.

10 tablets in the contour cellular package from the film of polyvinyl chloride and aluminum foil.

On 2 contour cellular packaging, together with the instructions for use in public and Russian, are inserted into a pack of cardboard.

Storage conditions

Store in the light-protected place at a temperature not higher than +25 ° C.

Keep out of the reach of children!

Storage term

Do not apply after the expiration date indicated on the package.

Conditions of vacation from pharmacies

On prescription

Manufacturer

JSC "Grindeks". Ul. Krustpils, 53, Riga, LV-1057, Latvia

An organization accepting claims in the territory of the Republic of Kazakhstan:

active substance: Diazepam;

1 tablet contains 5 mg diazepam;

excipients: Lactoses monohydrate, hydroxypropyl starch, microcrystalline cellulose, silicon dioxide, talc, magnesium stearate.

Dosage form.Pills.

Basic physico-chemical properties: Round white tablets with flat surfaces, with a chamfer and risk on one side.

Pharmacological group.

Anxiolitics. Benzodiazepine derivatives. ATH code N05B A01.

Pharmacological properties

Pharmacodynamics.

Diazepam is a psychotropic drug of benzodiazepine class with severe soothing, anti-tesry, anticonvulsant and a myarlaxing effect; He is also inherent in the hypnotic effect.

In the central nervous system (CNS), diazepams acts on the specific receptors of benzodiazepine, functionally closely related to gamma-amine-oil acid receptors (GAMK) - the main braking mediator of the central nervous system, therefore, as a result of the operation of the diazepam, the braking action of the GABA on the CNS increases.

Diazepam acts on the receptors of the limbic system and the cortex of the brain, showing sedative and anxiolytic effects. The myarlaxizing and anticonvulsant action of diazepam is associated with its ability to reduce the activity of epileptogenic foci of all parts of the brain, as well as with its peeling effect on the spinal cord reflexes. Diazepams practically does not act on the receptors of the peripheral vegetative nervous system and does not cause extrapyramidal disorders.

Pharmacokinetics.

Diazepams are quickly absorbed from the digestive tract, reaching the maximum concentration in the blood plasma for about 30-90 minutes. The degree of its absorption is high (75%).

Diazepams binds to blood plasma proteins (98-99%), soluble in lipids well, easily penetrates through the hematorecephalic and placental barriers.

The drug also penetrates breast milk. The apparent distribution volume is 1-2 l / kg.

The drug is metabolized in the liver with the formation of active metabolites - N-dismeteraldiazepama, Tepezepama and Oxazepama.

The half-life of diazepam - up to 24 hours. The half-life of the primary metabolite diazepam - N-dismeteraldiazepama - can reach 100 hours, and therefore the therapeutic effect of the drug is extended. Diazepams and its metabolites are mainly derived from the urine, mainly in the form of conjugates.

Clearance diazepam is 20-30 ml / min.

When repeated use, diazepam accumulates in the body. The half-life increases in newborns, elderly patients and patients with liver diseases; With renal failure, the change is small.

Clinical characteristics.

Indications

For short-term treatment, anxiety, anxiety and insomnia.

To stop muscle spasms and pains associated with a local pathological process or cerebrospinal diseases.

To prevent the spasmatic state and recurrence of seizures.

In the case of alcoholic abstine syndrome.

For premedication of surgical operations.

Anxolytic drugs are not used for the daily treatment of stress caused by anxiety.

Contraindications

• Increased sensitivity to diazepam, to other benzodiazepine derivatives or any component of the drug.
• Acute closed jaw.
• Acute respiratory failure.
• Foreign breathing.
• Night apnea syndrome.
• Heavy liver and renal failure.
• Phobia or obsessive disorders, chronic psychosis.
• Miasthenia gravis..
• Alcohol dependence, narcotic drugs (with the exception of acute cases of cessation of alcohol) or other means of depressing CNS.
• Poisoning psychotropic substances or drugs.
• It is impossible to apply in the form of monotherapy for the treatment of depression or anxiety associated with depression, as this may lead to suicide. Do not prescribe for the initial treatment of mental diseases.
• І trimester of pregnancy.
• Breastfeeding period.

Interaction with other medicines and other types of interactions.

The use of diazepam simultaneously with other drugs depressing the central nervous system (tranquilizers, sleeping pills, antidepressants, antipsychotic drugs, anticonvulsants, narcotic analgesics, drugs for anesthesia, sedative antihistamines), or with alcohol can enhance their depressing effect on the central nervous system. In addition, narcotic analgesics can cause Euphoria and in connection with this - the development of mental dependence. With the simultaneous use of diazepam with antiepileptic preparation with phenytio, antagonism is also possible; With the simultaneous use of benzodiazepines with levodopa, an accidental antagonism is observed.

With the simultaneous use of diazepam with opiates, the inhibitory effect on respiration can increase. When applied with other Miorolaksanta, the consequences are unpredictable, there is a risk of stopping breathing.

The drug potentiates anti-hypotensive drugs.

With the simultaneous use of diazepam with alpha-blockers and moxonidine, a sedative effect is enhanced.

The sedative effect of diazepam can also increase alpha-agonist LExcidin, Miorolaksant Baclofen or Tizandine, nabyl and cisaprid.

Simultaneous use with isoniazid slows the metabolism of diazepam. The metabolism of benzodiazepines inhibits disulfiram, reinforcing the sedative effect, possibly an increase in toxicity.

The effect of diazepam can enhance antiviral drugs (amprenavir, ritonavir), increasing the risk of oppression.

Plasma benzodiazepine concentrations increase antifungal drugs (fluconazole, itraconazole, ketoconazole).

Inhibitors of liver enzymes (cimetidine, omeprazole, fluvoxamine and fluoxetine) lower benzodiazepine clearance. In turn, the inductors of the liver enzymes (rifampicin) act the opposite, increasing the clearance.

Simultaneous use with antacids can slow down the absorption of diazepam.

Oral contraceptives can enhance the effect of diazepam.

Features of application

Diazepam should be used with care patients with impaired kidney and liver function, porphyria, muscle weakness, in the case of coma, organic brain lesions (especially atherosclerosis).

Patients with chronic respiratory failure should apply smaller doses.

Patients with respiratory impairment and reduced attention should be carefully assessing the need to use diazepam due to the threat of respiratory oppression.

Elderly patients and weakened patients dose should be reduced due to their greater sensitivity to benzodiazepines.

Benzodiazepines are prescribed to children only after a thorough assessment of the need for their use; The duration of treatment should be minimal. With the exception of absolute testimony (for example, epilepsy), children under 6 months the use of tablets are not recommended in connection with the safety assessment of the application due to the age differences of distribution and metabolism.

Hypoalbuminemia can potentiate diazepam effect.

With long-term treatment, diazepam should periodically determine the number of blood cells and check the functions of the liver function.

Benzodiazepine derivatives can cause amnesia, usually within a few hours after use. Risk increases with the use of large doses. To reduce the risk of anterograd amnesia, 7-8 hour continuous sleep should be provided.

The hypnotic effect can be alone after several weeks of recycling of benzodiazepines.

The drug should not be applied longer than 4 weeks.

If the tranquilizers of a benzodiazepine group are used for a long time or in very large doses, a physical or mental dependence on the drug can sometimes develop. Most often, it is manifested in patients whose history has alcoholism or drug addiction, as well as patients with severe identity changes. With a quick dose reduction or sudden termination of the application of diazepam, symptoms of cancellation may appear: headache, muscle pain, fear, tension, anxiety, confusion of consciousness, increased excitability; In severe cases - dramatization, depersonalization, hyperactus, numbness and tingling in the limbs, increased sensitivity to light, odor and physical touch, are possible hallucinations or seizures of seizures. To prevent the development of symptoms of cancellation, the use of the drug should be stopped, gradually reducing the dose.

To ensure the effective and safe use of the drug, it is necessary to prevent patients about the fact that it is impossible to increase the dose itself, as well as without permission, the doctor suddenly stop the use of the drug.

Patients taking diazepam must be prevented about the possible synergistic interaction between diazepam and alcohol. Alcohol can be taken no earlier than 36 hours after the application of diazepam.

When applying diazepam, together with other psychotropic drugs, caution should be taken. Benzodiazepines are not intended for the primary treatment of mental illness.

It should be noted that benzodiazepine derivatives can cause paradoxical reactions, such as anxiety, excitation, aggressiveness, nightmares, hallucinations. In such cases, the use of the drug should be discontinued. The risk of such reactions is more in elderly patients and children.

With prolonged use of benzodiazepine derivatives, it is possible to addictive. In case of sudden cessation of the use of the drug, the phenomenon of "rebound" is possible. It can be combined with a previously mentioned symptom of cancellation. Therefore, it is necessary to avoid sudden cancellation of the drug.

Diazpex ® tablets contain lactose. This drug cannot be used to patients with a rare congenital intolerance to galactose, lapp-lactase deficiency or malabsorption glucose-galactose.

Application during pregnancy or breastfeeding.

Some studies indicate an increased risk of congenital anomalies associated with the use of benzodiazepines in the first trimester of pregnancy, so their use is contraindicated. Diazepam is desirable not to appoint pregnancy in the last trimester. It is appointed only in urgent cases, if the expected therapeutic effect exceeds the risk.

Patients should be aware of the need for immediate advice with a doctor regarding the termination of the drug when pregnancy or suspected pregnancy.

The use of large doses or long-term use of low doses of benzodiazepines during pregnancy, especially in the last trimension of pregnancy, can cause a newborn heart rate violation, hypotension, hypothermia, weaken the sucking reflex, as well as moderately suppress breathing. In addition, in children whose mothers at the end of pregnancy were used for long-term benzodiazepine derivatives, physical dependence and the symptoms of cancellation may appear.

Diazepam penetrates into breast milk, so if necessary, the drug should stop breastfeeding.

The ability to influence the reaction rate when managing motor vehicles or other mechanisms.

The patient should be warned that during the application of diazepam, it is necessary to abandon the risk-related work, for which a quick response is necessary (work with technical devices, transport management, etc.), since the drug can cause drowsiness, weaken the memory and the ability to concentrate.

Alcohol potentiates mentioned effects.

Method of application and dose

Doses and duration of treatment are determined individually depending on the age and severity of the disease.

Anxiety and anxiety. Adults are usually prescribed 2.5 mg 3 times a day. Maximum daily dose - 30 mg.

For insomnia Apply 5-15 mg before bedtime.

Children from 12 to 18 years old the drug is used for 1-5 mg before bed for preventing night fears and walking during sleep.

To prevent muscular spasms Apply 2.5-15 mg per day, divided into multiple one-time doses. With cerebral spasms, adults are prescribed 2.5-60 mg per day.

Daily dose for children aged 5 to 12 years - 5 mg; aged 12 to 18 years - 10 mg (maximum 40 mg per day). The daily dose is divided into 2 receptions. If necessary, the tablet can be crushed and add to juice or in any other drink or semi-liquid food, for example, in an apple flesh, porridge.

Syndrome of alcoholic abstinence. 10 mg 3-4 times in the first half of the day, in the second - 5 mg 3-4 times a day. The drug can also be prescribed at 5-20 mg 1 time, which, if necessary, repeat every 2-4 hours.

Epilepsy(In comprehensive treatment). 2.5-60 mg per day, separated by several one-time doses.

For premedication. 5-20 mg; Children (up to 18 years) are used 200-300 μg / kg body weight. Maximum dose for children under 12 years old is 10 mg, children under 18 - 20 mg.

Elderly and weakened patients Prescribed no more than half of the recommended doses.

Patients with renal and liver failure Doses reduce.

Overdose

Symptoms. In case of overdose, the CNS and drowsiness are observed, up to coma. With moderate overdose, drowsiness, confusion of consciousness and lethargy is possible, in more severe cases - ataxia, hypotension, hypotension, respiratory depression, coma (rarely).

With the simultaneous use of diazepam with other drugs affecting the CNS, or alcohol, the symptoms of overdose are much more pronounced and can be lethal if the patient does not receive appropriate treatment.

Treatment. Immediately (for 1 hour) should be caused by vomiting if the patient is conscious, or rinse the stomach. You can enter activated carbon. It is necessary to control the breath and activity of the heart. The use of dialysis is limited. To reduce the depression of the central nervous system, a specific antagonist of benzodiazepine receptors - fluumazenil can be used.

To suppress excitability not to use barbiturates!

Adverse reactions

The most common drowsiness, fatigue, muscle weakness and dependence syndrome. These effects appear mainly at the beginning of treatment and when continuing treatment usually disappear. The severity of these side effects depends on the value of the dose.

Below, said adverse reactions are presented in accordance with the classification of organs of organs and frequency of occurrence (MEDDRA): very often (≥ 1/10), often (≥ 1/100 to< 1/10), нечасто (≥ 1/1000 до < 1/100), редко (≥ 1/10 000 до < 1/1000), очень редко (< 1/10 000), с неизвестной частотой (нельзя определить по имеющимся данным).

From the nervous system: often - drowsiness; Rarely - Ataxia, headache, dizziness, vertigo, disorientation, loss of consciousness, anger, tremor, dysarthria.

From the psyche:rarely - confusion of consciousness, deterioration of mood, depression, change of libido; Paradoxical reactions (increasing excitability and anxiety, hostility, manifestations of aggressiveness, hallucination, insomnia and an increase in muscle tone) - most often in children and elderly patients. In these cases, the use of the drug should be discontinued. Anterograd amnesia.

On the side of the musculoskeletal system: Often - muscle weakness, attacks of convulsion.

From the digestive tract: Rarely - constipation, digestive disorders, nausea, dry mouth, reinforced salivation, vomiting, colic.

From the authorities of the vision: Rarely - obscure vision, diplopia.

From the side of the cardiovascular system: Rarely arterial hypotension; Bradycardia; Pain in the chest; Heart failure, including cardiac arrest.

From the urinary system: Rarely - incontinence, urine delay.

From the skin:rarely rash.

From the respiratory system:rarely - in patients with respiratory diseases (chronic bronchitis), respiratory disabilities may increase (difficult breathing), respiratory failure.

From the hepatobiliary system: Very rarely - jaundice, violation of the liver function.

From the side of the blood:very rarely leukopenia, granulocyptopenia.

General violations: Often - fatigue.

Laboratory Indicators: It is very rare - an increase in the activity of transaminase and alkaline phosphatase.

In elderly patients, especially with organic brain injuries, as well as in patients with impaired liver function, the inhibitory effect of diazepam on the CNS, as well as other side effects; Increased risk of falls and fractures.

Physical and mental dependence may be manifested, an anterograde amnesia, paradoxical reactions (see the section "Features of application") may be possible.

Shelf life

Storage conditions

Keep out of the reach of children.

Store at a temperature not higher than 25 ° C.

Store in the original packaging to protect against the action of light.

Packaging

10 tablets in the blister; 1 or 2, or 3 blisters in a cardboard pack.

On prescription.

Manufacturer

JSC "Grindeks".

The location of the manufacturer and its address of the activities of the activity.

Applicant.

Caltsex JSC.

The location of the applicant.

Ul. Krustpils, 53, Riga, LV-1057, Latvia.