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Manufacturers: Tarchominskie Zaklady Farmaceutyczne “Polfa” (Poland)
Active ingredients
- Oxazepam
Disease class
- Mental and behavioral disorders caused by alcohol consumption - dependence syndrome
- Mental and behavioral disorders caused by alcohol consumption - withdrawal state
- Depressive episode
- Panic disorder [episodic paroxysmal anxiety]
- Neurasthenia
- Disturbances in falling asleep and maintaining sleep [insomnia]
- Anxiety and agitation
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Anxiolytic
- Muscle relaxant
- Hypnotic
- Anticonvulsant
Pharmacological group
- Anxiolytics
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
A benzodiazepine-type tranquilizer . Has sedative and anxiolytic effects. It has central muscle relaxant and anticonvulsant activity.
The effect of the drug is associated with an increase in GABA processes in the brain. It has an effect mainly on the retinal activating formation of the brain, reducing the influence of impulses from sensory type receptors on the limbic system and weakening emotional coloring.
Pharmacokinetics
Absorbed relatively slowly, but completely. Reaction with plasma proteins reaches 97%. The maximum concentration is reached on average after 2-3 hours. The drug is able to penetrate the placenta, the blood-brain barrier and be excreted in breast milk. Transformed in the liver to form pharmacologically inactive derivatives.
The half-life can range from 5-15 hours. Excreted by the kidneys and through the intestines. Elimination from the body after cessation of therapy is rapid.
Pharmacological properties of the drug Diazepam
A tranquilizer of the benzodiazepine group, it has anxiolytic, sedative, muscle relaxant and anticonvulsant effects, potentiating the effects of the GABAergic system by stimulating the central action of GABA, the main inhibitory neurotransmitter of the brain. Benzodiazepine derivatives act in the same way as benzodiazepine receptor agonists, which form a component of a functional supramolecular unit known as the benzodiazepine-GABA-chlorionophore receptor complex located on the neuronal membrane. Due to the selective stimulating effect on GABA receptors in the ascending reticular formation of the brain stem, it reduces excitation of the cortex, limbic region, thalamus and hypothalamus and has an anxiolytic and sedative-hypnotic effect. Due to its inhibitory effect on polysynaptic spinal reflexes, it has a muscle relaxant effect. Diazepam is quickly and completely absorbed from the digestive tract; the maximum concentration in blood plasma is achieved 30–90 minutes after oral administration. After an intramuscular injection, complete absorption also occurs, although this process is not always faster than after oral administration. The elimination curve of diazepam is biphasic: an initial phase of rapid and widespread distribution with a half-life of up to 3 hours is followed by a long terminal elimination phase (with a half-life of up to 48 hours). Diazepam is metabolized into the pharmacologically active nordiazepam (half-life - 96 hours), hydroxydiazepam and oxazepam. Diazepam and its metabolites are bound to plasma proteins (diazepam 98%); excreted mainly in the urine (about 70%) in the form of free or conjugated metabolites. The half-life may increase in newborns, elderly and senile patients and in patients with liver or kidney disease; however, it may take a longer time to achieve equilibrium concentration in the blood plasma. Diazepam and its metabolites pass through the blood-brain barrier and the placental barrier. They are also detected in breast milk at concentrations approximately 1/10 of the concentration in maternal plasma.
Contraindications
Coma , acute alcohol poisoning, shock , myasthenia gravis , acute poisoning with drugs that suppress the nervous system ( hypnotics, narcotic and psychotropic drugs ), closed-angle glaucoma, decompensated obstructive chronic pulmonary disease , acute pulmonary failure, severe depression , lactation and pregnancy , age less than 6 years, hypersensitivity to the components of the drug.
Drug interactions Diazepam
Concomitant use of cimetidine (but not ranitidine) reduces the clearance of diazepam. There are also reports that diazepam interferes with the metabolism of phenytoin. There is no data on interaction with antidiabetic agents, anticoagulants and diuretics. In the case of combined use of diazepam and neuroleptics, tranquilizers, antidepressants, hypnotics, anticonvulsants, analgesics and anesthetics, mutual potentiation of effects is possible. Diazepam in the form of an injection solution cannot be mixed in the same volume with other solutions, as this may lead to precipitation of the active substance.
Side effects
- Reactions from nervous activity: in the initial period of treatment, dizziness, drowsiness, impaired concentration, fatigue ataxia , unsteadiness of gait and impaired coordination of movements, dulling of emotions, lethargy, slowing of mental and motor reactions are possible; more rarely develop euphoria , headache , tremor, depression , depressed mood, memory impairment, stupor, extrapyramidal reactions of dystonic type , muscle weakness, weakness, dysarthria , confusion, paradoxical reactions (for example, psychomotor agitation, aggressive outbursts, fear, muscle spasms , suicidal tendencies, hallucinations , irritability, acute agitation, insomnia , anxiety).
- Hematopoietic reactions: neutropenia, leukopenia, anemia, agranulocytosis, thrombocytopenia.
- Digestive reactions: vomiting, dry mouth, heartburn, drooling , nausea, constipation , anorexia, diarrhea, increased concentrations enzymes , liver dysfunction, jaundice.
- Reactions from the genitourinary system: urinary retention, urinary incontinence, renal dysfunction, increased or decreased libido, dysmenorrhea .
- Effect on the fetus: depression of nervous activity, teratogenicity , respiratory failure or inhibition (if the mother of the newborn used Tazepam) of the sucking reflex.
- Allergic reactions : itching , rash.
- Other reactions: drug dependence, addiction, decreased blood pressure, depression of the respiratory center, bulimia, blurred vision, tachycardia , weight loss, anterograde amnesia .
- If the dose is suddenly reduced or taken, withdrawal syndrome may occur (headache, irritability, anxiety, agitation, anxiety, fear, sleep disturbance, nervousness, dysphoria, spasm of smooth muscles and skeletal muscles, increased sweating, depersonalization, depression, vomiting , nausea, tremor, paresthesia , perceptual disturbances, photophobia, convulsions, tachycardia , acute psychosis , hallucinations).
Use during pregnancy and breastfeeding
Oxazepam has a toxic effect on the fetus and increases the risk of birth defects when used in the first trimester of pregnancy. Taking therapeutic doses later in pregnancy may cause depression of the newborn's central nervous system. Chronic use during pregnancy can lead to physical dependence with the development of withdrawal syndrome in the newborn. Children, especially young children, are very sensitive to the CNS depressant effects of benzodiazepines. Use immediately before or during labor may cause respiratory depression in the newborn, decreased muscle tone, hypotension, hypothermia, and weak suckling syndrome of the newborn. Contraindicated during lactation.
Instructions for use of Tazepam (Method and dosage)
Instructions for use of Tazepam recommend individually selecting the dose and duration of therapy for each patient. The drug is taken with a small amount of liquid.
Adult patients with anxiety disorders are prescribed 10-30 mg of the drug up to four times a day.
When used as an adjuvant (in justified cases) for the treatment of sleep disorders , 10-30 mg of the drug is used an hour before bedtime. Patients using Tazepam for sleep disorders should be informed that after taking the drug, conditions must be created for continuous sleep for 8 hours.
Elderly patients
Elderly patients are more sensitive to drugs that act on the nervous system, so in this category of people it is recommended to use the lowest effective dose (usually 10 mg three times a day).
Patients with liver failure
Caution is recommended when using the drug in patients with liver damage. In this case, it may be necessary to reduce the dose of the medication.
Duration of treatment
The duration of treatment with Tazepam should be limited to the shortest possible period - usually up to 2 weeks, and if you take into account the period of slow withdrawal - up to 4 weeks. The mode of slow withdrawal of the drug must be set individually. Abrupt withdrawal of the drug can lead to withdrawal syndrome.
In individual cases, the doctor may decide to extend the maximum period of treatment after assessing the patient's condition. Long-term use of the drug is not recommended due to the risk of tolerance and drug dependence.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Tazepam, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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Overdose
In case of an overdose of oxazepam, the following symptoms may appear: a state of disorientation, drowsiness, loss of consciousness, slurred speech, coma . Particularly life-threatening are poisonings caused by the combined use of alcohol and oxazepam , or other drugs that suppress nervous activity and oxazepam .
In case of overdose, actions are taken aimed at eliminating the drug from the body or reducing its absorption in the digestive system (gastric lavage, administration of Activated Carbon ), they also monitor vital functions (pulse, respiration, blood pressure) and, if necessary, carry out symptomatic treatment.
Flumazenil is a specific antidote for oxazepam .
When treating an intentional overdose, it must be remembered that the patient could take several different drugs at the same time.
Use of the drug Diazepam
To achieve the optimal effect, the dose is selected individually. The usual oral dose for adults is 5–20 mg/day, depending on the severity of symptoms. A single dose when taken orally should not exceed 10 mg. In urgent cases or in life-threatening conditions, as well as in case of insufficient effect from oral administration, parenteral administration of diazepam in higher doses is possible. Treatment of anxiety conditions is usually carried out over several weeks, depending on the type of pathology and etiological factors. Positive clinical dynamics are observed within 6 weeks from the start of diazepam use; In the future, maintenance therapy is usually carried out. Systematic clinical studies of the effectiveness of long-term (more than 6 months) use of diazepam have not been conducted. In elderly and senile patients, oral treatment should begin with half the usual adult dose, gradually increasing it depending on need and tolerability. Children are prescribed orally at a dose of 0.1–0.3 mg/kg/day. For kidney or liver diseases, the dose should be selected individually. To achieve a sedative effect while maintaining consciousness before performing stressful procedures, adults are administered 10-30 mg intravenously, and children - 0.1-0.2 mg/kg body weight. The initial dose is 5 mg (for children - 0.1 mg/kg), then re-administered every 30 s at a dose 50% higher than the initial dose. For premedication, adults are administered 10–20 mg intramuscularly, children — 0.1–0.2 mg/kg 1 hour before induction of anesthesia; induction anesthesia - 0.2–0.5 mg/kg is administered intravenously. For states of excitement (acute anxiety states, motor agitation, delirium tremens), the initial dose is 0.1–0.2 mg/kg IM or IV every 8 hours until the severity of acute symptoms decreases; Maintenance therapy is carried out by oral administration. For status epilepticus, 0.15–0.25 mg/kg is administered intravenously in a stream every 10–15 minutes or intravenously; the highest daily dose is 3 mg/kg. For tetanus - 0.1–0.3 mg/kg IV every 1–4 hours. Diazepam can be administered IV drip or through a gastric tube (3–4 mg/kg per day). In case of muscle spasm (in case of injuries, spinal and supraspinal paralysis), diazepam is used in the same doses as to achieve a sedative effect while maintaining consciousness. For preeclampsia and eclampsia, 10–20 mg is administered intravenously; if necessary, additional intravenous bolus or drip administration is prescribed (the highest daily dose is 100 mg). To facilitate labor - 10-20 mg IM (in the presence of severe agitation - IV) when the cervix is dilated by 2-3 fingers.
Interaction
When used together with oral contraceptives, the effectiveness of Tazepam decreases.
When used simultaneously with Zidovudine, bioavailability increases and the frequency of headaches increases.
When used together with Phenytoin, there is a risk of reducing the level of oxazepam in the blood.
When used together with ethanol, its inhibitory effect on the nervous system increases.
Side effects of the drug Diazepam
Most often - lethargy, drowsiness and muscle weakness (usually depends on the dose); rarely - confusion, constipation, depression, dullness of emotions, decreased attention, diplopia, dysarthria, headache, hypotension, urinary incontinence, increased or decreased libido, nausea, xerostomia or increased salivation, skin rash, slurred speech, tremor, delay urine, headache, dizziness, blurred vision; very rarely - increased activity of transaminases and alkaline phosphatase, as well as jaundice. Paradoxical reactions such as acute agitation, anxiety, sleep disturbances and hallucinations have been described; If they occur, diazepam should be discontinued. With parenteral use - thrombosis and thrombophlebitis, local irritation (especially after rapid intravenous administration). Diazepam solution should not be injected into very small veins; It is unacceptable to administer intravenously and get the solution into adjacent tissues. IM injections may be accompanied by pain and erythema.
special instructions
The medicine should be used with caution if there is a tendency to hypotension , an increased risk of drug dependence, insufficiency of liver or kidney function, in the elderly, with spinal and cerebral ataxia , a tendency to abuse psychotropic drugs, hyperkinesis , organic brain diseases, hypoproteinemia, psychosis , sleep apnea .
Oxazepam is not recommended for long-term use due to the possibility of drug dependence. With long-term treatment, it is necessary to monitor blood counts and liver function.
Any change in dosage should be made under the supervision of a physician.
During treatment with the drug, it is prohibited to drive vehicles.
Oral tablets Tazepam
Instructions for medical use of the drug
Description of pharmacological action
Excites benzodiazepine receptors and increases the sensitivity of GABA receptors to the mediator, enhances the inhibitory effect of GABA on the central nervous system.
Indications for use
Anxiety in neurasthenic and depressive syndromes; state of anxiety (in old age), excitement and tension (with chronic alcoholism and abstinence); sleep disturbance.
Release form
film-coated tablets 10 mg; blister 25, cardboard pack 2;
Pharmacodynamics
Anxiolytic drug (tranquilizer) from the group of benzodiazepine derivatives. Has an anxiolytic and sedative effect. It has anticonvulsant and central muscle relaxant activity. The mechanism of action is associated with increased GABAergic processes in the brain. It mainly affects the activating reticular formation of the brain, reducing the perception of impulses from sensory receptors on the limbic system and reducing emotional coloring.
Pharmacokinetics
After oral administration, it is absorbed slowly and completely. Plasma protein binding is 97%. Cmax is reached within 1-4 hours and is 450 ng/ml after taking a dose of 30 mg. Penetrates through the blood-brain barrier, the placental barrier, into breast milk. Metabolized in the liver to form glucuronides that have no pharmacological activity. T1/2 - 5-15 hours. Excreted by the kidneys and in feces. Css is observed after 1-3 days of treatment. Accumulation upon repeated prescription is minimal (applies to benzodiazepines with short and medium T1/2), elimination after cessation of treatment is rapid.
Use during pregnancy
Contraindicated in the first trimester of pregnancy; in the following months - strictly as prescribed by the doctor. Breastfeeding should be stopped during treatment.
Contraindications for use
Hypersensitivity, respiratory failure of central origin, dizziness, balance disorders, glaucoma, myasthenia gravis, pregnancy (first trimester).
Side effects
Drowsiness, weakness, fatigue, weakening of memory, decreased ability to concentrate, impaired orientation and spatial assessment, nausea, diarrhea, abdominal discomfort, paradoxical reactions (psychomotor agitation, insomnia, aggressiveness, muscle tremors, convulsions), allergic skin manifestations.
Directions for use and doses
Orally, with a sufficient amount of liquid, for adults with anxiety and withdrawal syndrome - 15-30 mg/day, in 3-4 doses, if necessary (in a hospital setting) - up to 120 mg/day; for insomnia - 10–30 mg 1 hour before bedtime. Patients over 65 years old - no more than 40 mg/day.
Overdose
Symptoms: CNS depression of varying severity (from drowsiness to coma) - drowsiness, confusion, lethargy; in more severe cases (especially when taking other drugs that depress the central nervous system, or alcohol) - ataxia, hypotension, hypnotic state, coma. Treatment: induction of vomiting, gastric lavage, symptomatic therapy, monitoring of vital functions. For severe hypotension, norepinephrine is administered. The specific antidote is the benzodiazepine receptor antagonist flumazenil (administration only in a hospital setting). Hemodialysis is ineffective.
Interactions with other drugs
The effect is enhanced by neuroleptics, sleeping pills, antiepileptics, antihistamines, narcotics and painkillers.
Precautions for use
Prescribe with caution to patients with an increased risk of developing drug addiction. Constant use (for several months) leads to addiction and the development of psychophysical dependence. Children and people over 65 years of age should take in reduced doses and strictly as prescribed by a doctor. The drug is withdrawn gradually. During treatment you should not drink alcohol.
Special instructions for use
Any dose change should be carried out under the supervision of a physician. Use with caution if there is a tendency to arterial hypotension, with an increased risk of developing drug dependence, in elderly patients, with liver and/or renal failure, cerebral and spinal ataxia, hyperkinesis, a tendency to abuse psychotropic drugs, organic diseases of the brain, psychosis (possible paradoxical reactions), hypoproteinemia, sleep apnea (established or suspected). Oxazepam should not be used for a long time (for several months) due to the possibility of developing drug dependence. With long-term treatment, monitoring of liver function and peripheral blood condition is necessary. Impact on the ability to drive vehicles and operate machinery During the treatment period, you should not drive vehicles or engage in other potentially hazardous activities that require increased attention; You should not drink alcohol.
Storage conditions
In a place protected from light, at a temperature not exceeding 25 °C.
Best before date
36 months
ATX classification:
N Nervous system
N05 Psycholeptics
N05B Anxiolytics
N05BA Benzodiazepine derivatives
N05BA04 Oxazepam
Analogs
Level 4 ATC code matches:
Bromazepam
Helex
Rudotel
Relium
Nozepam
Xanax
Elenium
Valium Roche
Alprazolam
Tofisopam
Diazepam
Grandaxin
Mezapam
Sibazon
Seduxen
Relanium
Lorazepam
Analogues of Tazepam: Nozepam, Grandaxin, Oxazepam, Relanium, Sibazon, Oxazepam-Ferein, Phenazepam, Diazepam, Elenium.
Diazepam overdose, symptoms and treatment
Manifested by severe sedation, muscle weakness, deep sleep or paradoxical arousal. Intentional or accidental overdose of diazepam is rarely life-threatening. Significant overdose, especially in combination with other centrally acting drugs, can cause coma, areflexia, depression of cardiac and respiratory activity and respiratory arrest. Treatment - in most cases, only monitoring of vital functions is required. In case of severe overdose, appropriate measures are necessary (gastric lavage, mechanical ventilation, measures to maintain cardiovascular activity). The benzodiazepine antagonist flumazenil is recommended as a specific antidote.
List of pharmacies where you can buy Diazepam:
- Moscow
- Saint Petersburg
