Diazepex - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Diazepex

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Diazepex is a drug with anticonvulsant, anxiolytic, muscle relaxant, hypnotic, sedative effects.

Release form and composition

Dosage forms of Diazepex:

• tablets (10 pcs. in blisters, in a cardboard box 2 blisters);
• solution for injection 5 mg / ml: transparent, colorless or somewhat yellowish with a green tinge (in colorless glass ampoules of 2 ml, in blisters of 5 ampoules, in a cardboard box 2 packs).

Active ingredient in 1 tablet: diazepam - 2 or 5 mg.

Composition of 1 ml injection solution:

• active substance: diazepam - 10 mg;
• auxiliary components: propylene glycol-1,2, benzoic acid (E 210), sodium benzoate (E 211), 96% ethyl alcohol, benzyl alcohol, water for injection.

Indications for use

Pills

Monotherapy:

• anxiety;
• voltage;
• anxiety;
• depression;
• depression.

As an auxiliary component in complex therapy:

• dysalgomenorrhea;
• premenstrual syndrome;
• spasticity of skeletal muscles;
• peptic ulcer of the stomach and duodenum;
• post-traumatic conditions;
• alcoholism;
• arterial hypertension;
• convulsive syndrome;
• lumbago;
• rheumatoid arthritis;
• menopause;
• malignant tumors.

Injection solution

• status epilepticus;
• epileptic seizures (for the purpose of relief);
• tetanus;
• skeletal muscle spasm, spastic conditions associated with lesions of the spinal cord / brain (cerebral athetosis, paralysis);
• alcohol withdrawal syndrome, including alcoholic delirium;
• motor arousal of various etiologies in psychiatry / neurology;
• premedication (as a component of combined anesthesia).

Contraindications

Absolute

Tablets:

• myasthenia gravis;
• glaucoma;
• I trimester of pregnancy and the period of breastfeeding;
• individual intolerance to the components of the drug.

Injection solution:

• alcohol dependence (aggravated history, except for acute withdrawal symptoms), drug dependence;
• hypercapnia;
• suicidal tendencies;
• a burdened history of epilepsy or epileptic seizures (the beginning of the use of Diazepex or its abrupt withdrawal can lead to the development of status epilepticus or seizures);
• hepatitis;
• cerebral or spinal ataxia;
• glaucoma, angle-closure glaucoma (acute attacks);
• sleep apnea, severe respiratory / heart failure;
• myasthenia gravis;
• porphyria;
• I and III trimesters of pregnancy and the period of breastfeeding;
• age up to 3 years (benzyl alcohol is part of Diazepex);
• individual intolerance to the components of the drug, including hypersensitivity to other benzodiazepines.

Relative

Diseases / conditions for which Diazepex should be administered with caution:

• functional disorders of breathing, heart, kidneys and liver;
• organic brain damage;
• children and old age.

Method of administration and dosage

Pills

Diazepex is taken orally.

Recommended dosage regimen:

• states of anxiety / anxiety: 2–4 times a day, 2–5 mg;
• spastic states: 3-4 times a day, 2-10 mg.

For outpatients, the maximum daily dose is 15 mg.

Daily dose for children (frequency of administration - 1-3 times a day):

• up to 3 years: 1–5 mg;
• 4-12 years: 2-10 mg.

Injection solution

Diazpexa route of administration: intramuscularly (intramuscularly) or slowly intravenously (intravenously).

The scheme of application is determined by the doctor individually.

Recommended dosage regimen:

• tetanus: IV; 0.1–0.3 mg / kg every 1–4 hours (4–10 mg / kg per day);
• delirium: in / in; 10 mg, then every 5 minutes, 5 mg (until the state of arousal is removed);
• alcohol withdrawal syndrome (tension, anxiety, or autonomic equivalents of these disorders): i / m or i / v; 10 mg each, then 3-4 hours later the drug is administered at a dose of 5-10 mg;
• spastic conditions associated with damage to the spinal cord / brain: i / m; the initial dose is 10–20 mg;
• skeletal muscle spasm associated with local injury: IV; 10 mg once or twice;
• anesthesia (as a component of combined anesthesia at the beginning of anesthesia): IV; 0.2-0.5 mg / kg;
• premedication before anesthesia in case of defibrillation: IV slowly; 10-30 mg (in separate doses);
• premedication before anesthesia: IM; adults 10–20 mg 1 hour before the start of anesthesia;
• motor excitement of various origins in psychiatry and neurology: intramuscular or intravenous; 3 times a day, 10–20 mg;
• status epilepticus: IV; 10 mg;
• epileptic seizures (for the purpose of relief): in / in; 10–20 mg, then the drug can be injected intravenously or intramuscularly at a dose of 20 mg.

The average duration of the interval between the introduction of single doses is 3-4 hours, in acute cases, repeated use is possible within 1 hour.

Weakened / elderly patients require a dose reduction (usually 2-5 mg), its increase should be carried out gradually. The same regimen should be followed in cases of combination therapy with other sedatives.

Side effects

Pills

Possible side reactions: dizziness, ataxia, weakness, drowsiness, headache.

In rare cases, there is the development of such disorders as euphoria, visual impairment, jaundice, nausea, constipation, xerostomia, tachycardia, hypotension, granulocytopenia, leukopenia, shortness of breath, allergic reactions.

Injection solution

Possible side reactions: bradycardia, arterial hypotension, cardiac arrest, fatigue, drowsiness, muscle weakness, impaired coordination of movement, apnea, respiratory depression, thrombophlebitis / thrombosis at the site of intravenous administration of the solution.

In rare cases, the development of such disorders is observed, such as:

• depression, anterograde amnesia, confusion, behavioral / thinking disorders, paradoxical reactions (manifested as insomnia, nervousness, outbursts of anger, agitation, aggression, hostility, hallucinations, unusual excitement; requires the withdrawal of Diazepex);
• dizziness, headache, hiccups;
• tremor, dysarthria;
• jaundice, liver dysfunction;
• anemia, leukopenia, agranulocytosis, neutropenia, thrombocytopenia;
• allergic reactions (in the form of skin rash, itching);
• inactivity;
• tachycardia, fainting, cardiovascular collapse;
• urinary retention / urinary incontinence, weakening of libido;
• diplopia, blurred vision, nystagmus;
• functional changes in the salivary glands (in the form of xerostomia or increased salivation), constipation, nausea;
• local reactions with intramuscular injection (in the form of pain, redness at the injection site).

special instructions

With intravenous administration of Diazepex, an inflammatory process may occur at the injection site (manifested as edema, phlebitis, burning sensation, thrombophlebitis). In this regard, the introduction should be carried out slowly, using a catheter, not more than 5 mg (1 ml) per minute. Do not inject the solution into small veins (for example, hand veins). Avoid getting the drug into the perivascular space or arteries.

When administered intramuscularly, Diazepex must be injected deep into the muscle.

Do not mix the solution in the infusion system / syringe with other medicinal products.

When administered intravenously, elderly patients, patients in especially severe conditions, as well as patients with cardiorespiratory insufficiency, which is associated with the likelihood of cardiac arrest and / or apnea, need special attention.

When combined with narcotic analgesics, their dose should be significantly reduced (by at least 1/3).

The introduction of Diazepex in patients with shock, coma or acute alcohol intoxication with signs of depression is not recommended.

After intravenous administration, the drug acts quickly, but not for a long time, therefore it is not recommended to use it for maintenance therapy.

In case of impaired renal / hepatic function in cases of prolonged use of the drug, it is advisable to conduct a blood test and an assessment of the functional state of the liver.

With a strong feeling of fear and depression, Diazepex should not be used in monotherapy (due to the likelihood of developing a suicidal tendency).

During the use of the drug, there is a potential danger of physical / mental dependence, especially with a long course with high doses. There is also a high risk of this disorder in patients with a tendency to abuse alcohol or a history of drug dependence.

With a sudden cessation of therapy after the development of physical dependence, withdrawal syndrome may develop (manifested in the form of convulsions, tremors, colic, muscle cramps, vomiting, increased sweating). Severe symptoms can be observed in patients who use Diazpex in high doses for longer than necessary. Disturbances in milder forms (in the form of dysphoria, insomnia) can occur in patients who take a course for several months using therapeutic doses. After the end of the treatment course, the drug should be canceled gradually.

It is recommended to refuse to drive a motor vehicle while using Diazepex

Drug interactions

With the combined use of Diazepex with certain drugs / substances, the following effects may develop:

• estrogen-containing contraceptives, diltiazem, verapamil, ketoconazole, cimetidine, erythromycin, nefazodone, itraconazole, ranitidine: an increase in the concentration and, as a consequence, the toxicity of Diazepex (associated with inhibition of liver enzymes);
• alcohol, drugs that can cause depression of the central nervous system (including antipsychotics, drugs for anesthesia, drugs with sedative and hypnotic effects, opioid analgesics): an increase in the inhibitory effect of diazepam;
• rifampicin, carbamazepine: a decrease in the concentration and, therefore, the effectiveness of Diazpex.

Analogs

Diazepex analogs are: Diazepam, Giadazepam, Relanium, Sibazon and others.

Terms and conditions of storage

Store in a place protected from light and moisture, at room temperature (for tablets) or at a temperature of 2-8 ° C (for injection solution). Keep out of the reach of children.

Shelf life:

• tablets - 5 years;
• injection solution - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!