Diazepam - Instructions For Use, Indications, Doses, Analogues

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

Diazepam

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

Diazepam is an anxiolytic, sedative, anticonvulsant, central muscle relaxant tranquilizer.

Release form and composition

The drug is produced in the following dosage forms:

• Tablets: without a shell, round, with a dividing line on one side, white (10 pcs. In a blister, 2 or 10 blisters in a cardboard box);
• Solution for injection: colorless transparent liquid (2 ml in dark glass ampoules, 10 ampoules in a cardboard box).

The composition of 1 tablet includes:

• Active ingredient: diazepam - 2, 5 or 10 mg;
• Auxiliary components: lactose monohydrate, calcium stearate, povidone K-25, potato starch.

The composition of 1 ml of injection solution includes:

• Active ingredient: diazepam - 5 mg;
• Auxiliary component: benzyl alcohol (as a stabilizer).

Indications for use

Conditions / diseases for which the use of Diazepam is recommended:

• Status epilepticus;
• Sleep disorder, motor excitement of various etiologies in psychiatry and neurology, withdrawal symptoms due to chronic alcoholism;
• Neuroses, borderline states with elements of tension, anxiety, anxiety, fear;
• Spastic conditions associated with damage to the spinal cord or brain, as well as myositis, arthritis, bursitis with skeletal muscle tension;
• Tetanus.

Diazepam is used under anesthesia for premedication before anesthesia and / or as a component of combined anesthesia.

In childbirth, the drug is indicated to improve labor, with premature delivery, as well as in the case of premature placental abruption.

Contraindications

• Severe chronic hypercapnia;
• Severe myasthenia gravis;
• History of alcohol or drug dependence (excluding acute withdrawal symptoms);
• Hypersensitivity to the components of the drug, as well as to other drugs of the benzodiazepine series.

In the first trimester of pregnancy, the use of Diazepam is contraindicated and is allowed only if absolutely necessary. It is important to consider that the use of a tranquilizer during pregnancy can significantly alter the heart rate (HR) of the fetus.

In obstetrics, the use of the drug in doses necessary to facilitate labor can cause temporary muscle hypotension, hypothermia, respiratory failure in newborns (more often in premature infants), since they have an incompletely formed enzyme system that is involved in the metabolism of diazepam. For the same reason, taking the drug is contraindicated in children under 6 months of age.

If you need to take the drug regularly during lactation, you should stop breastfeeding.

Method of administration and dosage

Diazepam, depending on the form of release, is taken orally, administered intramuscularly, intravenously, rectally.

The daily dose varies over a wide range of 0.5-60 mg. A single dose, frequency and duration of use are set individually.

Side effects

• Nervous system: drowsiness, muscle weakness, dizziness; rarely - depression, confusion, visual impairment, dysarthria, diplopia, headache, ataxia, tremor; in isolated cases - paradoxical reactions (anxiety, hallucinations, agitation, sleep disturbances). Hiccups may sometimes occur after intravenous administration. In the case of prolonged use, memory impairment and the development of drug dependence are possible;
• Digestive system: rarely - nausea, drooling, dry mouth, constipation; in isolated cases - jaundice, increased activity of alkaline phosphatase and transaminases in blood plasma;
• Endocrine system: rarely - decreased or increased libido;
• Urinary system: rarely - incontinence (urinary incontinence);
• Cardiovascular system: a slight decrease in blood pressure is possible with parenteral administration;
• Respiratory system: in isolated cases - breathing disorders during parenteral administration;
• Allergic reactions: rarely - skin rashes.

special instructions

Special care should be taken in patients with respiratory and heart failure, organic brain lesions (it is recommended to avoid parenteral administration), myasthenia gravis, angle-closure glaucoma and a predisposition to it, as well as patients who have received anticoagulants, β-blockers, antihypertensive drugs of central action, cardiac glycosides (mainly at the beginning of therapy).

When discontinuing treatment, the dose must be reduced gradually. In case of sudden withdrawal of Diazepam after prolonged use, the following are possible: agitation, anxiety, convulsions, tremors.

If during treatment development of paradoxical reactions such as anxiety, acute agitation, hallucinations, sleep disturbances is observed, then Diazepam should be canceled.

After intramuscular injections, an increase in the activity of the enzyme creatine phosphokinase (CPK) in the blood plasma is possible, this should be taken into account when carrying out the differential diagnosis of myocardial infarction.

Avoid intra-arterial injection of the solution.

Drinking alcohol during the treatment period is unacceptable.

Due to the ability of the tranquilizer to cause a decrease in the speed of psychomotor reactions, patients who are engaged in potentially hazardous activities should be especially careful.

Drug interactions

With the simultaneous use of Diazepam with certain drugs, the following effects may occur:

• Bupivacaine: an increase in its concentration in blood plasma is possible;
• Oral contraceptives: likely to increase the effects of diazepam; increased risk of breakthrough bleeding;
• Diclofenac: increased dizziness is likely;
• Isoniazid: reduces the excretion of diazepam;
• Caffeine: reduces the sedative and probably anxiolytic effects of diazepam;
• Clozapine: possible respiratory depression, severe arterial hypotension, loss of consciousness;
• Rifampicin: increases the excretion of diazepam, since it significantly increases its metabolism;
• Levodopa: a decrease in antiparkinsonian action is possible;
• Medicines that have a depressing effect on the central nervous system (CNS) (including antipsychotics, sedatives, hypnotics, opioid analgesics, drugs for anesthesia): severe arterial hypotension increases, as well as a depressing effect on the central nervous system and on the respiratory center;
• Lithium carbonate: there is evidence of the development of a coma;
• Fluvoxamine: increases the side effects and plasma concentration of diazepam;
• Metoprolol: possible decrease in the speed of psychomotor reactions, deterioration of visual acuity;
• Phenobarbital and phenytoin: acceleration of diazepam metabolism is possible; in rare cases, diazepam enhances the effect and inhibits the metabolism of phenytoin;
• Muscle relaxants: their effect is enhanced, the risk of apnea increases;
• Paracetamol: probably a decrease in the excretion of diazepam and its metabolite (desmethyldiazepam);
• Drugs causing the induction of liver enzymes, incl. antiepileptic drugs (carbamazepine, phenytoin): can accelerate the elimination of diazepam;
• Risperidone: there is evidence of the development of neuroleptic malignant syndrome (NMS);
• Theophylline (in low doses): distorts the sedative effect of diazepam;
• Tricyclic antidepressants (including with amitriptyline): an increase in the concentration of antidepressants and an increase in cholinergic action, an increase in their depressing effect on the central nervous system, is likely;
• Cimetidine, omeprazole, disulfiram: an increase in the intensity and duration of action of diazepam is possible;
• Ethanol, ethanol-containing drugs: increase the depressing effect on the central nervous system (mainly on the respiratory center), can cause a syndrome of pathological intoxication.

Patients who have received β-blockers, centrally acting antihypertensive drugs, anticoagulants, cardiac glycosides for a long time cannot predict the mechanisms and degree of drug interaction.

Analogs

Diazepam's analogues are: Apaurin, Diazepam-Ratiopharm, Relanium, Relium, Giadazepam, Sibazon, Seduxen.

Terms and conditions of storage

Store in a dry, dark place out of reach of children at a temperature not exceeding 25 ° C.

The shelf life is 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!