Instruction for use: Bromidem

Trade name of the drug – Bromidem

Active substance: Bromazepam (Bromazepamum)

Dosage Form: tablet
Composition(per tablet):
1 tablet contains 6 mg of bromazepam or 12, in multiples of 25 pcs.

Pharmacotherapeutic group: Anxiolytic (tranquilizer),

ATX Code

N05BA08 bromazepam

The nosological classification (ICD-10)

F41 Other anxiety disorders: anxiety Relief; Nonpsychotic anxiety disorders; An alarm condition;
Anxiety; Disturbingly suspicious condition; Chronic anxiety; Sense of anxiety.

G47 Sleep disorders: Insomnia; Insomnia, especially difficulty falling asleep; desynchronosis; Prolonged sleep disturbance; Difficulty falling asleep; Short-term and transient insomnia; Short-term and chronic sleep disorders; Short or shallow sleep; Violation of sleep; Disturbed sleep, especially in the phase of falling asleep; Infringements sleep; sleep disturbances; Neurotic sleep disturbance; Shallow superficial sleep; shallow sleep; Poor quality of sleep; Night awakening; sleep Pathology; Postsomnic violation; transient insomnia; Trouble falling asleep; Early awakening; Early morning awakening; Early awakening; sleep disorder; somnipathy; persistent insomnia; difficult to fall asleep; difficulty falling asleep; Difficulty falling asleep in children; persistent insomnia; Worsening sleep; Chronic insomnia; Frequent night and / or early morning awakening; Frequent nocturnal awakening and a sense of the depth of the non-sleep; Night waking.

R45.1 Restlessness and agitation: Agitation; Anxiety; explosive excitability; The internal excitation; Excitability; Excitation; Excitation sharp; psychomotor excitement; hyperexcitability; motor stimulation; Relief of agitation; jitters; restless; Night concern; The acute stage of schizophrenia with excitement; Acute mental stimulation; paroxysm excitation; overexcitement; erethism; Increased nervous irritability; Increased emotional and cardiac excitability; Increased arousal; hyperphrenia; Psychomotor agitation; Psychomotor agitation; Psychomotor agitation in psychosis; Psychomotor agitation epileptic nature; psychomotor paroxysm; psychomotor seizures; excitation Symptoms; The symptoms of psychomotor agitation; Status agitation; Status anxiety; excitation condition; Status of high concern; Condition of psychomotor agitation; anxiety states; excited states; anxiety states with somatic diseases; feeling of excitation; Feeling restless; Emotional arousal.

R45.4 Irritability and anger: tantrum; Anger; Dysphoria; Neurosis with increased irritability; exasperation; Increased irritability; Increased irritability of the nervous system; Irritability; Irritability with nervousness; Irritability with psychotic disorders; The symptoms of irritability.

R45.7 State of emotional shock and stress, unspecified: Exposure to stressors; Exposure to extreme situations; Long-term emotional stress; Neuropsychiatric stress; occupational stress; Psychological stress at interrail; Psycho-emotional overload and stress; Psycho-emotional tension in stressful situations; emotional stress; stress condition; Stress; The stress load; stress state; stressful situations; stress state; The stresses of everyday life; Chronic stress.

Pharmacological Properties of BromidemPharmachologic effect
Mode of action - an anticonvulsant, anxiolytic, sedative.

Pharmacokinetics
Maximum plasma concentration achieved within 2 hours after administration. 70% of bromazepam is bound to plasma proteins. Isolation occurs from the urine, mainly as the glucuronide metabolites hydroxy 3-gidroksibromazepama derivative and 3-gidroksibenzolpiridina. Both metabolites are active, but their clinical pharmacological activity does not matter, since they are rapidly excreted. Approximately 2% of bromazepam enters the urine in unchanged form. Elimination half bromazepam plasma -. About 12 hours Like all benzodiazepines, bromazepam crosses the placental barrier and is excreted in breast milk.

Indications for Bromidem

Symptomatic treatment of functional disorders or somatic manifestations associated with the pathological condition of fear or mental stress, insomnia.

Contraindications for Bromidem

Hypersensitivity, myasthenia gravis, severe respiratory failure, children's age.

Bromidem Dosage and Administration
The dosage depends on the nature and severity of the symptoms and the susceptibility of the patient. At the beginning of therapy the adult dose is 6 mg per day (1.5 mg in the morning, at noon 1.5 mg and 3 mg in the evening). Gradually dose is adjusted depending on the therapeutic effect. The usual dose ranges from 6 to 18 mg per day (3 hours). In severe cases it may be necessary to increase the dosage of 24-36 mg per day. Abolition of the treatment should be carried out with a gradual reduction in dosage. For elderly or debilitated patients should reduce the dosage by half. Reducing the dosage should also be provided in the case of hepatic, renal or respiratory failure.

Side effect of Bromidem
Sleepiness (especially in elderly patients), muscular hypotonia, dizziness, ataxia, paradoxical reactions (irritability, aggressiveness, confusion, excitement), headaches, amnesia, gastrointestinal disorders, agranulocytosis, skin rash. In the event of abrupt discontinuation of treatment: an exacerbation of anxiety, insomnia, irritability, tremor, muscle pain, nausea, vomiting, headache, seizures, epileptic crises, inability to concentrate, feeling of depersonalization.

Overdose of Bromidem

Signs of intoxication: a very deep sleep, coma. Treatment: symptomatic.

Interaction

Sedation is enhanced by alcohol, drugs, psychotropic, analgesics and muscle relaxants. Rifampicin accelerates catabolism slows cimetidine, disulfiram, isoniazid, and oral contraceptives.

SPECIAL INSTRUCTIONS for Bromidem

In epileptic patients during treatment or after discontinuation of therapy may experience epileptic crises. In the case of machines or using machinery driving requires great care, especially during the period of adjustment to the dosage.

Storage conditions of Bromidem
In a dry, dark place at a temperature no higher than 25 ° C.
Keep out of the reach of children.
Shelf life
3 years.
Do not use beyond the expiration date printed on the package.
Conditions of supply of pharmacies
On prescription.