Bromazepam oshar -1.5mg - 3mg
Used to treat anxiety And insomnia It also works to relax muscles
Composition
Each capsule contains bromazepam 1.5 mg or 3 mg
Excipients : lactose monohydrate , corn starch , talc , magnesium stearate
Usage
Therapeutic indications:
Anxiety:
Benzodiazepines are only indicated when the disorder is severe, disabling or
subjecting the individual to extreme distress.
Contraindications:
Bromazepam must not be administered to patients with known hypersensitivity to the active substance or to any of the excipients , severe
respiratory insufficiency,
severe hepatic insufficiency (Bromazepam may cause encephalopathy)
myasthenia gravis
sleep apnea syndrome.
warnings and precautions:
Amnesia:
Benzodiazepines may induce anterograde amnesia
Psychiatric and paradoxical reactions:
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using
benzodiazepines
Toler ance:
Some loss of efficacy to the effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence:
Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products,. The risk of dependence increases with the increasing dose and duration of treatment; it is also greater in patients with a
history of alcohol or drug abuse.
Specific patient groups:
- Benzodiazepines should not be given to children without careful assessment
of the need to do so; the duration of treatment must be kept to a minimum.
- Elderly should be given a reduced dose.
- A lower dose is also recommended for patients with chronic respiratory
insufficiency due to the risk of respiratory depression.
- Benzodiazepines are not recommended for the primary treatment of
psychotic illness.
Benzodiazepines should not be used alone to treat depression or anxiety
associated with depression
Side Effects
Undesirable effects:
Immune System Disorders : Hypersensitivity, anaphylactic shock,
angioedema.
Psychiatric Disorders: Confusional state, emotional disorder, libido disorders, drug dependence, drug abuse, withdrawal syndrome,Depression Paradoxical reactions such as restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, inappropriate behaviour Anterograde amnesia, memory impairment
Nervous System Disorders : Somnolence, headache, dizziness, decreased
alertness, ataxia
Eye Disorders: Diplopia
Cardiac Disorders: Cardiac failure including cardiac arrest
Respiratory, Thoracic and Mediastinal Disorders: Respiratory depression
Skin and Subcutaneous Tissues Disorders: Rash, pruritus, urticaria
Musculoskeletal and Connective Tissue Disorders: Muscle weakness
Renal and Urinary disorders: Urinary retention
General Disorders : Fatigue
Pregnancy:
no specific clinical data are available for bromazepam,
the use of bromazepam during pregnancy may be considered, if therapeutic indications and posology are strictly respected.
Breast-feeding:
Since bromazepam is transferred to breast milk, breast feeding is not
recommended during treatment.
Effects on ability to drive and use machines:
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines.
| Properties |
Pharmacodynamic:
Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties.
Pharmacokinetics:
Absorption:
Bromazepam is rapidly absorbed from the gastro-intestinal tract. Peak plasma concentrations are usually reached within 2 hours of oral administration of bromazepam. The absolute and relative bioavailability of the capsules is 60 %
and 100 % respectively.
Distribution:
On average, 70 % of bromazepam is bound to plasma proteins. The volume of distribution is 50 litres. Steady state plasma concentrations are reached in
around 9 – 5 days.
Metabolism:
Bromazepam is metabolised in the liver. Quantitatively, two metabolites predominate: -3 hydroxy-bromazepam and -2)-2amino-5-bromo-3-hydroxybenzoyl) pyridine. Metabolites of Bromazepam do not contribute significantly to the
effects of the drug.
Elimination:
The urinary recovery of unchanged bromazepam and the glucuronide conjugates of -3hydroxy-bromazepam and -2)-2amino-5-bromo-3-hydroxybenzoyl) pyridine is 27 ,% 2 % and 40 % of the administered dose. Bromazepam has an limination half-life of about 20 hours.
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| Dosage |
Method of administration:
Anxiety : Duration of Treatment should be as short as possible.
The overall duration of treatment generally should not be more than 12 – 8 weeks
Adults : The lowest dose which can control symptoms should be used.
The usual dosage is from 3 mg to 18 mg daily in divided doses.
In exceptional circumstances, in hospitalised patients, up to the maximum daily dosage of 60 mg in divided doses, may be given.
Elderly : Elderly patients and Patients with impaired hepatic and/or renal
function require lower doses.
Children : Bromazepam should not be used in children less than 12 years of age
Overdose:
Symptoms:
Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of bromazepam is seldom life-threatening if the drug is taken alone, but may lead to slurred speech areflexia, apnea, hypotension, cardiorespiratory depression and coma.
Treatment:
Monitor the patient's vital signs and institute supportive measures as indicated. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects.
Further absorption should be prevented using an appropriate methods e.g. treatment within 2-1 hours with activated charcoal, If CNS depression is severe consider the use of flumazenil, (a benzodiazepine antagonist
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| Drug interactions |
Drug Interactions:
- Bromazepam should be used with caution when combined with other CNS
depressants.
- Enhancement of the central depressive effect may occur in case of concomitant
use with antipsychotics, anxiolytics/sedatives, some antidepressant agents,
opioids, anticonvulsants, sedative H1-antihistamines.
- Special care should be made with drugs depressing respiratory function
such as opioids (analgesics, antitussives, substitutive treatments),
- The co-administration of bromazepam with strong CYP3A4 inhibitors (for
example azole antifungals, protease inhibitors or some macrolides) should be made with caution and a substantial dose reduction considered.
- In the case of narcotic analgesics enhancement of euphoria may also occur,
leading to an increase in psychic drug dependence.
- Co-administration of cimetidine may prolong the elimination half-life of
bromazepam.
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| precautions and precautions |
warnings and precautions:
Amnesia:
Benzodiazepines may induce anterograde amnesia
Psychiatric and paradoxical reactions:
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using
benzodiazepines
Toler ance:
Some loss of efficacy to the effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence:
Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products,. The risk of dependence increases with the increasing dose and duration of treatment; it is also greater in patients with a
history of alcohol or drug abuse.
Specific patient groups:
- Benzodiazepines should not be given to children without careful assessment
of the need to do so; the duration of treatment must be kept to a minimum.
- Elderly should be given a reduced dose.
- A lower dose is also recommended for patients with chronic respiratory
insufficiency due to the risk of respiratory depression.
- Benzodiazepines are not recommended for the primary treatment of
psychotic illness.
Benzodiazepines should not be used alone to treat depression or anxiety
associated with depression
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| Package |
ge condition : store at temperature 30 º C
Package : A carton box contains 20 capsules.
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