Notens Tablet
Bromazepam
3mg
Aristopharma Limited
| Pack size | 50's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 5.00 AED |
Indications
Notens Tablet is used for:
Anxiety, Panic attack, Tension, Agitation
Adult Dose
Adult:
Oral
Symptomatic relief of tension, anxiety and agitation.
The recommended initial adult daily dosage is 6 to 18 mg in equally divided doses, depending on the severity of symptoms and response of the patient.
Treatment should be initiated by lower doses and adjusted as necessary.
The optimal dosage may range from 6 to 30 mg daily in individual patients, in divided doses.
The maximum recommended dose is 60 mg daily.
The average dose for ambulatory patients: 3 mg two or three times daily.
It is often an advantage to make the evening dose larger than other doses, or when the total dose is low (e.g. 3 or 6 mg), to give the total dose in the evening.
Severe hospitalized cases: 6 – 12 mg two or three times daily.
The overall treatment should not be more than 2 – 4 weeks, followed by a tapering-off process of up to 6 – 8 weeks
Child Dose
Bromazepam is not recommended in children as there is insufficient evidence of safety and efficacy in this group.
Renal Dose
Renal impairment:
No formal pharmacokinetic study has been conducted and no population pharmacokinetic data was collected in patients with renal impairment
No dosage adjustment needed.
Administration
May be taken with or without food.
Contra Indications
Patients who are hypersensitive to other benzodiazepines, this drug or to any ingredient in the formulation.
Myasthenia gravis
Severe hepatic insufficiency
Severe respiratory insufficiency
Sleep apnea syndrome
Narrow-angle glaucoma
Precautions
General Use: Only for severe anxiety disorders; not for depressive disorders or psychosis. Risk of anterograde amnesia with higher doses.
Concomitant Use: Avoid alcohol or CNS depressants as they may increase sedation and respiratory/cardiovascular depression.
History of Substance Abuse: Use with extreme caution in those with alcohol/drug abuse history due to risk of dependence.
Dependence/Tolerance: Risk of physical/psychic dependence with long-term use. Withdrawal symptoms may occur, so gradual dose reduction is necessary.
Lactose Intolerance: Not suitable for patients with lactose intolerance or galactose/glucose malabsorption issues.
Driving/Hazardous Activities: May impair mental alertness and coordination; avoid driving or operating machinery.
Mental Health: Avoid in patients with psychotic tendencies or emotional disorders; may trigger paradoxical reactions or suicidal tendencies.
Respiratory: Use cautiously in patients with respiratory issues, as it may cause respiratory depression.
Falls and Fractures: Increased risk in elderly and those taking sedatives.
Pregnancy-Lactation
Pregnant Women: The safety of use of bromazepam in pregnancy has not been established.
Therefore, BROMAZEPAM should not be used during pregnancy. Several studies have suggested an increased risk of congenital malformations (e.g., congenital malformations of the heart, cleft lip and/or palate) associated with the use of the benzodiazepines chlordiazepoxide and diazepam, and meprobamate, during the first trimester of pregnancies. Since BROMAZEPAM is also a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential.
Administration of BROMAZEPAM during the last three months of pregnancy or during labor is allowed only in the event of a strict medical indication when the expected benefits to the patient outweigh the possible risks to the fetus. Due to the pharmacological action of the product, effects such as irregular heartbeat in the unborn child, hypothermia, hypotonia, moderate respiratory depression, and poor feeding in the neonate can be expected.
Moreover, infants born to mothers who took benzodiazepines chronically during the later stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period. If BROMAZEPAM is prescribed to a woman of child-bearing potential, she should be warned to consult her physician regarding discontinuation of BROMAZEPAM if she plans to become or suspects that she is pregnant.
Nursing Women: Bromazepam and its metabolites are probably excreted in human milk.
Therefore, this drug should not be given to nursing mothers.
Interactions
May enhance the activity w/ CYP450 inhibitor (e.g. azole antifungals, macrolides, HIV protease inhibitors, Ca channel blockers).
Elevated plasma levels w/ disulfiram or cimetidine.
Additive CNS depressant effects w/ barbiturates, sedatives, anaeasth, anxiolytics, hypnotics, phenothiazines, other antipsychotics, skeletal muscle relaxants.
May potentiate anticholinergic effects of atropine, antihistamines and antidepressants.
Increased psychic drug dependence w/ narcotic analgesics.
Adverse Effects
Side effects of Bromazepam :
Most Frequent Adverse Reactions:
The most frequently reported adverse reactions with bromazepam are related to CNS effects and include drowsiness, ataxia and dizziness. These phenomena occur predominantly when starting bromazepam and usually disappear with repeated administration.
Serious and Important Adverse Reactions:
There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
Allergic reactions and a very few cases of anaphylaxis have been reported to occur with benzodiazepines.
Release of hostility and other paradoxical reactions such as irritability, excitability, restlessness, agitation, aggressiveness, delusion, anger, nightmares, hallucinations, psychosis, inappropriate behaviour and other adverse behavioural effects are known to occur with the use of benzodiazepines.
They are more likely to occur in children and elderly patients than in other patients. If these occur, use of BROMAZEPAM should be discontinued.
Anterograde amnesia may occur using therapeutic doses of benzodiazepines, the risk increasing with
higher doses. Effects of anterograde amnesia may be associated with inappropriate behaviour.
Chronic use (even at therapeutic doses) may lead to the development of physical and psychological drug dependence: discontinuation of BROMAZEPAM may result in withdrawal or rebound phenomena.
Abuse of benzodiazepines is more common in poly-drug abusers.
Mechanism of Action
Bromazepam is a benzodiazepine with general properties similar to diazepam. It is used in the treatment of anxiety occuring alone or associated with insomnia.
Note
Notens 3mg Tablet manufactured by Aristopharma Limited. Its generic name is Bromazepam. Notens is availble in Bangladesh.
Farmaco BD drug index information on Notens Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.