1.1 Therapeutic/Pharmacologic Class of Drug
ATC code: N05BA08
1.2 Type of Dosage Form
1.3 Route of Administration
1.4 Qualitative and Quantitative Composition
Active ingredient: bromazepam.
Tablets 1.5 mg, 3 mg and 6 mg.
Excipients: Lexotan tablets contain lactose. For warning
related to lactose, see 2.4.1 General (Warnings and Precautions).
2. CLINICAL PARTICULARS
2.1 Therapeutic Indication(s)
Anxiety, tension and other somatic or psychiatric complaints
associated with the anxiety syndrome.
Adjunctive use for treatment of anxiety or excitation associated with psychological disorders, such as mood disorders or
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual to extreme distress.
2.2 Dosage and Administration
Average dosing for outpatient therapy: 1.5-3 mg up to three
Severe cases, especially in hospital: 6-12 mg two or three
These amounts are general recommendations, and dosage
should be individually determined. Treatment of outpatients
should begin with low doses, gradually increasing to the optimum level. The duration of treatment should be as short as
possible. The patient should be reassessed regularly and the
need for continued treatment should be evaluated, especially
in case the patient is symptom free. The overall treatment
generally should not be more than 8-12 weeks, including a
tapering off process. In certain cases extension beyond the
maximum treatment period may be necessary, if so, it should
not take place without re-evaluation of the patient's status
with special expertise.
2.2.1 Special Dosage Instructions
Lexotan is usually not indicated in children, but if the
physician feels Lexotan treatment is appropriate, then the
dose should be adjusted to their low body-weight (about
0.1-0.3 mg/kg body-weight).
Elderly patients (see 3.2.5
Pharmacokinetics in special populations) and those with impaired hepatic function require
lower doses because of individual variations in sensitivity
Lexotan must not be administered to patients with known
hypersensitivity to benzodiazepines, severe respiratory insufficiency, severe hepatic insufficiency (benzodiazepines
are not indicated to treat patients with severe hepatic insufficiency as they may cause encephalopathy) or sleep apnea