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Lexotan

Bromazepam

 

1. DESCRIPTION

1.1 Therapeutic/Pharmacologic Class of Drug

Anxiolytic.

ATC code: N05BA08

 

1.2 Type of Dosage Form

Tablets.

 

1.3 Route of Administration

Oral.

 

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 schizophrenia.

 

Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

 

2.2 Dosage and Administration

Standard dosage

Average dosing for outpatient therapy: 1.5-3 mg up to three times daily.

Severe cases, especially in hospital: 6-12 mg two or three times daily.

 

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 and pharmacokinetics.

 

2.3 Contraindications

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 syndrome.

 

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