LEXOTAN TABLET 3 MG [SIN00382P]

Product Info

LEXOTAN TABLET 3 MG

[SIN00382P]

2.1 Therapeutic Indication(s)
Lexotan is indicated for anxiety, tension and other somatic or psychiatric complaints associated with the anxiety syndrome.

It can also be used as an adjunct for treatment of anxiety or excitation associated with psychiatric 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.

Duration of Treatment
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.

The patient should be checked regularly at the start of treatment in order to minimize the dosage and/or the frequency of administration and to prevent overdose due to accumulation.

2.2.1 Special Dosage Instructions
Pediatric use
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).

Geriatric use
Elderly patients (see 2.5 Use in Special Populations and 3.2.5 Pharmacokinetics in special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) require lower doses because of individual variations of potentially increased sensitivity and changed pharmacokinetics.

Hepatic Impairment
Patients with severe hepatic impairment should not be treated with Lexotan tablets (see section 2.3 Contraindications). In patients with mild or moderate hepatic impairment, the lowest dose possible should be given.

2.3 Contraindications
Lexotan is contraindicated in patients with:

• known hypersensitivity to benzodiazepines or any of the excipients

• severe respiratory insufficiency

• severe hepatic impairment as benzodiazepines may precipitate hepatic encephalopathy

• sleep apnea syndrome