COMPOSITION
Bromazepam: 7-bromo-1.3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepin-2 one. Capsules 1.5 mg and 3 mg.

PROPERTIES AND EFFECTS
In low dosage. LEXOTAN selectively reduces tension, anxiety and nervousness. In high dosage, sedative and muscle-relaxant properties appear.

PHARMACOKINETICS
Peak plasma concentrations are reached within one to two hours of oral administration of bromazepam. The average bioavailability of the unchanged substance is 84%. Bromazepam has an elimination half-life of 10-20 hours, but the half-life may be longer in elderly patients. Bromazepam is metabolized in the liver. Quantitatively, two metabolites predominate: 3-hydroxy-bromazepam and 2-(2-amino-5-bromo-3-hydroxybenzoyl) pyridine. They are excreted in the urine mainly in conjugated form. On average, 70% of bromazepam is bound to plasma proteins.

INDICATIONS
Emotional disturbances: anxiety and tension states, as adjuvant therapy for anxiety in depressed patients, nervous tension, restlessness, and anxiety-and tension-related insomnia. As an adjuvant to treatment of an underlying disease responsible for functional or psychosomatic impairments of various organs caused or exacerbated by anxiety and tension:
Cardiovascular and respiratory systems: (e.g. pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea and hyperventilation);
Gastrointestinal tract: (e.g. irritable bowel syndrome, ulcerative colitis, epigastric pain, spasm, meteorism and diarrhea);
Urogenital tract: (e.g. irritable bladder, urinary frequency, dysmenorrhea);
Other psychosomatic disturbances: (e.g.psychogenic headache, psychogenic dermatoses).
LEXOTAN is also suitable for treatment of anxiety and tension states due to chronic organic disease and as adjuvant to psychotherapy and to psychoneuroses.

DOSAGE
Average dosage for outpatient therapy; 1.5-3 mg up to three times daily. Severe cases, especially in hospital: 6-12 mg two to three times daily. Theses amount are general recommendations, and dosage should be individually determined. Treatment of outpatients should begin with low doses, gradually increased to the optimum level. After several weeks, but no later than three months, according to progress in therapy, an attempt should be made to withdraw treatment. Treatment of three months and less does not as a rule pose any problems. Should it be necessary to continue therapy beyond this point, withdrawal should be gradual.

SPECIAL DOSAGE INSTRUCTIONS
If use of the drug is indicated in children, the dosage should be adjusted to their lower bodyweight. Elderly and debilitated patients and patients with disturbances of hepatic and/or renal function require lower doses because of individual variations in sensitivity and pharmacokinetics.

RESTRICTIONS ON USE
LEXOTAN must not be administered to patients with known hypersensitivity to bezodiazepines. Patients with known or presumed dependence on alcohol, medicines or drugs should not take LEXOTAN, except in rare situations under medical supervision. In patients with myasthenia gravis who are prescribed LEXOTAN care should be taken on account of preexisting muscle weakness. The established principle of not prescribing drugs of any kind in early pregnancy should be borne in mind. As the active ingredient of LEXOTAN can pass into the breast milk, nursing mothers must not take LEXOTAN. In the first four to six hours after taking high doses, patients should avoid driving a car or operating dangerous machinery because LEXOTAN may, depending on the dosage and individual sensitivity, modify the patient’s reactions.

UNDESIRABLE EFFECTS
LEXOTAN is well tolerated in therapeutic doses. Fatigue, drowsiness and, rarely, muscle weakness may occur with high doses. These symptoms regress on reduction of the dosage. Although no evidence of toxic effects on the blood, or on liver or kidney function has been revealed in clinical practice, monitoring of the blood count and liver function is recommended in long term therapy. On prolonged treatment with high doses, as with all hypnotic, sedative and tranquilizing preparations, dependence may develop in predisposed individuals. Treatment with LEXOTAN should be terminated if paradoxical reactions such as acute anxiety, hallucinations, insomnia or excitation occur.
INTERACTIONS
As with all psychoactive substances, the effect of LEXOTAN may be intensified by alcohol. If LEXOTAN is combined with other centrally active drugs such as neuroleptics, tranquilizers, antidepressants, hypnotics, analgesics and anesthetics, its central sedative effect may be enhanced.

OVERDOSAGE
Intentional or accidental overdosage of LEXOTAN alone is seldom life-threatening. The symptoms take the form mainly of an intensification of the therapeutic effect (sedation, muscle weakness, deep sleep) or of paradoxical agitation. In most cases it is sufficient to monitor the vital functions and await recovery. Extremely high overdoses, especially in combination with other centrally acting drugs, can result in coma, areflexia, depression of cardiac and respiratory functions, and apnea. Suggested counter measures are gastric lavage and medical surveillance.

STABILITY
This medicine should be used before the date shown after EXP on the pack.

PACKS
Capsules 1.5 mg 20
Capsules 3 mg 20