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Lexotan

Lexotan

bromazepam

Manufacturer:

Delpharm

Distributor:

Zuellig
Concise Prescribing Info
Contents
Bromazepam
Indications/Uses
Anxiety, tension & other somatic or psychiatric complaints associated w/ anxiety syndrome. Adjunct for the treatment of anxiety or excitation associated w/ psychiatric disorders eg, mood disorders or schizophrenia.
Dosage/Direction for Use
Outpatient therapy 1.5-3 mg up to tid. Severe hospital cases 6-12 mg bid-tid. Duration of treatment: Overall treatment should not be >8-12 wk (including tapering-off process).
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to benzodiazepines. Severe resp or hepatic insufficiency; sleep apnea syndrome. May precipitate hepatic encephalopathy.
Special Precautions
Avoid concomitant use w/ alcohol &/or CNS depressants due to potential clinical effects including severe sedation, resp &/or CV depression. May induce anterograde amnesia at higher therapeutic dose. Caution in patients w/ medical history of alcohol or drug abuse. May develop loss of response after repeated use for a prolonged time. Should not be used alone to treat depression or anxiety associated w/ depression; not recommended for the treatment of psychotic illness. Care in patients w/ pre-existing muscle weakness, chronic resp insufficiency due to risk of resp depression. Use may lead to the development of physical & psychological dependence; w/drawal symptoms including headache, diarrhea, muscle pain, extreme anxiety, tension, restlessness, confusion & irritability; rebound anxiety. Not to be taken by patients w/ Lapp lactase deficiency or glucose galactose malabsorption. Sedation, amnesia & impaired muscular function may adversely affect ability to drive or use machinery. Caution in patients w/ mild to moderate hepatic impairment. Increased risk of congenital malformations during 1st trimester of pregnancy; avoid during pregnancy. Should not be taken during lactation. Discontinue use if psychiatric & paradoxical reactions occur in childn & elderly.
Adverse Reactions
Confusional state, disorientation, emotional & mood disturbances; pre-existing depression; paradoxical reactions (eg, restlessness, agitation, irritability, aggressiveness, delusion, anger, nightmares, hallucinations, psychoses, inappropriate behavior, nervousness, anxiety, abnormal dreams, hyperactivity & other adverse behavioral effects); physical & psychological drug dependence; drowsiness, headache, dizziness, decreased alertness, ataxia; anterograde amnesia; diplopia; GI disorders; skin reactions; muscle weakness; fatigue; fall, fracture; resp depression; cardiac failure including cardiac arrest.
Drug Interactions
May possibly prolong elimination t1/2 w/ cimetidine, propranolol. Increased exposure (AUC) & t1/2 w/ fluvoxamine. Enhanced sedation & cardio-resp depression w/ centrally acting depressants including alcohol. Enhanced euphoria w/ narcotic analgesic.
MIMS Class
Anxiolytics
ATC Classification
N05BA08 - bromazepam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Presentation/Packing
Form
Lexotan tab 1.5 mg
Packing/Price
100's
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