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Lexilium (Bromazepam) 3mg by SAMI Pharmaceuticals (pvt) ltd. 10 Tablets / Strip

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Product Description

LEXILIUM Tablets

(Bromazepam)

COMPOSITION:

Each tablet contains: Bromazepam BP…..3mg

INDICATIONS AND USAGE:

LEXILIUM (Bromazepam) is useful for the short-term, symptomatic relief of manifestations
of excessive anxiety in patients with anxiety neurosis. Benzodiazepines are only indicated
when the disorder is severe, disabling or subjecting the individual to extreme distress
Emotional disturbances: Acute tension and anxiety states. Difficulties in interpersonal
contacts, agitation, insomnia, agitated depressive reactions
i. Functional disturbances: Cardiovascular and respiratory systems: (Pseudoangina pectoris,
precordial anxiety, emotiogenic hypertension trachycardia, dyspnea, hyperventilation)
ii. Gastrointestinal system: Irritable bowel syndrome, epigastric pain, spasm, bloating, diarrhoea etc.
iii. Genitourinary system: Frequency, irritable bladder and dysmenorrhoea:
iv. Psychosis disorders: Psychogenic headache, psychogenic dermatosis, asthma, gastric and
duodenal ulcer, ulcerative colitis, emotional reactions to chronic organic disease and
adjuvant to psychotherapy in psychoneurosis

DOSAGE & ADMINISTRATION:

Average dose for ambulant therapy:

1.5 – 3mg three times daily

Severe cases especially in hospitals:

6 – 12mg two to three times daily

These are average recommendations and dosage should be individually determined.
Treatment of ambulant patients in general begins with the lowest dose, gradually increasing
if necessary to the optimum level. After about 8 to12 weeks, according to progress in
therapy, dosage can usually be reduced gradually and then stopped

CONTRA-INDICATIONS:

LEXILIUM (Bromazepam) is contra-indicated in-patients with known hypersensitivity to
benzodiazepines, myasthenia gravis, severe hepatic insufficiency, severe respiratory
insufficiency or sleep apnea syndrome

SPECIAL PRECAUTIONS:

General Precautions:

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

Use in the elderly:

Elderly and debilitated patients or those with organic brain syndrome, have been found
to be prone to CNS depression after even low doses of benzodiazepines. Therefore,
medication should be initiated in these patients with very low initial doses and increments
should be made gradually

Impaired Hepatic or Renal Function:

In patients with impaired hepatic or renal function, it is recommended to initiate therapy,
if necessary, at a very low dose and to increase the dosage only to the extent that such an
increase is compatible with the degree of residual function of these organs. Such patients
should be followed closely & have periodic laboratory assessment

WARNINGS:

LEXILIUM (Bromazepam) is not recommended for use in patients with depressive disorders
or psychosis. Patients should be advised against the concurrent use of alcohol and other
CNS depressant drugs. Patients with known or presumed dependence from alcohol or
drugs should not take benzodiazepines, except in rare situations under medical supervision

Paediatric Use:

Because of the lack of sufficient clinical experience, Bromazepam is not recommended
for use in patients less than 18 years of age

Driving and Hazardous Activities:

Since Bromazepam has a central nervous system depressant effect, patients should be
warned against driving, operating dangerous machinery or engaging in other hazardous
activities requiring mental alertness and physical co-ordination and should be cautioned
that the effects of alcohol on such activities may be increased

Use in Pregnancy:

The safety of use of Bromazepam in pregnancy has not been established. Therefore,
Bromazepam should not be used during pregnancy

Use by Nursing Mothers:

Bromazepam and its metabolites are probably excreted in human milk. Therefore, this
drug should not be given to nursing mothers

CONTRA-INDICATED ADVERSE EFFECTS:

The most frequently repeated adverse reactions with Bromazepam have been drowsiness,
ataxia and dizziness. Some other side effects such as irritability, excitability, restlessness,
agitation, delusion, rages, nightmares, hallucinations, psychosis, inappropriate behavior
and other adverse behavioral effects are known to occur with the use of benzodiazepines

STABILITY:

See expiry on the pack

PRESENTATION:

LEXILIUM 3mg tablet in pack of 30's

INSTRUCTIONS:

Keep out of reach of children
Avoid exposure to heat, light and humidity
Store at 25ºC or below
Improper storage may deteriorate the medicine

Manufactured by:

SAMI PHARMACEUTICALS (PVT) LTD.
F-95, S.I.T.E., Karachi-Pakistan


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  1. to muhc bad qulity for this web site

    Posted by hong on 9th Apr 2012

    this product is bad. and always bad retern of this stie. please dont purchase any products of this web site thanks



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