Brand Name: LECTOPAM® 
Manufacturer: Roche
Generic Name: Bromazepam
Drug Type: Anxiolytic - Sedative 


Pharmacology: 

Bromazepam is a benzodiazepine with anxiolytic and sedative properties
which are of value in the symptomatic relief of pathological anxiety in
psychoneurotic patients.

Orally administered bromazepam is completely absorbed and peak blood levels
are achieved 1 to 4 hours after administration.

Bromazepam has a mean serum half-life of 12 hours (8 to 19 hours).

Over a 72 hour interval, 69% of a 12 mg oral dose was recovered in the
urine, in the form of conjugated metabolites.

Indications: 

For the short-term, symptomatic relief of manifestations of excessive
anxiety in patients with anxiety neurosis.

Contraindications: 

Known hypersensitivity to benzodiazepines and in patients with myasthenia
gravis.

Warnings: 

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.

Children: 

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

Occupational Hazards: 

Since bromazepam has a CNS depressant effect, patients should be warned
against driving, operating dangerous machinery, or engaging in other
hazardous activities requiring mental alertness and physical coordination,
and should be cautioned that the effects of alcohol on such activities may
be increased.

Pregnancy: 

Safety in pregnancy has not been established. Therefore, it should not be
used during pregnancy.

Several studies have suggested an increased risk of congenital
malformations associated with the use of the benzodiazepines, such as
chlordiazepoxide and diazepam, and also meprobamate, during the first
trimester of pregnancy.

Since bromazepam is also a benzodiazepine derivative, its administration is
rarely justified in women of child bearing potential. If the drug is
prescribed to a woman of child bearing potential, she should be warned to
consult her physician regarding discontinuation of the drug if she plans to
become or suspects that she is pregnant.

Lactation: 

Bromazepam and its metabolites are probably excreted in human milk.
Therefore, its use should be avoided in nursing mothers.

Precautions: 

Geriatrics: 

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, depending on the
response of the patient, in order to avoid oversedation or neurological
impairment. 

The initial dose for the elderly or debilitated patients should not exceed
3 mg.

Dependence liability: 

Bromazepam should not be administered to individuals prone to drug abuse. 

Caution should be observed in all patients who are considered to have
potential for psychological dependence. 

Withdrawal symptoms similar to those occurring with other drugs of this
class including alcohol, have been observed after abrupt discontinuation of
the drug. 

These include irritability, nervousness, insomnia, agitation, tremors,
convulsions, diarrhea, abdominal cramps, vomiting and memory impairment. 

Since these symptoms are similar to those for which the patient is being
treated, it may appear that he has suffered a relapse upon discontinuation
of the drug. 

It is suggested that the drug should be withdrawn gradually, if the
individual is suspected of being dependent, or the drug perhaps has been
used in prolonged high doses.

Mental and emotional disorders: 

It should be recognized that suicidal tendencies may be present in patients
with emotional disorders and that protective measures and appropriate
treatment may be necessary and should be instituted without delay. 

Since excitement and other paradoxical reactions can result from the use of
anxiolytic-sedatives in psychotic patients, bromazepam should not be used
in ambulatory patients suspected of having psychotic tendencies.

As with other benzodiazepines, bromazepam should not be used in individuals
with physiological anxiety or normal stresses of daily living, but only in
the presence of disabling manifestations of an appropriate pathological
anxiety disorder.

These drugs are not effective in patients with characterological and
personality disorders or those with obsessive-compulsive disorders.

Bromazepam is also not recommended for management of depressive or
psychotic disorders.

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 and have periodic laboratory
assessments.

Laboratory tests: 

If bromazepam should be administered for repeated cycles of therapy,
periodic blood counts and liver function tests are advisable.

Drug Interactions: 

Bromazepam may potentiate or interact with the effects of other CNS acting
drugs such as alcohol, narcotics, barbiturates, nonbarbiturate hypnotics,
antihistamines, phenothiazines, thioxanthenes, butyrophenones, monoamine
oxidase inhibitors, tricyclic antidepressants and anticonvulsants.

Therefore, if bromazepam is to be combined with other drugs acting on the
CNS, careful consideration should be given to the pharmacology of the agent
involved because of possible additive or synergistic drug effects.

Patients should also be advised against the simultaneous use of other CNS
depressant drugs and should be cautioned not to take alcohol during the
administration of bromazepam because of the potentiation of effects that
might occur.

Adverse Effects: The most frequently reported adverse reactions have been
drowsiness, ataxia and dizziness.

Release of hostility and other paradoxical effects such as irritability and
excitability are known to occur with the use of benzodiazepines.

Other side effects less frequently reported, listed by body systems,
include the following:

Neurologic: blurred vision, headache, seizures, slurred speech, difficulty
in depth perception.

Psychiatric: agitation, mental confusion, depression, irritability,
nervousness, sleep disorders, euphoria, lethargy, stupor.

Gastrointestinal: dry mouth, nausea, non-specific gastrointestinal
disturbances, vomiting.

Musculoskeletal: muscle spasm, muscle weakness.

Cardiovascular: hypotension, palpitations, tachycardia.

Dermatologic: pruritus, rash.

Genitourinary: incontinence, change in libido.

Hematologic: decreased hemoglobin and hematocrit, increased and decreased WBC.

Hepatic: elevations of alkaline phosphatase, bilirubin, AST (SGOT), ALT
(SGPT).

Miscellaneous blood chemistry: increased and decreased blood sugar levels.

Overdose: 

Symptoms: 

Overdosage manifestations include drowsiness, somnolence, ataxia, impaired
vision, depressed reflexes and finally coma. Hypotension and respiratory
depression may occur with large overdoses.

Treatment: 

Vital signs should be monitored and general supportive measures should be
employed as indicated. Gastric lavage should be instituted as soon as
possible. Vomiting may be induced if the patient is fully awake. The value
of dialysis has not been determined. As is frequently the case in
intentional overdose, the probability of multiple agents having been
ingested should be considered.

Dosage: 

The dosage of bromazepam must be individualized and carefully titrated in
order to avoid excessive sedation or mental and motor impairment. 

Short courses of treatment should usually be the rule for the symptomatic
relief of excessive anxiety and the initial course of treatment should not
last longer than one week without reassessment of the need for a limited
extension. 

If necessary, drug dosage can be adjusted after 1 week of treatment. 

Initially, not more than 1 week's supply of the drug should be provided and
automatic prescription renewals should not be allowed. 

Subsequent prescriptions, when required, should be limited to short courses
of therapy.

Adults: 

Initially; 6 to 18 mg/day in equally divided doses, depending on the
severity of symptoms and response of the patient. Treatment should be
initiated by lower doses and adjusted as necessary. The optimal dosage may
range from 6 to 30 mg daily in individual patients, in divided doses. Doses
up to 60 mg daily may be used in exceptional cases.

Elderly and debilitated patients: 

The initial daily dose in these patients should not exceed 3 mg in divided
doses. This dosage can be carefully adjusted, depending on tolerance and
reponse of the patient.

Supplied:

1.5 mg: Each white cylindrical biplane tablet with beveled edges and scored
on one side, engraved ²on other side contains: bromazepam 1.5 mg.
Nonmedicinal ingredients: microcrystalline cellulose, lactose 96 mg, talc
and magnesium stearate. Energy: 1.5 kJ (0.4 kcal). Gluten-, paraben-,
sodium-, sulfite- and tartrazine-free. Bottles of 100 and 500.

3 mg: Each pink cylindrical biplane tablet with beveled edges and scored on
one side, engraved šon other side contains: bromazepam 3 mg. Nonmedicinal
ingredients: microcrystalline cellulose, lactose 94 mg, talc, magnesium
stearate and erythrosine aluminum lake. Energy: 1.5 kJ (0.4 kcal). Gluten-,
paraben-, sodium-, sulfite- and tartrazine-free. Bottles of 100 and 500.

6 mg: Each pale green cylindrical biplane tablet with beveled edges and
scored on one side, engraved ºon the other side contains: bromazepam 6 mg.
Nonmedicinal ingredients: microcrystalline cellulose, lactose 91 mg, talc,
magnesium stearate, iron oxide and indigotine aluminum lake. Energy: 1.5 kJ
(0.4 kcal). Gluten-, paraben-, sodium-, sulfite- and tartrazine-free.
Bottles of 100 and 500. 

Store at 15 to 30°C.

http://www.rxmed.com/monographs/lectopam.html

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613-256-8340   PO Box 171  Almonte  Ontario  K0A 1A0  Canada
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