Uses: Panic Disorders and Anxiety

Quantity: 100 Tabs

Chemical Name: Lorazepam

Therapeutic indications

FOR SHORT TERM (2-4 weeks only) USE (adults only)

- Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short-term psychometric, organic or psychotic illness.

AS PREMEDICATION (adults and children 5 years and above)

Before operative dentistry and general surgery

NOT FOR USE

- Long term (i.e. longer than 4 weeks)

- For mild/moderate anxiety

- For insomnia or anxiety in children

Dosage (Posology) and method of administration

Route of administration: oral

Treatment to be given:

- Under close medical supervision

- At the lowest effective dose

- For the shortest possible duration (not exceeding 4 weeks)

Doses should be individualised

Extension of use should not take place without further clinical evaluation

When treatment is started the patient should be informed that

- treatment will be of limited duration

- the dosage will be progressively decreased

- there is a possibility of rebound phenomena

Dosage:

Adults:

Anxiety: 1-4mg daily in divided doses.

Insomnia: 1-2mg before retiring

Premedication before operative dentistry or general surgery:

2-3mg the night before operation 2-4mg one to two hours before the procedure

Elderly:

The elderly may respond to lower doses (half normal adult dose or less)

Children (aged 5-13 years):

Premedication: 0.5-2.5mg at 0.05mg/kg to the nearest 0.5mg according to weight, not less than one hour before operation.

Patients with Renal or Hepatic impairment:

Lower doses may be sufficient in these patients. Use in patients with severe hepatic insufficiency is contraindicated..

Contraindications

- Hypersensitivity to benzodiazepines or to any of the other ingredients

- Acute pulmonary insufficiency: respiratory depression; sleep apnoea (risk of further respiratory depression)

- Obsessional states (inadequate evidence of safety and efficacy)

- Severe hepatic insufficiency (may precipitate encephalopathy)

- Planning a pregnancy

- Pregnancy

- Myasthenia gravis;

Benzodiazepines should not be used alone in depression or anxiety with depression (may precipitate suicide)

Special warnings and precautions for use

Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence of Tranqipam, these substances should either be avoided or taken in reduced dosage.

Due to the potential adverse reactions including ataxia, muscle weakness, dizziness, drowsiness and fatigue , Benzodiazepines may be associated with an increased risk of falling especially in elderly patients. As a result, caution should be exercised particularly when getting up at night. The elderly should receive a reduced dose.

Tranqipam is not intended for the primary treatment of psychotic illness or depressive disorders, and should not be used alone to treat depressed patients. The use of benzodiazepines may have a disinhibiting effect and may release suicidal tendencies in depressed patients. Therefore, large quantities of Tranqipam should not be prescribed to these patients.

Pre-existing depression may emerge during benzodiazepine use.

The use of benzodiazepines may lead to physical and psychological dependence. The risk of dependence on Tranqipam is low when used at the recommended dose and duration, but increases with higher doses and longer-term use. The risk of dependence is further increased in patients with a history of alcoholism or drug abuse, or in patients with significant personality disorders. Therefore, use in individuals with a history of alcoholism or drug abuse should be avoided.

Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly. (see 4.8 Undesirable effects). Therefore, the drug should always be discontinued gradually.

It may be useful to inform the patient that treatment will be of limited duration and that it will be discontinued gradually. The patient should also be made aware of the possibility of "rebound" phenomena to minimise anxiety should they occur.

Abuse of benzodiazepines has been reported.

Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.

Anxiety or insomnia may be a symptom of several other disorders. The possibility should be considered that the complaint may be related to an underlying physical or psychiatric disorder for which there is more specific treatment.

Caution should be used in the treatment of patients with acute narrow-angle glaucoma.

Patients with impaired renal or hepatic function should be monitored frequently and have their dosage adjusted carefully according to patient response. Lower doses may be sufficient in these patients. The same precautions apply to elderly or debilitated patients and patients with chronic respiratory insufficiency.

As with all CNS-depressants, the use of benzodiazepines may precipitate encephalopathy in patients with severe hepatic insufficiency. Therefore, use in these patients is contraindicated.

Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematology and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary.

Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines. This effect may be advantageous when Tranqipam is used as a premedicant. However, if Tranqipam is used for insomnia due to anxiety, patients should ensure that they will be able to have a period of uninterrupted sleep which is sufficient to allow dissipation of drug effect (e.g., 7-8 hours).

Paradoxical reactions have been occasionally reported during benzodiazepine use. Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued (see Undesirable effects).

Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines

Patients should be advised that sedation, amnesia, impaired concentration, dizziness, blurred vision and impaired muscular function may occur and that, if affected, they should not drive or to use machines, or take part in other activities where this would put themselves or others at risk. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Concurrent medication may increase these effects

This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

- The medicine is likely to affect your ability to drive

- Do not drive until you know how the medicine affects you

- It is an offence to drive while under the influence of this medicine