DIAZEPAM

Posology As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 14 days. Patients who have received benzodiazepines for a long time may require an extended withdrawal period. Long-term chronic use is not recommended.

Adults:

Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: 2-30mg daily in divided doses. Insomnia associated with anxiety: 5mg to 15mg before retiring. Management of cerebral palsy spasticity in selected cases: 2mg to 60mg daily in divided doses.

Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 2mg to 15mg daily in divided doses. In the control of muscle spasms as in tetanus: 3mg to 10mg/kg body weight daily. The selected dose should relate to the severity of the case and in extremely severe cases higher doses have been used.

Intravenous diazepam is recommended initially (see separate prescribing information). Adjunct to the management of some types of epilepsy: 2mg to 60mg daily in divided doses. Symptomatic treatment of acute alcohol withdrawal: 5mg to 20mg, repeated if necessary in 2 to 4 hours.

Premedication: 5mg to 20mg.

Paediatric population:

Alternative presentations of diazepam are recommended for paediatric usage in order to obtain suitable doses of less than 5mg. Spastic children with minimal brain damage: 5-40mg daily in divided doses. 4): 2mg-10mg Elderly and debilitated patients: Doses should not exceed half the above recommended adult doses.

Hepatic impairment Patients with impaired hepatic function should be given a reduced dose. Renal impairment Patients with impaired renal function should be given a reduced dose.

Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision predominantly occur at the start of therapy but usually disappear with repeated administration. Among elderly patients there may be confusion conditions at high dose levels.

There is an increased risk of falls and associated fractures in elderly patients using benzodiazepines. Increased salivary and bronchial secretion has been reported, in particular in children. Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.

4). 4). Abuse of benzodiazepines has been reported.

The frequencies of adverse events are ranked according to the following:

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data). System Organ Class Frequency Undesirable effects Blood and lymphatic system disorders Rare Blood dyscrasias Very rare Leukopenia Immune system disorders Very rare Anaphylaxis.

Psychiatric disorders Common Confusion. b Nervous system disorders Very common Drowsiness. Common Ataxia, impaired motor ability, tremor. c Concentration difficulties, balance disorders, dizziness, headache, slurred speech. Rare Unconsciousness, insomnia, dysarthria.

Eye disorders Not known Reversible disorders of vision: blurred vision, diplopia, nystagmus. Cardiac disorders Rare Bradycardia, heart failure including cardiac arrest. Vascular disorders Rare Hypotension, syncope. Respiratory, thoracic and mediastinal disorders Uncommon Respiratory depression.

Rare Respiratory arrest, increased bronchial secretion. Not Known Apnoea Gastrointestinal disorders Uncommon Gastrointestinal disorders (nausea, vomiting, constipation, diarrhoea), increased salivary secretion. Rare Dry mouth, increased appetite.

Warnings Benzodiazepines are not recommended for the main treatment of psychosis. Risk from concomitant use of opioids Concomitant use of diazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as diazepam with opioids should be reserved for patients for whom alternative treatment options are not possible.

2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Concurrent alcohol use/CNS depressant agents The concomitant use of diazepam and alcohol (ethanol) (alcoholic beverage or alcoholcontaining medication) and/or central nervous system depressants should be avoided.

5). Seizures In patients presenting with drowsiness or hypotonia after diazepam, an infection affecting the nervous system should be excluded before attributing symptoms to diazepam. Starting an anti-epileptic medication can be followed by an increase in seizures or the onset of a new type of seizure in the patient.

This is independent of the natural fluctuations to be expected in certain types of epilepsy. Possible causes for seizures after diazepam include: epileptic syndrome of the patient, a concurrent modification of the anti-epileptic treatment, a pharmacokinetic interaction with another medicine, toxicity or overdose.

Otherwise, it may be that there is no explanation other than a paradoxical reaction. Pharmacological tolerance Some loss of efficacy of diazepam may develop after repeated use for a few weeks. Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardiorespiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.

2). Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses given for short periods of time. As sudden discontinuation of benzodiazepines may result in convulsions, particular care should be taken in patients with epilepsy, other patients who have had a history of seizures or in alcohol or drug dependants.

1. • Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur). • Acute pulmonary insufficiency; respiratory depression, acute or chronic severe respiratory insufficiency (ventilatory failure may be exacerbated).

• Myasthenia gravis (condition may be exacerbated). • Sleep apnoea (condition may be exacerbated). • Severe hepatic insufficiency (elimination half-life of diazepam may be prolonged). • Acute porphyria. • Diazepam should not be used as monotherapy in patients with depression or those with anxiety and depression as suicide may be precipitated in such patients.

6). 6).