CHLORDIAZEPOXIDE Capsules Ref.[7216] Active ingredients: Chlordiazepoxide

Posology

Anxiety

Adults

Starting dose 5mg daily: usual dose up to 30mg in divided doses. For severe symptoms 20mg, 2-4 times a day. Maximum dose up to 100mg daily, in divided doses, adjusted on an individual basis.

Treatment should not continue as full dose for more than 4 weeks including 2 week tapering off process.

Insomnia associated with anxiety

Adults

10–30 mg at bedtime.

Treatment would normally vary from a few days to two weeks with a maximum of four weeks, including two weeks tapering off.

Muscle Spasm

Adults

10mg to 30mg daily in divided doses

Symptomatic relief of acute alcohol withdrawal

Adults

25 to 100mg, repeated if necessary in 2 to 4hrs.

Special populations

Elderly or debilitated patients, patients with organic brain damage, respiratory impairment should normally not exceed half of the doses normally recommended.

Patients with impaired hepatic or renal function

Dosage should not exceed half the adult dose and steps should be taken to ensure that there is no accumulation of plasma chlordiazepoxide.

Contraindicated in severe hepatic insufficiency (see section 4.3).

Paediatric patients

Chlordiazepoxide Capsules are not for paediatric use.

Treatment should be given at the lowest effective dose. The dosage and duration of treatment should be determined on an individual basis dependent by the patient’s response and severity of the disorder. Given that chlordiazepoxide is a long-acting benzodiazepine, the patient should be monitored regularly at the start of the treatment to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation.

Treatment should be as short as possible duration (not exceeding 4 weeks) and given under close medical supervision. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. Extension of use should not take place without further clinical evaluation. Chronic use is not recommended (little is known of the long term safety and efficacy: potential for dependence – see section 4.4).

When treatment is started the patient should be informed that the treatment will be of limited duration, the dosage will be progressively decreased and that there is a possibility of rebound phenomena (see section 4.4). Treatment should be tapered off gradually. Patients who have taken benzodiazepines for a prolonged time may require a longer period of dosage reduction and specialist help may be appropriate.

Method of administration

Chlordiazepoxide capsules are for oral administration and must be taken with water and not be chewed.

When taken alone in overdosage, Chlordiazepoxide presents few problems in management. Benzodiazepines potentiate the effects of other CNS depressants including alcohol. When taken with centrally-acting drugs, especially alcohol, effects of overdose are likely to be more severe and in absence of supportive measures, may prove fatal.

Symptoms

Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, dysarthria, hypotonia, nystagmus, hypotension, respiratory depression, rarely coma and very rarely death Coma usually lasts a few hours but in the elderly may be more contracted and cyclical. Respiratory depression is more serious in those with severe obstructive airways disease. If excitation occurs, barbiturates should not be used. Patients who are asymptomatic at 4 hours are unlikely to develop symptoms.

Management

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

Treatment is symptomatic.

• Maintain clear airways and adequate ventilation, if indicated
• The value of gastric decontaminants is uncertain. Consider activated charcoal (50g for an adult: 1g/kg for a child) within 1 hour of ingestion if more than 1mg/kg has been taken provided the patient is not too drowsy.
• Gastric lavage – unnecessary if only benzodiazepine taken
• Supportive measures as indicated by the patients clinical condition
• The value of dialysis has not been determined. Flumazenil, a benzodiazepine antagonist, is available but should rarely be required. It may be required in children who are naïve to benzodiazepines or patients with COPD as alternative to ventilation. Flumazenil may be used as an antidote; however it has a short half-life (about 1 hour) and in this situation an infusion may therefore be required. Flumazenil should not normally be used in patients with mixed overdoses, a history of seizures, head injury, chronic benzodiazepine use, co-ingestion of a benzodiazepine and tricyclic antidepressant or other pro convulsantor as a “diagnostic test”.

If excitation occurs, barbiturates should not be used.

Shelf life: 24 months.

Store below 25°C.

Polypropylene tablet containers with low density polyethylene caps.

Pack sizes: 28, 30, 56, 60, 100 and 500 capsules.

White opaque PVC/PVdC 250mm / 40 gsm film and 20mm aluminium foil.

Pack sizes: 28, 30 and 100 capsules.

None.