Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Short-term (2-4 weeks) symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness.
Muscle spasm of varied aetiology.
Symptomatic relief of acute alcohol withdrawal.
Usual dose 10 mg, 2–3 times a day and up to 30 mg daily in divided doses. For severe symptoms 20 mg, 2–4 times a day. Maximun dose up to 100 mg daily in divided doses. Adjusted on an individual basis.
Generally, duration of treatment should not be more than 4 weeks, including a tapering-off process.
10 to 30 mg before retiring. Generally, duration of treatment varies from a few days to two weeks, with a maximum including a tapering-off process of four weeks.
25 to 100 mg and repeated if necessary in 2 to 4 hours.
10 to 30 mg daily in divided doses.
Librium is not for paediatric use.
Elderly or debilitated patients, patients with organic brain damage, respiratory impairment and/or hepatic or renal dysfunction should normally not exceed half of the doses normally recommended.
The lowest dose which can control symptoms should be used. 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. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. Treatment should not be continued at the full dose beyond four weeks.
In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status with special expertise. Little is known regarding the efficacy or safety of benzodiazepines in long-term use. Long-term chronic use is not recommended.
Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate.
Librium capsules are for oral administration and must be taken with water and not be chewed.
When taken alone in overdosage, Librium presents few problems in management. When taken with centrally-acting drugs, especially alcohol, the effects of overdose are likely to be more severe and in the absence of supportive measures may prove fatal.
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, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
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.
The benefit of gastric decontamination is uncertain. Consider activated charcoal (charcoal dose: 50 g for an adult, 1 g/kg for a child) in adults or children who have taken more than a potentially toxic amount within 1 hour, provided the airway can be protected.
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 an alternative to ventilation. Flumazenil has a short half-life (about an hour) and in this situation an infusion may therefore be required. Flumazenil should not normally be used in patients with a history of seizures, head injury, chronic benzodiazepine use, co-ingestion of a benzodiazepine and tricyclic antidepressant or other proconvulsant.
If excitation occurs, barbiturates should not be used.
PVDC blister pack 36 months.
HDPE bottle 24 months.
Plastic bottle 24 months.
Amber glass bottle 24 months.
Librium capsules should not be stored above 30°C.
PVDC Blister pack container 10 capsules.
HDPE bottle with jay-cap (snap-fit) closure containing 100 capsules.
Plastic bottle with screw cap containing 100 capsules.
Amber glass bottle with screw cap containing 100 capsules.
Not all pack sizes may be marketed.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordence with local requirements.
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