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LIBRIUM is a brand name for Chlordiazepoxide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
Anxiety states-- 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.
Insomnia associated with anxiety-- 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. Symptomatic relief of acute alcohol withdrawal-- 25 to 100 mg and repeated if necessary in 2 to 4 hours.
Muscle spasm of varied aetiology-- 10 to 30 mg daily in divided doses. Paediatric patients Librium is not for paediatric use. Special patient groups 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.
Method of administration:
Common adverse effects include drowsiness, sedation, dizziness, somnolence, fatigue, balance disorder, unsteadiness and ataxia; these are dose-related and may persist into the following day even after a single dose. However, these phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
The elderly are particularly sensitive to the effects of centrally-depressant drugs and may experience confusion, especially if organic brain changes are present; and the dosage of Librium should not exceed one-half that recommended for other adults.
Evaluation of undesirable effects is based on the following frequency information: 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 (frequency cannot be estimated from available data).
g. g. g. g. rash) Musculoskeletal and connective tissue disorders: Due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly Frequency not known: Muscle weakness Renal and urinary disorders: Rare: Urinary retention, incontinence Reproductive system and breast disorders: Rare: Libido disorders, erectile dysfunction, menstrual disorder General disorders and administration site conditions: Common: Fatigue Frequency not known: Changes in salivation Amnesia Anterograde amnesia may occur at the therapeutic doses, with increasing risk at higher doses.
4) Depression Pre-existing depression may be unmasked by benzodiazepines. Psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behavior and other adverse behavioural effects are known to occur when using benzodiazepine- like agents.
They may be quite severe with this product. They are more likely to occur in children and the elderly. Dependence Use (even therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in the withdrawal or rebound phenomena.
Tolerance:
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence and withdrawal:
The dependent potential of the benzodiazepines is low, particularly when limited to short-term use. Risk for physical and psychological dependence increases when high doses are used, especially when given over long periods. This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders.
Regular monitoring in such patients is essential. Routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Symptoms such as headaches, muscle pain, extreme anxiety, restlessness, confusion, depression, nervousness, rebound insomnia, irritability, sweating and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations, psychotic manifestations or epileptic seizures.
Abuse of benzodiazepines has been reported.
Rebound insomnia and anxiety:
This is a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.
Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
1 - myasthenia gravis - severe pulmonary insufficiency - respiratory depression - severe hepatic insufficiency - sleep apnoea syndrome - phobic or obsessional states - chronic psychosis - spinal or cerebral ataxia
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Chlordiazepoxide in United Kingdom.
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Librium capsules are for oral administration and must be taken with water and not be chewed.
Psychological dependence may occur. Abuse of benzodiazepines has been reported Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Duration of treatment:
The duration of treatment should be as short as possible (see Posology) depending on the indication, but should not exceed 4 weeks, including tapering-off process. Routine repeat prescriptions should be avoided. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.
Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop.
Amnesia:
Amnesia may occur. Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 to 8 hours (see Undesirable effects).
Psychiatric and paradoxical reactions:
Rare behavioural effects including restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.
Should these effects occur, use of the medicinal product should be discontinued. They are more likely to occur in children and the elderly.
Risk from concomitant use of opioids:
Concomitant use of Librium and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines 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). 2) A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
Benzodiazepines are contraindicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy and reduced doses should be given to patients with renal or hepatic disease. Benzodiazepines are not recommended for the primary treatment of psychotic illness, phobia or obsessive-compulsive diseases.
Librium should not be used alone to treat depression or anxiety associated with depression, since it may uncover depression with suicidal tendencies. Extreme caution should be used in prescribing benzodiazepines to patients with personality disorders.
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. Due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose- galactose malabsorption should not take this medicine.