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CHLORDIAZEPOXIDE is a brand name for Chlordiazepoxide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For short term (2 – 4 weeks only) use • 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 psychosomatic, organic or psychotic illness. • Muscle spasm of varied aetiology. • Symptomatic relief of…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration: oral and must be taken with water and not be chewed. 4). Treatment should be given for the shortest possible duration. If this medicine is being used for the treatment of epilepsy this medicine should be used for as long as the prescriber considers it necessary.
Posology:
Treatment to be given • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks) 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.
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. 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. 4). When treatment is started the patient should be informed that • treatment will be of limited duration • the dosage will be progressively decreased • there is the possibility of rebound phenomena.
Anxiety Adults 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. Maximum 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 Adults • 10-30mg at bed time. • Treatment would normally vary from a few days to two weeks with a maximum including a tapering-off process of four-weeks. Muscle Spasm Adults 10 mg to 30 mg daily in divided doses.
Common adverse effects include light-headedness and drowsiness, sedation, unsteadiness and ataxia; these are dose related but even after a single dose, may persist into the following day. However, these phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
2). 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: Frequency not known: Due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly. 4 Special warnings and precautions). Symptoms reported following discontinuation of chlordiazepoxide include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Amnesia Anterograde amnesia may occur at the therapeutic doses, with increasing risk at higher doses.
Drug dependence, tolerance and potential for abuse:
Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with chlordiazepoxide should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
1. 6) • Myasthenia gravis • Chronic psychosis. • Spinal or cerebral ataxia Chlordiazepoxide should not be used alone in depression or anxiety with depression (may precipitate suicide).
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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Symptomatic relief of acute alcohol withdrawal Adults 25 to 100 mg, repeated if necessary in 2hrs to 4hrs. Special populations Elderly and/or debilitated patients Dosage should not exceed half the adult dose. Children Chlordiazepoxide Capsules are not for paediatric use.
3) Patients who have taken benzodiazepines for a prolonged time may require a longer period of dosage reduction and specialist help may be appropriate.
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 benzodiazepinelike 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.
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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Tolerance:
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence:
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.
Therefore • regular monitoring of such patients is essential • routine repeat prescriptions should be avoided • treatment should be withdrawn gradually. 2) depending on the indication, but should not exceed 4 weeks, including tapering-off process.
If physical dependence has developed, abrupt termination of treatment results in withdrawal symptoms. These include headache, muscle pain, extreme anxiety, tension, restlessness, confusion, depression, nervousness, rebound insomnia, irritability, sweating and diarrhoea, sleep disturbance and mood changes following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.
In severe cases the following may occur: a feeling of unreality or of being separated from the body (derealisation), depersonalisation, hyperacusis, confusional state, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, psychotic manifestations including hallucinations or epileptic seizures.
Withdrawal symptoms will be worse in patients who have been dependent on alcohol or other narcotic drugs in the past, but can occur following abrupt cessation of treatment in patients receiving normal therapeutic doses for a short period of time.
When chlordiazepoxide is being used it is important not to change to a benzodiazepine with a short duration of action, as withdrawal symptoms may be precipitated. 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.
Drug withdrawal syndrome Prior to starting treatment with chlordiazepoxide, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with chlordiazepoxide should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care, and for use in epilepsy).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise […]