Loading…
DIAZEPAM is a brand name for Diazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Diazepam has potent anxiolytic, anticonvulsant and central muscle-relaxant properties; these effects are probably mediated through special areas in the CNS (Central Nervous System). It also has uses in pre-operative medication and is used in the treatment skeletal-muscle spasm and the associated pain. Adults: 1.…
Verbatim from this product's MHRA label. Tap a section to expand.
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 As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed a time period of 4 weeks, including the period of tapering off and treatment should be gradually withdrawn.
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: 5-30 mg daily in divided doses.
Insomnia associated with anxiety: 5-15 mg at bedtime. Cerebral palsy: 5-60 mg daily in divided doses. Upper motor neuronic spasticity: 5-60 mg daily in divided doses. Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 5-15 mg daily in divided doses.
Adjunct to the management of some types of epilepsy: 2-60 mg daily in divided doses. Alcohol withdrawal: 5-20 mg, repeated if necessary in 2 to 4 hours. Oral premedication in dental patients: 5 mg the night before, 5 mg on waking and 5 mg two hours before the appointment.
Oral premedication before surgery: 5-20 mg.
Elderly and debilitated patients:
For all indications doses should be half of those recommended for other adults. 4): The use of diazepam in hepatic impairment may precipitate coma, therefore the dose should be reduced or an alternative drug considered. In severe renal impairment the dose should be reduced.
Paediatric population Alternative pack sizes of diazepam are recommended for paediatric usage in order to obtain suitable doses of less than 5 mg. 4): 2 mg to 10 mg. Spastic children with minimal brain damage: 5–40 mg daily in divided doses.
Method of administration For oral use.
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). Blood and lymphatic system disorders Very rare Leukopenia.
Immune system disorders Very rare Anaphylaxis. 4). Very common Drowsiness. Common Ataxia, impaired motor ability, tremor. c Concentration difficulties, balance disorders, dizziness, headache, slurred speech. Nervous system disorders 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. Uncommon Respiratory depression.
Rare Respiratory arrest, increased bronchial secretion. Respiratory, thoracic and mediastinal disorders Not known Apnoea. Uncommon Gastrointestinal disorders (nausea, vomiting, constipation, diarrhoea), increased salivary secretion. Gastrointestinal disorders Rare Dry mouth, increased appetite.
The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. 5). • Duration of treatment - The lowest dose that can control the symptoms should be used. The duration of treatment should be as short as possible depending on the indication.
The patient must be evaluated after a period of no more than 4 weeks and then regularly thereafter in order to assess the need for continued treatment, especially if the patient is free of symptoms. In general, treatment must not last any longer than 8-12 weeks, including the tapering off process.
Extension beyond these periods should not take place without re-evaluation of the situation. 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 diazepam is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
•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 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.
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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Diazepam in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Hepatobiliary disorders Rare Jaundice, changes of hepatic parameters (elevation of ALT, AST, alkaline phosphatase). Skin and subcutaneous tissue disorders Uncommon Allergic skin reactions (itching, erythema, rash). Musculoskeletal and connective tissue disorders Uncommon Myasthenia.
Renal and urinary disorders Rare Urinary retention, incontinence. Reproductive system and breast disorders Rare Gynaecomastia, impotence, increased or reduced libido. d General disorders and administration site conditions Not known Anaphylaxis Investigations Very rare Elevation of transaminases.
a Known to occur when using benzodiazepines or benzodiazepine-like agents. These reactions may be quite severe. They are more likely to occur in children and the elderly. 4). b Pre-existing depression may be unmasked during benzodiazepine use.
c May occur using therapeutic dosages, the risk increasing at higher dosages. 4). d The likelihood and degree of severity of withdrawal symptoms is dependent on the duration of treatment, dose level and degree of dependency. 4 Special warnings and precautions).
Symptoms reported following discontinuation of benzodiazepines 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. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 Diazepam Tablets should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with Diazepam, 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 Diazepam 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 rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
8). These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. 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 or epileptic seizures.
Rebound insomnia and anxiety; a transient syndrome whereby […]