DIAZEPAM

Posology As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 14 days. 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: 2mg three times daily up to 30mg daily in divided doses. Insomnia associated with Anxiety: 5mg to 15mg before retiring. Muscle Spasms: 2mg to 15mg daily in divided doses up to 60mg in severe spastic disorders such as cerebral spasticity, epilepsy and muscle spasms associated with upper-motor neurone disease.

In the control of muscle spasms as in tetanus: 3mg to 10mg/kg bodyweight daily. Alcohol Withdrawal Symptoms: 5mg to 20mg repeated within 2 to 4 hours if necessary. Premedication in Dental Patients: 5mg the night before, 5mg on waking and another 5mg 2 hours before the appointment.

Older people or Debilitated patients:

The dosage should be half that recommended in adults.

Use in children and adolescents:

Night Terrors and Somnambulism: 1mg to 5mg daily before retiring. Premedication: 2mg to 10mg. Management of Cerebral Spasticity: 2mg to 40mg daily in divided doses. In the control of Muscle spasms as in Tetanus: 3mg to 10mg/kg bodyweight daily.

Doses should be repeated only on medical advice. Long-term chronic use is not recommended and treatment should always be tapered off gradually. When a benzodiazepine is used as a hypnotic, treatment should, if possible, be intermittent.

Route of administration Oral. 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.

Diazepam may cause drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, sedation, blurring of vision and ataxia. These may 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). System Organ Class Frequency Undesirable effects Rare Blood dyscrasiasBlood 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 Gastrointestinal disorders Uncommon Gastrointestinal disorders (nausea, vomiting, constipation, diarrhoea), Increased salivary secretion.

Rare Dry mouth, increased appetite. 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.

4 Special warnings and precautions)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. 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.

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The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. 5). Duration of Treatment - The duration of treatment should be as short as possible depending on the indication, but should not exceed 4 weeks including tapering off process.

Treatment should not continue beyond 4 weeks without re-evaluation of the patient's condition. 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 minimizing anxiety over such symptoms should they occur while diazepam is being discontinued. There are indications that, in the case of benzodiazepines with a long duration of action such as diazepam, withdrawal phenomena can become manifest between doses, 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. 2 Posology and Method of Administration), porphyria, coma and organic brain changes, particularly arteriosclerosis.

Risk from concomitant use of opioids:

Concomitant use of Diazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Diazepam 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 Posology and Method of Administration). Tolerance Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardiorespiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.

Loss of efficacy to the hypnotic effects may develop after repeated use for a few weeks. Dependence The risk of dependence (physical or psychological) increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse, or in patients with a marked personality disorder.

Therefore • regular monitoring of such patients is essential • routine repeat prescriptions should be avoided • treatment should be withdrawn gradually 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 diazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.

2). If physical dependence has […]

6) • Acute porphyria Diazepam should not be used as monotherapy in patients with depression or those with anxiety with depression as suicide may be precipitated in such patients.