DIAZEPAM

2. General Diazepam Injection BP contains propylene glycol and ethanol. g. 4). 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 Adults Severe acute anxiety or agitation: 10 mg by slow IV injection or IM injection which may be repeated after 4 hours. Delirium Tremens: 10 – 20 mg by IV or IM injection. Higher doses may be needed depending on the severity of symptoms.

Acute Muscle Spasm: 10 mg by slow IV injection or IM injection which may be repeated after 4 hours if required.

Tetanus:

Initially an IV dose of 100 – 300 micrograms/kg body weight every 1 - 4 hours. Continuous IV infusion of 3 – 10 mg / kg body weight per 24 hours can also be used. The chosen dose should be related to the severity of the case and in extremely severe cases higher doses have been used.

Status epilepticus, febrile convulsions, convulsions due to poisoning: 10 mg by IV injection, repeated if necessary 10 minutes later. If indicated, this may be followed by slow intravenous infusion (maximum dose 3 mg / kg body weight over 24 hours).

Pre-operative medication or premedication: 10 – 20 mg to be administered immediately before the procedure. Higher doses may be necessary according to the clinical response.

Elderly or Debilitated Patients:

Doses should not exceed half those normally recommended. Hepatic Impairment In patients with chronic hepatic disease the dosage of Diazepam Injection BP may need to be reduced. 4). Renal Impairment In renal failure there is no clinically significant change to the half-life of diazepam and a dose adjustment is usually not necessary.

4) Cardiorespiratory Impairment A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. 4). 5 mg / kg / day) Treatment with Diazepam Injection BP at the doses recommended for paediatric patients in the indications below may correspond to a propylene glycol dose which may exceed the associated EMA exposure limit.

4).

Status epilepticus, convulsions due to poisoning, febrile convulsions:

By intravenous injection: Paediatric population Dosing recommendation Neonates 300–400micrograms / kg, then 300–400micrograms / kg after 10minutes if required. Each injection to be given over 3–5 minutes. Children 1 month 300–400micrograms / kg (maximum per dose 10mg), – 11 years then a further 300–400micrograms / kg injection after 10minutes, if required.

Each injection to be given over 3 – 5 minutes Children 12 – 17 years 10 mg then a further 10 mg after 10 minutes, if required. Each injection to be given over 3 – 5 minutes.

Tetanus:

By intravenous injection: • 100– 300 micrograms / kg every 1–4hours. By intravenous infusion: • 3–10mg / kg body weight, adjusted according to response, to be given over 24 hours. 2 mg / kg body weight. 5 ml per minute). Method of administration Diazepam Injection BP may be given IV injection, IM injection, or by IV infusion.

The absorption from IM injection of diazepam may be variable, particularly for the gluteal muscles, and therefore the IM route of administration should only be used if IV administration is not possible. 2. Diazepam Injection BP should not be diluted when administered via intravenous or intramuscular injection.

0 ml solution per minute). It is advisable to keep the patient supine for at least an hour after administration. Except in emergencies, a second person should always be […]

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. Elderly patients may experience confusion 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, particularly in children.

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, Thrombocytopenia, Agranulocytosis Immune system disorders Very rare Hypersensitivity reactions, including anaphylaxis.

4). Psychiatric disorders Common Confusion. 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. Ear and labyrinth disorders Not known Vertigo Cardiac disorders Rare Bradycardia, heart failure including cardiac arrest. Rare Hypotension, syncope.

The incidence of hypotension may be reduced by not exceeding the recommended rate of administration. Patients should be managed in the supine position and kept there throughout the procedure. Vascular disorders Not known Intravenous injections of diazepam may be associated with local reactions and thrombophlebitis and venous thrombosis may occur.

Uncommon Respiratory depression. Rare Respiratory arrest, increased bronchial secretion. Respiratory, thoracic and mediastinal disorders Not Known Apnoea, worsening of obstructive pulmonary disease Uncommon Gastrointestinal disorders (nausea, vomiting, constipation, diarrhoea), increased salivary secretion.

Gastrointestinal disorders 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). 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. General disorders and administration site conditions Not known Anaphylaxis, injection site pain or irritation (see also Vascular disorders) 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). 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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4. 4. 4. 1 3 PHARMACEUTICAL FORM Sterile injection. 1 Therapeutic indications Adults Diazepam is an anxiolytic, anti-convulsant and central muscle-relaxant. Diazepam is used to relieve anxiety and provide sedation in severe acute anxiety or agitation and for the management of agitation associated with delirium tremens.

Diazepam is used to relieve acute muscle spasm and tetanus. Acute convulsions including status epilepticus, also convulsions due to poisoning and febrile convulsions. As an adjunct during endoscopy, in dentistry, surgery, radiology. Cardiac catheterisation, cardioversion, used pre-operatively to relieve anxiety, provide sedation, light anaesthesia and anterograde amnesia.

Paediatric patients Diazepam Injection BP is used: • to treat status epilepticus, convulsions due to poisoning, and febrile convulsions; • to treat tetanus; • as a pre-operative medication or premedication. 2. General Diazepam Injection BP contains propylene glycol and ethanol.

g. 4). 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 Adults Severe acute anxiety or agitation: 10 mg by slow IV injection or IM injection which may be repeated after 4 hours.

Delirium Tremens: 10 – 20 mg by IV or IM injection. Higher doses may be needed depending on the severity of symptoms. Acute Muscle Spasm: 10 mg by slow IV injection or IM injection which may be repeated after 4 hours if required.

Tetanus:

Initially an IV dose of 100 – 300 micrograms/kg body weight every 1 - 4 hours. Continuous IV infusion of 3 – 10 mg / kg body weight per 24 hours can also be used. The chosen dose should be related to the severity of the case and in extremely severe cases higher doses have been used.

Status epilepticus, febrile convulsions, convulsions due to poisoning: 10 mg by IV injection, repeated if necessary 10 minutes later. If indicated, this may be followed by slow intravenous infusion (maximum dose 3 mg / kg body weight over 24 hours).

Pre-operative medication or premedication: 10 – 20 mg to be administered immediately before the procedure. Higher doses may be necessary according to the clinical response.

Elderly or Debilitated Patients:

Doses should not exceed half those normally recommended. Hepatic Impairment In patients with chronic hepatic disease the dosage of Diazepam Injection BP may need to be reduced. 4). Renal Impairment In renal failure there is no clinically significant change to the half-life of diazepam and a dose adjustment is usually not necessary.

4) Cardiorespiratory Impairment A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. 4). 5 mg / kg / day) Treatment with Diazepam Injection BP at the doses recommended for paediatric patients in the indications below may correspond to a propylene glycol dose which may exceed the associated EMA exposure limit.

4).

Status epilepticus, convulsions due to poisoning, febrile convulsions:

By intravenous injection: Paediatric population Dosing recommendation Neonates 300–400micrograms / kg, then 300–400micrograms / kg after 10minutes if required. Each injection to be given over 3–5 minutes. Children 1 month 300–400micrograms / kg (maximum per dose 10mg), – 11 years then a further 300–400micrograms / kg injection after 10minutes, if required.

Each injection to be given over 3 – 5 minutes Children 12 – 17 years 10 mg then a further 10 mg after 10 minutes, if required. Each injection to be given over 3 – 5 […]

1). • Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur) • Acute pulmonary insufficiency, respiratory depression, acute or chronic severe respiratory insufficiency (ventilator failure may be exacerbated).

• Sleep apnoea syndrome (condition may be exacerbated). • Marked neuromuscular respiratory weakness including unstable myasthenia gravis (condition may be exacerbated). • Severe hepatic impairment (elimination half-life of diazepam may be prolonged).

6) Diazepam Injection should not be used alone in the treatment of depression or anxiety associated with depression due to the risk of precipitation of suicide in this patient group.