DIAZEPAM

V. M. injection which may be repeated after an interval of not less than 4 hours. V. M. higher doses may be needed, depending on the severity of the symptoms. V. M. injection which may be repeated after an interval of not less than 4 hours.

V. 3mg/kg bodyweight, repeated at intervals of 1 to 4 hours. The selected dose should relate to the severity of the case and in extreme severe cases higher doses have been used. 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, convulsions due to poisoning: 10 – 20 mg IV or IM, repeated if necessary 30 - 60 minutes later.

If indicated, this may be followed by slow intravenous infusion (maximum dose 3 mg/kg body weight over 24 hours). 2mg/kg body weight. The usual adult dose is 10 to 20mg but 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. V. ) or 1mg per year of life.

Tetanus:

By intravenous injection: • 100– 300 micrograms / kg every 1–4 hours. By intravenous infusion: • 3–10 mg / kg body weight, adjusted according to response, to be given over 24 hours. 2 mg/kg bodyweight. 5 ml per minute). The following points regarding dosage of benzodiazepines should be noted: 1.

The lowest dose which can control the symptoms should be used. It should not be continued beyond four weeks. 2. Long term chronic use is not recommended. 3. Treatment should always be tapered off gradually 4. Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.

5. When a benzodiazepine is used as a hypnotic, treatment should, if possible, be intermittent. 5ml of the solution per half a minute) until the patient becomes drowsy, the eyelids droop and the speech becomes slurred but the patient is still able to respond to requests.

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, Thrombocytopenia, Agranulocytosis.

Immune system disorders Very rare Hypersensitivity reactions, including anaphylaxis. 4). 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.

Intramuscular administration The IM use of diazepam injection can lead to a rise in serum creatinine phosphokinase activity, with a maximum level occurring between 12 and 24 hours after injection. This fact should be taken into account in the differential diagnosis of myocardial infarction.

The absorption from IM injection of diazepam may be variable, particularly for the gluteal muscles. This route of administration should only be used if IV administration is not possible. Propylene glycol Diazepam Injection contains propylene glycol.

Various adverse events, such as hyperosmolality, lactic acidosis; renal dysfunction (acute tubular necrosis), acute renal failure; cardiotoxicity (arrhythmia, hypotension); central nervous system disorders (depression, coma, seizures); respiratory depression, dyspnoea; liver dysfunction; haemolytic reaction (intravascular haemolysis) and haemoglobinuria; or multisystem organ dysfunction, have been reported with high doses or prolonged use of propylene glycol.

Therefore doses higher than 500 mg/kg/day may be administered in children > 5 years old but will have to be considered case by case. Adverse events usually reverse following weaning off of propylene glycol, and in more severe cases following hemodialysis.

Medical monitoring is required. P. 10mg/2ml). Exceeding this threshold may induce serious adverse effects in this population when administered with any substrate for alcohol dehydrogenase (such as ethanol). P. 10mg/2ml). The co-administration of propylene glycol at or above this safety threshold with any substrate for alcohol dehydrogenase (such as ethanol) may induce adverse effects in this population.

P. 10mg/2ml). • Patients with hepatic or renal impairment Various adverse events attributable to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure, and liver dysfunction. P. 10mg/2ml) has therefore been set by the EMA in patients with compromised hepatic or renal function.

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).

• 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).

• Acute porphyria. 6). 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. Diazepam injection contains 15mg/ml benzyl alcohol.

Must not be given to premature babies or neonates. May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.