DIAZEPAM RECTUBES

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 Sensitivity to diazepam varies with age.

25 mg/kg body weight A maximum dose of 30 mg diazepam is recommended, unless adequate medical supervision and monitoring are available. 5 mg/kg body weight If convulsions are not controlled other anticonvulsive measures should be instituted.

The dose can be repeated every 12 hours. Method of administration The solution is administered rectally. Adults should be in the lateral position; children should be in the prone or lateral position. a) Tear open the foil pack. Remove the cap.

b) Insert the tube nozzle completely into the rectum. For children under 15kg, insert only half way. Hold the tube with the spout downwards. The contents of the tube should be completely emptied by using firm pressure with the index finger and thumb.

c) To avoid suction, maintain pressure on the tube until it is withdrawn from the rectum. Press together the patient’s buttocks for a short time. In anxiety, the duration of treatment should be as short as possible and generally not more than 8-12 weeks, including a tapering off process (see

During the first week of administration or when high doses are used they may have a sedative effect and cause some degree of drowsiness. In such cases there is an advantage in administering half the total daily intake at night, the remainder being given in divided doses during the day.

The elderly and debilitated are particularly sensitive to the effects of central depressant drugs and may experience confusion, especially if organic brain changes are present; the dosage of diazepam should not exceed one-half that recommended for other adults.

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 Very rare LeukopeniaBlood and lymphatic system disorders Rare Blood dyscrasias Immune system disorders Very rare Anaphylaxis.

Common Confusion. 4). Abuse of benzodiazepines Very common Drowsiness. Common Sedation, unsteadiness, ataxia (these effects are doserelated and may persist into the following day even after a single dose), impaired motor ability, tremor.

c Concentration difficulties, balance disorders, dizziness, headache, slurred speech. Nervous system disorders Rare Unconsciousness, insomnia, dysarthria, light headedness, vertigo, dystonic effects 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.

4 Special Warnings and Special Precautions for Use). Patients requiring chronic dosing should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration, to prevent overdose due to accumulation.

1. 6). 4 Special warnings and precautions for use 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.

1. 6).