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DIAZEPAM DESITIN is a brand name for Diazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epileptic and febrile convulsions - to relieve muscle spasm caused by tetanus - as a sedative in minor surgical and dental procedures - initial use in anxiety and agitation, when the disorder is severe, disabling or subjecting the individual to extreme distress Diazepam Desitin may be used in these indications when a…
Verbatim from this product's MHRA label. Tap a section to expand.
5 mg / kg. Dosage depends on age, weight and individual response. Diazepam Desitin is also available in unit-doses of 5 mg. For doses of 5 mg Diazepam Desitin 5 mg Rectal solution is recommended. Because Diazepam Desitin is provided in fixed unit-doses of 5 and 10 mg, the dose is obtained by rounding upward to the next available dose.
Recommended doses:
Paediatric population Children: Under 10 kg (under 1 year): not recommended. 10 to 15 kg (1 to 3 years): one 5 mg tube of Diazepam Desitin 5 mg Rectal solution should be used. Insert tube half way to mark on nozzle. Over 15 kg (over 3 years): one 10 mg tube If no effect is seen after 10 minutes, the dose can be repeated in children.
The dose can be repeated every 12 hours. In case of repeated administration respiration should be monitored. Adults Adults: two 10 mg tubes If no effect is seen after 10 minutes, an additional 10 mg tube can be given to adults. The dose can be repeated every 12 hours.
In case of initially higher doses or repeated administration respiration should be monitored. If convulsions are still not controlled other anticonvulsive measures should be instituted. Treatment should be as short as possible. The lowest dose that can control the symptoms should be used.
The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. Elderly and debilitated patients Elderly and debilitated patients should be given not more than one half the usual adult dose.
Patients with liver or kidney dysfunction Dosage reduction may also be required in patients with liver or kidney dysfunction. Patients with chronic respiratory insufficiency A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
Method of administration For rectal administration only. Tubes are for single use only. The foil should be removed only before use. 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. Open the tube by twisting of the cap. b) Insert the tube nozzle completely into the rectum. For children under 15 kg, 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.
Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision. These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
Other adverse reactions like gastrointestinal disturbances, changes in libido or skin reactions have been reported occasionally. Elderly or debilitated patients are particularly susceptible to side effects and may require lower doses.
Undesirable effects are presented below by MedDRA System Organ Class, using the following frequency convention: 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 Rare: Blood dyscrasias including thrombocytopenia Metabolism and nutrition disorders Rare: Increased appetite Psychiatric disorders Common: Reduced alertness, numbed emotions, confusion, anterograde amnesia which can be associated with inappropriate behaviour, paradoxical reactions* Uncommon: Impaired concentration Rare: Loss of libido, increased libido In susceptible patients, an unnoticed depression may become evident.
4). Psychic dependence may occur. Abuse of benzodiazepines has been reported. *Paradoxical reactions (acute excitation, suicidal tendencies, restlessness, agitation, irritability, instability, anxiety, aggressiveness, rages, tension, delusions, nightmares, insomnia, psychoses, hallucinations, hostility, inappropriate behaviour) are known to occur with benzodiazepines and are more likely in children and the elderly.
If these undesirable effects occur, the medicinal product should be discontinued. **In the morning after evening administration, hang-over effects (disturbance of concentration and residual tiredness) and daytime sedation can impair reaction capacity.
Diazepam should only be used with particular caution in patients with: - renal or hepatic dysfunction - chronic pulmonary insufficiency - organic brain changes, particularly arteriosclerosis Diazepam should not be used in cases of loss or bereavement as psychological adjustments may be inhibited.
At the beginning of therapy, individual patient response to the medicinal product should be monitored, in order to ensure prompt recognition of any relative overdose due to accumulation. This particularly applies to elderly and debilitated patients, children and adolescents.
Diazepam should not be used concurrently with alcohol, the sedative effect may be enhanced. 5). 5). 5). Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate and limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation. Paediatric population Diazepam should not be given to children and adolescents without careful assessment of the need to do so; the duration of treatment must be kept to a minimum.
Specific patient groups Elderly patients (≥ 65 years) Caution is advised in elderly patients due to the risk of falling and consequently fractures, particularly when getting up at night. 2). High-risk patients Diazepam is not recommended for the primary treatment of psychotic illness.
8). As with other benzodiazepines extreme caution should be used if prescribing diazepam for patients with personality disorders. The disinhibiting effects of benzodiazepines may be manifested as the precipitation of suicide in patients who are depressed or show aggressive behaviour towards themselves and others.
3). Diazepam should be used with extreme caution in patients with a history of alcohol or drug abuse. Patients in shock may be treated with Diazepam only if measures are concurrently undertaken to correct the volume deficiency to avoid additional negative effects on circulation.
1 - Myasthenia gravis - Severe respiratory insufficiency - Sleep apnoea syndrome - Severe hepatic insufficiency
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. The medicinal product is particularly suitable for acute clinical intervention. When longer-term treatment with diazepam is to be discontinued, the dose should be reduced gradually.
8).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see details below).
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Kinetics of diazepam may be affected by hypovolaemia since diazepam has a high distribution volume and lipophilic properties. Development of tolerance Loss of efficacy (tolerance) can occur following long-term and repeated benzodiazepine intake over a period of weeks.
Development of dependence Benzodiazepine use can lead to the development of psychological and physical dependence. This applies not only to abuse of particularly high doses but also within the therapeutic dose range. The risk of drug dependence increases with the dose and duration of treatment.
This risk is also increased in patients with a history of dependence on alcohol or medicinal products or drug abuse. Long-term administration should be avoided unless there is a compelling indication and the therapeutic benefit has been carefully weighed up against the risk of tolerance and dependence.
The patient must be evaluated after a period of no more than 4 weeks. 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.
If physical dependence has developed, abrupt withdrawal of treatment is accompanied by withdrawal symptoms (see below). Drug discontinuation effects/Withdrawal symptoms Withdrawal symptoms may occur with benzodiazepines following normal use of therapeutic doses for only short periods and may consist of sleep disturbances, increased dreaming, headaches, muscle pain, extreme anxiety, tension, restlessness, sweating, trembling, mood changes, confusion and irritability.
In severe cases, the following symptoms may occur: confusional state, derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
This should be considered when treating patients for more than a few days. Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, may occur on withdrawal of treatment.
It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
The patient should be informed at the beginning of treatment about the limited duration of treatment and the gradual dose reduction should be precisely explained. It is also important that the patient is made aware of the risk of rebound phenomena, in order to reduce anxiety about such symptoms should they occur during withdrawal of the medicinal product.
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. Amnesia […]