Loading…
NITRAZEPAM MIXTURE is a brand name for Nitrazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime sedation is acceptable. An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief. Benzodiazepines are not recommended for…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Nitrazepam Mixture is a long acting benzodiazepine. Dosage should be adjusted on an individual basis. Treatment should, if possible, be on an intermittent basis. Treatment should be as short as possible and should be started with the lowest recommended dose which can control the symptoms.
The maximum dose should not be exceeded.
Duration of treatment:
The duration of treatment should be as short as possible (see Posology) depending on the indication but should not exceed 4 weeks including any dose-tapering period for insomnia. Extension beyond this period should not take place without re-evaluation of the situation.
4). Treatment should be given for the shortest possible duration. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while Nitrazepam mixture oral suspension is being discontinued.
Adults: 5 mg (10 ml) before retiring to bed. This dose may, if necessary, be increased to 10 mg (20 ml). 5 mg (5 ml) before retiring to bed. This dose may, if necessary, be increased to 5 mg (10 ml). If organic brain changes are present, the dosage should not exceed 5 mg in these patients.
Other populations:
In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, the dosage may need to be reduced.
Paediatric population:
Nitrazepam Mixture is contraindicated for use in children. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use.
In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. Long-term chronic use is not recommended. 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 decreased.
Moreover, it is important that the patient should be aware of the possibility of rebound phenomena (see Undesirable Effects) thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.
The following commonly occur predominantly at the start of therapy and usually disappear with repeated administration: ataxia or double vision, confusion, dizziness, drowsiness, fatigue, headache, muscle weakness, numbed emotions, reduced alertness.
The elderly are particularly sensitive to the effects of centrally-depressant drugs. Undesirable effects may persist into the following day due to the long half-life. Within the system organ classes, adverse drug reactions are listed under heading of frequency (number of patients expected to experience the reaction, using the following convention: Very common (>1/10) : common (>1/100 to 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 available data) Blood and lymphatic system disorders: Frequency not known: Blood disorder Immune system disorders: Frequency not known: Allergic skin reaction, anaphylactic reaction, angioedema Psychiatric disorders: Common: Numbed emotions, confusional state, depression (pre-existing depression may be unmasked).
4), agitation, aggression, delusion, anger, nightmare, hallucination, psychotic disorder.
Nervous system disorders:
Common: Drowsiness, reduced alertness, headache, dizziness Rare: Vertigo, dysarthria Frequency not known: Balance disorder, hypokinesia, tremor, anterograde amnesia, epilepsy The elderly are particularly sensitive to the effects of centrally-depressant drugs.
4, Special warnings and precautions). 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.
An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief. Benzodiazepines are not recommended for the primary treatment of phobic or obsessional states, chronic psychosis or psychotic illness.
Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy. 3 – contraindicated in severe respiratory insufficiency).
Tolerance:
Some loss of efficacy of the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. 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.
1 Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypertension have been reported on rare occasions in susceptible patients.
The use of nitrazepam is also contraindicated in patients with the following:
Acute pulmonary insufficiency; Respiratory depression; Phobic or obsessional states; Chronic psychosis; Myasthenia gravis; Sleep apnoea syndrome; Severe hepatic insufficiency; Acute porphyria; Children. Short-term treatment in children and juveniles
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nitrazepam in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Nitrazepam therapy should not be stopped abruptly, but the dose tapered off. The product should be taken just before going to bed. In addition, for long-acting benzodiazepines, it must be stated that the patient 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.
Method of administration Oral administration. 5 ml up to 20 ml is included in the package.
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.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 nitrazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with nitrazepam, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with nitrazepam should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Amnesia:
Benzodiazepines may induce anterograde amnesia. The condition occurs most often 1-2 hours after ingesting the product and may last up to several hours. Therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see also Undesirable Effects).
If the patient is awoken during the period of maximum drug activity, recall may be impaired.
Psychiatric and paradoxical reactions:
Extreme caution should be used when prescribing benzodiazepines to patients with personality disorders. Abnormal psychological reactions and rare behavioural effects like restlessness, agitation, excitement, confusion, irritability, paradoxical aggressive outbursts, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and the uncovering of depression with suicidal tendencies are known to occur when using benzodiazepines.
They may be quite severe and are more likely in children and the elderly. Should they occur, use of the medicinal product should be discontinued.
Concomitant use of alcohol/CNS depressants:
The concomitant use of nitrazepam with alcohol or/and CNS depressants should be avoided. 5).
Risk from concomitant use of opioids:
Concomitant use of Nitrazepam Mixture and opioids may […]