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Mogadon 5mg by Valeant x 1 Strip

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Product Description

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Nitrazepam

Nitrazepamis a type of benzodiazepine drug and is marketed in English-speaking countries under the following brand names: Alodorm, Arem, Insoma, Mogadon, Nitrados, Nitrazadon, Ormodon, Paxadorm, Remnos, and Somnite.It is a hypnotic drug used in the treatment of moderate to severe insomnia which has sedative and motor impairing properties,as well as anxiolytic, amnestic, anticonvulsant, and skeletal muscle relaxant properties. Nitrazepam is available in 5 mg and 10 mg tablets. In the Netherlands, Australia, Israel, and the United Kingdom it is only available in 5 mg tablets. In Denmark it is available as 2.5 mg and 5 mg tablets under the name Pacisyn.

Tolerance to the sleep inducing effects of nitrazepam occurs after about seven days;tolerance also frequently occurs to the anticonvulsant effects of nitrazepam.A benzodiazepine dependence can develop with a benzodiazepine withdrawal syndrome occurring when the drug is stopped or the dose lowered.Common withdrawal symptoms include; anxiety, insomnia, concentration problems and fatigue.Long-term effects of benzodiazepines such as nitrazepam include worsening mental and physical health as well as cognitive deficits;i

;immunological disturbancesand an increased risk of developing cancer has also been associated with long-term use.

Nitrazepam at doses of 5 mg or higher impairs driving skillsand nitrazepam, like other hypnotic drugs is associated with an increased risk of road traffic accidents.In the elderly nitrazepam is associated with an increased risk of falls and hip fractures due to impairments on body balance.The elimination half-life of nitrazepam is 40 hours in the elderly and 29 hours in younger adults.Nitrazepam is commonly taken in overdose by drug abusers or suicidal individuals, sometimes leading to death.Nitrazepam is teratogenic if taken in overdose during pregnancy with 30 percent of births showing congenital abnormalities.Nitrazepam is a popular drug of abuse in countries where it is available.

comorbid psychiatric disorders.The Dutch, British and French system called the System of Objectified Judgement Analysis for assessing whether drugs should be included in drug formularies based on clinical efficacy, adverse effects, pharmacokinetic properties, toxicity and drug interactions was used to assess nitrazepam. A Dutch analysis using the system found that nitrazepam is unsuitable to be included in drug prescribing formularies.
Therapeutic uses

Nitrazepam is used to treat short-term sleeping problems (insomnia),namely difficulty falling asleep, frequent awakening, early awakenings, or a combination of each.

Nitrazepam is sometimes used for refractory epilepsies. However, long term prophylactic treatment of epilepsy has considerable drawbacks. Most importantly the loss of antiepileptic effects due to tolerance which renders prolonged nitrazepam therapy ineffective. Nitrazepam also has the drawback of significant side effects such as sedation, which is why nitrazepam and benzodiazepines in general are only prescribed in the acute management of epilepsies.Nitrazepam has been found to be more effective than clonazepam in the treatment of West syndrome which is an age dependent epilepsy, affecting the very young. However, as with other epilepsies treated with benzodiazepines, long term therapy becomes ineffective with prolonged therapy and the side effects of hypotonia and drowsiness are troublesome with nitrazepam therapy, other antiepileptic agents are therefore recommended for long term therapy, possibly Corticotropin (ACTH) or viga
piness, impaired psychomotor and cognitive functions may persist into the next day which may impair the ability of users to drive safely and increases the risk of falls and hip fractures.Significant impairment of visual perception and sedative effects persisting into the next day typically occurs with nitrazepam administration as was demonstrated in a human clinical trial assessing the effect of nitrazepam on peak saccade velocity.

Impairment of psychomotor function may especially occur after repeated administration, with the elderly being more vulnerable to this adverse effect. Overall accuracy of completing tasks is impaired after repeated administration of nitrazepam and is due to drug accumulation of nitrazepam. The elderly are more vulnerable to these side effects.
Less common side effects

Hypotension,faintness, palpitation, rash or pruritus, gastrointestinal disturbances, changes in libido. Very infrequently, paradoxical reactions may occur,for example, excitement, stimulation, hallucinations, hyperactivity and insomnia. Also depressed or increased dreaming, disorientation, severe sedation, retrograde amnesia, headache, hypothermia, delirium tremens.Acroparaesthesia has been reported as a side effect from nitrazepam with symptoms including, pins and needles in hands and loss of power of fingers and clumsiness of the fingers.Severe liver toxicity has also been reported.
Tolerance dependence and withdrawal
Tolerance

Tolerance to a drug's effects occurs after regular exposure to a drug. The mechanism of nitrazepam tolerance may be due to down-regulation of benzodiazepine receptors (observed in rats).When tolerance and habituation occurs to nitrazepam its pharmacokinetic profile changes with absorption of the drug slowing down, elimination increasing and brain concentration of nitrazepam increasing significantly.Increased levels of GABA in cerebral tissue and alterations in the activity state of the serotoninergic system occurs as a result of nitrazepam tolerance.

After six days of use, tolerance to nitrazepam's but not temazepam's sleep-inducing effects and performance-impairing effects occurred in a study. One study demonstrated tolerance to the sleep promoting effects of nitrazepam and temazepam after seven days nightly administration in 19 elderly inpatients. Self reported quality of sleep was found to be increased after the first nights administration of either nitrazepam or temazepam but by day seven self reported quality of sleep was found to have returned to baseline in these patients, suggesting the development of tolerance after seven days use. The effect was more pronounced in patients of lower intelligence.In mice tolerance to the anticonvulsant properties of nitrazepam developed profoundly and rapidly over six days, and then did not proceed. Some anticonvulsant effects were still apparent after six days administration.In humans tolerance to the anticonvulsant effects of nitrazepam is a frequent occurrence.
Dependence and withdrawal
See also: benzodiazepine withdrawal syndrome

Benzodiazepine drugs such as nitrazepam can cause dependence and addiction and is what is known as the benzodiazepine withdrawal syndrome. Withdrawal from nitrazepam or other benzodiazepines often leads to withdrawal symptoms which are similar to those seen with alcohol and barbiturates, including delirium tremens.The higher the dose and the longer the drug is taken the greater the risk of experiencing unpleasant withdrawal symptoms. Withdrawal symptoms can however occur at standard dosages and also after short term treatment. Benzodiazepine treatment should be discontinued as soon as possible via a slow and gradual dose reduction regime.Common withdrawal symptoms include, anxiety, insomnia, concentration problems and fatigue.

Frequent use of nitrazepam may cause dependence and when the drug is reduced or stopped, withdrawal symptoms occur. Withdrawal symptoms including a worsening of insomnia compared to baseline typically occurs after discontinuation of nitrazepam even after short term single nightly dose therapy.Dependence on benzodiazepines such as nitrazepam or temazepam often occurs due to discharging patients from hospital on benzodiazepines who were started on benzodiazepine hypnotics in hospital. It is recommended that hypnotic use in hospital be limited to five days to avoid the development of drug dependence and withdrawal insomnia.

After discontinuation of nitrazepam a rebound effect may occur about four days after stopping medication.Nitrazepam has more side effects than other hypnotic drugs and tolerance to sedative properties and rebound insomnia after discontinuation occurs after only seven days administration. Tolerance to the anticonvulsant and anxiolytic effects also develops rapidly during daily administration.

Abrupt withdrawal after long term use from therapeutic doses of nitrazepam may result in a severe benzodiazepine withdrawal syndrome. Reports in the medical literature report of two psychotic states developing after abrupt withdrawal from nitrazepam including delirium after abrupt withdrawal of 10 mg of nitrazepam and in another case auditory hallucinations and visual cognitive disorder developed after abrupt withdrawal from 5 mg of nitrazepam and 0.5 mg of triazolam. Gradual and careful reduction of the dosage was recommended to prevent severe withdrawal syndromes from developing. Antipsychotics increase the severity of benzodiazepine withdrawal effects with an increase in the intensity and severity of convulsions. Depersonalisation has also been reported as a benzodiazepine withdrawal effect from nitrazepam.
Special precautions

Benzodiazepines require special precaution if used in the alcohol or drug dependent individuals and individuals with comorbid psychiatric disorders.It has been recommended that caution should be exercised in prescribing nitrazepam to anyone who is of working age due to the significant impairment of psychomotor skills; This impairment is greater the higher the dosage that is prescribed.Nitrazepam in doses of 5 mg or more causes significant deterioration in vigilance performance combined with increased feelings of sleepiness.Doses as low as 5 mg of nitrazepam can impair driving skills. Therefore people driving or conducting activities which require vigilance should exercise caution in using nitrazepam or possibly avoid it all together.
Elderly

Nitrazepam, similar to other benzodiazepines and nonbenzodiazepines causes impairments in body balance and standing steadiness in individuals who wake up at night or the next morning. Falls and hip fractures are frequently reported. The combination with alcohol increases these impairments. Partial, but incomplete tolerance develops to these impairments.Nitrazepam has been found to be dangerous in elderly patients due to a significant increased risk of falls.This increased risk is probably due to the persisting drug effects of nitrazepam well into the next day.Nitrazepam is a particularly unsuitable hypnotic for the elderly as it induces a disability characterised by general mental deterioration, inability to walk, incontinence, dysarthric, confusion, prone to stumbling, falls, and disoriention which can occur from doses as low as 5 mg. The nitrazepam induced symptomatology can lead to a misdiagnosis of brain disease in the elderly, for example dementia and can also lead to the symptoms of postural hypotension which may also get misdiagnosed. It was reported that a geriatric unit was seeing as many as 7 patients a month with nitrazepam induced disabilities and health problems. It was recommended that nitrazepam should join the barbiturates in not being prescribed to the elderly.Only nitrazepam and lorazepam were found to increase the risk of falls and fractures in the elderly.CNS depression occurs much more frequently in the elderly and is especially common in doses above 5 mg of nitrazepam.Both young and old patients report sleeping better after three nights use of nitrazepam however they also report feeling less awake and are slower on psychomotor testing up to 36 hours after intake of nitrazepam. The elderly showed cognitive deficits, making significantly more mistakes in psychomotor testing than younger patients despite similar plasma levels of the drug, suggesting that the elderly are more sensitive to nitrazepam due to increased sensitivity of the aging brain to nitrazepam. Confusion and disorientation can result from chronic nitrazepam administration to elderly subjects. Also the effects of a single dose of nitrazepam may last up to 60 hours after administration.
Children

Nitrazepam is not recommended for use in those under eighteen years of age. Use in very young children may be especially dangerous. Children treated with nitrazepam for epilepsies may develop tolerance within months of continued use, with dose escalation often occurring with prolonged use. Sleepiness, deterioration in motor skills and ataxia were common side effects in children with tuberous sclerosis treated with nitrazepam. The side effects of nitrazepam may impair the development of motor and cognitive skills in children treated with nitrazepam. Withdrawal of nitrazepam only occasionally resulted in a return of seizures and some children withdrawn from nitrazepam appeared to improve. Development, for example, able to walk at five years was impaired in many children taking nitrazepam but was not impaired with several other non benzodiazepine antiepileptic agents. It has been recommended that children being treated with nitrazepam should be reviewed and have their nitrazepam gradually discontinued whenever appropriate. Excess sedation, hypersalivation, swallowing difficulty, high incidence of aspiration pneumonia as well as several deaths has been associated with nitrazepam therapy in children.
Pregnancy

The use of nitrazepam during pregnancy can lead to intoxication of the new born. A neonatal withdrawal syndrome can also occur if nitrazepam or other benzodiazepines are used during pregnancy with symptoms such as hyper-excitability, tremor and gastro-intestinal upset (diarrhea or vomiting) occurring. Breast feeding by mothers using nitrazepam is not recommended.Nitrazepam is a long acting benzodiazepine and there is a risk of drug accumulation, even though no active metabolites are formed during metabolism. Accumulation can occur in various body organs including the heart, accumulation is even greater in babies. Nitrazepam rapidly crosses the placenta and also is present in breast milk in high quantities. Therefore benzodiazepines including nitrazepam should be avoided during pregnancy.In early pregnancy nitrazepam levels are lower in the baby than in the mother and in the later stages of pregnancy nitrazepam is found in equal levels in both the mother and the unborn child.Internationally benzodiazepines are known to cause harm when used during pregnancy and nitrazepam is a category D drug during pregnancy.

Benzodiazepines are lipophilic and rapidly penetrate membranes and therefore rapidly penetrate the placenta with significant uptake of the drug. Use of benzodiazepines such as nitrazepam in late pregnancy especially high doses may result in floppy infant syndrome.Use in the third trimester stage of pregnancy may result in the development of a severe benzodiazepine withdrawal syndrome in the neonate. Withdrawal symptoms from benzodiazepines in the neonate may include hypotonia, and reluctance to suck, to apnoeic spells, cyanosis, and impaired metabolic responses to cold stress. These symptoms may persist for hours or months after birth.

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