|
|
|
|
Product Catalogue
ICN (VALEANT)
MOGADON
Scientific Name:
Nitrazepam
|
|
Composition
Each tablet contains: Nitrazepam 5 mg.
Properties and effects
Sleep disorders
When taken in the evening, Mogadon induces a sleep of six-to eight hour's duration.
Epilepsy
Mogadon is suitable for the treatment of nodding spasms with hypsarrhythmia (West's syndrome) and childhood epileptic encephalopathy with diffuse, slow spike waves (Lennox syndrome). Like all other medicines for the treatment of petit mal, Mogadon should be administered concomitantly with barbiturates and hydantoins in order to prevent convulsive episodes in latent grand mal.
Indications and usage
Sleep disorders
Mogadon is indicated for sleep disorders that require treatment and which are caused, for instance by irritability, overwork, conflicts, anxiety, worry, tension and feelings of oppression. In organic sleep disorders, Mogadon is also indicated in conjunction with the specific treatment for the underlying disease.
Epilepsy
Nodding spasms with hypsarrhythmia (West's syndrome) and childhood epileptic encephalopathy with diffuse slow spike waves (Lennox syndrome).
Dosage and administration
Sleep disorders
Mogadon should be taken in the evening before the patient goes to bed.
Adults: 1 tablet (5 mg) in the evening.
This is a mean dosage which can be reduced or increased to 10 mg for out-patients or 20 mg for inpatients, depending on the response.
Children: administer strictly as indicated in the case of sleep disorders.
Infants, 0-1 year:1/4 – 1/2 tablet. Infants receive approximately 1/4 mg per month of age.
Young children, 1-6 years: 1/2-1 tablet.
Children of school age, 6-14 years: 1 tablet.
Elderly patients: 1/2-1 tablet.
The tablets may be swallowed whole, chewed or dissolved in liquid.
Duration of treatment: In the case of long-term treatment, Mogadon should be withdrawn for a treatment-free period at regular intervals to ascertain whether the therapy need to be continued. Mogadon therapy should not be stopped abruptly.
Epilepsy
Infants up to 1 year: 1-2 tablets.
Children from 2-14 years: 3 tablets.
These daily doses should be administered as three individual doses if possible.
Such high doses may cause bronchial hypersecretion in infants with epilepsy. The latter must be examined before treatment is started in order to determine whether the upper airways are clear.
Restrictions on use
Contraindications
Mogadon is contraindicated in patients with known hypersensitivity to benzodiazepines or known dependency on other agents including alcohol.
Mogadon is also contraindicated in patients with chronic hypercapnia or severe respiratory failure.
Precautions
Caution should be exercised in patients with myasthenia gravis and prescribed Mogadon therapy due to pre-existing muscle weakness. Caution is also necessary in the presence of known cadiorespiratory insufficiency since sedatives such as Mogadon can potentiate existing respiratory depression. Conversely, in certain cases, the calming effect of the preparation can be beneficial in that it limits the exertion demanded by the action of breathing
Mogadon should only be administered with care to patients presenting with sleep apnoea syndrome
In infants and young children Nitrazepam should be used only with particular care, considering that hypersalivation, hypersecretion in the respiratory tract, drowsiness and depressing respiration, may occur. Caution is also necessary in patients with existing problems like disphagie, aspiration tendency and gastroesophageal reflux.
The individual dosage should be adapted carefully under supervision of a neurological children's ward
.
Vigilance, ability to react
Patients taking Mogadon should be advised not to perform activities requiring their concentrated attention such as operating dangerous machinery or driving motor vehicles. Patients must also be instructed not to drink alcohol during treatment with Mogadon since the two substances can have a mutually potentiating effect.
Dependency
The administration of benzodiazepines can lead to dependence. This risk is increased during prolonged treatment, administration of high dose levels and in pre-disposed patients. Withdrawal symptoms mainly appear when treatment has been discontinued abruptly and are limited in milder cases to tremor, restlessness, sleep disorders, anxiety, headaches and poor concentration. Symptoms such as sweating, muscle and abdominal cramps, impaired perception and, very occasionally, delirium and cerebral convulsive seizures can occur.
The onset of withdrawal symptoms varies from a few hours to one week or more following treatment withdrawal, depending on the duration of effect of the treatment.
In order to reduce the risk of dependency to a minimum, benzodiazepines should be prescribed only after careful consideration of the indication and, where possible, for as short a period as possible (as a hypnotic, generally for not longer than four weeks). Periodical checks should be carried out to establish whether continued treatment is required. Longer-term treatment is indicated only in certain patients and the risk/benefit ratio is less clear Treatment should be gradually withdrawn by reducing the dosage stepwise in order to avoid the onset of withdrawal syndromes. Strict medical supervision and patient care are required if withdrawal symptoms appear.
Pregnancy, lactation
There are clear indications regarding risks of the human foetus, but the therapeutic benefits for the mother may outweigh these
Nitrazepam crosses the placenta barrier and diffuses into breast milk.
Undesirable effects
Depending on the dose, the age and condition of the patient, the undesirable effects which can occur are mild confusion, dizziness, fatigue or muscular weakness. These effects are generally dose dependent and usually disappear when the dosage is reduced.
Interactions
If Mogadon is combined with other centrally acting drugs such as neuroleptics, tranquillizers, antidepressants, hypnotics, anticonvulsants, analgesics, anaesthetics and muscle relaxants, it should be borne in mind that mutual potentiation of their effects and side effects may occur. Unforeseeable reactions may occur during concomitant consumption of alcohol.
Overdosage
Intentional or accidental overdosage of Mogadon is seldom life-threatening. In the main, the symptoms represent are intensification of the therapeutic effects (sedation, muscle weakness, deep sleep), but also include paradoxical excitation. In most cases, it is sufficient to monitor the vital functions and wait.
Stability
This medicine should not be used after the expiry date (EXP) shown on the pack.
Packing
20 Tablets.
|
|
|
|