Lormetazepam tablets

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Therapeutic indications Short-lasting treatment of insomnia. Benzodiazepines and similar drugs are indicated only in severe cases, when the disease incapacitates or subjects the patient to grave states of anxiety. Administration and dosage The treatment should be as short as possible. In general, its duration ranges from a few days to two weeks, with a maximum of four weeks including the final stage of gradual reduction. The treatment, in all the patients, should be withdrawn gradually in order to minimize possible abstinence symptoms See warnings and special precautions of use. The usual dose in adults is 1 mg administered 15 to 30 minutes before going to bed. In cases of grave or persistent insomnia, not responding to this dosage regimen, the dose can be increased to 2 mg. The recommended dose in old people is 0,5 mg before going to bed. Lormetazepam has not been studied for the treatment of children. Contraindications Severe respiratory failure. Hypersensitivity to benzodiazepines or to lormetazepam or to any of the components of the product. Warnings and special precautions of use Tolerance: After the repeated administration for several weeks, the hypnotic effects of benzodiazepines and similar drugs may diminish. The patient should be warned that, since his tolerance to other depressants of the central nervous system can diminish in the presence of lormetazepam, those substances should be avoided or their dosage should be reduced. The use of benzodiazepines and similar drugs may lead to a physical and psychical dependence. The risk of dependence to lormetazepam is low when it is used at the recommended doses and time, but it increases at higher doses and when the treatment is prolonged. The risk also increases in patients with a history of alcoholism, drugs abuse and in those patients with significant personality disorders. The dependence will induce an abstinence syndrome especially if the treatment is suddenly interrupted; this is the reason why it is always recommended to reduce the dose gradually. The abstinence syndrome can include headache, muscular pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating and a rebound phenomenon consisting of the recurrence in an intensified way of the symptoms that led to the treatment with benzodiazepines. In grave abstinence cases disorientation, depersonalization, hyperacusis, tinnitus, weakness and tingling in the extremities, hypersensitivity to light, noise and physical contact, involuntary movements, vomits, hallucinations and seizures may occur. Seizures may be more common in patients with pre-existent comitial disorders or in those who are being administered medicaments that reduce the convulsive threshold, such as antidepressants. Duration of the treatment: The treatment should be as short as possible see Administration and Dosage , and it should not exceed 4 weeks including the final phase of gradual reduction. This treatment should not be prolonged without reappraising the situation. It could be useful to inform the patient that the treatment will have a limited duration and that it will be gradually discontinued, as well as of the possibility of a rebound effect, in order to minimize his anxiety in the event it occurred. It has been described that in the case of benzodiazepines and similar short-action drugs the dependence phenomenon may appear in the dosage interval, especially when the dose is high. It has been described the appearance of anterograde amnesia or memory deterioration in association with the use of benzodiazepines. This condition normally occurs several hours after the intake, so the patients should make sure that they would be able to have an uninterrupted hours sleep to dispel the effect of the drug see Adverse Reactions. Paradoxical reactions such as restlessness, nervousness, irritability, aggressiveness, illusion, rage, nightmares, hallucinations, psychosis, inadequate behaviour and other behaviour disorders, have been occasionally reported during the use of benzodiazepines. They are more likely to appear in old people and in children. Should they occur, the treatment should be discontinued. Specific groups of patients: Patients with irregular renal or hepatic function should be frequently monitorized and the dose should be carefully adjusted according to their response. Low doses may be enough in these patients. The same precautions should be applied to old patients and weakened patients and to those with chronic respiratory failure. Although rarely, benzodiazepines may cause hypotension so they should be administered with precaution to patients who may suffer tension drops with possibility of cardiovascular or cerebrovascular complications. This is particularly important in old people. Interactions with other medicaments and other ways of interaction The sedative effect of lormetazepam may be increased when combined with alcohol, which would affect the ability to drive vehicles or operate machinery, and therefore their simultaneous intake is not recommended. With the use of narcotic analgesics an increase in euphoria may occur and, therefore, a greater psychic dependence. The substances that inhibit certain hepatic enzymes in particular P cytochrome may reinforce the activity of benzodiazepines. In the event the drug is prescribed to a fertile woman she should be warned to consult her doctor in order to discontinue the treatment in the event she intended to get pregnant or if she thinks she is pregnant. The newborns from mothers who have taken benzodiazepines for several or many weeks before the delivery may show abstinence symptoms in the post-natal period. The product should only be administered under strict medical prescription during the last three months of pregnancy or during delivery, since the pharmacological action of the product may cause hypothermia, hypotony and moderate respiratory depression in the newborn. Effects on the ability to drive vehicles and operate machinery The same as for the rest of the depressants of the CNS, patients should be warned not to use dangerous machinery or vehicles as long as it is not verified that the drug does not cause them somnolence or dizziness. Adverse reactions When they occur, they normally take place at the commencement of the therapy and, in general, their intensity diminishes or disappears with the continuous use or when the dose is reduced. The adverse reactions most frequently reported in association with the use of benzodiazepines include diurnal somnolence, dizziness, muscular weakness and ataxia. With less frequency confusion, depression, fatigue, headache, diminution of the state of vigilance, dazzled state, nausea, changes in the appetite, sleep disorders, skin reactions, visual disturbances, changes in the libido and gastrointestinal symptoms have been reported. Overdosage In any overdosage the intake of numerous drugs should be taken into account. The overdosage with benzodiazepines is normally shown by various grades of depression of the CNS that range from somnolence to coma. In moderate cases the symptoms include somnolence, mental confusion and lethargy. Should gastric lavage not be satisfactory, the absorption can be reduced with the help of activated charcoal. Especial attention should be paid to the respiratory and cardiovascular functions in intensive care. Hypotension, unlikely though, can be controlled with noradrenalin. Lormetazepam is hardly dialyzable. The benzodiazepinic antagonist flumazenil can be useful in hospitalized patients. The information about this product should be consulted before its use. Pharmacodynamic properties Lormetazepam is a benzodiazepine with tranquillizer, muscular relaxing, sedative and hypnotic properties. Clinical studies have proven minimal effects in the REM phase and in the psychomotor function the day after the treatment with lormetazepam. Pharmacokinetic properties Lormetazepam is quickly absorbed in the gastrointestinal tract and it is metabolized through an only pass to the glucuronide form, which is pharmacologically inactive. Main metabolites are not produced and the risk of accumulation is small. Lormetazepam has a terminal phase half-life of about 11 hours. Preclinical safety data Fertility in male and female rats has not been negatively affected after the oral administration of lormetazepam. Dicalcium phosphate, microcrystalline cellulose, starch carboximethylether disodium salt, talcum, magnesium stearate, orange aluminium lacquer E Lactose, microcrystalline cellulose, talcum, magnesium stearate, blue lacquer E Nature and content of the container Blister, that is composed of polyvinyl chloride PVC sheet in the obverse, and aluminium with heat-seal lacquer in the other side. Shelf life 5 years. Special precautions of storage Usual. Si continuas navegando entendemos que aceptas su uso.

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