Drug form:
tablets coated with film-coated, with a separation groove for the reception inside.
Composition
* The active substances: luvox maleate 50 or 100 mg.
* Other components of matter: mannitol, corn starch, pre starch, sodium stearila fumarat, anhydrous colloidal silicon dioxide, metilgidroksipropiltsellyuloza, polyethylene 6000, talc, titanium dioxide (E171).
* The product does not contain any lactose or sugar (E121).
Pharmacodynamics
Mechanism of action Luvox associated with selective inhibition of a seizure of serotonin neurons of brain and is characterized by a minimum impact on noradrenergicheskuyu transfer. Luvox has ulterior ability to communicate with a-adrenergic, b-adrenergic, gistaminergicheskimi, muskarinovymi cholinergic, dofaminergicheskimi or serotoninergicheskimi receptors.
Pharmacokinetics
After ingestion Luvox completely absorbed from the gastrointestinal tract. The maximum concentration of drug in plasma observed after 3-8 hours after injection. The average half of the blood plasma of a single dose for 13-15 hours, some increases in the multiple admission (17-22 hours), and equilibrium concentrations in blood plasma (steady-state), usually achieved through a 10-14 days.
Luvox biotransformiruetsya in the liver (mainly through oxidative demethylation) to at least nine metabolites that appear through the kidneys. Two major metabolite have negligible pharmacological activity. Other pharmacologically inactive metabolites. Degree Luvox bind to proteins of human blood plasma is about 80% (in vitro).
Indications
Treatment and prevention of depressive disorders. Treatment of the symptoms of obsessive compulsive disorder.
Contraindications
Luvox pill contraindicated use in combination with inhibitors monoaminoksidazy (MAO inhibitors). The interval between the cancellation of the irreversible MAO inhibitor action and the start of treatment Luvoxom shall not be less than two weeks. Luvoxom treatment can be started the next day following the lifting of reversible inhibitor of MAO activity (eg, moklobemida). In principle, the interval between the cancellation and the start of treatment Luvox any MAO inhibitor should not be less than one week.
In addition, Luvox contraindicated in patients with known hypersensitivity to fluvoksamina maleate, or to one of the fillers that make up the drug, as well as patients with marked liver disorders.
Children up to age 8 years.
The use during pregnancy and lactation period
Studies on reproduction in laboratory animals that received high doses of Luvox, revealed no reduction in fertility, sexual behavior and violations of teratogenic effects in their offspring. Nevertheless, it is necessary to observe the usual precautions regarding the use of any drugs during pregnancy. Luvox penetrate in small quantities in breast milk. In this regard, it is not applicable to the period of lactation.
Precautions and warnings
In patients with depression is typically a high likelihood of suicide attempts, which may be retained until a sufficient remission.
Treatment of patients suffering from hepatic or renal failure should start with low doses of Luvox under strict medical supervision. In rare cases, treatment Luvoxom can lead to an increase of enzyme activity of the liver, often accompanied by relevant clinical symptoms. In these cases Luvox should be abolished. Despite the fact that studies on laboratory animals fluvoksamin not cause convulsive activity, caution must be exercised in the appointment of the drug to patients with a history of seizures. Luvoxom Treatment should be discontinued in case of an epileptic seizure. Data obtained in the treatment of patients older and younger patients showed that there was no clinically significant differences between generally applicable to them daily doses. However, increasing doses of the drug in elderly patients should always be done slowly and with greater caution.
Luvox can lead to modest reductions in heart rate (by 2-6 beats per minute).
Due to the lack of clinical experience Luvox is not recommended for the treatment of depression in children.
There have been reports of such abnormal intradermal hemorrhages as ekhimoz and purpura observed in applying the election serotonin inhibitors reverse the seizure. There is a need for caution in designating these medicines, especially in the case of patients receiving both drugs acting on the function of platelets (eg, atypical antipsychotic, and means fenotiaziny, many tricyclic antidepressants, aspirin, non-steroidal anti-inflammatory drugs), as well as patients with a history of bleeding.
Interaction with other drugs
Luvox can not be used in combination with MAO inhibitors. Luvox may prolong the elimination of drugs, metaboliziruemyh by oxidation in the liver. Perhaps the clinically significant interactions with drugs, characterized by a narrow dose-effect "(eg, warfarin, phenytoin, teofillin, klozapin and carbamazepine).
Against the background of the application Luvox may be a slight increase in plasma concentrations of benzodiazepines, metaboliziruemyh in the liver by oxidation.
If you are applying Luvox previously observed increase of the stable levels of tricyclic antidepressants. In this regard, it is not advisable to appoint Luvox in combination with these drugs.
In studies of interactions Luvox indicated increasing concentrations of propranolol after the introduction of Luvox. In this regard, it is possible to recommend lowering doses of propranolol in the event of additional appointments Luvox.
In applying Luvox in combination with warfarin for two weeks, there was a significant increase of concentrations of warfarin in blood plasma, and prothrombin time prolongation. Thus, in patients receiving anticoagulants and inside Luvox should monitor the prothrombin time, and to select doses of anticoagulants.
Luvox does not interact with digoxin and atenolol.
Luvox used in combination with medications for the treatment of severe lithium patients responding poorly to drug therapy. It should be noted that lithium (and possibly tryptophan) enhances serotoninergicheskie Luvox effects, and therefore this kind of combination drug therapy should be undertaken with caution.
As with the use of other psychotropic drugs during treatment Luvoxom not advisable to consume alcohol.
Effects on ability to driving a car or in the management of machines and mechanisms
Luvox, appointed by the healthy volunteers in doses up to 150 mg, no effect on psychomotor functions related to driving a car or with the management of machines and mechanisms. At the same time, there are reports of sleepiness, observed during the treatment Luvoxom. In this regard, it is recommended to be cautious until the final determination of individual responses to medicine.
Dosing and Administration
Depression
The recommended starting dose is 50 or 100 mg (one-time, evening). We recommend a gradual increase starting dose to effective dose. The effective daily dose, usually 100 mg, selected individually depending on patient response to treatment. The daily dose can be as high as 300 mg. Daily intake of more than 150 mg should be distributed on multiple devices.
In accordance with official recommendations of the WHO treatment with antidepressants should be continued for at least 6 months after cure depressive episode.
To prevent a recurrence of depression are recommended to take 100 mg Luvox once a day.
Obsessive compulsive disorder.
We recommend that you start with a dose of 50 mg Luvox a day for 3-4 days. The effective daily dose is usually between 100 and 300 mg. Doses should increase gradually until an effective daily dose should not exceed 300 mg in adults. Doses up to 150 mg can be taken as a single dose, preferably at night. Daily intake of more than 150 mg is recommended to allocate up to 2 or 3 steps.
Doses for children over 8 years and adolescents:
Initial dose is 25 mg / day at a time. Maintenance dose of 50-200 mg / day. The daily dose should not exceed 200 mg. Daily intakes above 100 mg is recommended to allocate up to 2 or 3 steps.
When a good response to drug treatment may be continued by means of individually selected daily dose. If improvement is not achieved after 10 weeks of treatment, fluvoksamin should be repealed. Until now, there was no organized system of research that could answer the question about how long the treatment can be conducted fluvoksaminom, however, obsessive compulsive disorders are chronic in nature, and therefore can be considered a useful extension Luvoxom treatment beyond 10 weeks in patients with good responses to this drug. Selection of the minimum effective maintenance dose should be done with caution on an individual basis. Some clinicians recommend the concomitant psychotherapy in patients responding well to drug therapy.
Treatment of patients suffering from hepatic or renal failure should start with the lowest dose under strict medical supervision.
Tablets Luvox should not zapivaya razzhevyvaya and little water.
Adverse effects
The most frequent symptom, associated with the use of Luvox is nausea, sometimes accompanied by vomiting. This side effect, usually disappears in the first two weeks of treatment.
Other side effects observed in controlled clinical trials of more than 1% of patients and there is more often than with placebo were as follows:
* Central nervous system: drowsiness, dizziness, headache, insomnia, anxiety, psychomotor agitation, anxiety, tremor;
* Digestive tract: constipation, anorexia, dyspepsia, diarrhea, unpleasant sensations in the epigastrium, dry mouth, feeling of discomfort;
* Skin: increased sweating;
* Other: asthenia, palpitation, tachycardia.
As with the application of other polling serotonin inhibitors reverse capture rarely observed transient hyponatremia, terminated after the abolition of Luvox. In some cases it may be due to syndrome of inappropriate secretion antidiureticheskogo hormone. Most reports were associated with the treatment of patients with senile age.
Hemorrhage: See "Safety precautions and warnings."
Sometimes there may be an increase or decrease in body weight.
In rare cases, symptoms such as headache, nausea, dizziness and anxiety, there were sharply after the abolition of Luvox.
Some of the above-mentioned undesirable phenomena can be symptoms of depression and do not necessarily caused by Luvoxom.
Overdosage
Symptoms
The most characteristic symptoms include gastrointestinal disturbances (nausea, vomiting and diarrhea), drowsiness and dizziness. In addition, there are reports of violations of cardiac (tachycardia, bradycardia, arterial hypotension), liver dysfunction, convulsions and even coma.
So far received over 300 reported cases of intentional overdose Luvox. The highest recorded dose Luvox received one patient was 10 000 mg; this patient was cured as a result of a purely symptomatic treatment. More serious complications were observed in cases of intentional overdose Luvox on the background of concomitant pharmacotherapy.
Treatment
There is no specific antidote. If overdose is recommended gastric lavage, which should take place as soon as possible after taking the medication, and symptomatic treatment. In addition, it is recommended that multiple receive activated charcoal. Enhanced diuresis or dialysis seem unreasonable.
Composition
Tablets, coated with film-coated, with a separation groove in the blisters, packed in cardboard packaging of 15 tablets of 50 mg fluvoksamina maleate, or in cardboard packaging of 15 tablets of 100 mg fluvoksamina maleate.
Storage conditions
Luvox tablets should be stored in a dry place inaccessible to children, protecting from direct sunlight at a temperature no higher than 250 ° C.
Keep the medicine out of reach of children!
Shelf life
3 years, subject to store undamaged in original packaging.
The drug can not be applied at the end of life.
Terms of leave from pharmacies
Prescription physician.
