Composition, form of production and packaging
The tablets covered with a film shell of white color, oval, biconcave, with engraving "20" on one side and risk on the other side.
1 tab.
paroxetine hydrochloride hemihydrate 22.8 mg,
which corresponds to the content of paroxetine 20 mg
Excipients: calcium hydrophosphate dihydrate - 317.75 mg, sodium carboxymethyl starch type A - 5.95 mg, magnesium stearate - 3.5 mg.
The composition of the film shell: opedraj white YS-1R-7003 - 7 mg (hypromellose - 4.2 mg, titanium dioxide - 2.2 mg, macrogol 400 - 0.6 mg, polysorbate 80 - 0.1 mg).
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Paroxetine is a potent and selective 5-hydroxytryptamine reuptake inhibitor (5-HT, serotonin). It is believed that its antidepressant activity and effectiveness in the treatment of obsessive-compulsive (OCD) and panic disorder is due to the specific inhibition of reuptake of serotonin in neurons of the brain.
According to its chemical structure, paroxetine differs from tricyclic, tetracyclic and other known antidepressants.
Paroxetine has a weak affinity for muscarinic cholinergic receptors, and studies in animals have shown that it has only weak anticholinergic properties.
In accordance with the selective effect of paroxetine, in vitro studies have shown that it, unlike tricyclic antidepressants, has a weak affinity for? 1 -,? 2 - and? -adrenoceptors, as well as to dopamine (D 2 ), 5-HT 1 -like, 5HT 2 - and histamine (H 1 ) receptors. This lack of interaction with postsynaptic receptors in vitro is supported by the results of in vivo studies that demonstrated the lack of paroxetine's ability to oppress the central nervous system and cause arterial hypotension.
Pharmacodynamic effects
Paroxetine does not impair psychomotor functions and does not enhance the inhibitory effect of ethanol on the central nervous system.
Like other selective serotonin reuptake inhibitors, paroxetine causes symptoms of excessive stimulation of 5-HT receptors when administered to animals that previously received MAO inhibitors or tryptophan. Studies of EEG behavior and changes have demonstrated that paroxetine causes mild activating effects at doses in excess of those required to inhibit serotonin reuptake. By its very nature, its activating properties are not "amphetamine-like".
Studies in animals have shown that paroxetine does not affect the cardiovascular system.
In healthy subjects paroxetine does not cause clinically significant changes in blood pressure, heart rate and ECG.
Studies have shown that, unlike antidepressants that inhibit norepinephrine reuptake, paroxetine has a much lower ability to inhibit the antihypertensive effects of guanethidine.
PHARMACOKINETICS
Suction
After ingestion paroxetine is well absorbed and metabolized at the "first pass".
Due to metabolism at the "first passage", less paroxetine enters the systemic bloodstream than that absorbed from the digestive tract. As the amount of paroxetine increases in the body with a single intake of large doses or with repeated intake of usual doses, the partial metabolism of the first passage occurs and the clearance of paroxetine from the plasma decreases. This leads to a disproportionate increase in the concentrations of paroxetine in the plasma. Therefore, its pharmacokinetic parameters are not stable, resulting in nonlinear kinetics. It should be noted, however, that the nonlinearity is usually poorly expressed and is observed only in those patients who, when taking low doses of the drug in the plasma, achieve low levels of paroxetine. Stable concentrations in the plasma are achieved 7-14 days after the start of treatment with paroxetine. Its pharmacokinetic parameters, most likely, do not change during prolonged therapy.
Distribution
Paroxetine is widely distributed in tissues, and pharmacokinetic calculations show that only 1% of the total amount of paroxetine present in the body remains in the plasma. At therapeutic concentrations, approximately 95% of the paroxetine in the plasma is associated with proteins.
There was no correlation between paroxetine concentrations in plasma and its clinical effect (ie, with adverse reactions and efficacy). It was found that paroxetine penetrates into breast milk of women in small amounts, as well as in embryos and fruits of laboratory animals.
Metabolism
The main metabolites of paroxetine are polar and conjugated oxidation and methylation products, which are easily eliminated from the body. Given the relative absence of pharmacological activity in these metabolites, it can be argued that they do not affect the therapeutic effects of paroxetine.
Metabolism does not impair the ability of paroxetine to selectively inhibit the reuptake of serotonin.
Excretion
With urine in the form of unchanged paroxetine excreted less than 2% of the dose, while excretion of metabolites reaches 64% of the dose. About 36% of the dose is excreted with feces, probably getting into it with bile; Excretion with feces of unchanged paroxetine is less than 1% of the dose. Thus, paroxetine is eliminated almost entirely through metabolism.
Excretion of metabolites is biphasic in nature: first it is the result of the metabolism of the "first passage", then it is controlled by systemic elimination of paroxetine.
T 1/2 of paroxetine varies, but is usually about 1 day (16-24 hours).
INDICATIONS
Depression
Depression of all types, including reactive and severe depression, as well as depression, accompanied by anxiety.
In the treatment of depressive disorders, paroxetine has about the same efficacy as tricyclic antidepressants. There is evidence that paroxetine can give good results in patients in whom standard antidepressant therapy has proven ineffective.
Taking paroxetine in the morning does not adversely affect the quality and duration of sleep. In addition, as the effect of paroxetine treatment appears, sleep can improve.
When using short-acting hypnotic drugs in combination with antidepressants, no additional side effects occurred. In the first few weeks of therapy, paroxetine effectively reduces symptoms of depression and suicidal thoughts.
The results of studies in which patients took paroxetine for up to 1 year, showed that the drug effectively prevents relapses of depression.
Obsessive-compulsive disorder
Paroxetine is effective in the treatment of obsessive-compulsive disorder (ROC), including. and as a means of supporting and prophylactic therapy. In addition, paroxetine effectively prevented recurrence of OCD.
Panic disorder
Paroxetine is effective in the treatment of panic disorder with and without agoraphobia, incl. as a means of supporting and prophylactic therapy. It has been established that in the treatment of panic disorder, the combination of paroxetine and cognitive-behavioral therapy is significantly more effective than the isolated application of cognitive-behavioral therapy.
In addition, paroxetine effectively prevented the recurrence of panic disorder.
Social phobia
Paroxetine is an effective treatment for social phobia, incl. and as a long-term maintenance and prophylactic therapy.
Generalized anxiety disorder
Paroxetine is effective in generalized anxiety disorder, incl. and as a long-term maintenance and prophylactic therapy. Paroxetine also effectively prevents relapses in this disorder.
Post-Traumatic Stress Disorder
Paroxetine is effective in the treatment of post-traumatic stress disorder.
DOSING MODE
Paroxetine is recommended to be taken 1 time / day in the morning during a meal. The tablet should be swallowed whole, without chewing.
Depression
The recommended dose for adults is 20 mg / day. If necessary, depending on the therapeutic effect, the daily dose may increase weekly by 10 mg / day to a maximum dose of 50 mg / day. As with any antidepressant treatment, the effectiveness of therapy should be evaluated and, if necessary, the dose of paroxetine should be adjusted 2-3 weeks after the start of treatment and in the future, depending on the clinical indications.
To relieve depressive symptoms and prevent relapses, adequate duration of stopping and maintenance therapy should be observed. This period can be several months.
Obsessive-compulsive disorder
The recommended dose is 40 mg / day. Treatment begins with a dose of 20 mg / day, which can be increased weekly by 10 mg / day. If necessary, the dose can be increased to 60 mg / day. It is necessary to observe adequate duration of therapy (several months and longer).
Panic disorder
The recommended dose is 40 mg / day. Treatment of patients should begin with a dose of 10 mg / day and weekly increase the dose by 10 mg / day, focusing on the clinical effect. If necessary, the dose may be increased to 60 mg / day. A low initial dose is recommended to minimize the possible increase in symptoms of panic disorder, which may occur at the beginning of treatment with any antidepressant. It is necessary to observe adequate periods of therapy (several months and longer).
Social phobia
The recommended dose is 20 mg / day. If necessary, the dose may be increased weekly by 10 mg / day, depending on the clinical effect to 50 mg / day.
Generalized anxiety disorder
The recommended dose is 20 mg / day. If necessary, the dose may be increased weekly by 10 mg / day, depending on the clinical effect to 50 mg / day.
Post-Traumatic Stress Disorder
The recommended dose is 20 mg / day. If necessary, the dose may be increased weekly by 10 mg / day, depending on the clinical effect to 50 mg / day.
Paroxetine withdrawal
As in the treatment of other psychotropic drugs, avoid abrupt withdrawal of paroxetine.
The following cancellation schedule can be recommended: reduction of the daily dose by 10 mg per week; after reaching a dose of 20 mg / day patients continue to take this dose for 1 week, and only after that the drug is canceled completely. If withdrawal symptoms develop during dose reduction or after drug withdrawal, it is advisable to resume taking the previously prescribed dose. In the future, the doctor may continue to reduce the dose, but more slowly.
Individual patient groups
In elderly patients , paroxetine concentrations in plasma can be increased, but the range of its plasma concentrations coincides with those in younger patients. In this category of patients, therapy should be started with a dose recommended for adults, which can be increased to 40 mg / day.
The concentrations of paroxetine in plasma are increased in patients with severe renal dysfunction (KC less than 30 ml / min) and in patients with impaired liver function . Such patients should be given doses of the drug that are in the lower part of the therapeutic dose range.
The use of paroxetine in children and adolescents (under 18 years of age) is contraindicated.
SIDE EFFECT
The frequency and intensity of some of the undesirable reactions of paroxetine listed below may decrease as the treatment continues, and such reactions usually do not require withdrawal of the drug.
The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10 000, < 1/1000), very rarely (<1/10 000), including individual cases, and the frequency is unknown. The occurrence of frequent and infrequent adverse reactions was determined on the basis of general safety data obtained from more than 8000 patients participating in clinical trials and was calculated from the difference between the incidence of adverse reactions in the paroxetine group and the placebo group. The occurrence of rare and very rare undesirable reactions was determined on the basis of post-registration data, and it concerns the frequency of reports of such reactions rather than the true frequency of the reactions themselves.
From the hemopoietic system and lymphatic system: infrequently - pathological bleeding, mainly hemorrhage into the skin and mucous membranes (including ecchymosis); very rarely - thrombocytopenia.
On the part of the immune system: very rarely - severe allergic reactions (including anaphylactoid reactions and angioedema).
From the endocrine system: very rarely - the syndrome of inadequate secretion of ADH.
From the side of metabolism and nutrition: often - decreased appetite, increased cholesterol concentration; rarely - hyponatremia. Hyponatremia occurs mainly in elderly patients and is sometimes caused by the syndrome of inappropriate secretion of ADH.
Mental disorders: often - drowsiness, insomnia, agitation, pathological dreams (including nightmares); infrequently - confusion, hallucinations; rarely - manic reactions, anxiety, depersonalization, panic attacks, akathisia; the frequency is unknown - suicidal thoughts and suicidal behavior. Cases of suicidal thoughts and suicidal behavior were documented during treatment with paroxetine or in the early stages after discontinuation of treatment. These symptoms can also be caused by the disease itself.
From the nervous system: often - dizziness, tremor, headache, impaired concentration; infrequently - extrapyramidal disorders; rarely convulsions, restless legs syndrome; very rarely - serotonin syndrome (symptoms may include agitation, confusion, increased sweating, hallucinations, hyperreflexia, myoclonus, tachycardia with tremors and tremors). In patients with impaired motor function or who used antipsychotics, the development of extrapyramidal symptoms, including orofacial dystonia, was sometimes reported.
From the side of the organ of vision: often - blurred vision; infrequently - mydriasis; very rarely - acute glaucoma.
From the side of the organ of hearing and balance: the frequency is unknown - the noise in the ears.
From the heart: infrequently sinus tachycardia; rarely - aetiology.
From the side of the vessels: infrequently - postural hypotension, short-term increase and decrease in blood pressure. A brief increase and decrease in blood pressure was recorded after paroxetine treatment, usually in patients with prior hypertension or anxiety.
On the part of the respiratory system, thorax and mediastinum: often - yawning.
From the digestive tract: very often - nausea; often - constipation, diarrhea, vomiting, dry mouth; very rarely - gastrointestinal bleeding.
From the liver and biliary tract: rarely - increased activity of liver enzymes; very rarely, unwanted reactions from the liver (such as hepatitis, sometimes accompanied by jaundice and / or liver failure). An increase in hepatic enzyme activity has been reported. Post-registration reports of adverse reactions from the liver (such as hepatitis, sometimes accompanied by jaundice and / or liver failure) have been received very rarely. The question of the advisability of discontinuing paroxetine treatment should be addressed in cases where there is a prolonged increase in the performance of functional hepatic samples.
From the skin and subcutaneous tissues: often - increased sweating; infrequently - skin rashes, itching; very rarely photosensitivity reactions, severe skin reactions (including erythema multiforme, Stephen-Johnson syndrome and toxic epidermal necrolysis), urticaria.
Disorders from the kidneys and urinary tract: infrequent - urinary retention, urinary incontinence.
From the genitals and the breast: very often - sexual dysfunction; rarely - hyperprolactinaemia, galactorrhea, menstrual cycle disorders (including menorrhagia, metrorrhagia and amenorrhea); very rarely - priapism.
From the musculoskeletal system: rarely - arthralgia, myalgia. Epidemiological studies, mainly conducted in patients aged 50 years and older, showed an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism that leads to this risk is unknown.
Common reactions: often - asthenia, weight gain; very rarely - peripheral edema.
Symptoms arising from discontinuation of paroxetine treatment: often - dizziness, sensory disturbances, sleep disorders, anxiety, headache; infrequently - agitation, nausea, tremor, confusion, increased sweating, emotional lability, visual disturbances, palpitations, diarrhea, irritability. A sharp discontinuation of the drug causes withdrawal syndrome. As cases other psychotropic drugs, treatment discontinuation paroxetine (especially sharp) can cause symptoms such as vertigo, sensory disorders (including paresthesias, sensation of the electric current discharge and tinnitus), sleep disorders (including vivid dreams), agitation or anxiety, nausea, headache, tremor, confusion, diarrhea, sweating, palpitations, emotional instability, irritability, and visual disturbances. In most patients, these symptoms are mild to moderate and go spontaneously. It is not known any one group of patients who would be at increased risk of these symptoms; Therefore, if paroxetine treatment is no longer necessary, the dose should be reduced slowly until the full withdrawal of the drug.
Adverse reactions observed in clinical studies in children
were observed following adverse reactions: emotional lability (including self-harm, suicidal thoughts, suicide attempts, crying and mood fluctuations), bleeding, hostility, decreased appetite, tremor, sweating, hyperkinesia and agitation . Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with major depressive disorder. Hostility was reported in children of obsessive-compulsive disorder, especially in children younger than 12 years.
In clinical studies, a gradual decrease in the daily dose (daily dose was reduced to 10 mg / day at intervals of one week to a dose of 10 mg / day for one week) caused withdrawal symptoms paroxetine (emotional lability, nervousness, dizziness, nausea and abdominal pain) which recorded a minimum of 2% of patients on lower doses of paroxetine or after its total abolition and to meet at least 2 times more often than in the placebo group.
CONTRAINDICATIONS
- hypersensitivity to paroxetine and any other component, part of the drug;
- in combination with MAO inhibitors. In exceptional cases, linezolid (an antibiotic which is a reversible non-selective MAO inhibitor) allowed to combine with paroxetine provided that suitable alternatives linezolid treatment available, and the potential benefits of application linezolid exceed the risks of serotonin syndrome or neuroleptic malignant syndrome, both reactions in certain patients. Equipment for the careful observation of symptoms of serotonin syndrome and monitoring of blood pressure pressure must be available. Paroxetine treatment is allowed:
-After 2 weeks after cessation of treatment irreversible MAOI, or
-through at least 24 hours after cessation of treatment reversible MAO inhibitors (e.g., moclobemide, linezolid, methylthioninium chloride (methylene blue);
-should pass at least 1 week between paroxetine and canceling the start of therapy in any MAO inhibitors;
- combined use with thioridazine. paroxetine should not be used in combination with thioridazine, since, like other drugs that suppress the activity of the hepatic isoenzyme CYP450 2D6, paroxetine thioridazine may increase the plasma concentration, which can lead to y Lienen QTc interval and related ventricular arrhythmias such as "pirouette", a potentially life-threatening, and sudden death
- the combined use with pimozide;
- Use in children and adolescents younger than 18 years. Controlled clinical trials of paroxetine in the treatment of depression in children and adolescents has not proved its effectiveness, so the drug is not indicated for the treatment of this age group. The safety and efficacy of paroxetine has not been studied in patients with the use of the younger age group (under 7 years).
PREGNANCY AND LACTATION
Fertility
According to animal studies, paroxetine can affect the quality of sperm characteristics. These in vitro studies of human material could indicate some influence on the quality of semen characteristics, but reports of cases in humans the use of certain drugs of SSRIs (including paroxetine) have shown that the effect on sperm quality characteristics proved to be reversible.
Until now, there was no effect on fertility in humans.
Pregnancy
Animal studies have not revealed teratogenic paroxetine or selective embryotoxic activity.
Epidemiological studies of pregnancy outcomes when taking antidepressants in the I trimester showed an increased risk of congenital malformations, particularly cardiovascular (eg ventricular and atrial defects partitions) associated with paroxetine. According to reports the occurrence of defects in the cardiovascular system in paroxetine during pregnancy is approximately equal to 1/50, whereas the expected occurrence of such defects in the general population is approximately 1/100 newborns.
In the appointment of paroxetine doctor should consider alternative treatment for pregnant women and women planning pregnancy, and paroxetine should be used only if the potential benefits outweigh the possible risk. If it is decided to terminate treatment with paroxetine during pregnancy, the doctor should follow the recommendations section "Dosage" and "Cautions".
There are reports of premature birth in women who received paroxetine during pregnancy, or other drugs group SSRIs, although a causal association between these drugs and preterm birth has not been established.
It is necessary to closely monitor the health of those newborns whose mothers took paroxetine in late pregnancy, as there are reports of complications in neonates exposed to paroxetine or other SSRIs in the III trimester of pregnancy. However, a causal relationship between these complications and that medical therapy has not been confirmed. Described clinical complications include: respiratory distress, cyanosis, apnea, seizures, temperature instability, difficulty in feeding, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, increased neuroreflex excitability syndrome, irritability, lethargy, constant crying and drowsiness.In some reported symptoms were described as neonatal withdrawal symptoms. In most cases described complications arose immediately after birth or shortly thereafter (<24 h).
According to epidemiological studies taking medication SSRIs (including paroxetine) during pregnancy, especially in the later stages, is associated with an increased risk of persistent pulmonary hypertension of newborns. The increased risk is observed in children born to mothers who took SSRI drugs late in pregnancy, 4-5 times higher than observed in the general population (1-2 per 1000 pregnancies). Animal studies have shown reproductive toxicity of the drug, but a direct adverse impact in relation to pregnancy, embryo-fetal development, birth or postnatal development has not been shown.
Breastfeeding period
In breast milk penetrate small amounts of paroxetine. In published studies of children who are breastfed paroxetine concentrations were undetectable (<2 ng / ml) or very low (<4 ng / ml). Children are no signs of drug effects were detected . Nevertheless, paroxetine should not be taken during breastfeeding except in cases where the benefit of therapy for the mother outweighs the potential risks for the child.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with severe renal impairment (creatinine clearance less than 30 mL / min), the dose should be reduced to the lower limit of the dose range.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with severe hepatic impairment dose should be reduced to the lower limit of the dose range.
APPLICATION FOR CHILDREN
Antidepressant treatment of children and adolescents with major depressive disorder and other mental illnesses, is associated with an increased risk of suicidal thoughts or suicidal behavior.
In clinical trials, adverse events related to suicidality (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, deviant behavior and anger) were more frequently observed in children and adolescents treated with paroxetine compared with those of patients in this age group who received placebo. There is currently no data on the long-term safety of paroxetine for children and teenagers, who have dealt with the influence of the drug on the growth, maturation, cognitive and behavioral development.
As a result of clinical trials in children and adolescents incidence of adverse events when canceling paroxetine was 32%, while the incidence of adverse events in the placebo group was 24%.
APPLICATION IN ELDERLY PATIENTS
In elderly patients , treatment should begin with a dose for adults, the dose may be further increased to 40 mg / day.
SPECIAL INSTRUCTIONS
Children and adolescents (under 18)
drug Paxil В® should not be used in children and adolescents younger than 18 years.
Antidepressant treatment of children and adolescents with major depressive disorder and other mental illnesses, is associated with an increased risk of suicidal thoughts or suicidal behavior.
In clinical studies, adverse events associated with suicide attempts and suicidal thoughts and hostility (predominantly aggression, deviant behavior and anger) were more frequently observed in children and adolescents treated with paroxetine compared with patients in this age group who received placebo. There is currently no data on the long-term safety of paroxetine for children and teenagers, who have dealt with the influence of the drug on the growth, maturation, cognitive and behavioral development.
Clinical worsening and suicide risk in adults
Younger patients, especially those with major depressive disorder may be at increased risk for suicidal behavior during treatment with paroxetine. The analysis of placebo-controlled studies in adults with mental illness, indicates an increase in the frequency of suicidal behavior in young adults (aged 18-24 years) in patients receiving paroxetine compared with placebo: 17/776 (2.19%) against 5 / 542 (0.92%) respectively, although this difference is not considered statistically significant. Patients older age groups (25 to 64 years of age and over 65 years) to increase the frequency of suicidal behavior in the observed. Adults of all ages suffering from major depressive disorder,a statistically significant increase in suicidal behavior during treatment with paroxetine compared with the placebo group (incidence of suicide attempts:. 11/3455 (0.32%) against 1/1978 (0.05%), respectively However, most of these cases the intake of paroxetine (8 of 11) have been reported in young patients, aged 18-30 years. The data obtained in the study in patients with major depressive disorder may indicate an increase in the frequency of suicidal behavior in patients younger than 24 years, with tradayuschih various mental disorders.However, most of these cases, in patients receiving paroxetine (8 of 11) have been reported in young patients, aged 18-30 years. The data obtained in the study in patients with major depressive disorder may indicate an increase in the frequency of suicidal behavior in patients younger than 24 years old, suffering from various mental disorders.However, most of these cases, in patients receiving paroxetine (8 of 11) have been reported in young patients, aged 18-30 years. The data obtained in the study in patients with major depressive disorder may indicate an increase in the frequency of suicidal behavior in patients younger than 24 years old, suffering from various mental disorders.
In patients with depression, exacerbation of the symptoms of this disorder, and / or the emergence of suicidal ideation and suicidal behavior (suicidality) can be observed regardless of whether they receive antidepressants. This risk persists until then, until a marked remission. Improving the condition of the patient may not be available in the first week of treatment and more, and therefore the patient should be closely observed for early detection of clinical worsening and suicidality, especially at the beginning of treatment, as well as periods of change doses, whether they increase or decrease. Clinical experience with all antidepressant shows that risk of suicide may increase in the early stages of recovery.
Other mental disorders for which treatment using paroxetine, may also be associated with an increased risk of suicidal behavior. Moreover, these disorders can be comorbid conditions, concomitant major depressive disorder. Therefore, when treating patients with other psychiatric disorders, should follow the same precautions as for the treatment of major depressive disorder.
Those most at risk of suicidal thoughts or suicide attempts exposed patients with a history of suicidal behavior or suicidal thoughts, patients of young age, and patients with severe suicidal thoughts prior to treatment, and, therefore, all of them need special attention during treatment. Patients (and those who care for them) to warn of the need to monitor the deterioration of their condition (including development of new symptoms) and / or the emergence of suicidal behavior or thoughts about self-harm during the course of treatment, especially at the beginning of treatment, or during while changing the dose of the drug (increase and decrease). In case of these symptoms should immediately seek medical help.
It must be remembered that the appearance of symptoms such as agitation, akathisia or mania can be related to the underlying disease or be a consequence of the applied therapy. At occurrence of symptoms of clinical deterioration (including the development of new symptoms) and / or suicidal thoughts / behavior, especially upon sudden their appearance, the growth of the severity of symptoms, or if they were not part of the prior symptom in a given patient, it is necessary to revise regimen up to discontinuation of the drug.
akathisia
Occasionally paroxetine treatment or another drug SSRI is accompanied by the appearance of akathisia, which manifests internal sense of anxiety and agitation, the patient could not sit or stand; when akathisia the patient usually experiences a subjective discomfort. The probability of occurrence of akathisia is highest in the first few weeks of treatment.
Serotonin syndrome, neuroleptic malignant syndrome
In rare cases, treatment with paroxetine may serotonin syndrome or symptoms such neuroleptic malignant syndrome, especially paroxetine used in combination with other serotonergic agents and / or antipsychotics. These syndromes represent a potential threat to life and, therefore, treatment with paroxetine should be discontinued in the event of their occurrence (they are characterized by groups of symptoms such as hyperthermia, muscle rigidity, myoclonus, autonomic dysfunction with possible rapid changes in indicators of vital signs, mental status changes, including confusion, irritability, extreme severe agitation, progressing to delirium and coma), and start supporting symptomatically.Paroxetine should not be administered in combination with serotonin precursors (such as L-tryptophan, oksitriptan) due to the risk for serotonin syndrome.
Mania and bipolar disorder,
major depressive episode may be the initial
