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Paxil 10 mg
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Active Ingredient: Paroxetine

Paxil is used for treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat generalized anxiety disorder or social anxiety disorder. Paxil is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Side Effects of Paxil

The frequency and intensity of some of the following side effects of paroxetine may decrease as treatment continues, and such effects usually do not require discontinuation of the drug. Side effects are stratified below organ systems and frequency. The frequency gradation is as follows: very frequent (> 1/10), frequent (> 1/100, <1/10) infrequent (> 1/1000, <1/100), rare (> 1/10 000, <1/1000 ) and very rare (<1/10 000), including individual cases. The incidence of frequent and infrequent side effects was determined on the basis of generalized data on the safety of the drug on more than 8000 patients participating in clinical trials, it was calculated by the difference between the frequency of side effects in the paroxetine group and in the placebo group. The occurrence of rare and very rare side effects was determined on the basis of post-marketing data, and it relates to the frequency of reports of such effects rather than the true frequency of the effects themselves.

Violations of the blood and lymphatic system

Infrequent: abnormal bleeding, mainly hemorrhage in. skin and mucous membranes (most often bruising).

Very rare: thrombocytopenia, violations by immune system

Very rare: allergic reactions (including urticaria and angioedema).

Endocrine disorders

Very rare: antidiuretic hormone secretion disorder syndrome, metabolic and nutritional disorders

Frequent: decrease in appetite, increase in level of cholesterol.

Rare: hyponatremia. Hyponatremia occurs predominantly in elderly patients and may be due to the syndrome of impaired secretion of antidiuretic hormone.

Mental disorders

Frequent: drowsiness, insomnia, agitation, unusual dreams (including nightmares).

Infrequent: confusion, hallucinations.

Rare: manic reactions. These symptoms may also be due to the disease itself.

Nervous system disorders

Frequent: dizziness, tremor, headache.

Infrequent: extrapyramidal disorders.

Rare: convulsions, akathisia, restless legs syndrome.

Very rare: serotonin syndrome (symptoms may include agitation, confusion, increased sweating, hallucinations, hyperreflexia, myoclonus, tremor tachycardia, and tremor). In patients with impaired motor function or treated with antipsychotics, extrapyramidal symptoms, including oro-facial dystonia, have rarely been reported.

Violations of the organs of sight

Frequent: blurred vision.

Infrequent: mydriasis

Very rare: acute glaucoma.

Heart disorders

Infrequent: sinus tachycardia

Vascular disorders

Infrequent: postural hypotension

Disorders of the respiratory system, chest and mediastinum

Frequent: yawning.

Gastrointestinal disturbances

Very frequent: nausea.

Frequent: constipation, diarrhea, vomiting, dry mouth.

Very rare: gastrointestinal bleeding.

Hepatobiliary disorders

Rare: elevated liver enzymes.

Very rare: hepatitis, sometimes accompanied by jaundice, and / or liver failure. Sometimes there is an increase in liver enzyme levels. Post-marketing reports of liver damage (such as hepatitis, sometimes with jaundice, and / or liver failure) are very rare. The question of whether to discontinue treatment with paroxetine should be addressed in cases where there is a long-term increase in the performance of hepatic function tests.

Violations of the skin and subcutaneous tissues

Frequent: sweating.

Infrequent: skin rashes.

Very rare: photosensitivity reactions.

Kidney and urinary tract disorders

Rare: urinary retention, urinary incontinence.

Disorders of the reproductive system and mammary glands

Very frequent: sexual dysfunction.

Rare: hyperprolactinemia / galactorrhea.

General disruption

Frequent: asthenia, weight gain.

Very rare: peripheral edema.

Symptoms that occur when discontinuing treatment with paroxetine

Frequent: dizziness, sensory disturbances, sleep disturbances, anxiety, headache.

Infrequent: agitation, nausea, tremor, confusion, sweating, diarrhea.

As with the abolition of many psychotropic drugs, stopping paroxetine treatment (especially abrupt) can cause symptoms such as dizziness, sensory disturbances (including paresthesias, electric current and noise in the ears), sleep disorders (including bright dreams), agitation or anxiety, nausea, headache, tremor, confusion, diarrhea and sweating. In most patients, these symptoms are mild or moderately pronounced and disappear spontaneously. No patient group is known to be at increased risk of such symptoms; so if. Paroxetine treatment is no longer necessary, its dose must be reduced slowly until the drug is completely discontinued.

Adverse events observed in clinical trials in children

In clinical trials, the following side effects occurred in children in 2% of patients and were found in the paroxetine group twice as often as in the placebo group: emotional lability (including self-harm, suicidal thoughts, suicidal attempts, tearfulness and mood swings), hostility, loss of appetite, tremor, sweating, hyperkinesia and agitation.

Suicidal thoughts and suicidal attempts were mainly observed in clinical trials in adolescents with major depressive disorder, in which the efficacy of paroxetine has not been proven. Hostility was observed in children with obsessive-compulsive disorder, especially in children younger than 12 years old.

Symptoms of paroxetine withdrawal (emotional lability, nervousness, dizziness, nausea and abdominal pain) were recorded in 2% of patients with paroxetine dose reduction or after its complete abolition and were 2 times more common than in the placebo group.

Special instructions

Children and teenagers (under 18)

Treatment by antidepressants of children and adolescents who suffer from major depressive disorder and other mental illnesses is associated with an increased risk of suicidal thoughts and suicidal behavior. In clinical studies, adverse events related to suicidal attempts and suicidal thoughts, hostility (mainly aggression, deviant behavior and anger) were more often observed in children and adolescents who received paroxetine than in patients of this age group who received placebo. There are currently no data on the long-term safety of paroxetine for children and adolescents, which would concern the effect of this drug on growth, maturation, cognitive and behavioral development.

Clinical deterioration and suicidal risk in adults

Young patients, especially those with a major depressive disorder, may be at increased risk of suicidal behavior during paroxetine therapy. Analysis of placebo-controlled studies in adults suffering from mental illness suggests an increase in the frequency of suicidal behavior in young patients (aged 18–24 years) with paroxetine compared with the placebo group (2.19% to 0.92%, respectively ), although this difference is not considered statistically significant. In patients of older age groups (from 25 to 64 years and over 65 years), an increase in the frequency of suicidal behavior was not observed. In adults of all age groups suffering from major depressive disorder, there was a statistically significant increase in cases of suicidal behavior during treatment with paroxetine compared with the placebo group (incidence of suicidal attempts: 0.32% to 0.05%, respectively). However, most of these cases with paroxetine (8 out of 11) were reported in young patients between the ages of 18-30. The data obtained in a study in patients with major depressive disorder may indicate an increase in the incidence of suicidal behavior in patients under 24 years of age suffering from various mental disorders. In patients with depression, worsening of the symptoms of this disorder and / or the appearance of suicidal thoughts and suicidal behavior (suicidality) can be observed regardless of whether they receive antidepressants. This risk persists until a pronounced remission is achieved. Improvement of the patient’s condition may be absent in the first weeks of treatment or more, and therefore the patient must be carefully monitored for timely detection of clinical exacerbation and suicidality, especially at the beginning of the course of treatment, as well as during periods of dose changes, whether they increase or decrease. Clinical experience with all antidepressants shows that the risk of suicide may increase in the early stages of recovery. Other mental disorders that paroxetine is used to treat may also be associated with an increased risk of suicidal behavior. In addition, these disorders can be comorbid conditions associated with major depressive disorder. Therefore, in the treatment of patients suffering from other mental disorders, the same precautions should be observed as in the treatment of major depressive disorder. Patients with a history of suicidal behavior or suicidal thoughts, young patients, as well as patients with strong suicidal thoughts before treatment, are at greatest risk of suicidal thoughts or attempts, and therefore they all need to pay special attention during treatment. Patients (and those who care for them) should be warned about the need to monitor the deterioration of their condition and / or the appearance of suicidal thoughts / suicidal behavior or thoughts about hurting themselves during the entire course of treatment, especially at the beginning of treatment, during a dose change. (increase and decrease). If these symptoms occur, you should immediately seek medical attention. It must be remembered that symptoms such as agitation, akathisia or mania may be associated with the underlying disease or be a consequence of the therapy used. If symptoms of clinical deterioration (including new symptoms) and / or suicidal thoughts / behavior occur, especially when they suddenly appear, the severity of manifestations increases, or if they were not part of the previous symptom complex in this patient, the treatment regimen should be reviewed up to drug withdrawal.

Akathisia

Occasionally, treatment with paroxetine or another drug from the group of selective serotonin reuptake inhibitors (SSRIs) is accompanied by the occurrence of akathisia, which is manifested by a feeling of internal anxiety and psychomotor agitation when the patient cannot sit or stand still; with akathisia. the patient usually experiences subjective discomfort. The likelihood of akathisia is highest in the first few weeks of treatment.

Serotonin syndrome / neuroleptic malignant syndrome

In rare cases, serotonin syndrome or symptoms similar to the malignant neuroleptic syndrome may occur with paroxetine treatment, especially if paroxetine is used in combination with other serotonergic drugs and / or neuroleptics. These syndromes represent a potential life-threatening condition, and therefore treatment with paroxetine should be stopped if they occur (they are characterized by groups of symptoms such as hyperthermia, muscle rigidity, myoclonus, autonomic disorders with possible rapid changes in vital signs, changes in mental status, including confusion, irritability, extremely severe agitation, progressing to delirium and coma), and initiate symptomatic supportive therapy. Paroxetine should not be administered in combination with serotonin precursors (such as L-tryptophan, oxytriptan) due to the risk of developing serotonergic syndrome.

Mania and bipolar disorder

A major depressive episode may be the initial manifestation of bipolar disorder. It is believed (although not proven by controlled clinical trials) that treating such an episode with an antidepressant alone can increase the likelihood of accelerated development of a mixed / manic episode in patients at risk for developing bipolar disorder. Before starting treatment with an antidepressant, thorough screening should be conducted to assess the risk of bipolar disorder in a given patient; Such screening should include a detailed psychiatric history, including evidence of suicide, bipolar disorder and depression in the family. Paroxetine is not registered to treat a depressive episode as part of bipolar disorder. Paroxetine should be used with caution in patients with a history of mania.

Monoamine oxidase inhibitors (MAO)

Paroxetine treatment should begin cautiously no earlier than 2 weeks after cessation of therapy with MAO inhibitors; The dose of paroxetine should be increased gradually until the optimum therapeutic effect is achieved.

Impaired renal or hepatic function

It is recommended to use caution when treating paroxetine in patients with severe renal impairment and patients with impaired liver function.

Epilepsy

Like other antidepressants, paroxetine should be used with caution in patients with epilepsy. Convulsive seizures The frequency of convulsive seizures in patients taking paroxetine is less than 0.1%. In the event of a convulsive seizure, treatment with paroxetine should be stopped.

Electroconvulsive therapy

There is only limited experience with simultaneous use of paroxetine and electroconvulsive therapy.

Glaucoma

Like other drugs of the SSRI group, paroxetine causes mydriasis, and it should be used with caution in patients with angle-closure glaucoma.

Hyponatremia

In the treatment of paroxetine, hyponatremia occurs rarely and predominantly in elderly patients and is leveled after discontinuation of paroxetine.

Bleeding

Hemorrhages in the skin and mucous membranes (including gastrointestinal hemorrhages) have been reported in patients with paroxetine. Therefore, paroxetine should be used with caution in patients who simultaneously receive drugs that increase the risk of bleeding, in patients with a known tendency to bleeding and in patients with diseases that predispose to bleeding.

Heart disease

When treating patients with heart disease, normal precautions should be observed.

Symptoms that may occur when discontinuing paroxetine treatment in adults are:

As a result of clinical studies in adults, the incidence of adverse events with the elimination of paroxetine was 30%, while the incidence of adverse events in the placebo group was 20%.

Such withdrawal symptoms as dizziness, sensory disturbances (including paresthesias, sensation of electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headaches and diarrhea are described. These symptoms are usually mild or moderate, but in some patients they can be severe. They usually occur in the first few days after discontinuation of the drug, but in rare cases occur in patients who have accidentally missed a single dose. As a rule, these symptoms disappear spontaneously and disappear within 2 weeks, but in some patients they can last much longer (2-3 months or more). It is recommended to reduce the dose of paroxetine gradually, over several weeks or months before it is completely canceled, depending on the needs of the particular patient. The occurrence of withdrawal symptoms does not mean that the drug is abused or addictive, as is the case with drugs and psychotropic substances.

Symptoms that may occur when discontinuing paroxetine treatment in children and adolescents:

As a result of clinical studies in children and adolescents, the incidence of adverse events with the abolition of paroxetine was 32%, while the incidence of adverse events in the placebo group was 24%. Symptoms of paroxetine withdrawal (emotional lability, including suicidal thoughts, suicidal attempts, mood changes and tearfulness, as well as nervousness, dizziness, nausea and abdominal pain) were recorded in 2% of patients with paroxetine dose reduction or after its complete withdrawal and met 2 times more often than in the placebo group.

Bone fractures

According to the results of epidemiological studies of the risk of bone fractures, a connection of bone fractures with antidepressants, including the SSRI group, has been identified. The risk was observed during the course of treatment with antidepressants and was maximum at the beginning of the course of therapy. The possibility of bone fractures should be considered when prescribing paroxetine.

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