Paroxetine Hydrochloride Tablets

This product is oval film coated tablets, one side is scored, one side is engraved with "STL20", after removing the coating white or white.

Key words:

Classification:

Antidepressants

Hotline:

+86-579-82131973

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Graphic Details

Date of approval: May 21, 2007

First revision date: September 15, 2010

Second revision date: October 31, 2013

Third revision date: May 05, 2015

Fourth revision date: December 1, 2015

Fifth revision date: February 26, 2020

6th revision date: July 28, 2020

7th revision date: August 31, 2020

Instructions for Paroxetine Hydrochloride Tablets

Please read the instructions carefully and use them under the guidance of a physician.

Warning

Suicidal tendencies and antidepressants

The Depression (MDD)and other mental disordersShort-term clinical trial results show that compared with placebo,-depressive drugs increased in children, adolescents and youth (≤ 24years)The patient's suicidal thoughts and the implementation of suicidal behavior (suicidal tendencies)of the windrisk. Anyone who considers this product or otherAntidepressant medication for children, adolescents and youth (≤ 24years), must be weighted between their risks and clinical needs.Heng. Short-term clinical trials have not shown that age is older than 24 compared with placeboUse of antidepressants in adults agedincreased risk of suicidal tendencies; while at age 65Among adults age and older, the use of antidepressants after suicidal tendencyThe risk is reduced. Depression and certain mental disorders are themselves associated with an increased risk of suicide and must be closely observed for worsening of clinical symptoms after initiation of antidepressant therapy in all age groups,Suicidal tendencies, abnormal changes in behavior. Family members and caregivers should be advised to observe closely and communicate with doctors. This productNot approved for use in pediatric patients (See Precautions-Warning, Worsening of Clinical Symptoms and Suicide Risk,[Precautions]-patient medication information, andchildren's medication]).

[Name of Drug]]

Common Name: Paroxetine Hydrochloride Tablets

英文名称：Paroxetine HydrOchloride Tablets

汉语拼音：Yansuan Paluoxiting Pian

[ingredients]]

The main ingredient of this product is paroxetine hydrochloride.

Chemical Name:(-)-(3S,4R)-4-(4-Fluorophenyl)-3-{[3,4-(methylenedioxy) phenoxy] methyl} piperidine hydrochloride hemihydrate

Chemical structural formula:

Molecular formula: C_l9H₂₀FN0₃·HCl·l／2H₂0

Molecular weight: 374．84

character]

This product is oval film coated tablets, one side is scored, one side is engraved with "STL20", after removing the coating white or white.

indications]

This product is used to treat depression, obsessive-compulsive disorder, panic disorder with or without square terror, social phobia/social anxiety disorder.

After the curative effect is satisfied, continue to take this product can prevent the recurrence of depression, panic disorder and obsessive-compulsive disorder.

[Specification] 20mg (toC_l9H₂₀FN0₃).

Usage and dosage]

Oral, it is recommended to take daily breakfast (with or without food), tablets swallowed intact do not chew.

Adults:Depression:

The usual dose is 20mg daily. Take 2After ~ 3 weeks, according to the patient's response, some patients need to increase the dosage, with a weekly increase of 10mg, with a daily maximum of 50mg, and should follow the doctor's advice. The interval between dose adjustments is at least one week.

Obsessive Compulsive Disorder:

The usual dose is 40mg dailyThe initial dose is 20mg daily., in increments of 10mg per week. The maximum daily dose is 60mg. The interval between dose adjustments is at least one week.

Panic Disorder:

The usual dose is 40mg dailyThe initial dose is 10mg daily.According to the patient's response, the daily dose can be increased by 10mg every week, and the maximum daily dose can reach 50mg. The interval between dose adjustments is at least one week.

Social phobia/social anxiety disorder:

The usual dose is 20mg dailyFor 20mg.Patients who do not respond can be increased by 10mg per week, up to a maximum of 50mg per day, depending on the patient's clinical response. The interval between dose adjustments is at least one week.

As with all antidepressants, the dose should be adjusted during treatment according to the condition. Patients should be treated long enough to consolidate the effect, depression should be maintained for at least several months after recovery, and obsessive-compulsive disorder and panic disorder should be maintained for longer periods of time. The method of drug withdrawal is similar to other psychiatric drugs, which should be gradually reduced and should not be stopped suddenly.

discontinuation of paroxetine:

Like other psychotropic drugs, this product should not be stopped suddenly (See [Precautions] and [Adverse Reactions] sections). The drug withdrawal plan adopted in the clinical trial is to gradually reduce the dose at weekly intervals, and the daily dose per week is reduced by 10mg compared with the daily dose last week, and the dose is reduced once a week.

When the daily dose is reduced to 20mg dailyAt that time, the patient continued to take the drug l at that dose.Weeks, then off the drug. If intolerable symptoms occur after dose reduction or discontinuation, a return to the previous dose may be considered. The doctor can then proceed with the reduction program, but at a slower rate.

Renal/hepatic impairment:

Severe renal impairment (Creatinine clearance <30ml/min) or patients with liver damage, the blood drug concentration is higher than that of healthy people after taking this product. Therefore, the recommend dose is 20mg daily. If the dose needs to be increased, it should also be limited to the lower limit of the drug.

adverse reaction]

Some of the adverse reactions listed below may lessen or decrease with prolonged treatment and generally do not lead to discontinuation of treatment. Adverse drug reactions are listed below by system organ classification and incidence. The incidence was defined as: very common (≥ 1／10), common (≥ 1/l00,<1/10), occasionally (≥ 1/1,000,<1/100), rare (≥ 1/10,000,<1/1,000), very rare (<1/10,000), including individual reports. Rates of common and occasional events were generally judged based on safety summary data in the patient (>8000) population treated with paroxetine in clinical trials, and generally referred to additional incidences compared with placebo. Rare and very rare events are generally judged on the basis of post-marketing data and refer to the reporting rate rather than the true incidence.

Blood and lymphatic system:

EvenSee: Abnormal bleeding, mainly in skin and mucous membranesAnemia, leukopenia, lymphadenopathy, purpura;

Rare: Abnormal red blood cells, basophilia, prolonged bleeding time, hypereosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, lymphocytic abnormalities, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocytosis, thrombocytopenia.

immune system

veryCommon: Allergic reactions (including urticaria and angioedema).

Endocrine system

Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis:

very rareSee: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)。

metabolism and nutrition

Common: increased cholesterol levels, loss of appetite, weight gain;

Occurring: edema, peripheral edema, alanine aminotransferaseElevated, aspartate aminotransferaseElevation, thirst, weight loss;

Rare: Elevated alkaline phosphatase, bilirubinemia, BUNElevated, creatinine phosphate kinase increased, dehydration, gamma globulin increased, gout, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, high phosphorus (acid salt), hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, elevated lactate dehydrogenase, and elevated non-protein nitrogen (NPN).

Hyponatremia has been reported mainly in elderly patients, sometimes by syndrome of inappropriate antidiuretic hormone secretion (SIADH).Caused.

Mental abnormality:

Common: drowsiness, insomnia and excitement, abnormal dreams (including nightmares).

Occidental: confusion, illusion.

Rare: manic.

Nervous system

Common: vertigo, tremor, headache, emotional instability;

Occasional: extrapyramidal symptoms, abnormal thinking, alcoholism, ataxia, dystonia, dyskinesia, euphoria, hostility, hallucinations, hypotonia, hypokinesia, dyscoordination, apathy, increased libido, mania, neurosis, paralysis, paranoia;

Rare: convulsions, akathisia, restless legs syndrome, abnormal gait, akinesia, social aversion, aphasia, choreoathesia, perioral paresthesia, delirium, delusions, diplopia, drug dependence, dysphasia, fasciculation, grand mal convulsions, hyperalgesia, hysteria, bipolar disorder, cerebrospinal meningitis, neuralgia, neuropathy, increased ocele reflex, depression, neuropathy trism syndrome, withdrawal syndrome;

Very rare: serotonin syndrome (Symptoms may include excitement, confusion, hyperhidrosis, hallucinations, hyperreflexia, myoclonus, shivering tachycardia, and tremors).

Some patients report extrapyramidal symptoms, including orofacial dystonia, sometimes with underlying dyskinesia, or on antipsychotic medication.

Eyes

Common: Blurred vision.

Ocdental: pupil dilation (See [Precautions])

Very rare: acute glaucoma.

Cardiovascular system

Common: hypertension, tachycardia;

Sinus tachycardia, orthostatic hypotension, bradycardia, hematoma, hypotension, migraine, orthostatic hypotension, syncope;

Rare: Angina pectoris, arrhythmias, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarction, myocardial ischemia, pallor, phlebitis, pulmonary embolism, supra-ventricular premature contractions, thrombophlebitis, thrombosis, varicose veins, vascular headache, ventricular premature contractions.

Respiratory system, thoracic cavity and mediastinum

veryCommon: Yawning

occasional: asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory influenza;

Rare: Emphysema, hemoptysis, hiccups, pulmonary fibrosis, pulmonary edema, increased sputum volume, stridor and voice changes, pulmonary embolism.

Digestive system

veryCommon: nausea.

Common: constipation, diarrhea, vomiting, dry mouth.

EvenSee: Night bruxism, colitis, dysphagia, belching, gastritis, gastroenteritis, gingivitis, glossitis, hypersalivation, abnormal liver function, rectal bleeding, ulcerative stomatitis;

Rare: aphthous stomatitis, bloody diarrhea, hyperphagia, cardia spasm, gallstone disease, duodenitis, enteritis, esophagitis, fecal impaction, fecal incontinence, gingival bleeding, hematemesis, hepatitis, ileitis, intestinal obstruction, intestinal obstruction, jaundice, melasma, mouth ulcer, peptic ulcer, salivary gland enlargement, salivary inflammation, gastric ulcer, stomatitis, tongue discoloration, tongue swelling, dental caries.

veryRare: Gastrointestinal bleeding.

hepatobiliary system

Rare: elevated transaminases;

Very rare: hepatic events (such as hepatitis, jaundice, liver failure).

Elevated liver transaminases have been reported. We have also received post-marketing reports of hepatic events (eg, hepatitis, sometimes with jaundice and/or liver failure)These reports are rare. If liver function tests continue to increase, discontinuation of paroxetine should be considered.

Skin and subcutaneous tissue

Common: sweating, itching;

EvenSee: rash, acne, alopecia, contact dermatitis, dry skin, hemorrhagic spots, eczema, herpes simplex, photosensitivity, urticaria;

Rare: angioedema, erythema nodular, erythema multiforme, exfoliative dermatitis, mycotic dermatitis, furunculosis, herpes zoster, hirsutism, maculopapular rash, seborrheic dermatitis, skin discoloration, skin hypertrophy, skin ulcers, reduced sweating and blistering herpes;

veryRare: photosensitive reaction.

Kidney and genitourinary system

Very common: Sexual dysfunction.

Occasion: urinary retention, urinary incontinence, amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urgency, vaginitis;

Rare: Hyperprolactinemia/galactorrhea, abortion, breast atrophy, breast distension, endometriosis, epididymitis, fibrocystic mastopathy, nephrolithiasis, renal pain, leucorrhea, mastitis, irregular uterine bleeding, nephritis, oliguria, salpingitis, urethritis, ureuria, uterine spasm, urolithiasis, irregular menstruation (including menorrhagia, bleeding and amenorrhea), and candidal disorders.

Systemic and site of administration reactions

Common: weakness, weight gain;

Ocdental: chills, facial edema, malaise, neck pain;

Rare: Adrenergic drug syndrome, cellulitis, candidiasis, neck stiffness, pelvic pain, peritonitis, sepsis, and ulcers.

Very rare: peripheral edema.

Musculoskeletal system:

Common: arthralgia;

Ocdental: arthritis, arthrosis;

Rare: bursitis, myositis, osteoporosis, generalized convulsions, tenosynovitis, hand-foot convulsions.

Specific feelings:

Common: tinnitus;

occasional: maladjustment, conjunctivitis, earache, eye pain, keratoconjunctivitis, dilated pupils, otitis media;

Rare: Amblyopia, unequal pupil size, blepharitis, cataract, conjunctival edema, corneal ulcer, earDeafness, exophthalmos, ocular hemorrhage, glaucoma, auditory hypersensitivity, night blindness, otitis externa, incorrect smell, photophobia, ptosis, retinal hemorrhage, loss of taste and visual field defects.

Discontinuation of Paroxetine Symptoms:

Common: vertigo, sensory disturbances, sleep disorders, anxiety, headache.

Occurrence: Excitement, nausea, tremor, confusion, sweating, diarrhea.

Like many other psychotropic drugs, the withdrawal of paroxetine (especially when abruptly discontinued)Symptoms such as dizziness, sensory disturbances (including paresthesia, electric shocks, and tinnitus), sleep disturbances (including intense dreams), excitement or anxiety, nausea, headache, tremors, confusion, diarrhea, and sweating may occur. In most patients, these events were mild to moderate and self-limiting. No group of patients were found to have a higher risk of developing these symptoms, so it is recommended that if paroxetine is no longer needed, the drug should be gradually reduced (see Usage and Dosage and Precautions).

Adverse events in pediatric clinical studies:

In clinical studies in children, at least 2% of patients reported the following adverse events, at least twice as common as placebo: emotional instability (including self-harm, suicidal thoughts, suicide attempts, crying and mood swings), hostility, loss of appetite, tremor, sweating, cramps and agitation. Suicidal thoughts and suicide attempts were mainly seen in clinical trials of adolescents with major depressive disorder. Hostility is more common in children with obsessive-compulsive disorder, especially in children under the age of 12.

A tapering dosing regimen was used in the trial (Weekly daily dose of 10mgdecreasing to a daily dose of 10mg and continuing to take one week after discontinuation). During tapering or at the time of discontinuation, at least 2% of patients reported the following symptoms at a rate at least twice that of placebo: emotional instability, nervousness, dizziness, nausea, and abdominal pain (see section Precautions).

Post-Market Report:

Since the launch of the drug, spontaneous reports of adverse events have been received from patients taking paroxetine. Adverse events not listed above that may not be causally related to the drug include: acute pancreatitis, elevated liver function tests (The most severe cases are deaths due to hepatic necrosis and a marked elevation of transaminases associated with severe liver dysfunction), Guillain-Barre syndrome, Stevens-Johnson syndrome, toxic epidermal necrosis laxity, priapism, syndrome of abnormal secretion of antidiuretic hormone, symptoms of prolactinemia, galactorrhea; extrapyramidal symptoms include akathisia, bradykinesia, cogwheel-like rigidity, tension disorder, hypertonia, oculomotor nerve crisis related to the concomitant medication of piperazine; Tremor tussis; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngospasm, optic neuritis, porphyria, ventricular fibrillation, ventricular tachycardia (including torsades de pointes), thrombocytopenia, hemolytic anemia, adverse events associated with hematopoietic impairment (including aplastic anemia, pancytopenia, myelodysplasia, and anaphylactoid vasculitis syndrome), and pura syndrome (eg). After 4 weeks of simultaneous administration of paroxetine and phenytoin, I received a report of an elevated phenytoin blood concentration. There was also a report of severe hypotension after paroxetine was added to long-term metoprolol treatment.

taboo]

It is prohibited for those who are known to be allergic to this product and its excipients.

This product should not be combined with monoamine oxidase inhibitors (including the antibiotic drug linezolid, a reversible, non-selective monoamine oxidase inhibitor, and methylene blue (methylene blue))Or use within two weeks after the end of treatment with a monoamine oxidase inhibitor. Similarly, monoamine oxidase inhibitors should not be used within two weeks after the end of treatment with this product (see [Drug Interactions] for details).

This product should not be used in combination with thioridazine. Because with other inhibition of liver cytochrome P450Isoenzyme CYP450 2D6This product can cause an increase in the plasma concentration of thioridazine (see [Drug Interactions]). Thioridazine can cause prolongation of the QT interval with severe ventricular arrhythmias and, in severe cases, torsades de pointes ventricular tachycardia and sudden death.

This product should not be combined with piperazine (pimozide)Combined use (see Drug Interactions).

[Note]]

Warning

Worsening of clinical symptoms and risk of suicide:

suffering from depressionadults and childrenPatients, whether or not taking antidepressants, are at risk of worsening their depression and of experiencing suicidal ideation and suicidal behavior and abnormal changes in behavior.This risk will continue until the disease is found to be significantly relieved. Depression and certain mental disorders are known to be associated with suicide risk, and these mental disorders themselves are the strongest predicators of suicide. However, there have long been concerns that antidepressants may play a role in inducing worsening of depressive symptoms and suicidal ideation and behavior in some patients early in treatment. Antidepressants (selective serotonin reuptake inhibitors and others) Short-term placebo-controlled studies pooled analysis showed that antidepressants increased the risk of suicidal ideation and behavior compared with placebo in children, adolescents, and young adults (18-24 years) with depression and other psychiatric disorders. However, short-term clinical trials did not show that in adults older than 24 years, the use of antidepressants increased the risk of suicidal ideation and behavior compared with placebo; in adults 65 years and older, the use of antidepressants The risk of suicidal ideation and behavior was reduced.

placebo-controlled trials in children and adolescents with depression, chases, or other psychiatric disorders (total of 24 short-term clinical trials, 9 antidepressants, more than 4400 patients) and placebo-controlled trials in adults with depression or other psychiatric disorders (total of 295 short-term clinical trials [median duration of 2 months],11 antidepressants, more than 77000 patients), the risk of suicidal ideation and behavior varies widely among drugs, but most drug studies show an increased risk of suicidal ideation and behavior in younger patients. The absolute risk of suicidal ideation and behavior varied across different indications, with the absolute risk being highest in depression. Although the absolute risk varied across indications (drug versus placebo), the risk was relatively stable across age groups across indications. Table 1 provides the risk differences(Number of cases of drug versus placebo-treated differences in risk of suicidal ideation and behavior per 1000 patients).

Table 1

Age range	Difference in risk of suicidal ideation and behavior between drug and placebo treatment per 1000 patients
Increased number of cases compared to placebo
<18	Increase 14Example
18-24	Increase5Example
Reduced number of cases compared to placebo
25-64	MinusLess 1Example
≥ 65	MinusLess 6Example

There were no suicides in pediatric clinical trials and suicides in adult clinical trials, but these data are not sufficient to evaluate the effect of the drug on suicide.

Risk of suicidal thoughts and behaviorIn the process of long-term medication (if more than a few months)Whether it will continue is not yet known. However, data from placebo-controlled maintenance therapy clinical trials in adult patients with depression amply show that the use of antidepressants can delay the recurrence of depression.

Regardless of the indication, all patients receiving antidepressant therapy should be closely observed and monitored for worsening of clinical symptoms, suicidal ideation and behavior, and abnormal changes in behavior. This is especially true during the initial months of treatment and when the dose is increased or decreased.

When treating adult and pediatric patients with depression, other psychotic or non-psychotic disorders with antidepressantsThe following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, akasidation (psychomotor restlessness) andHypomania and mania. Although a causal relationship between the occurrence of these symptoms and the worsening of depression and/or the development of suicidal ideation and behavior has not been established, it is noted that the occurrence of these symptoms may be a precursor to the development of suicidal ideation and behavior.

WhenAdjustments to the treatment regimen, including discontinuation of drug therapy, should be carefully considered if the patient's depressive symptoms continue to worsen, suicidal ideation and behavior, or symptoms that may be a precursor to worsening depressive symptoms or suicidal ideation and behavior. This is especially true if these symptoms are severe, sudden, or inconsistent with the patient's current symptoms.

If a decision is made to discontinue treatment, the dose should be reduced as soon as possible, but be aware thatSudden discontinuation may cause certain symptoms (See [Precautions] and [Usage and Dosage]).

When treating a child patient with depression or other psychotic or non-psychotic disorders with an antidepressant, family members and caregivers should be reminded of the need to monitor the patient for intensification, irritability, abnormal changes in behavior, other symptoms mentioned above, and suicidal ideation and behavior, and to report these symptoms to the health care professional as soon as they occur. Family members and caregivers should monitor the patient daily. When using this product, prescribing should start with the minimum amount and be coordinated with good patient management and to reduce the risk of overdose.

Screening of patients with bipolar disorder:

Depressive episode may be the initial manifestation of bipolar disorder. It is generally believed that (Although not clear through the control test)Treatment of such episodes with antidepressants alone may increase the likelihood of mixed/manic episodes in patients at risk for bipolar disorder. It is not clear whether the symptoms mentioned above mean that such a shift is possible. However, before antidepressant treatment was started,Patients with depressive symptoms should be adequately screened to determine whether they are at risk for bipolar disorder; this screening should include a detailed psychiatric history, including family history of suicide and family history of bipolar disorder and depression. This product has not been approved for the treatment of bipolar disorder.

5a serotonin syndrome:

Similar to other serotonergic drugs, serotonin syndrome (a potentially life-threatening condition) may occur when treated with paroxetine, especially when combined with other drugs that may act on the serotonin transmitter system (e. g., triptan, selectiveSerotonin reuptake inhibitor, norepinephrine reuptake inhibitor, lithium salt, sibutramine, amphetamine, St. John's wort [Hypericum extract], phenatinenimb and its analogs, tramadol, dextromethorphan, tapentadol, pethidine, methadone, pentazocine, tricyclicsantidepressants, tryptophan, and buspirone), when combined with drugs that impair serotonin metabolism (e. g., MAOlsmethylene blue), when combined with serotonin precursors (e. g. tryptophan supplements), with antipsychotic drugsor when combined with other dopamine antagonists.

Serotonin syndrome may include changes in mental status (eg, agitation, hallucinations, delirium, coma), self-major nerve instability (eg, tachycardia, blood pressure instability, hyperthermia,sweating, flushing, and dizziness) neuromuscularSystemic disorders (eg, tremor, tonic, myoclonus, hyperreflexia, movement disorders), seizures, and gastricIntestinal symptoms (eg, nausea, vomiting, diarrhea). The most severe serotonin syndrome with neuroleptic malignancySyndromes present similarly, including hyperthermia, muscle rigidity, autonomic instability may be accompanied by vital signsrapid fluctuations, as well as changes in mental state.

Use of this product with MAOls is prohibited. Patients receiving MAOls such as linezolid or intravenous methylene blueParoxetine should also not be used. The route of administration of methylene blue in all reports is 1 mg/kg to 8 mg/kg dose range.Intravenous administration. No reports of other routes (e. g., oral tablets or local tissue injection) or lowerThe dose was given methylene blue.In some cases, patients who are taking paroxetine may have to receive linezolidor intravenously treated with MAOIs such as methylene blue. Paroxetine should be discontinued before starting MAOls therapy.

If clinically justified, paroxetine and certain selective serotonin reuptake inhibition should be used in combination.agents, norepinephrine reuptake inhibitors, or other serotonergic drugs (e. g., triptans, tricyclicantidepressants, mirtazapine, fentanyl, lithium salts, tramadol, buspirone, tryptophan, and St. John's wort [HypericumPlant extract]), it is recommended to closely observe the patient's condition, especially at the beginning of treatment and when increasing the dose.

Combinations of paroxetine and serotonin precursors (eg, tryptophan supplements) are not recommended.

When these events occur, paroxetine and any concomitant serotonergic drugs must be stopped immediately,and started symptomatic and supportive treatment.

angle closure glaucoma:

For the anatomic structure of the narrow angle, not a clear iridectomy patients, so thatPupil dilation after multiple antidepressants (including paroxetine) may cause angulotoxicity due to angle closure.Light eye attack.

Possible interaction with thioridazine:

An in vivo trial showed that drugs that inhibit CYP2D6 (such as parosilTing) can increase the plasma level of thioridazine, so paroxetine and thioridazine are not recommend (see [banavoid] and [caveats)). Thioridazine can cause QT interval prolongation with severe ventricular arrhythmias,Severe cases can lead to torsades de pointes and sudden death.

General Information: Mania/Hypomania:

During premarket trials, hypomania or mania occurred in approximately 1.0% of patients receiving hydrochloric acidIn unipolar depression patients treated with paroxetine tablets, hypomania or mania occurs in approximately 1.19 percent of active controls.treatment and 0.3 percent of unipolar depressed patients treated with placebo. in a category classified as bipolar disorderIn the subgroup of patients with obstruction, the incidence of mania in the paroxetine hydrochloride tablet treatment group was 2.2%, while the combined activity-controlgroup was 1.6 percent. As with all other drugs that are effective in the treatment of depression, in patients with maniaIn patients with a history of paroxetine hydrochloride tablets should be used with caution.

Seizures:

In premarket trials, seizures occurred in 0.1% of patients treated with paroxetine hydrochloride tabletsThe incidence is similar to that associated with other drugs that are effective in the treatment of depression. In having epileptic hairIn patients with a medical history, paroxetine hydrochloride tablets should be used with caution. Any patient who has a seizure shouldStop using paroxetine hydrochloride tablets.

Stop treatment with paroxetine hydrochloride tablets:

Support the most of paroxetine hydrochloride tablets for a variety of approved indications.In recent clinical studies, a tapering regimen was used rather than immediate discontinuation of treatment. Generic anxiety and post-traumaticDose downregulation used in clinical trials of stress disorders employs a regimen of decreasing the daily dose by 10mg/day on a weekly basis.When the daily dose reached 20mg/day, the patient continued to receive this dose for 1 week before discontinuation of treatment.

The following adverse events occurred in patients treated with paroxetine hydrochloride tablets after the use of this regimen in the studyThe rate was> 2% and was at least twice as high as in the placebo group: abnormal dreams, paresthesia, and dizziness.In most patients, these events were mild to moderate in severity and self-limiting without medical intervention.

Paroxetine hydrochloride tablets and other selective serotonin reuptake inhibitors and norepinephrine reuptakeDuring the time of the inhibitor market, some adverse events in spontaneous reports occurred after discontinuation of these drugs (especially sudden discontinuationafter medication), including: emotional dysphoria, irritability, emotional agitation, dizziness, sensory disorders (e. g., similar to electricitysensory disturbance and tinnitus in the sense of hitting), anxiety,Confusion, headache, lethargy, emotional instability, insomnia, and mild irritabilityCrazy. Although most of these events are self-limiting,However, there are still reports of severe discontinuation symptoms.When stopping treatment with paroxetine hydrochloride tablets, patients should be monitored for these symptoms. in any possibleUnder the circumstances,It is recommended that the dose be gradually reduced rather than abruptly stopped. If the dose is lowered or after stopping treatmentIf symptoms of intolerance occur, it may be necessary to consider continuing the administration of the previously prescribed dose. The doctor can thenmore slowly continue to reduce the dose(See (Usage and Dosage)).

Adverse Events Reported in Pediatric Patients after Discontinuation of Paroxetine Hydrochloride Tablets[Children's medication].

Tamoxifen:

Some clinical studies have shown that,in breast cancer recurrence 1 mortality risk due to the effect of paroxetine onCYP2D6 is irreversibly inhibited (see (Drug Interactions)) and therefore combined with paroxetine.

Use will reduce its efficacy. This risk may increase with the duration of concomitant medication. However, other studies have notconfirm the risk. It has not been determined whether the combined administration of paroxetine and tamoxifen will affect the efficacy of tamoxifenIt has a significant negative impact. A study shows that the risk may increase as the duration of combination therapy is prolonged.Plus. When tamoxifen is used for the prevention and treatment of breast cancer, prescribers should consider minimal inhibition of CYP2D6 orAlternative antidepressants without inhibitory effect.

Can't sit still:

The use of this product or other selective serotonin reuptake inhibitors is associated with the development of akinas, which isIt is characterized by restless inner feelings and psychomotor excitement,For example, often due to conscious distress, can notSit or stand quietly. This is most likely to occur during the first few weeks of treatment.

Hyponatremia:

Selective 5-hydroxychromophoric reuptake inhibitors including paroxetine and norepinephrine reuptakeTake inhibitor treatment, may lead to hyponatremia. In very bad cases, hyponatremia is an abnormal secretion of antidiuretic stimulation.syndrome (SIADH) as a result. There have been cases of serum sodium levels below 110rmmoL. elderly patientsPatients who received selective serotonin reuptake willow prickles and Fadrenal reuptake inhibitors developed low sodiumThe risk of hyperlipidemia may be higher. In addition, among those who are taking diuretics or those who have the most inadequate capacity, out.The risk of hyponatremia may be higher (see [Geriatric use)). Patients with symptomatic hyponatremiaconsideration should be given to discontinuing treatment with this product, and appropriate medical intervention should be given. Pack of signs and symptoms of hyponatremiaincluding headache, loss of concentration, memory impairment, confusion, weakness, unstable standing and possible fall. in strictIn severe or acute cases, signs and symptoms also include hallucinations, syncope, episodes of dysentery, confusion, respiratory arrest, andDeath.

Abnormal bleeding:

Selective serotonin reuptake inhibitors including paroxetine and norepinephrine reTaking inhibitors may increase the risk of bleeding events. Combined use of aspirin, nonsteroidal anti-inflammatory drugs, warfarinAs well as other anticoagulants may increase this risk.case reports and epidemiological studies (case-control and cohort setting) drugs that interfere with serotonin reuptake have been associated with gastrointestinal bleeding episodes.Selective 5-There was a wide range of bleeding events associated with serotonin reuptake inhibitors and noradrenaline reuptake inhibitors.These include ecchymosis, hematoma, epistaxis, and petechiae, as well as life-threatening bleeding events. For paroxetine and non-steroidalThe risk of bleeding associated with the combined use of anti-inflammatory drugs, aspirin, or other drugs that affect the anticoagulant effect, patients shouldParticularly cautious.

Fracture:

Risk of fracture after exposure to certain antidepressants, including selective serotonin reuptake inhibitorsAn association between antidepressant treatment and fractures has been reported in epidemiological studies.

The conclusion of this view case appears.There are many reasons for this, but it is not clear to what extent the risk of fracture is related to selective serotonin reuptake.directly related to inhibitor therapy. In patients treated with paroxetine, unexplained bone pain, punctateThe possibility of tenderness, swelling or bruising should be considered for pathological fractures, I .e.Fractures caused by minor trauma.

Use in patients with concomitant diseases:

Among those with specific concomitant systemic diseases, about the infusion of enzyme Parosi.Clinical experience with the use of Ting tablets is limited. In a disease or condition that may affect metabolic or hemodynamic responsesIn patients, caution is advised to use paroxetine hydrochloride tablets.

Like other selective serotonin reuptake inhibitors, paroxetine hydrochloride tablets are very important in pre-market studies.There are few reports of dilated pupils. Several cases of acute angle-closure glaucoma associated with paroxetine therapy are reported in the literature.Acute angle closure can occur in patients with narrow-angle glaucoma due to mydriasis,Therefore, for narrow-angle glaucomaPatients should be cautious when prescribing paroxetine hydrochloride tablets.

Paroxetine hydrochloride has not been evaluated or used in patients with a history of recent myocardial infarction or unstable heart diseaseThe experience of the film. These patients were not enrolled in clinical studies in premarket trials. But,In the double-blind,ComfortIn the controlled trial, the ECG evaluation of 682 patients receiving paroxetine hydrochloride tablets showed thatRoxetine tablets were not associated with significant ECG abnormalities. Similarly, this product does not cause any clinical occurrence of heart rate and blood pressure.important changes.

Parosil in patients with severe renal impairment (creatinine clearance <30 m/min) or severe hepatic impairmentThe blood concentration of tine increased. Therefore, in these patients, a lower starting dose should be used (see (Administrationvolume]).

Egoist reference information:

Paroxetine Hydrochloride TabletsChew or crush, swallow whole.Patients should be warned about the concomitant use of paroxetine hydrochloride tablets and triptans, tramadol, or other serotonergicRisk of serotonin syndrome when taking the drug.

Patients should be advised that administration of paroxetine hydrochloride may cause mild mydriasis, which in susceptible individuals mayCauses angle-closure glaucoma. Most glaucoma that existed before treatment is open-angle glaucoma, because the angle-closure type is green.Light eyes can be treated thoroughly by iridectomy after diagnosis. Open-angle glaucoma is not angle-closure glaucomarisk factors. If a patient is diagnosed with angle-closure glaucoma,Preventive surgery such as iris can be completed.resection).

The prescribing physician or other healthcare professional should inform the patient, the patient's family, and the patient's caregiver aboutThe benefits and risks associated with the treatment of paroxetine hydrochloride tablets, and the appropriate use of paroxetine hydrochloride tablets should be considered.Methods to provide advice. The prescribing physician or medical professional should guide the patient, the patient's family, and the patient's care.The management staff read the medication guide,And help them understand the content. Patients should have information on the medication guide.opportunities for discussion and access to answers to their questions.

Patients should be informed of the problems listed below and should be asked if they are taking paroxetine hydrochloride tablets.Inform the prescribing physician of these conditions.

Clinical Worsening and Suicide Risk:

Especially in the early stages of antidepressant treatment and when the dose is adjusted up or downThe patient, the patient's family and the patient's nursing staff pay special attention to whether the patient has anxiety, agitation, panic attacks,Insomnia,Irritability, hostility, aggression, impulsivity, akathisia (psychomotor noise), hypomania,mania, other abnormal behavior changes,Worsening depression and suicidal ideation. Because the patient's changes can suddenly come out.Now,The patient's family and caregivers should be aware of these symptoms on a daily basis. These symptoms such as severe, suddenParticular attention should be paid to and reported to the patient's prescribing physician when symptoms occur or are not part of the patient's pre-existing symptoms.health or medical professionals. These symptoms may be associated with an increased risk of suicidal ideation and behavior, requiring very closemonitoring, and may need to change medications.

Drugs that interfere with hemostasis (eg, nonsteroidal anti-inflammatory drugs, aspirin, warfarin):

Patients should be special.Caution with the combination of paroxetine and nonsteroidal anti-inflammatory drugs, aspirin, or other drugs that affect the anticoagulant effect.use, because the combined use of psychoactive drugs that interfere with serotonin reuptake and these drugs is associated with a risk of bleedingHigh correlation.

Interference with cognitive and motor abilities:

Any active psychoactive drug may impair judgment, thinking, or motor skills.Can. Although controlled clinical studies have shown that paroxetine hydrochloride tablets do not impair psychomotor performance, patientsuse hazardous machinery, including driving with extreme caution, until they have reason to determine that paroxetine hydrochloride,The treatment does not interfere with their ability to participate in these activities.

Complete the treatment process:

Although patients may experience improvement after 1 to 4 weeks of treatment with paroxetine hydrochloride tabletsHowever, they should be advised to continue treatment as directed.

conjoint drug:

Patients should be informed of possible drug interactions if they are taking or plan to takeAny prescription or non-prescription drugs

Alcohol:

Although studies have shown that paroxetine hydrochloride)does not increase the effects of alcohol-induced mental and motor skills onloss,However, patients should still be advised to avoid alcohol when taking paroxetine hydrochloride tablets.

[Medication for pregnant and lactating women]:

Some clinical trials suggest that SSRIs (including paroxetine) mayThis can affect sperm quality.Such effects appear to be reversible after treatment discontinuation.Changes in sperm quality can beThis can affect the fertility of some men.

Pregnancy and lactation:

Animal studies have shown that paroxetine does not have any teratogenicity,No selective embryo toxicityUse.Report of a recent epidemiological study of pregnancy outcomes after exposure to antidepressant drugs in the first trimester of pregnancyshowed an increased risk of congenital malformations associated with the use of paroxetine, particularly in cardiovascular (e. g., atrioventricularseptal defect). This data indicates that the mother was exposed to paroxetine,The risk of cardiovascular defects in infants is approximately1 in 50, while the expected risk for the general population is about 1 in 100.

For pregnant women or women planning to become pregnant, the prescribing physician can only determine whether the potential benefit of paroxetine is greaterUse only when there is a potential risk,Otherwise, alternative treatment measures should be selected. If a pregnant woman needs to stop usingRoxetine, see [Administration and Dosage]1 Pa discontinuation of rooxetine and [caveats one adultDiscontinuation of paroxetine treatment for symptoms.

Although the causal relationship between preterm birth and drug therapy has not been established, there have been exposures to paroxetine or other selectiveReport of preterm delivery in pregnant women with serotonin reuptake inhibitors.

If the mother continues to use paroxetine until the third trimester of pregnancy, the newborn should be observed becauseThere have been reports of complications in neonates exposed to paroxetine or other sSRls during the late trimester of pregnancy.However, a causal relationship with drug therapy has not been proven. Reported clinical findings include: respiratory distress,cyanosis,Apnea, seizures,Unstable body temperature, difficulty feeding, vomiting, hypoglycemia, hypertonia,Hypotonia, hyperreflexia, tremor, nervousness, irritability, lethargy,Crying and drowsiness often. In some cases,The reported symptoms were described as neonatal withdrawal symptoms. In most cases, these complications are reported to occur.Immediately or shortly after delivery(<24 hours).

Epidemiological studies have shown the use of selective 5-HT reuptake inhibition during pregnancy, especially in late pregnancy.agents (including paroxetine),It increases the risk of persistent pulmonary hypertension in the newborn. Used in late pregnancyin the population with selective 5-HT reuptake inhibitors,reported increased risk is higher than the general population (the rate is per1-2 of 1000 women) 4 to 5 times more.

A small amount of paroxetine is excreted by milk.

In published studies, serum concentrations were undetectable (<2ng/m) or very low in breastfed infants<4ng/m). There were no signs of drug effects in these infants. Still,Paroxetine still not available for breastfeedingofUnless there is evidence that the expected benefit to the mother outweighs the possible risk to the baby.

Medications for children:

The safety and effectiveness of the drug in children and adolescents under 18 years of age have not been established.

Medication for the elderly:

Selective 5-tryptamine reuptake inhibitors including paroxetine and norepinephrine reuptake inhibitorsUptake inhibitors,associated with clinically significant hyponatremia in older patients,This does not occur in patients in the year.The risk of benign events is higher (see (Caution 1-Hyponatremia).

In premarket paroxetine clinical trials worldwide,17% of patrons receiving paroxetineapproximately 700 cases) were aged 65 years or older.Pharmacokinetic studies have shown that,In the year crowd,

Paroxetine clearance decreased. Therefore,A lower starting dose is recommended for older patients.but older patientsThere was no overall difference in adverse events in mild patients, and yearsThe efficacy was comparable between mild and patient-year patients (cf.Dosage]).

(Drug interaction) Tryptophan:

with other 5-hydroxyl colorsAmine reuptake inhibitors, like paro when administered in combinationInteraction may occur between oxetine and tryptophan.When administering to patients who are taking paroxetine hydrochloride tabletsNausea: sweating and dizziness. Therefore,The combination of paroxetine hydrochloride and tryptophan is not recommended (see [Precautions]-5-hydroxytryptamine syndrome).

monoamine oxidase inhibitors:

See (contraindications) and Precautions).

Piperazine:

In a controlled study in healthy subjects, the amount of paroxetine tablets was raised to 60 per daymg, after co-administration of a single dose of 2mg of piperazine,Compared with the list drug treatment of piperidine,PiperazineAUC increased by an average of 151 percent,Cmax increased by an average of 62%.The increase of AUC and Cm of piperazine was determined by paroxetine'sCYP2D6 inhibitory effect. Due to the narrow therapeutic index of perazine and the known effect of prolonging the OT interval,Therefore, the combined use of piperazine with paroxetine hydrochloride tablets is prohibited (see[taboo]).

serotonergic drugs:

Based on norepinephrine retin inhibitors including paroxetine hydrochloride and selectionThe mechanism of action of serotonin reuptake inhibitors and the possible occurrence of 5-by tryptamine syndrome,Suggested joint useParoxetine hydrochloride tablets and other drugs that may affect the serotonergic neurotransmitter system (such as triptansthings,Lithium, fentanyl,tramadol, amphetamine, or St. John's wort [Hypericum])Be cautious (see [Precautions "for serotonin syndrome).

Concomitant use of paroxetine hydrochloride tablets with MAOl (including linezolid and intravenous methylene blue) is prohibited (see [taboo]). Do not recommend paroxetine hydrochloride tablets with other selective serotonin reuptake inhibitorsAdenosine reuptake inhibitors or tryptophan in combination.

Thioridazine:

See [Contraindications) and [Precautions).

Warfarin:

Preliminary data suggest a pharmacodynamic interaction between paroxetine and warfarin (in prothrombinincreased bleeding under constant conditions). Due to the lack of clinical experience, paroxetine hydrochloride tablets should be combined with warfarin.Caution.See [Precautions]).

triptans:

in the post-marketing report,Few reports of selective serotonin reuptake inhibitors and triptansSerotonin syndrome developed after treatment. If it is clinically necessary to carry out paroxetine hydrochloride tablets and triptan drugscombination therapy, it is recommended to observe the patient closely, especially during the treatment initiation and dose escalation phase (see [Notematters) serotonin syndrome).

Drugs that can affect liver metabolism:

Metabolism and pharmacokinetics of paroxetine may be induced by drug-metabolizing enzymesThe effect of guidance or inhibition.

Cimetidine:

Cimetidine inhibits a number of cytochrome P450 (oxidases). In one study,given orallyParoxetine hydrochloride tablets (30mg once daily) for 4 weeks and cimetidine (300mg three times dailylast week during the period of co-administration,Steady-state The steady-state plasma concentration of paroxetine increased by about 50%. Therefore,with theseWhen the drug is administered in combination, after the initial dose of 20mg of paroxetine hydrochloride tablets is given, it should be based on the clinical effect.Paroxetine hydrochloride tablets for dose adjustment. The effect of paroxetine on the pharmacokinetics of cimetidine was not studied.

Phenobarbital:

Phenobarbital is capable of inducing a variety of cytochrome P450 (oxidation) enzymes. When in phenobarbital steady state(100mg once a day for 14 days) When paroxetine hydrochloride tablets are given a single oral dose of 30mg, relative to PaRoxetine monotherapy,AUC and T12 decreased with paroxetine (mean 25 and 138 percent, respectively). Not studiedEffect of rooxetine on the pharmacokinetics of phenobarbital. Due to the nonlinear pharmacokinetics of paroxetine hydrochloride tabletsTherefore, the results of this study may not be representative of long-term co-administration.Since given in combination with phenobarbitalThere is no need to adjust the initial dose of paroxetine hydrochloride tablets, so any follow-up should be based on clinical effects.Adjustment of dose.

Phenytoin:

When given paroxetine hydrochloride tablets at phenytoin steady state (300mg once daily for 14 days)AUC and Tve of paroxetine relative to paroxetine hydrochloride tablet monotherapy at a single oral dose of 30mg(an average decrease of 50 per cent and 35 per cent, respectively). in anotherIn this study, when in the steady state of paroxetine (30mg,once daily for 14 days) when given a single oral dose of 300mg of phenytoin, comparedTreatment, phenytoin AUC decreased slightly (average decrease of about 12%). Since both drugs exhibit non-linear drugThe above study is not representative of the long-term co-administration of the two drugs. Due to the association with phenytoinThere is no need to adjust the initial dose of paroxetine hydrochloride tablets,Therefore, any clinical effect should be based onSubsequent dose adjustment (see Post-marketing reports [Adverse Reactions]).

Drugs metabolized by cYP2D6:

multiple drugs,including the most effective drugs in the treatment of depression (paroxetine,Other selective serotonin re-take inhibition states,Neng Shen tricyclic antidepressants),by cytochromeP450 co-worker Sui CYP2D6 metabolism. Phase with other alcohol over CYP2D6 metabolism,Paroxetine may significantlyInhibits the activity of this isozyme.Most patients (>90%)The CYP206 co-worker does work in paro hydrochlorideThe early days of administration of the oxetine tablets were saturated.In one study, salt was given daily at steady stateAcid Paroxetine Tablets (20mg,once daily) make a single dose of desipramine (10Omg) of Cmane,AUC and T12 increased by an average of 2,5 and 3 times. In one study, 20mg was given daily in patients receiving risperidone (4 to 8mg/day) stablyin oneParoxetine increased the mean plasma risperidone concentration approximately 4-fold,Mono-average plasma 9-risperidone concentration decreases approximately10%, the concentration of plasma active ingredients (the sum of risperidone plus hydroxy risperidone) increased 1.4 times. In CYP2D6.among patients with rapid metabolic health records,Paroxetine at 20mg daily versus atomoxetine at 20mg every 12 hoursOnce the way of combined administration. This makes the steady-state AUC value of atofenoxetine higher than that of atofenoxetine monotherapy.6 to 8 times, atomoxetine Cmax values are 3 to 4 times higher. Therefore, atomoxetine may need to be adjusted,recommend the initial dose of atomoxetine is downregulated when atomoxetine is administered in combination with paroxetine.

Combination of paroxetine hydrochloride tablets with other drugs metabolized by cytochrome CYP2D6 has not been formally studiedUse, but the dose of paroxetine hydrochloride tablets or other drugs should be lower than the normal prescribed dose.

Thus, paroxetine hydrochloride tablets are associated with other drugs that are metabolized by this drug, including in the treatment of depression.specific drugs (e. g. nortriptyline, amitriptyline, imipramine, ditipramine and fluoxetine), phenothiazine,Risperidone, class 1C antiarrhythmic drugs (e. g:propafenone, flecainide and ncani) or able to suppressCaution should be exercised when co-administration of such drugs (e. g., quinidine).

However, the risk of severe ventricular arrhythmias and sudden death may be associated with elevated plasma thioridazine levels.Therefore, thioridazine should not be administered in combination with paroxetine (see [Contraindications]).

Tamoxifen is a prodrug that requires CYP2D6 metabolic activation.Paroxetine-induced inhibition of CYP2D6may result in the active metabolite 4-hydroxy-N-demethyltamoxifen (Endoxiten) at blood concentrationsreduce the efficacy of tamoxifen (see Precautions).

At steady state, when the CYP2D6 pathway is saturated, clearance of paroxetine is mediated primarily by P4s0 co-workers,This enzyme, unlike CYP2D6, does not show evidence of saturation (see (Notes]).

Drugs metabolized by cytochrome CYP3A4:

Involving paroxetine versus terfinadine in homeostasis (a cytochromesubstrates of CYP3A4) in vivo interaction studies of co-administration showed that paroxetine did not affectPharmacokinetics.in addition,In vitro studies have also shown that ketoconazole (a potent inhibitor of CYP3A4 activity) acts as aA variety of substrates of this South (including terfinidineastemizole,Cisapride, triazolam and cyclosporine)The inhibitory potency of the metabolism is at least 100 times higher than that of paroxetine. In vitro KG based on paroxetine and the effect of paroxetine onThe association between the lack of in vivo clearance of terfenadine predicts the effect of paroxetine on other CYP3A4 substrates.inhibition of CYP3A4 activity by paroxetine is unlikely to be clinically significant.

tricyclic antidepressants:

Special caution should be exercised when combining tricyclic antidepressants and paroxetine hydrochloride tablets becauseParoxetine may inhibit the metabolism of tricyclic antidepressants. Combined with salt-brewed paroxetine tablets, tricyclic-When depressive drugs, it may be necessary to monitor the plasma concentration of tricyclic antidepressants and to reducedose (see [Drug interactions) Drugs metabolized by cytochrome CYP2D6).

Drugs that bind highly to plasma proteins:

Because paroxetine has a higher binding rate to plasma proteins,Accept another.In patients with a drug that has a high rate of binding to plasma proteins, administration of paroxetine hydrochloride tablets may cause other drugsThe free concentration of the substance increases, resulting in adverse events.In contrast, paroxetine was replaced by other drugs with high binding ratesIt may also cause adverse reactions.

Drugs that interfere with hemostasis (e. g., non-inverted anti-inflammatory drugs, aspirin, and warfarin):

platelet-releasedSerotonin plays an important role in hemostasis. Epidemiological studies with case-control and cohort designs have beendemonstrated that between the use of psychoactive drugs that may interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleedingThere is an association and evidence that the combined use of non-steroidal anti-inflammatory drugs or aspirin may increase the risk of bleeding.Studies have reported that,Selective serotonin reuptake inhibitors or norepinephrine to refield inhibitors and Hua.When used in conjunction with Lin,The anticoagulant effect can change, including increased bleeding. Patients being treated with warfarinCareful monitoring should be performed when starting or stopping paroxetine therapy.

Alcohol:

Although studies have shown that paroxetine hydrochloride tablets do not increase alcohol-induced mental and motor skills affectedloss,However, patients should still be advised to avoid alcohol when taking paroxetine hydrochloride tablets.

Lithium:

Multiple dosing studies have shown that,There is no pharmacokinetic interaction between paroxetine hydrochloride tablets and lithium carbonaterole.However, due to the possibility of 6-tryptamine syndrome, salt-brewed paroxetine tablets should be administered in combination with lithium.This should be particularly cautious.

Digoxin:

When the rate of giving land is high in steady state,The steady-state pharmacokinetics of paroxetine did not change.Take ParoWith oxetine, the mean digoxin AUC at steady state decreased by 15%.Due to less clinical experience, paroxetine is associated with highCaution should be given with particular caution.

The Western Ocean:

In the steady state, Disizin may not shadow the Paro.Pharmacokinetics of tins. Roxetine evaluated by ShangEffects on Dixizin.

Cyclocline:

Compared with the steady state, the single drug treatment of the ring,Daily oral paroxetine hydrochloride tablets (30mg perDay 1times) make propidium (6mg,Oral, peronce a day) of steady-state AUCo-24,Increased Cmax and Cmin values, respectively35 per cent, 37 per cent and 67 per cent. If an anti-choledochic effect is observed, the dose of propidium should be reduced.

beta blockers:

In one study,Prozalol (80mg twice daily) was given orally for 18 days,with hydrochloric acidDuring the last 10 days of the combined administration of rooxetine tablets (30mg once daily), the established steady-state plasma concentration of propranolol did not change.The effect of propranolol on paroxetine has not been evaluated (see Adverse Reactions]post-marketing report).

Theophylline:

Elevated theophylline levels have been reported in studies associated with treatment with paroxetine hydrochloride tablets. Although for bothThe interaction between the two groups has not been formally studied,However, it is still recommend to monitor theophylline when these drugs are administered in combinationThe level.

Fchanavir/Ritonavir:

Fonavir Ritonavir administered in combination with paroxetine makes the plasma water of paroxetineflat significantly decreased.Any dose adjustment should be based on clinical effects (tolerability and efficacy).

Electroconvulsive therapy (ECT ):

At present, there is no ECT and hydrochloric acid.Clinical study on the combined use of rooxetine tablets.

Human experience:

Since the listing of this product in the United States,During paroxetine treatment, worldwideA total of 342 spontaneous cases of intentional or unintentional overdose were reported (cica 1999). These cases includeRoxetine monotherapy overdose, and overdose in combination with other drugs. Among them, 17 cases (a total of 48 cases) of fatal diseasecases may be related only to paroxetine. 8 fatal cases with recorded intake of paroxetine were killed by other drugs, alcoholor significant merger status.Of the 145 nonfatal cases with an unknown outcome, most recovered,And there are no sequelae. The maximum known intake was 20 mg paroxetine taken by one patient (33 times the maximum recommend daily dose), the patient recovered.Common adverse events associated with paroxetine overdose include: somnolence, coma, nausea,Tremor, heartbeatspeed, confusion, vomiting and dizziness. Other associated with paroxetine overdose (single or with othercombination) of significant signs and symptoms include mydriasis, extraction (including status epilepticus), ventricularArrhythmias (including torsade de pointes)hypertension, aggressive reaction,Syncope,low bloodPressure, coma, bradycardia, dystonia, rhabdomyolysis, symptoms of impaired liver function (including hepaticExhaustion, liver necrosis, jaundice, hepatitis and fatty liver), serotonin syndrome, manic reaction, muscle formation rate, interest rateRenal failure and urinary retention.

Management of overdose:

Currently, there is no specific antidote for paroxetine. Treatment for overdoseGeneral measures should be employed in the management of any effective drug overdose in the treatment of depression.Airway patency, adequate oxygen supply and ventilation should be ensured, and heart rhythm and vital signs monitored. AlsoGeneral supportive and symptomatic treatment measures are recommended. The use of emesis is not recommended. Due to the distribution volume of paroxetinelarger volume, forced diuresis, dialysis, hemoperfusion or exchange transfusion is unlikely to benefit patients.

Particular attention should be paid to the possibility of a previous overdose of a tricyclic antidepressant, who is taking or has recently taken paropatients with cetine.In this case,Tricyclic antidepressant parent substances and/or active metabolites of the cheap product can be.can increase the likelihood of significant clinical sequelae and prolong the time required for close medical attention (see [Drug interactioneffects] drugs metabolized by cytochrome CYP2D6).In the course of overdose management, physicians should consider the possibility of multiple drug association.

[Pharmacologically rational) Pharmacological action:

Paroxetine hydrochloride is a potent, highly selectiveThe mechanism of action of 5-HT reuptake inhibitor and paroxetine hydrochloride is to make the synaptic cleftIncreased 5-HT concentration,Enhancement of central serotonin

Can nerve function.only weakly inhibits the reuptake of norepinephrine and dopamine,with muscarinic receptors,adrenal glandThe energy of a hair 1. ˉ2. β-type body,Dopamine 2 receptor (D2),Serotonin 1,2 receptors (5-hT,5-HTe)and histamine H receptors with almost no affinity. No inhibition of monoamine oxidation.

toxicological studiesGenotoxicity:

Paroxetine Ames test,Mouse Lymphoma Test,Out-of-procedure DNA synthesis testtest.The results of human lymphocyte chromosome aberration test, small restricted bone pass micronucleus test and rat dominant lethal test station were allNegative.

Reproductive toxicity:

In the reproductive toxicity test,Rats were given paroxetine 15 mg/kg/day (in mg/m2,quitemaximum human recommend dose (MRHD2 times), subjectDecreased pregnancy rate.In toxicity tests between 2 and 52 weeks,It was found that the reproductive tract of male rats was irreversibly damaged (50 mg/kg/day,testicular vas deferens atrophy with inhibition of spermatogenesis at 25 mg/kg/day).Rats and families were given paroxetine 50 mg/kg and 20 mg/kg/day (equivalent to 8 and 2 times MRHD in mg/m2, respectively) during the organogenesis period, respectively. No teratogenic effect was found, but rats were continuously administered in late pregnancy and throughout lactation, and the death of young rats increased 4 days before lactation, which occurred at 1 mg/kg/day.(in mg/m2, equivalent to 1/6 of MRHD, respectively), the cause of death is not clear, and no effect on the death of young mice can be determined.

Carcinogenicity:

In a two-year carcinogenicity test in rodents, mice and rats were administered up to 25mg, respectively.／kg/day and 20 mg/kg/day (in mg/m²calculated, corresponding to 2.4 and 3.9 times the clinical recommend dose for the treatment of depression, respectively). The results showed that the incidence of reticulocytoma in male rats in the high dose group was significantly increased (l/100,0/50,0/50 and 4/50 in the control, low, medium and high dose groups, respectively), and the incidence of lymphoreticulocytoma increased in a dose-dependent manner. No effect was seen in female rats. There was a dose-related increase in the number of tumors in mice, but no drug-related increase in the number of mice with tumors. The relevance of these findings to humans is unclear.

pharmacokinetics]

Paroxetine hydrochloride solution was completely absorbed after oral administration. 30mg orally dailyTake 30 continuously.days, the mean elimination half-life was approximately 21 hours (CV 32%). Paroxetine is mainly degraded by metabolism, and its metabolites have no pharmacological activity. It shows a non-linear pharmacokinetic process when the dose is increased. PalmerLuoCetine is partially metabolized by CYP2D6,metabolic productionmainly through the urine excretion,A small amount is excreted by the class stool.Not yetData to evaluate the pharmacokinetics of paroxetine in CYP2D6 deficient subjects (lack of metabolizers).4 Health RecordsCmax in male subjects in a meta-analysis of studies with multiple doses of paroxetine 20mg/day to 40 mg/day in volunteersor AUC values were not significantly lower than in female subjects.

Absorption and distribution:

This product can be completely absorbed after oral administration, after absorption by the first pass metabolismNormal male daily oral paroCetine 30mg,Most patients can reach steady state in about 10 days, and very few patients need a little longer time,steady stateCmax was 61.7ng/ml, Tmax was 5.2hr, Cmm was 30.7ng ml, T2 was 21 hours (cv 32%).Steady-state Cmax and Cmn values were 6-14 times higher than predicted in single-dose clinical trials.Based onAUCo-24 calculated steady stateThe drug exposure was 8 times the predicted value of the single dose clinical trial. The overaccumulation was due to the pre-generation of paroxetineRapid enzyme saturation results.with food and/or no food at the time of single dose administration,Studying the effect of food on paroxetine bio-profitsImpact of use.When taken with food, AUC increased slightly (6%), but Cma increased more (29%),The peak time of plasma concentration was shortened from 6.4 hours to 4.9 hours.Paroxetine95% bound to plasma proteins,Distributed in all tissues of the body, including the central nervous system, only1% remain in the systemic circulation.

Metabolism and excretion:

Daily oral paroxetine hydrochloride tablets 30mg,taken continuously for 30 days, with an average elimination half-life of about21 hours (cV32%). In a steady-state dose proportionality study involving elderly and non-elderly patients, elderlyThe dosage is 20mg to 40mg daily, and the dosage for non-elderly people is 20mg to 50mg daily. View in Two CrowdsThe observed non-linearity again reflects the saturable metabolic pathway of paroxetine. Cm values after a daily dose of 20mgcompared,The value at the 40mg daily dose is only about 2 to 3 times the doubled value. The main generation of paroxetine after oral absorptionThe oxidation and methylation products are polar covalent complexes,Easy to clear. with glucuronic acid and sulfateValency conjugates predominate, and the main metabolites have been isolated and identified. The data show that the metabolites of the drug are 5-hydroxy.The active inhibition of tryptamine reuptake was less than 1/50 of that of the parent drug.CYP2D6 is involved in part of the metabolism of paroxetine.Saturation of this enzyme at clinical doses overturned the pharmacokinetics of paroxetine with increasing doses and duration of treatment.The process is non-linear.The effect of this enzyme on the metabolism of paroxetine suggests some potential drug-drug interactions.Can (see [Precautions]).

Ten days after oral paroxetine solution 30mg dose, nearly 64% was excreted in urine, of which 2% was mothermedicine,62% are metabolites; About 36% is excreted by feces (probably via bile), most of which are largeMetabolites,Paroxetine is partially metabolized by CYP2D6, and the metabolites are excreted mainly in urine and a small amount in feces. There are no data available to evaluate the pharmacokinetics of paroxetine in patients with CYP2D6 deficiency (lack of metabotropic form).

[Storage] shading, sealed preservation.

[packaging] aluminum plastic packaging. 6sheet/plate, l2sheet/plate.

Period of Validity 24Months

[executive standard] YBH04912004

[Approval No.] Chinese Medicine H20040533

production enterprise]

Company: Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Address:No.58, Gaofan Section, Baitang Lower Line, Wucheng District, Jinhua City, Zhejiang Province

Postal Code: 321016

None