Paroxetine Hydrochloride Tablets

This product is an antidepressant, a potent, highly selective 5-hydroxytryptamine reuptake inhibitor, which can increase the concentration of 5-hydroxytryptamine in the synaptic cleft and enhance the central 5-hydroxytryptamine nerve function. It only weakly inhibits the reuptake of norepinephrine and dopamine, and has almost no affinity with muscarinic 1, 2 receptors or adrenaline receptors, dopamine 2 receptors, 5-hydroxytryptamine 1, 2 receptors and histamine H1 receptors. It also has no inhibitory effect on monoamine oxidase.

Paroxetine hydrochloride, chemical name: ㈠-trans-4R-(4-fluorophenyl)-3S-{[3′,4′-(methylenedioxy)phenoxy]methyl}-piperidine hydrochloride hemihydrate

This product is a film-coated tablet, which appears white or off-white after removing the coating.

Treat various types of depression. Including depression with anxiety and reactive depression. Common depressive symptoms: fatigue, sleep disorders, lack of interest and pleasure in daily activities, loss of appetite. Treat obsessive-compulsive neurosis. Common obsessive symptoms: feeling repeated and persistent thoughts, impulses or imaginations that can cause significant anxiety, leading to repetitive behaviors or psychological activities. Treat panic disorder with or without agoraphobia. Common panic attack symptoms: palpitations, sweating, shortness of breath, chest pain, nausea, tingling and a sense of impending death. Treat social phobia/social anxiety disorder. Symptoms of anxiety: palpitations, sweating, shortness of breath, etc. It usually manifests as a significant or persistent fear of one or more social situations or performance occasions, leading to avoidance. br

Oral administration. It is recommended to take it at breakfast every day. Swallow the tablets whole without chewing. Adult depression and social phobia/social anxiety disorder: The general dose is 20 mg per day. After taking it for 2-3 weeks, the dose can be increased by 10 mg per week based on the patient's response. The maximum daily dose can reach 50 mg. Please follow the doctor's advice. Obsessive-compulsive neurosis: The general dose is 40 mg per day, the initial dose is 20 mg per day, and the dose is increased by 10 mg per week. The maximum daily dose can reach 60 mg. Panic disorder: The general dose is 40 mg per day, the initial dose is 10 mg per day, and the dose is increased by 10 mg per week based on the patient's response, and the maximum daily dose can reach 50 mg. Panic disorder symptoms may worsen in the early stages of treatment, so the initial dose is 10 mg.

According to literature reports, the main adverse reactions observed in clinical controlled studies of paroxetine hydrochloride are central nervous system: drowsiness, insomnia, agitation, tremor, anxiety, dizziness; gastrointestinal system includes constipation, nausea, diarrhea, dry mouth, vomiting and flatulence; others include fatigue and sexual dysfunction (including impotence and decreased libido). The intensity and frequency of most adverse reactions decrease with the duration of medication and usually do not affect treatment. There have been reports of restlessness, hallucinations, hypomania, red-green color blindness, vomiting and serotonin syndrome. Like other 5-hydroxytryptamine reuptake inhibitors, there have been reports of transient changes in blood pressure when taking this product. This situation often occurs in patients with underlying hypertension or anxiety, but there are few reports of tachycardia. There have been reports of impaired consciousness. b

It is contraindicated for those who are allergic to this product.

Precautions for children: This product should not be used in children or adolescents under the age of 18 (see [Precautions]). Precautions for pregnancy and lactation: Fertility: Some clinical trials have shown that SSRIs (including paroxetine) may affect sperm quality. Such effects appear to be reversible after treatment is discontinued. Changes in sperm quality may affect the fertility of some men. Pregnancy and lactation: Animal studies have shown that this product has no convulsant-causing properties and no selective embryotoxic effects. Recent epidemiological studies on pregnancy outcomes after exposure to antidepressants in the first three months of pregnancy have reported an increased risk of congenital malformations associated with the use of paroxetine, especially in cardiovascular aspects (such as atrioventricular septal septal defect). The data indicate that the risk of cardiovascular defects in infants exposed to paroxetine is about 1/50, while the expected risk in the general population is about 1/100. For pregnant women or women who are planning to become pregnant, the prescriber should only use paroxetine when the potential benefits outweigh the potential risks, otherwise an alternative treatment measure should be selected. If a pregnant woman needs to stop using paroxetine, the prescriber should refer to [Usage and Dosage] - Discontinuation of Paroxetine and [Precautions] - Symptoms of discontinuation of paroxetine treatment in adults. Preterm births have been reported in pregnant women exposed to paroxetine or other SSRIs, although the causal relationship between preterm births and drug treatment has not been clearly established. If the mother continues to use this product into the third trimester, the condition of the newborn should be observed, because complications have been reported in newborns exposed to paroxetine or other SSRIs in the late third trimester of pregnancy, but the causal relationship with drug treatment has not been confirmed. Reported clinical findings include: respiratory distress, cyanosis, respiratory arrest, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, nervousness, irritability, lethargy, frequent crying and drowsiness. In some cases, the symptoms reported are described as withdrawal symptoms in newborns. In most cases, these complications have been reported to occur immediately or shortly after delivery (24 hours). Epidemiological studies have shown that the use of selective serotonin reuptake inhibitors (including paroxetine) during pregnancy, especially in late pregnancy, is associated with an increased risk of persistent pulmonary hypertension of the newborn. In people who have used selective serotonin reuptake inhibitors in late pregnancy, the increased risk is reported to be 4 to 5 times higher than the general population (rate of 1-2 per 1000 women). A small amount of paroxetine is excreted in breast milk. In published studies, serum concentrations in breastfed infants were undetectable (2 ng/ml) or very low (4 ng/ml). There were no signs of drug effects in these infants. Nevertheless, Seroxat should not be used during lactation unless there is evidence that the expected benefit to the mother outweighs the possible risks to the infant. Elderly precautions: In elderly subjects, elevated plasma concentrations of this product may occur. The starting dose should be the same as that for adults and can be increased by 10 mg per week to a maximum daily dose of 40 mg based on patient response.

1. When this product is used in combination with tryptophan, it may cause high serotonin syndrome, which is manifested as agitation, restlessness and gastrointestinal symptoms. In addition, increased muscle tension, high fever or impaired consciousness may occur, so this product should not be used in combination with tryptophan. 2. Drug enzyme inducers or inhibitors of liver enzymes may affect the metabolism and pharmacokinetic properties of this product. When this product is used in combination with known drug metabolism inhibitors, the lower limit of the dosage range should be used. When used in combination with known enzyme inducers, there is no need to consider adjusting the initial dose. 3. Patients taking this product should avoid drinking alcohol. 4. Monoamine oxidase inhibitors should not be used within 2 weeks before and after taking this product. After 2 weeks of stopping monoamine oxidase inhibitors, starting this drug should be cautious. The dosage should not be too high.

Store in sealed container. Validity period is tentatively 18 months

20mg

36 months

Zhejiang Jianfeng Pharmaceutical Co., Ltd.

• Founded in:

  1998-12-31

• Address:

  2nd Floor, Office Quality Inspection Building, Building X02, No. 58, Gaofan Section, Baitang Xiaxian, Wucheng District, Jinhua City, Zhejiang Province

• Tax NO.:

  913307017125704667

• Registered Funds:

  298.53 million yuan

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