Paroxetine Hydrochloride Tablets

Pharmacological action Paroxetine hydrochloride is an antidepressant and a potent, highly selective 5-HT reuptake inhibitor. It can increase the 5-HT concentration in the synaptic cleft and enhance the central serotonergic nerve function. It only weakly inhibits the reuptake of norepinephrine and dopamine. It has almost no affinity with muscarinic receptors or α1, α2, β-adrenergic receptors, dopamine receptors (D2), 5-HT1 receptors, 5-HT2 receptors and histamine (H1) receptors. It has no inhibitory effect on monoamine oxidase. See the inner package insert for details.

Paroxetine hydrochloride. Chemical name: (-)-trans-4-(4-fluorophenyl)-3-{[3,4(methylenedioxy)phenoxy]methyl}piperidine hydrochloride. Molecular weight: C19H20NO3F·HCl

This product is a white oval film-coated tablet with double-sided convexity.

Depression. It can also treat obsessive-compulsive disorder, panic disorder, or social anxiety disorder.

Oral administration. It is recommended to take it at breakfast every day. Swallow the tablets whole without chewing. Depression: The general dose is 20 mg per day. After taking it for 2 to 3 weeks, some patients need to increase the dose according to the patient's response, and increase it by 10 mg per week. According to foreign experience, 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. According to foreign experience, the maximum daily dose can reach 60 mg. See the inner package insert for details.

Some of the adverse reactions listed below may be alleviated or reduced as the treatment time is prolonged, and generally will not lead to discontinuation of the drug. The adverse drug reactions of various organ systems are listed below. The incidence is defined as: very common (≥1/10), common (≥1/100, [1/10), uncommon (≥1/1,000, [1/100), rare (≥1/10,000, [1/1,000), very rare ([1/10,000), including individual reports. The incidence of common and uncommon events is generally determined based on the safety summary data of patients in the paroxetine treatment group (>8000) in clinical trials, generally referring to the additional increased incidence compared with the placebo group. Rare and very rare events are generally determined based on post-marketing data, which refers to the reporting rate rather than the actual incidence. Please refer to the inner package insert for details.

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

Precautions for children: Use with caution. Precautions for pregnancy and lactation: Use with caution. Precautions for the elderly: Reduce the dosage as appropriate, and the daily dose should not exceed 40 mg.

1. Clinical studies have shown that the absorption and pharmacokinetics of paroxetine are not affected by the following factors or are only slightly affected (i.e., the effect is so small that the dosing regimen does not need to be changed): food antacids digoxin propranolol 2. Serotonergic drugs, like other selective 5-HT reuptake inhibitors (SSRIs), may lead to 5-HT-related effects (serotonin syndrome: see [Contraindications] and [Precautions]) when used in combination with this product. The clinical condition needs to be closely monitored. 3. Drug metabolism

Keep away from light, sealed and stored in a dry place.

20mg (based on paroxetine)

36 months

Beijing Foyou Pharma Co., Ltd.

• Founded in:

  1999-02-03

• Address:

  No. 8 Guangyuan East Street, Tongzhou Industrial Development Zone, Tongzhou District, Beijing

• Tax NO.:

  91110112700216160K

• Registered Funds:

  480 million yuan

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