Sertraline Hydrochloride Capsules

Sertraline hydrochloride is a selective 5-hydroxytryptamine reuptake inhibitor. Its mechanism of action is related to its inhibition of 5-hydroxytryptamine reuptake in central neurons. At clinical doses, sertraline blocks the uptake of 5-hydroxytryptamine by human platelets. Studies suggest that sertraline is a potent and selective neuronal 5-hydroxytryptamine reuptake inhibitor, with only weak effects on norepinephrine and dopamine. In vitro studies have shown that sertraline has no significant affinity for adrenergic receptors (α1, α2, β), cholinergic receptors, GABA receptors, dopaminergic receptors, histamine receptors, 5-hydroxytryptamine receptors (5HT1A, 5HT1B, 5HT2) or benzodiazepine receptors. The antagonistic effect on the above receptors is believed to be related to the sedative and anticholinergic effects of other medications used for psychiatric disorders.

The main ingredient of this product is sertraline hydrochloride. Its chemical name is: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride.

This product is a hard capsule; the contents are white powder.

Sertraline is used to treat symptoms related to depression, including depression with anxiety, with or without a history of mania. After satisfactory treatment, continued use of sertraline can effectively prevent the recurrence and recurrence of depression. Sertraline is also used to treat obsessive-compulsive disorder. After the initial treatment responds, sertraline maintains its effectiveness, safety and tolerability in the treatment of obsessive-compulsive disorder for two years.

Adults take the medicine once a day, either in the morning or evening, with or without food. The effective dose for treating depression and obsessive-compulsive disorder is usually 50 mg/day. For a small number of patients who have poor efficacy but good tolerance to the drug, the drug dose can be gradually increased over a few weeks based on the efficacy, increasing by 50 mg each time, up to a maximum of 200 mg/day, once a day. Because the elimination half-life of sertraline is 24 hours, the interval for adjusting the dose should not be less than 1 week. The effect of the medication can be seen in about 7 days, and the full effect will not be seen until the 2nd to 4th week of medication. The effect of obsessive-compulsive disorder may take longer to appear. For long-term medication, the dose should be adjusted according to the efficacy and maintained at the lowest effective therapeutic dose.

1 According to the literature, in controlled clinical studies of sertraline and placebo for the treatment of depression, common adverse reactions are as follows: Autonomic nervous system: dry mouth and sweating. Central and peripheral nervous systems: dizziness and tremor. Gastrointestinal tract: diarrhea/loose stools, indigestion and nausea. Psychiatric: anorexia, insomnia and lethargy. Reproductive system: sexual dysfunction (mainly delayed ejaculation in men). 2 Sertraline tablets have been on the market for many years. According to the literature, the adverse events spontaneously reported by patients while taking sertraline are as follows: Autonomic nervous system: pupil dilation and abnormal penile erection. Systemic: allergic reactions, allergic reactions, allergic-like reactions, asthma, fatigue,

It is contraindicated for use in patients who are allergic to sertraline; it is contraindicated for use in combination with monoamine oxidase inhibitors.

Precautions for children: Although sertraline is metabolized slightly faster in children, lower doses are recommended to avoid excessive blood concentrations, especially for children aged 6 to 12 years with a lower body weight. Precautions for pregnancy and lactation: Reproductive toxicity studies have been conducted in rats and rabbits, and no evidence of teratogenicity was found at doses of 20 and 10 times the maximum human dose (on a mg/kg/day basis). However, at doses of 2.5 to 10 times the maximum human dose (on a mg/kg/day basis), sertraline was associated with delayed ossification of the embryo, which may be secondary to effects on the embryonic barrier. At doses of approximately 5 times the maximum human dose (on a mg/kg/day basis), maternal administration of sertraline resulted in decreased neonatal survival. Decreased neonatal survival has been described for other antidepressants, but the clinical significance of these effects is unclear. There are no adequate well-controlled studies in pregnant women. Precautions for the elderly: The dosage range for elderly patients is the same as that for younger patients. A total of more than 700 elderly patients (65 years old) participated in clinical trials to confirm the efficacy of sertraline in this population. The form and incidence of adverse reactions in elderly patients are similar to those in younger patients.

Monoamine oxidase inhibitors (MAOIs): Sertraline combined with MAOIs, including the selective MAOI selegiline and the reversible MAOI moclobemide, has been associated with serious side effects, sometimes fatal. Some cases have presented with symptoms similar to serotonin syndrome, including: fever, rigidity, muscle spasms, autonomic dysfunction with rapid fluctuations in vital signs; changes in mental status including mental confusion, irritability, and extreme agitation until the development of delirium and coma. Therefore, sertraline should not be taken while taking MAOIs or within 14 days of stopping MAOIs; similarly, more than 14 days must pass after sertraline is stopped before starting treatment with MAOIs. Central nervous system depressants and alcohol:

Seal and store in a cool and dry place. The validity period is tentatively 24 months

50mg (calculated as sertraline)

24 months

Penglai Jinchuang Pharmaceutical Co., Ltd.

• Founded in:

  2002-02-25

• Address:

  Jinchuang Road, Penglai Economic Development Zone

• Tax NO.:

  91370684738184803L

• Registered Funds:

  30 million yuan

• Email:

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