Escitalopram Oxalate Tablets

1. Pharmacological action: Escitalopram is the mono-S-enantiomer of the dicyclic hydrogenated phthalide derivative citalopram. The mechanism of escitalopram's antidepressant effect may be related to inhibiting the reuptake of 5-HT by neurons in the central nervous system, thereby enhancing the function of central serotonergic nerves. In vitro and animal experiments have shown that escitalopram is a highly selective 5-HT reuptake inhibitor (SSRI) with little effect on the reuptake of norepinephrine and dopamine. In terms of 5-HT reuptake inhibition, the activity of escitalopram is at least 100 times stronger than that of the R-enantiomer. No drug resistance was observed in rat depression models after long-term (up to 5 weeks) administration of escitalopram. Escitalopram has no affinity for 5-HT1-7 receptors, α receptors, β receptors, D1-5 receptors, H1-3 receptors, M1-5 receptors, and benzodiazepine receptors, or has only a low affinity. 2. Escitalopram has no affinity for Na, K, Cl-, and Ca2 channels, or has only a low affinity. Toxicological studies: In the Ames test for genotoxicity citalopram, in the absence of metabolic activators, two of the five test strains (TA98 and TA1537) were positive. In the Citalopram CHL chromosome aberration test, the results were positive with or without metabolic activators. The results of the Citalopram mouse lymphoma cell forward gene mutation test (HPRT), rat liver cell unscheduled DNA synthesis test (UDS), human lymphocyte chromosome aberration test, and mouse micronucleus test were all negative. In the reproductive toxicity fertility test, rats were orally given citalopram at 32, 48, and 72 mg/kg/day. It can be seen that the mating rate of each dose group was reduced, the fertility was reduced when the dose was ≥32 mg/kg/day, and the pregnancy time was prolonged when the dose was 48 mg/kg/day. 3. In the rat embryo-fetal developmental toxicity test, rats were orally given escitalopram at 56, 112, and 150 mg/kg/day. When the medium and high doses (calculated based on mg/m2, equivalent to ≥56 times the maximum recommended human dose [MRHD] of 20 mg/day), fetal weight reduction and delayed ossification were observed. Maternal toxicity (abnormal clinical conditions, reduced weight gain, and reduced food intake) was observed in all dose groups, and no teratogenic effects were observed. The no-effect dose for development was 56 mg/kg/day, which is approximately 28 times the MRHD. Pregnant rats were given escitalopram at 6, 12, 24, and 48 mg/kg/day during the perinatal period. The highest dose group (equivalent to approximately 24 times the MRHD) had a slight increase in offspring mortality and slight growth retardation, and mild maternal toxicity (abnormal clinical conditions, reduced weight gain, and reduced food intake) was observed. A slight increase in offspring mortality was observed in the 24 mg/kg/day dose group. The no-effect dose was 12 mg/kg/day, which is approximately 6 times the MRHD. In animal reproductive toxicity tests, Citalopram can cause adverse effects on embryonic/fetal development and postnatal development, including teratogenicity at doses higher than human therapeutic doses. 4. In rat embryonic/fetal toxicity tests, rats were orally administered Citalopram at 32, 56, and 112 mg/kg/day. At high doses, embryonic/fetal growth inhibition, reduced fetal survival rate, increased fetal abnormality rate (including cardiovascular and skeletal defects) and maternal toxicity (normal clinical abnormalities, reduced weight gain) were observed. The no-effect dose for development was 56 mg/kg/day. Rabbits were orally administered Citalopram at doses up to 16 mg/kg/day without abnormalities. In perinatal toxicity tests, rats were orally administered Citalopram at 4.8, 12.8, and 32 mg/kg/day. In the high-dose group, increased mortality and stagnation of pup growth were observed within 4 days after birth. The no-effect dose was 12.8 mg/kg/day. Carcinogenicity Citalopram was orally administered to NMRI/BOM mice and COBSWI rats for 18 and 24 months, respectively. No carcinogenicity was observed in mice at doses up to 240 mg/kg/day. An increased incidence of small intestinal tumors was observed in rats at doses of 8 or 24 mg/kg/day. The relevance of this phenomenon to humans is unclear.

Escitalopram oxalate. Its chemical name is: S()-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate. Molecular weight: C20H21FN2O·C2H2O4

Round, white film-coated tablets. 10 mg: Oval, white film-coated tablets.

Treat depression.

Usage: Oral, can be taken with food. Dosage: Depressive disorder, once a day. The usual dose is 10 mg per day. Depending on the individual response of the patient, the maximum daily dose can be increased to 20 mg. Antidepressant effects are usually achieved in 2-4 weeks. After symptom relief, treatment should be continued for at least 6 months to consolidate the effect. Panic disorder with or without agoraphobia, once a day. The recommended starting dose is 5 mg per day, which is increased to 10 mg per day after 1 week. Depending on the individual response of the patient, the dose can be further increased to a maximum dose of 20 mg per day. The best effect can be achieved after about 3 months of treatment. The course of treatment generally lasts several months. For elderly patients (65 years old), it is recommended to start treatment with half of the above conventional starting dose, and the maximum dose should be reduced accordingly. This product is not

1. Events of suicidal thoughts and behaviors have been reported during treatment with this product or in the early stages of discontinuation of treatment. 2. Such events have been reported in SSRI treatment. Cases of QT-interval prolongation reported post-marketing are mainly found in patients with existing heart disease, and the reason is unclear. In a double-blind placebo-controlled study of healthy subjects, the QTC (Fridericia correction) interval of the electrocardiogram of patients in the 10 mg/day group of this product changed by 4.3 milliseconds from baseline, and the 30 mg/day group changed by 10.7 milliseconds. Discontinuation symptoms often occur when SSRIs/SNRIs are stopped (especially suddenly). Dizziness, sensory disturbances (including paresthesias and electric shock sensations), sleep disorders (including insomnia and tense dreams), agitation and anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally, these events are mild or moderate and self-limited, but may be severe or prolonged in some patients. Therefore, it is recommended that when treatment with this product is no longer needed, the dosage should be gradually reduced until the drug is stopped.

1. Patients who are allergic to the active ingredients or any of the excipients of this product are prohibited from using it. 2. It is prohibited to use it in combination with non-selective, irreversible monoamine oxidase inhibitors (MAOI). 3. It is prohibited to use it in combination with linezolid. 4. It is prohibited to use it in combination with pimozide. 5. This product is prohibited in patients with known QT prolongation or congenital QT syndrome.

Precautions for children: null Precautions for pregnancy and lactation: null Precautions for the elderly: null

Drug interactions may occur if taken with other drugs. Please consult your doctor or pharmacist for details.

Keep tightly closed.

10mg (as escitalopram)

24 months

Hunan Dongting Pharmaceutical Co., Ltd.

• Founded in:

  1997-03-26

• Address:

  No. 16 Dongyan Road, Chenjiagang Community, Deshan Subdistrict Office, Changde Economic and Technological Development Zone, Hunan Province (No. 16 Dongyan Road, Deshan District, Changde City)

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  914307001838043692

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  309.624852 million yuan

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