Citalopram Hydrobromide Tablets

Pharmacological action Citalopram is an antidepressant and a dicyclic hydrogenated phthalide derivative. The mechanism of action of Citalopram against depression may be related to inhibiting the reuptake of 5-HT by neurons in the central nervous system, thereby enhancing the function of central serotonin nerves. In vitro and animal experiments indicate that Citalopram is a highly selective 5-HT reuptake inhibitor with little effect on the reuptake of norepinephrine and dopamine. Rats were given Citalopram for 14 days, and the effect of inhibiting 5-HT uptake was not tolerated. Citalopram is a racemate, and its effect of inhibiting 5-HT reuptake is mainly exerted by its (S)-enantiomer. Citalopram has no affinity for 5-HT1A, 5-HT2A, D1 receptor, D2 receptor, α1 receptor, α2 receptor, β receptor, H1 receptor, GABA receptor, M receptor, and benzodiazepine receptor, or has only a low affinity. Toxicological studies In the Ames test for genetic toxicity, in the absence of metabolic activators, two of the five test strains (TA98 and TA1537) were positive. In the CHL chromosome aberration test, the results were positive regardless of the presence or absence of metabolic activators. The results of the in vitro mouse lymphocyte gene mutation test (HPRT), the in vitro/in vivo combined rat liver cell unscheduled DNA synthesis test, the in vitro human lymphocyte chromosome aberration test, and the mouse micronucleus test were all negative. Reproductive toxicity In the fertility and early embryonic development toxicity test, rats were orally administered citalopram 16/24 (male/female), 32, 48, 72 mg/kg/day, and the mating rate of each dose group was reduced. The fertility was reduced when the dose was ≥32 mg/kg/day [calculated as mg/m2 (the same below), equivalent to 5 times the maximum recommended daily dose of 60 mg (MRHD) for humans], and the pregnancy time was prolonged when the dose was 48 mg/kg/day (equivalent to 8 times the MRHD). In the embryo-fetal developmental toxicity test, rats were orally administered citalopram at 32, 56, and 112 mg/kg/day. At the highest dose (equivalent to 18 times the MRHD), embryo/fetal growth inhibition, reduced fetal survival rate, increased fetal abnormality rate (including cardiovascular and skeletal muscle defects) and maternal toxicity were observed, and the no-effect dose was 56 mg/kg/day. Rabbits were orally administered citalopram at doses up to 16 mg/kg/day (equivalent to 5 times the MRHD) without abnormalities. Perinatal rats were orally administered citalopram at 4.8, 12.8, and 32 mg/kg/day. The highest dose group (equivalent to 5 times the MRHD) showed increased mortality and growth stagnation of pups within 4 days after birth. No abnormalities were observed at a dose of 12.8 mg/kg/day. Carcinogenicity NMRI/BOM mice were orally administered citalopram for 18 consecutive months, and no carcinogenicity was observed at doses up to 240 mg/kg/day (equivalent to 20 times the MRHD). Oral administration of citalopram to COBSWI rats for 24 months increased the incidence of small intestinal tumors at doses of 8 or 24 mg/kg/day (1.3 and 4 times the MRHD, respectively, calculated on a mg/m2 basis). The relevance of this phenomenon to humans is unclear.

The main ingredient of this product is Citalopram hydrobromide, chemical name: 1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, hydrobromide.

This product is a white oval film-coated tablet.

Depressive disorders (endogenous and non-endogenous depression).

Adults: Take Citalopram Hydrobromide Tablets once daily. The initial dose is 20 mg per day. If clinically necessary, it can be increased to 40 mg per day or a maximum dose of 60 mg per day. Elderly patients (65 years old): For patients over 65 years old, the maximum daily dose is 40 mg. Antidepressant treatment is symptomatic and must be continued for an appropriate period of time. Generally, 4-6 months are required for manic-depressive mental disorders. If insomnia or severe akathisia occurs, sedatives are recommended in the acute phase. Children and adolescents (<18 years old): This product is not suitable for children and adolescents under 18 years old. Patients with reduced renal function: No dose adjustment is required for patients with mild to moderate reduced renal function. There is no data for patients with severe reduced renal function (CLCR<20ml/minute). Patients with reduced liver function: It is recommended that the daily dose for patients with reduced liver function should not exceed 30 mg. Or follow the doctor's advice.

The side effects observed with Citalopram Hydrobromide are usually few, mild and transient. The most common adverse reactions are: nausea, increased sweating, decreased salivation, headache and shortened sleep time. They are usually more obvious in the first or second week of treatment and generally disappear gradually as the depressive state improves. Seizures have been observed in rare cases. In patients with pre-existing bradycardia, bradycardia can complicate treatment.

It is contraindicated to use in combination with monoamine oxidase inhibitors; it is contraindicated for those who are allergic to this product and/or any of its ingredients.

Precautions for children: Antidepressants are not suitable for children and adolescents under 18 years of age. In clinical trials of children and adolescents under 18 years of age, the frequency of suicide-related behaviors (suicidal attempts and suicidal ideas) and hostility (aggression, oppositional behavior and irritability) in the FDA group was found to be higher than that in the placebo group. Even in clinical trials, patients still need to be closely monitored for suicidal manifestations. In addition, long-term safety data related to growth, maturation, and cognitive and behavioral development in children and adolescents are still lacking. Precautions for pregnancy and lactation: Pregnancy Published data on pregnant women (more than 2,500 exposure results) show that there is no teratogenic fetal/neonatal toxicity. However, FDA should not be used during pregnancy unless there is a clear need and only after careful consideration of the risk/benefit. If the mother continues to use FDA until late pregnancy (especially in late pregnancy), the newborn should be observed. Abrupt discontinuation of medication should be avoided during pregnancy. The following symptoms may occur in newborns whose mothers use SSRI/SNRI in late pregnancy: respiratory distress, cyanosis, apnea, convulsions, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, nervousness, irritability, lethargy, constant crying, somnolence and sleep difficulty. Elderly precautions: For elderly patients over 65 years old, the maximum daily dose is 20 mg.

Concomitant use of monoamine oxidase inhibitors may result in hypertensive crisis.

Store at room temperature below 25°C.

20mg (as Citalopram)

60 months.

Kunming Jida Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-14

• Address:

  No. 389, Kexin Road, High-tech Development Zone, Kunming, Yunnan Province

• Tax NO.:

  91530000622600182R

• Registered Funds:

  370 million yuan

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