Venlafaxine Hydrochloride Capsules

Non-clinical studies have shown that venlafaxine and its active metabolite O-desmethylvenlafaxine are strong inhibitors of 5-HT and NE reuptake and weak inhibitors of dopamine. In vitro tests have not found that venlafaxine and O-desmethylvenlafaxine have significant affinity for M cholinergic receptors, H1 histamine receptors, and α1-adrenergic receptors. Venlafaxine and O-desmethylvenlafaxine have no MAO inhibitory activity. Animal experiments have shown that venlafaxine has analgesic effects on pain models of mice or rats caused by acetic acid, brewer's yeast, and photothermal stimulation.

The main component is venlafaxine hydrochloride. Chemical name: (±)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol hydrochloride.

This product is a capsule, and the contents are white powder.

This product is suitable for various types of depression, including depression accompanied by anxiety and generalized anxiety disorder.

Venlafaxine extended-release tablets should be taken at a relatively fixed time in the morning or evening with food, once a day, with water. The tablet should be taken as a whole and avoid breaking, crushing, chewing and soaking in water. For the initial treatment of various types of depression, for most patients, the recommended starting dose is 75 mg per day, taken as a single dose. Although the relationship between dose and antidepressant effect has not been fully explored, for some patients who do not respond to a dose of 75 mg per day, the dose can be increased to a maximum of approximately 225 mg per day. Because venlafaxine and its major metabolites reach steady-state concentrations by the fourth day in most patients, the interval between increases is at least 4 days, with each increase in increments of 75 mg per day. In studies evaluating efficacy, medication intervals of more than 2 weeks are allowed.

According to the classification of CIOMS adverse reaction incidence, the adverse reactions are listed as follows: Common: ≥1% Uncommon: ≥0.1% and Rare: ≥0.01% and Very rare: Adverse reactions of various body systems Systemic symptoms Common: Weakness/fatigue; Uncommon: Photosensitivity reaction; Very rare: Allergy; Cardiovascular system Common: Hypertension, vasodilation (mostly flushing); Uncommon: Hypotension, orthostatic hypotension, syncope, tachycardia; Very rare: QT interval prolongation, ventricular fibrillation, ventricular tachycardia (including torsad

This product is contraindicated for patients who are allergic to it and those who are taking monoamine oxidase inhibitors.

Precautions for children: Safety and efficacy have not been evaluated in adolescents under 18 years of age. In clinical studies conducted on children (especially patients with depression), reports of hostility and suicide-related adverse events (such as suicidal ideation and self-injury) increased. Clinical needs and potential risks must be weighed when considering use in children and adolescents. Although no studies have directly evaluated the effects of venlafaxine on the growth, development and maturation of children and adolescents, previous studies suggest that venlafaxine may have a negative effect on height and weight (see [Precautions]-Changes in height and weight). When deciding to use venlafaxine in pediatric patients, especially for long-term use, regular monitoring of height and weight is recommended. There is no systematic evaluation of the safety of continuous use of venlafaxine for more than 6 months in pediatric patients. In studies of pediatric patients (aged 6 to 17 years), the incidence of decreased appetite, weight loss, increased blood pressure and increased cholesterol levels in pediatric patients was found to be similar to that in adult patients. If children/adolescents use venlafaxine, regular weight and blood pressure measurements are recommended. If there is persistent increase in blood pressure, venlafaxine should be discontinued. Children/adolescents who use venlafaxine for a long time should have their serum cholesterol checked. Therefore, the warnings for adult patients also apply to children (see [Precautions] - Persistent hypertension and elevated serum cholesterol). Safety for children under 6 years of age has not been evaluated. Precautions during pregnancy and lactation: Teratogenic effects in pregnancy Venlafaxine hydrochloride tablets were administered to rats and rabbits at doses (converted in mg/m2) equivalent to 2.5 times (rats) and 4 times (rabbits) of the maximum recommended human dose. Venlafaxine had no teratogenic effects. However, if venlafaxine is used from the beginning of pregnancy until the pups are weaned, when the drug dose is equivalent to 2.5 times the maximum recommended human dose, the weight of the pups will decrease, the chance of stillbirth will increase, and the mortality rate of the pups will also increase in the first 5 days of life. The reason for the increase in mortality is unknown. Venlafaxine doses equivalent to 1/4 of the maximum recommended human dose will not cause an increase in the mortality rate of the pups. There are currently no appropriate and well-controlled studies in pregnant women. Because the results of animal reproduction studies do not necessarily predict the response in humans. Therefore, unless necessary, venlafaxine should not be used in pregnant women. Non-teratogenic effects: When fetuses are exposed to venlafaxine hydrochloride extended-release capsules, other SNRIs (5-HT and norepinephrine reuptake inhibitors) or SSRIs in the third trimester of pregnancy, the duration of hospitalization after delivery and the complications of respiratory support and gastric tube feeding are increased. Reported clinical manifestations also include respiratory distress, cyanosis, increased/decreased muscle tone, unstable body temperature, feeding difficulties, vomiting, hypoglycemia, hyperreflexia, tremor, excitement and constant crying. These manifestations are similar to the direct toxic effects of SSRIs and SNRIs and may also be a withdrawal syndrome. It should be noted that the clinical manifestations of some patients are similar to serotonin syndrome (see [Drug Interactions]). When venlafaxine hydrochloride extended-release capsules are used in pregnant women in the third trimester of pregnancy, doctors should carefully weigh the pros and cons of treatment (see [Usage and Dosage]). Labor and delivery The effect of venlafaxine on human labor and delivery is unknown. Lactating women have reported that venlafaxine and ODV can be secreted in breast milk. Because venlafaxine hydrochloride extended-release capsules have the potential for serious adverse reactions to the feeding fetus, the necessity of the mother's medication must be considered, and a choice must be made between stopping breastfeeding and stopping the medication. Precautions for the elderly: Pre-marketing studies have shown that the efficacy, safety, pharmacokinetics and clinical manifestations of this product in elderly patients are not significantly different from those in young patients, and there is no need to adjust the dosage of the drug according to the patient's age. Like other antidepressants, there have been several reports of hyponatremia and syndrome of inappropriate antidiuretic hormone secretion, which are common in the elderly, and some more sensitive elderly individuals cannot be ruled out. Therefore, elderly patients should be given individualized medication, and special caution should be used when increasing the dosage. When there are other clinical conditions common in the elderly, such as renal or hepatic dysfunction, the dosage should be appropriately reduced.

Alcohol Patients should be advised to avoid drinking alcohol while taking venlafaxine. Cimetidine The combined use of venlafaxine and cimetidine will inhibit the first-pass metabolism of venlafaxine. The clearance of oral venlafaxine is reduced by approximately 43%, and the AUC and Cmax of the drug are increased by approximately 60%, but the combined use of cimetidine has no effect on the metabolism of ODV. Because the amount of ODV in the blood circulation is much greater than venlafaxine, the additive pharmacological effect of venlafaxine and ODV is only slightly enhanced, and the dosage of the drug does not need to be adjusted for most adults. However, for patients with pre-existing hypertension, the elderly, and patients with impaired liver function, the interaction between venlafaxine and cimetidine may be more significant and should be used with caution. Diazepam Diazepam has an effect on the metabolism of venlafaxine and

Store in sealed container. Valid for 24 months

25mg

24 months

Chengdu Hengrui Pharmaceutical Co., Ltd.

• Founded in:

  2001-03-07

• Address:

  No. 18, Baicao Road, West Park, Chengdu Hi-tech Zone

• Tax NO.:

  91510100727431952L

• Registered Funds:

  29.18 million yuan

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