Item nanme:Escitalopram oxalate tablets Item character:This product is white
Indication: Treatment of depression and panic disorder with or without agoraphobia
Item specifications: 10mg*7tab/box
Usage and dosage:-Usage: oral, can be taken with food.
consumption:
depression
Once a day. The usual dose is 10 mg per day, and the maximum dose can be increased to 20 mg per day according to the individual response of patients. Generally, antidepressant effect can be obtained in 2-4 weeks. After remission, the treatment should be continued for at least 6 months to consolidate the curative effect.
Panic disorder with or without agoraphobia
Once a day. It is suggested that the initial dose should be 5 mg per day, and it should be increased to 10 mg per day after 1 week. According to the individual reaction of patients, the dose can be increased to the maximum dose of 20 mg per day.
The best effect can be achieved after 3 months of treatment. The course of treatment usually lasts for several months.
Elderly patients (> 65 years old)
It is recommended to start the treatment with half of the above conventional starting dose (5 mg), and the maximum daily dose should not exceed 10 mg.
Children and adolescents (< 18 years old)
This product is not suitable for children and teenagers under 18 years old.
Patients with decreased renal function
Patients with mild to moderate renal dysfunction do not need to adjust the dose, and patients with severe renal dysfunction (clcr < 30 ml / min) should be cautious.
Patients with decreased liver function
It is suggested that the initial dose should be 5 mg per day for 2 weeks. Depending on the individual response of the patient, the dose can be increased to 10 mg per day. It is suggested that attention should be paid to the patients with severe decrease of liver function and the dosage should be increased carefully.
Cytochrome P450 2C (CYP2C19) slow metabolizer
For patients with known chronic metabolism of CYP 2c19, it is recommended that the initial dose of 5 mg per day be continued for 2 weeks. Depending on the individual response of the patient, the dose can be increased to 10 mg per day.
Withdrawal
Sudden withdrawal should be avoided. When it is necessary to stop the treatment, the dosage should be gradually reduced within 1-2 weeks to avoid withdrawal symptoms.
The safety of more than 20 mg daily dose has not been confirmed.
Adverse reactions Most of the adverse reactions occurred in the first 1-2 weeks of treatment, and the severity and incidence of adverse reactions decreased after continuous treatment.
1. Suicidal consciousness and behavior have been reported in the early stage of treatment or interruption.
2. Such events were reported in SSRI treatment.
The cases of QT interval prolongation reported after marketing mainly exist in patients with heart disease, and the reason is unclear. In a double-blind placebo-controlled study in healthy subjects, the QTc (fridericia corrected) interval of ECG in patients treated with 10mg / day of this product changed by 4.3 MS compared with baseline, and 10.7 MS in patients treated with 30mg / day of this product.
Discontinuation of SSRIs / SNRIs (especially sudden discontinuation) often leads to withdrawal symptoms. Dizziness, sensory disorders (including paresthesia and electroconvulsive sensation), sleep disorders (including insomnia and stressful dreams), agitation and anxiety, nausea and / or vomiting, tremor, confusion of consciousness, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual impairment were the most frequently reported reactions. Generally, these events are mild or moderate and self limiting, but in some patients, they may be severe or prolonged. Therefore, it is suggested that the dosage should be gradually reduced to discontinuation when the treatment is no longer needed. (see usage, dosage and precautions)
Taboo: 1. It is forbidden to use if you are allergic to the active ingredients or any excipients.
2. It is forbidden to use with non selective and irreversible monoamine oxidase inhibitor (MAOI) (see [warning] and [drug interaction]).
3. It is forbidden to use linezolid in combination with linezolid. See drug interaction for details.
4. Drug combination with pimozide is prohibited. See drug interaction for details.
5. It is forbidden to use this product in patients with known QT interval prolongation or congenital QT syndrome.
Matters needing attention: Antidepressants are not suitable for children and adolescents under 18 years old. In clinical trials in children and adolescents under 18, it was found that the frequency of suicide related behaviors (suicide attempts and suicidal ideas) and hostility (aggressive, antagonistic and irritable) in the treatment group was higher than that in the placebo group. Even for the clinical needs of clinical trials, the signs of suicide should be monitored closely.
The following special warnings and caution are applicable to all types of SSRI drugs.
Contradictory anxiety
Some patients with panic disorder may aggravate anxiety symptoms at the beginning of antidepressant treatment, which usually decreases gradually within 2 weeks after the treatment. It is suggested that lowering the initial dose can reduce the anxiety effect of the drug.
Epileptic seizure
The first time the patients with epilepsy or patients who have been diagnosed with epilepsy should stop using this product when the frequency of seizure increases. SSRI drugs should be avoided for unstable epileptic patients and should be monitored during treatment for patients with controlled seizures.
mania
SSRI should be used carefully in patients with manic or leprosy. Patients who have been converted to manic episodes should stop using SSRI drugs.
diabetes
For diabetic patients, the use of SSRI drugs may affect the regulation of blood sugar. Patients who use insulin and / or oral hypoglycemic drugs need to adjust the dose of these drugs.
Suicide, conception of suicide or deterioration of illness
Depression itself may have inherent symptoms of suicide attempts, self injury and suicide (suicide related events) and will continue until significant improvement occurs due to treatment. Since it may not have improved in the first few weeks or weeks after treatment, patients using antidepressants should be monitored closely before the disease improves. Clinical experience generally believes that the risk of suicide may increase in the early stages of recovery. Other mental events occurred with the use of this product are also related to the increased risk of suicide related events. In addition, mental events may be associated with depression. Such prevention should also be carried out when treating other mental disorders associated with depression. Patients who had suicide related events or serious suicide ideas before the treatment of this product have known that the risk of suicide concept or suicide attempt is greater, and should be carefully monitored during treatment. Meta analysis of antidepressants and placebo-controlled studies in adults with depression showed that patients under 25 had higher risk of suicide than those treated with placebo. Patients, especially those with high risk, or early treatment and dose adjustment periods should be closely monitored during antidepressant treatment.
Patients (and caregivers) should closely monitor any clinical deterioration, suicide or ideation and abnormal behavioral changes, and seek immediate medical advice if these symptoms occur.
Sit still / restless in mental exercise
The use of ssris/snris is related to the occurrence of sit still, which is manifested as the reluctant or painful upset of the subjects, which needs to be moved frequently and can not sit or stand quietly. Sit still can't occur most in the first few weeks of treatment. If the patient has these symptoms, it may be harmful to continue to increase the dose.
Hyponatremia
Hyponatremia (possibly due to abnormal secretion of antidiuretic hormone) is rarely reported with SSRI drugs, and symptoms are usually relieved after drug treatment is stopped. Attention should be paid to patients with such risks as the elderly, cirrhosis, or combination of drugs known to cause hyponatremia.
hemorrhage
There are reports of subcutaneous bleeding using SSRI drugs, such as ecchymosis and purpura. Caution is recommended for the use of SSRI drugs in the following populations, including : Patients with oral anticoagulants, or drugs known to have an impact on platelet function (such as atypical antipsychotics and phenothiazine drugs, most tricyclic antidepressants, acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamole) and patients with known bleeding tendencies.
Electrocontic therapy (ECT)
At present, there is only limited clinical experience in the treatment of combined SSRI drugs and electric convulsions, so it is suggested to be cautious.
Reversible, selective MAO-A inhibitors
It is not recommended to use this product with MAO-A inhibitors because there may be a risk of serotonin syndrome. (see drug interactions)
The combination of non selective and irreversible MAO inhibitors is shown in the drug interaction term.
Serotonin syndrome
It is suggested that caution should be taken when combined with 5-hydroxytryptamine drugs (such as sumatractam or other triacetam drugs, tramadol and tryptophan). A rare case of 5-HT syndrome was reported when combined with SSRI and 5-hydroxytryptamine. If the following symptoms such as shock, tremor, myoclonus and hyperheat appear after the combination, it is suggested that 5-hydroxytryptamine syndrome may occur. If this problem occurs, SSRI and 5-hydroxytryptamine drugs should be stopped immediately and treated with symptomatic treatment.
St John's grass
Combination of SSRI and Chinese herbal medicines containing St. John's (hypericin) may increase adverse reactions.
Symptoms of stopping medicine
Drug withdrawal symptoms are common when discontinuing treatment, especially when the drug is stopped suddenly (see adverse reactions). Of the observed adverse clinical events, about 25 percent of patients treated with this product and 15 percent of placebo patients had symptoms of drug withdrawal. The risk of drug withdrawal symptoms may depend on several factors, including the duration and dose of treatment, and the rate of dose reduction. The most frequently reported drug withdrawal reactions include dizziness, sensory disorders (including sensory abnormalities and convulsions), sleep disorders (including insomnia and tension), agitation and anxiety, nausea and / or vomiting, tremor, blurred consciousness, sweating, headache, diarrhea, palpitation, emotional instability, irritability, and visual impairment. These symptoms are usually mild to moderate, but some patients may be severe. These symptoms usually occur within days of the initial interruption of treatment, and few reports of these symptoms occur in patients who have been inadvertently taking the drug.
Generally, these symptoms are self limiting and are usually eliminated within 2 weeks, although in some individuals it may be extended (2-3 months or more). Therefore, it is suggested that the drug should be stopped according to the needs of patients and go through a gradual reduction process of a few weeks or months.
Impact on driving and operating machine capability
Although the study showed that the product did not affect the level of intelligence and psychomotor operation, any psychoactive drug may affect judgment and skills. Patients should be aware of the potential risks that may affect the ability to drive and operate the machine.
Please put it in a place that is not easy for children.
Medication for pregnant and lactating women: pregnant woman
There is limited clinical data on pregnant women using this product.
The teratogenesis of rats was observed in the study of reproductive toxicology, but no increase in the incidence of teratogenesis was found. The clinical data of this product for pregnant women is limited. This product is not used in pregnant women. If there is clinical need, it can only be used after careful consideration of its risk / benefit.
If pregnant women use this product, the fetus should be monitored continuously until the end of pregnancy, especially at the end of pregnancy 3 months. Sudden withdrawal of drugs should be avoided during pregnancy. Pregnant women have been using SSRI drugs until the newborn is born, and the reported newborns will have the following effects: respiratory distress, cyanosis, apnea, epilepsy, temperature instability, vomiting, hypoglycemia, irritability, tremor, hypertension, increased muscle tension, neurohypersensitivity, sleepiness, continuous crying, sleepiness, sleepiness, sucking or sleeping difficulties. It may be 5-hydroxytryptamine or drug stopping syndrome. Pregnant women should not stop drugs suddenly when using SSRI drugs. Most of the complications occur immediately or quickly (24 hours) after delivery.
Epidemiological data indicate that the use of SSRI drugs in pregnant women, especially in the late pregnancy, may increase the risk of persistent pulmonary hypertension (PPHN) in newborns. About 5 of 1000 pregnant women who used SSRI were observed. PPHN was found in 1 to 2 of every 1000 pregnant women in a group of people.
Lactating women
Escitalopram can be secreted in milk. Nursing women should not be treated with this product or stop breastfeeding during the drug use.
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