药品名称：Escitalopram Oxalate
中文名称：草酸依地普仑片
适应症：用于治疗抑郁症
FDA的最终批准，生产及销售草酸依地普仑片（Escitalopram Oxalate tablets，5mg，10mg，20mg）。阿拉宾度已准备好了该药的商业销售。
阿拉宾度在一份新闻稿中称，该药的简化新药申请（ANDA）在之前已获得了暂时性批准（tentative approval）。
草酸依地普仑片是森林实验室（Forest Lab）Lexapro片的等价仿制药，是一种抗抑郁药，用于治疗抑郁症。

Introduction
　　Antidepressant; selective serotonin-reuptake inhibitor (SSRI) and S-enantiomer of citalopram.1
　　Uses for Escitalopram Oxalate
　　Major Depressive Disorder
　　Management of major depressive disorder.1
　　Efficacy in hospital settings not established.1 8
　　Generalized Anxiety Disorder
　　Management of generalized anxiety disorder.1
　　Escitalopram Oxalate Dosage and Administration
　　General
　　•
　　Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, and vice versa.1
　　•
　　Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 e f g (See Worsening of Depression and Suicidality Risk under Cautions.)
　　•
　　Sustained therapy may be required; monitor periodically for need for continued therapy.1
　　•
　　Avoid abrupt discontinuance of therapy.1 To avoid withdrawal reactions, taper dosage gradually.1 5 6 7 (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
　　•
　　Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
　　Administration
　　Oral Administration
　　Administer orally once daily (morning or evening) without regard to meals.1
　　Dosage
　　Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
　　Available as escitalopram oxalate; dosage is expressed in terms of escitalopram.1
　　Escitalopram dosages of 10 mg daily appear to be comparable to racemic citalopram dosages of 40 mg daily.2
　　Adults
　　Major Depressive Disorder
　　Oral
　　Initially, 10 mg daily.1 May be increased to 20 mg daily after ≥1 week; no additional therapeutic benefit with higher dosages.1
　　Optimum duration not established; may require several months of therapy or longer.1 5
　　Generalized Anxiety Disorder
　　Oral
　　Initially, 10 mg daily.1 Dosage may be increased to 20 mg daily after ≥1 week.1
　　Not studied >8 weeks of therapy; periodically reevaluate need for therapy.1
　　Special Populations
　　Hepatic Impairment
　　10 mg daily.1
　　Renal Impairment
　　No dosage adjustment required in patients with mild to moderate renal impairment; not studied in patients with severe renal impairment (Clcr <20 mL/minute).1
　　Geriatric Patients
　　10 mg daily.1
　　WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.
　　Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.
　　USES: Escitalopram is an antidepressant (selective serotonin reuptake inhibitor-SSRI) used to treat depression and anxiety. It works by restoring the balance of certain natural substances (neurotransmitters such as serotonin) in the brain. Escitalopram may improve your feelings of well-being and energy level and decrease nervousness.
　　OTHER USES: This section contains uses of this drug that are not listed in the approved US professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
　　This medication may also be used to treat other mental/mood disorders (such as obsessive-compulsive disorder, panic disorder).
　　HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking escitalopram and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
　　Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning or evening. Take it at the same time each day. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
　　If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
　　To reduce your risk of side effects, your doctor may direct you to start taking this drug at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
　　It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.
　　This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nervousness, headache, numbness, tingling, trouble sleeping, confusion) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
　　It may take 1 to 2 weeks to feel a benefit from this drug and 4 weeks to feel the full benefit of this medication. Tell your doctor if your condition persists or worsens.