美国FDA于3月20日批准Forest Laboratories 公司的草酸艾司西酞普兰(escitalopram oxalate,Lexapro)用于12~17岁青少年重度抑郁症患者的急性治疗和维持治疗。本品是第2个批准用于治疗青少年重度抑郁症患者的药物。在美国重度抑郁症大约影响了200万的青少年。
本品的获准是基于2项安慰剂对照的临床研究结果。其中1项研究为本品与安慰剂的对照试验,为期8周,受试者年龄在12~17岁,每天本品的服用剂量在10~20 mg,剂量可根据患者情况进行调整。本研究的结果表明服用本品后CDRS-R 值较基线值相比的改善情况明显优于安慰剂对照组,且具有显著疗效。
另一项研究为消旋的西酞普兰(racemic citalopram)与安慰剂的对照研究,该研究同样也为期8周,患者的年龄从7~17岁,每天的西酞普兰服用剂量在20~40 mg。剂量可根据患者情况进行调整。结果表明,与安慰剂相比,服用西酞普兰后,患者CDRS-R 值与基线值相比的改善程度具有显著。FDA决定Lexapro的有效性,很大程度上来自该研究的类推结果。
本品用于青少年重度抑郁症维持治疗的研究,FDA批准其用于青少年重度抑郁症的维持治疗是将本品在成年患者中维持治疗的有效性进行类推的结果。此外,FDA还参考了本品在在成年患者和青少年患者中的药代动力学参数情况。
本品具有很好的耐受性,在青少年患者中的不良反应与在成年患者的出现的不良反应类似。
青少年抑郁症治疗的药物选择通常会因为要考虑药物的有效性和耐受性而受到限制,美国得克萨斯州大学西南医学中心的精神病学教授Graham Emslie,认为FDA批准本品对于青少年抑郁患者而言可以明显地病情,大大增加了对抗疾病的战斗力。
本品目前被批准用于青少年(2~17岁)重度抑郁患者的急性治疗和维持治疗,还用于广泛焦虑症成年患者的治疗。其通过修复大脑内化学物质的平衡而起作用,可以增加5-羟色胺的活性。5-羟色胺是大脑内控制情绪的关键物质。自2002年获准以来,本品的已经在1800万患者中进行了处方。
Lexapro is used for: Treating depression or generalized anxiety disorder. It may also be used for other conditions as determined by your doctor. Lexapro is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.
Do NOT use Lexapro if: • you are allergic to any ingredient in Lexapro • you are taking citalopram • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days • you are taking a fenfluramine derivative (eg, dexfenfluramine), an H1 antagonist (eg, astemizole, terfenadine), nefazodone, pimozide, or sibutramine Contact your doctor or health care provider right away if any of these apply to you.
Before using Lexapro : Some medical conditions may interact with Lexapro . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: • if you are pregnant, planning to become pregnant, or are breast-feeding • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement • if you have allergies to medicines, foods, or other substances • if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse • if you have a history of seizures, liver problems, severe kidney problems, stomach or bowel bleeding, or metabolism problems • if you are dehydrated, have low blood sodium levels, or drink alcohol • if you will be having electroconvulsive therapy (ECT) Some MEDICINES MAY INTERACT with Lexapro . Tell your health care provider if you are taking any other medicines, especially any of the following: • Fenfluramine derivatives (eg, dexfenfluramine), linezolid, lithium, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, St. John's wort, or trazodone because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased • Tramadol because the risk of seizures may be increased • H1 antagonists (eg, astemizole, terfenadine) or phenothiazines (eg, chlorpromazine, thioridazine) because severe heart problems, including irregular heartbeat, may occur • Carbamazepine or cyproheptadine because they may decrease Lexapro 's effectiveness • Clozapine, pimozide, risperidone, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Lexapro This may not be a complete list of all interactions that may occur. Ask your health care provider if Lexapro may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Lexapro : Use Lexapro as directed by your doctor. Check the label on the medicine for exact dosing instructions. • Lexapro comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lexapro refilled. • Take Lexapro by mouth with or without food. • Taking Lexapro at the same time each day will help you remember to take it. • Continue to take Lexapro even if you feel well. Do not miss any doses. • Do not suddenly stop taking Lexapro without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Lexapro and whenever a change in dose is made. • If you miss a dose of Lexapro , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Ask your health care provider any questions you may have about how to use Lexapro.
Important safety information: • Lexapro may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Lexapro with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. • Do not drink alcohol while you are using Lexapro . • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lexapro ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. • One to 4 weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Lexapro for longer than prescribed without checking with your doctor. • Children, teenagers, and young adults who take Lexapro may be at increased risk for suicidal thoughts or actions. Watch all patients who take Lexapro closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. • Lexapro and a medicine called citalopram have the same active ingredient. Do not take Lexapro if you are also taking citalopram. • If your doctor tells you to stop taking Lexapro , you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Lexapro . • Lexapro may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. • Serotonin syndrome is a possibly fatal syndrome that can be caused by Lexapro . Your risk may be greater if you take Lexapro with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms. • Caution is advised when using Lexapro in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels. • Caution is advised when using Lexapro in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions. • Lexapro should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. • Lexapro may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Lexapro . • PREGNANCY and BREAST-FEEDING: Lexapro may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lexapro while you are pregnant. Lexapro is found in breast milk. Do not breast-feed while taking Lexapro. Possible side effects of Lexapro : All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; lightheadedness when you stand or sit up; loss of appetite; nausea; stomach upset; tiredness; trouble sleeping. Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; fast or irregular heartbeat; hallucinations; memory loss; menstrual period changes; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; vision changes; worsening of depression. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at .
If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include coma; fast, slow, or irregular heartbeat; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting. Proper storage of Lexapro : Store Lexapro at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lexapro out of the reach of children and away from pets.
General information: • If you have any questions about Lexapro , please talk with your doctor, pharmacist, or other health care provider. • Lexapro is to be used only by the patient for whom it is prescribed. Do not share it with other people. • If your symptoms do not improve or if they become worse, check with your doctor. This information is a summary only. It does not contain all information about Lexapro . Additionally, your doctor may have prescribed Lexapro for a use not mentioned above. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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