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EsketamineWarningEsketamine is given in a doctor's office or medical clinic. This medication may cause drowsiness, dizziness, fainting, anxiety, or serious (possibly fatal) slow/shallow breathing. It may also cause you to feel disconnected from your body, thoughts, feelings, space, and time (dissociation). You must be monitored for at least 2 hours after each treatment by a health care professional to make sure these side effects go away and it is safe for you to leave the medical clinic or doctor's office. This medication also has a risk for abuse and physical and psychological dependence. See also How to Use section. To receive esketamine in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. 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. 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 right away 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. PrecautionsBefore using esketamine, tell your doctor or pharmacist if you are allergic to it; or to ketamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems (such as aneurysm in the brain/chest/aorta/abdomen/arms/legs, arteriovenous malformation), bleeding/increased pressure in the brain, high blood pressure (including a syndrome of high blood pressure with seizures, severe headache, and coma), heart disease, stroke, liver disease, a certain mental/mood disorder (psychosis), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until the next day after a good night's sleep and until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using esketamine. Esketamine may harm an unborn baby. Ask about reliable forms of birth control while using this medication. However, since untreated mental/mood problems (such as depression) can harm a pregnant woman and her unborn baby, do not stop using this medication unless directed by your doctor. Ask your doctor if a different medication would be right for you. If you become pregnant or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication. This medication passes into breast milk and may harm a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding. Side EffectsSee also Warning and How to Use sections. Problems with thinking clearly, feeling drunk, a feeling of spinning, or nausea, vomiting, dizziness, drowsiness, tiredness, or reduced sense of touch may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: increased urination at night, burning/pain when you urinate, urgent or frequent urination. This medication may raise your blood pressure. An increase in blood pressure can last about 4 hours after a dose of esketamine. Your health care professional will check your blood pressure before and after your dose. Get medical help right away if you have any very serious side effects, including: chest pain, shortness of breath, sudden severe headache, vision changes, seizures, loss of consciousness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |