Asendin

Asendin is a prescription medication used to treat depression.

Asendin is in a class of medications called tricyclic antidepressants (TCAs). It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

This medication comes in tablet form and is taken one or more times a day. If you take Asendin once a day, you should take it at bedtime.

Common side effects of Asendin include drowsiness, dry mouth, constipation, and blurred vision.

Asendin can also cause drowsiness. Do not drive or operate heavy machinery until you know how Asendin affects you.

Asendin is a prescription medication used to treat depression.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of amoxapine (Asendin) is 200 to 300 mg daily.

• In general, lower dosages are recommended for elderly patients.

Some hospitalized patients who have been refractory to antidepressant therapy and who have no history of convulsive seizures may have doses given up to 600 mg daily in divided doses.

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as Asendin during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take Asendin, but in some cases, a doctor may decide that Asendin is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take Asendin or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking Asendin, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with Asendin. Read the information carefully and ask your doctor or pharmacist if you have any questions.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Serious side effects have been reported with Asendin including the following:

• Clinical Worsening and Suicide Risk. Tell your healthcare provider right away if you have any of the following signs or symptoms especially if they are new, worse, or worry you:
  •   thoughts about suicide or dying
  •   attempts to commit suicide
  •   new or worse depression/anxiety
  •   feeling very agitated or restless
  •   panic attacks
  •   trouble sleeping (insomnia)
  •   acting on dangerous impulses
  •   other unusual changes in behavior or mood

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.

• Neuroleptic Malignant Syndrome (NMS). Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect and has been reported in association with antipsychotic drugs and with Asendin. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
• Tardive Dyskinesia (TD). Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect. TD may develop in patients treated with neuroleptic (i.e., antipsychotic) drugs. (Asendin is not an antipsychotic, but it has substantive neuroleptic activity.) TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
• Seizures. Asendin should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Asendin can also cause drowsiness. Do not drive or operate heavy machinery until you know how Asendin affects you.

Asendin should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, or increased intraocular pressure.

Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant drugs, particularly when given in high doses, can induce sinus tachycardia, changes in conduction time, and arrhythmias. Myocardial infarction and stroke have been reported with drugs of this class.

Do not take Asendin if you:

• are allergic to Asendin or to any of its ingredients
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
• stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician
• are in an acute recovery period after a myocardial infarction

Serious side effects have been reported with Asendin. See the “Asendin Precautions” section.

Common side effects of Asendin include the following:

• drowsiness
• dry mouth
• constipation
• blurred vision
• anxiety
• insomnia
• restlessness
• nervousness
• palpitations
• tremors
• confusion
• excitement
• nightmares
• ataxia
• alterations in EEG patterns
• edema
• skin rash
• nausea

This is not a complete list of Asendin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• anticoagulants (blood thinners) such as warfarin (Coumadin)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac,Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• antihistamines
• cimetidine (Tagamet)
• flecainide (Tambocor)
• levodopa (Sinemet, Larodopa)
• lithium (Eskalith, Lithobid)
• medications for high blood pressure, seizures, Parkinson's disease, asthma, colds, or allergies
• methylphenidate (Ritalin)
• muscle relaxants
• propafenone (Rhythmol)
• sedatives
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), and sertraline (Zoloft)
• sleeping pills and tranquilizers
• thyroid medications
• alcohol

This is not a complete list of Asendin drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Asendin falls into category C. There are no well-controlled studies that have been done in pregnant women. Asendin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Asendin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Asendin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

It may take several weeks or longer for you to feel the full effect of amoxapine. Continue to take amoxapine even if you feel well.

Do not stop taking amoxapine without talking to your doctor.

Antidepressants, such as amoxapine, has been associated with clinical worsening and suicide risk. Tell your healthcare provider right away if notice any behavior changes that worry you.