Asendin

Before taking amoxapine,

• tell your doctor and pharmacist if you are allergic to amoxapine, doxepin (Sinequan), any other medications, or any of the inactive ingredients in amoxapine tablets. Ask your doctor or pharmacist for a list of the inactive ingredients.
• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take amoxapine. If you stop taking amoxapine, you should wait at least 14 days before you start to take an MAO inhibitor.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin); 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); quinidine; sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sleeping pills; thyroid medications; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• tell your doctor if you are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses) and if you have or have ever had a heart attack, glaucoma (an eye disease), an enlarged prostate (a male reproductive organ), difficulty urinating, seizures, an overactive thyroid gland, or liver, kidney, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking amoxapine, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking amoxapine.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• skin rash with fever;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• pounding heartbeats or fluttering in your chest;
• little or no urination;
• chest pain or pressure, pain spreading to your jaw or shoulder;
• sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Side effects may be more likely in older adults.

Common side effects may include:

• drowsiness;
• constipation;
• dry mouth; or
• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to 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.

Before taking Asendin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• tell your doctor and pharmacist if you are allergic to Asendin, doxepin (Sinequan), any other medications, or any of the inactive ingredients in Asendin 
• are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses)
• have or have ever had a heart attack, glaucoma (an eye disease)
• have or have ever had an enlarged prostate (a male reproductive organ)
• have or have ever had difficulty urinating
• have or have ever had seizures
• have or have ever had overactive thyroid gland, or liver, kidney, or heart disease
• are pregnant, plan to become pregnant. If you become pregnant while taking Asendin, call your doctor immediately.
• are breast-feeding
• if you are having surgery, including dental surgery
• drink alcohol. Alcohol can add to the drowsiness caused by this medication.
• have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take Asendin. If you stop taking Asendin, you should wait at least 14 days before you start to take an MAO inhibitor.

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

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.

Take Asendin exactly as prescribed.

Asendin comes in tablet form and is taken one or more times a day. Once an effective dose is obtained, a single dose at bedtime is recommended.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Asendin at the same time.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amoxapine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxapine in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., movement disorders, unusual drowsiness) or age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving amoxapine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bromopride
• Clorgyline
• Grepafloxacin
• Isocarboxazid
• Levomethadyl
• Linezolid
• Methylene Blue
• Metoclopramide
• Moclobemide
• Phenelzine
• Ranolazine
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Aceclofenac
• Acemetacin
• Albuterol
• Alfentanil
• Alfuzosin
• Almotriptan
• Amitriptyline
• Amphetamine
• Amtolmetin Guacil
• Apomorphine
• Aprindine
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Azimilide
• Azithromycin
• Benzphetamine
• Bretylium
• Bromfenac
• Bromocriptine
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Celecoxib
• Chloral Hydrate
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clomipramine
• Clonidine
• Clonixin
• Cocaine
• Codeine
• Cyclobenzaprine
• Darunavir
• Dasatinib
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Diclofenac
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Droxicam
• Eletriptan
• Enflurane
• Epinephrine
• Erythromycin
• Escitalopram
• Etilefrine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Foscarnet
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Halofantrine
• Halothane
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Ibuprofen
• Ibutilide
• Iloperidone
• Imipramine
• Indomethacin
• Iobenguane I 123
• Iproniazid
• Isoflurane
• Isradipine
• Ketoprofen
• Ketorolac
• Lapatinib
• Levalbuterol
• Levomilnacipran
• Levorphanol
• Levothyroxine
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lopinavir
• Lorcainide
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Meperidine
• Methadone
• Methamphetamine
• Methoxamine
• Midodrine
• Milnacipran
• Mirtazapine
• Moricizine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nefopam
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norepinephrine
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Oxaprozin
• Oxilofrine
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Paliperidone
• Palonosetron
• Parecoxib
• Pargyline
• Pazopanib
• Pentamidine
• Pentazocine
• Phenylbutazone
• Phenylephrine
• Piketoprofen
• Piroxicam
• Pranoprofen
• Procainamide
• Procarbazine
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quinidine
• Quinine
• Rasagiline
• Remifentanil
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sematilide
• Sertraline
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sulindac
• Sumatriptan
• Sunitinib
• Tapentadol
• Tedisamil
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tiaprofenic Acid
• Tiotropium
• Tolfenamic Acid
• Tolmetin
• Toremifene
• Tramadol
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Tryptophan
• Valdecoxib
• Vardenafil
• Vasopressin
• Venlafaxine
• Vilanterol
• Vilazodone
• Voriconazole
• Vortioxetine
• Ziprasidone
• Zolmitriptan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Arbutamine
• Atomoxetine
• Cannabis
• Carbamazepine
• Dicumarol
• Paroxetine
• Phenprocoumon
• S-Adenosylmethionine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
• Heart attack, recent—Should not be used in patients with these conditions.

• Glaucoma, history of or
• Heart disease or
• Schizophrenia or
• Seizures, history of or
• Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For depression:
    • Adults—At first, 50 milligrams (mg) two or three times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day unless you are in a hospital. Some hospitalized patients may need higher doses. If you are taking this medicine once a day, it is best to take it at bedtime.
    • Older Adults—At first, 25 milligrams (mg) two or three times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day unless you are in a hospital. Some hospitalized patients may need higher doses. If you are taking this medicine once a day, it is best to take it at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.