Asendin - Amoxapine (Oral Route)

    Asendin – Amoxapine (Oral Route)

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    Description and Brand Names of Asendin – Amoxapine (Oral Route)

    US Brand Name

    1. Asendin

    Descriptions

    Amoxapine is used to treat the symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. This medicine is a tricyclic antidepressant (TCA).

    This medicine is available only with your doctor’s prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using Asendin – Amoxapine (Oral Route)

    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

    Breastfeeding

    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.

    Drug Interactions

    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.

    • Bepridil
    • Cisapride
    • Clorgyline
    • Dronedarone
    • Grepafloxacin
    • Isocarboxazid
    • Levomethadyl
    • Linezolid
    • Mesoridazine
    • Methylene Blue
    • Metoclopramide
    • Moclobemide
    • Phenelzine
    • Pimozide
    • Ranolazine
    • Selegiline
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • 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
    • Alfuzosin
    • Almotriptan
    • Amiodarone
    • Amitriptyline
    • Amprenavir
    • Apomorphine
    • Aprindine
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Azimilide
    • Azithromycin
    • Bretylium
    • Bromocriptine
    • Brompheniramine
    • Buspirone
    • Chloral Hydrate
    • Chloroquine
    • Chlorpheniramine
    • Chlorpromazine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clomipramine
    • Clonidine
    • Clozapine
    • Cocaine
    • Cyclobenzaprine
    • Dasatinib
    • Desipramine
    • Desvenlafaxine
    • Dextromethorphan
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Domperidone
    • Doxepin
    • Droperidol
    • Eletriptan
    • Enflurane
    • Epinephrine
    • Erythromycin
    • Escitalopram
    • Etilefrine
    • Fentanyl
    • Fingolimod
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Fluvoxamine
    • Foscarnet
    • Frovatriptan
    • Gatifloxacin
    • Gemifloxacin
    • Granisetron
    • Halofantrine
    • Halothane
    • Hydroxytryptophan
    • Ibutilide
    • Iloperidone
    • Imipramine
    • Indacaterol
    • Iobenguane I 123
    • Iproniazid
    • Isoflurane
    • Isradipine
    • Lapatinib
    • Levalbuterol
    • Levofloxacin
    • Levomilnacipran
    • Levothyroxine
    • Lidoflazine
    • Lithium
    • Lopinavir
    • Lorcainide
    • Lorcaserin
    • Lumefantrine
    • Mefloquine
    • Meperidine
    • Methadone
    • Methoxamine
    • Midodrine
    • Milnacipran
    • Moricizine
    • Moxifloxacin
    • Naratriptan
    • Nefazodone
    • Nefopam
    • Nilotinib
    • Norepinephrine
    • Norfloxacin
    • Nortriptyline
    • Octreotide
    • Ofloxacin
    • Ondansetron
    • Oxilofrine
    • Paliperidone
    • Pargyline
    • Pazopanib
    • Pentamidine
    • Perflutren Lipid Microsphere
    • Phenylephrine
    • Posaconazole
    • Procainamide
    • Procarbazine
    • Prochlorperazine
    • Promethazine
    • Propafenone
    • Protriptyline
    • Quinidine
    • Quinine
    • Rasagiline
    • Saquinavir
    • Sematilide
    • Sertraline
    • Sodium Phosphate
    • Sodium Phosphate, Dibasic
    • Sodium Phosphate, Monobasic
    • Solifenacin
    • Sorafenib
    • Sotalol
    • Spiramycin
    • Sulfamethoxazole
    • Sunitinib
    • Tapentadol
    • Tedisamil
    • Telavancin
    • Telithromycin
    • Tetrabenazine
    • Toremifene
    • Tramadol
    • Trazodone
    • Trifluoperazine
    • Trimethoprim
    • Trimipramine
    • Tryptophan
    • Vandetanib
    • Vardenafil
    • Vasopressin
    • Venlafaxine
    • Vilanterol
    • 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

    Other Interactions

    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.

    Proper Use of Asendin – Amoxapine (Oral Route)

    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.

    Precautions

    It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

    Amoxapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child’s doctor right away.

    Do not take amoxapine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®, or tranylcypromine [Parnate®]) in the past two weeks. Do not start taking a MAO inhibitor within two weeks of stopping amoxapine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

    This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

    Check with your doctor right away if you are having convulsions (seizures); difficulty with breathing; a fast heartbeat; high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

    Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

    This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

    This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

    Side Effects of Asendin – Amoxapine (Oral Route)

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    1. Excitement
    2. fast, irregular, pounding, or racing heartbeat or pulse
    3. fear or nervousness
    4. mood or mental changes
    5. nightmares
    6. restlessness
    7. shakiness and unsteady walk
    8. shakiness in legs, arms, hands, or feet
    9. sleeplessness
    10. swelling
    11. trouble sleeping
    12. unable to sleep
    13. unsteadiness, trembling, or other problems with muscle control or coordination

    Rare

    1. Abdominal or stomach pain
    2. actions that are out of control
    3. black, tarry stools
    4. bleeding gums
    5. bloating
    6. blood in urine or stools
    7. blurred vision
    8. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    9. chest pain or discomfort
    10. chills
    11. clay-colored stools
    12. confusion
    13. confusion about identity, place, and time
    14. constipation
    15. continuing ringing or buzzing or other unexplained noise in ears
    16. convulsions
    17. cough or hoarseness
    18. dark urine
    19. decrease in frequency of urination
    20. decrease in urine volume
    21. difficulty in breathing
    22. difficulty in passing urine (dribbling)
    23. difficulty in speaking
    24. disturbed concentration
    25. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    26. double vision
    27. drooling
    28. extremely high fever or body temperature
    29. false beliefs that cannot be changed by facts
    30. fast, weak heartbeat
    31. fever with or without chills
    32. general feeling of tiredness or weakness
    33. headache
    34. hearing loss
    35. high fever
    36. high or low blood pressure
    37. hives or welts
    38. inability to move arms, legs, or facial muscles
    39. inability to speak
    40. increased need to urinate
    41. increased sweating
    42. indigestion
    43. irritability
    44. itching
    45. lack of coordination
    46. light-colored stools
    47. lip smacking or puckering
    48. loss of appetite
    49. loss of bladder control
    50. lower back or side pain
    51. muscle cramps
    52. muscle spasm or jerking of all extremities
    53. muscle trembling, jerking, or stiffness
    54. nausea and vomiting
    55. nervousness
    56. numbness
    57. pain or discomfort in arms, jaw, back, or neck
    58. painful or difficult urination
    59. pains in stomach, side, or abdomen, possibly radiating to the back
    60. pale, clammy skin
    61. passing urine more often
    62. pinpoint red spots on skin
    63. pounding in the ears
    64. puffing of cheeks
    65. rapid or worm-like movements of tongue
    66. redness of skin
    67. seeing, hearing, or feeling things that are not there
    68. severe muscle stiffness
    69. shortness of breath
    70. shuffling walk
    71. skin rash
    72. slow speech
    73. sore throat
    74. sores, ulcers, or white spots on lips or in mouth
    75. stiffness of limbs
    76. sudden loss of consciousness
    77. sweating
    78. swollen glands
    79. talking, feeling, and acting with excitement
    80. testicular swelling
    81. thirst
    82. trouble in holding or releasing urine
    83. twisting movements of body
    84. uncontrolled chewing movements
    85. uncontrolled movements, especially of face, neck, and back
    86. unpleasant breath odor
    87. unusual bleeding or bruising
    88. unusually pale skin
    89. upper right abdominal pain
    90. vomiting of blood
    91. yellow eyes and skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    1. Change in consciousness
    2. drowsiness
    3. epileptic seizure that will not stop
    4. fatigue
    5. increased blood pressure
    6. increased thirst
    7. loss of consciousness
    8. swelling of face, fingers, or lower legs
    9. total body jerking
    10. troubled breathing
    11. weight gain

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    1. Dry mouth

    Less common

    1. Increased appetite
    2. increased flow of breast milk

    Rare

    1. Agitation
    2. breast enlargement
    3. change in taste bad unusual or unpleasant (after)taste
    4. decreased interest in sexual intercourse
    5. depression
    6. excess air or gas in stomach or intestines
    7. full feeling
    8. hair loss, thinning of hair
    9. heartburn
    10. inability to have or keep an erection
    11. increased in sexual ability, desire, drive, or performance
    12. increased interest in sexual intercourse
    13. increased sensitivity of skin to sunlight
    14. loss in sexual ability, desire, drive, or performance
    15. menstrual changes
    16. nasal stuffiness
    17. painful ejaculation
    18. passing gas
    19. rapid weight gain
    20. redness or other discoloration of skin
    21. seizures
    22. severe sunburn
    23. stupor
    24. swollen, painful, or tender lymph glands on side of face or neck
    25. tearing of the eyes
    26. unexpected or excess milk flow from breasts

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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