Amitriptyline (Oral Route)

    Amitriptyline (Oral Route)

    15
    0
    SHARE

    Description and Brand Names of Amitriptyline (Oral Route)

    US Brand Name

    1. Elavil
    2. Vanatrip

    Descriptions

    Amitriptyline is used to treat 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 Amitriptyline (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 amitriptyline in children below 12 years of age. 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 amitriptyline in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require an adjustment in the dose for patients receiving amitriptyline.

    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.

    • Amifampridine
    • Bepridil
    • Cisapride
    • Clorgyline
    • Dronedarone
    • Furazolidone
    • Grepafloxacin
    • Iproniazid
    • Isocarboxazid
    • Levomethadyl
    • Linezolid
    • Mesoridazine
    • Methylene Blue
    • Metoclopramide
    • Moclobemide
    • Nialamide
    • Pargyline
    • Phenelzine
    • Pimozide
    • Piperaquine
    • Procarbazine
    • Ranolazine
    • Selegiline
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Toloxatone
    • 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
    • Amisulpride
    • Amoxapine
    • Amprenavir
    • Apomorphine
    • Aprindine
    • Arsenic Trioxide
    • Artemether
    • Asenapine
    • Astemizole
    • Atazanavir
    • Azimilide
    • Azithromycin
    • Bretylium
    • Brompheniramine
    • Buspirone
    • Chloral Hydrate
    • Chloroquine
    • Chlorpheniramine
    • Chlorpromazine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clomipramine
    • Clonidine
    • Cocaine
    • Crizotinib
    • Cyclobenzaprine
    • Dabrafenib
    • Dasatinib
    • Desipramine
    • Desvenlafaxine
    • Dextromethorphan
    • Disopyramide
    • Dofetilide
    • Dolasetron
    • Domperidone
    • Doxepin
    • Droperidol
    • Eletriptan
    • Enflurane
    • Epinephrine
    • Erythromycin
    • Eslicarbazepine Acetate
    • Etilefrine
    • Fentanyl
    • Fingolimod
    • Flecainide
    • Fluconazole
    • Fluoxetine
    • Foscarnet
    • Frovatriptan
    • Gatifloxacin
    • Gemifloxacin
    • Halofantrine
    • Haloperidol
    • Halothane
    • Hydroxytryptophan
    • Ibutilide
    • Iloperidone
    • Imipramine
    • Indacaterol
    • Iobenguane I 123
    • Isoflurane
    • Isradipine
    • Ivabradine
    • Lapatinib
    • Levalbuterol
    • Levofloxacin
    • Levomilnacipran
    • Levothyroxine
    • Lidoflazine
    • Lithium Carbonate
    • Lopinavir
    • Lorcainide
    • Lorcaserin
    • Lumefantrine
    • Mefloquine
    • Meperidine
    • Methadone
    • Methoxamine
    • Midodrine
    • Milnacipran
    • Mirtazapine
    • Moricizine
    • Moxifloxacin
    • Naratriptan
    • Nefazodone
    • Nefopam
    • Nilotinib
    • Norepinephrine
    • Norfloxacin
    • Nortriptyline
    • Octreotide
    • Ofloxacin
    • Ondansetron
    • Oxilofrine
    • Paliperidone
    • Pazopanib
    • Pentamidine
    • Pentazocine
    • Perflutren Lipid Microsphere
    • Phenylephrine
    • Pixantrone
    • Posaconazole
    • Procainamide
    • Prochlorperazine
    • Promethazine
    • Propafenone
    • Propoxyphene
    • Protriptyline
    • Quetiapine
    • Quinidine
    • Quinine
    • Rasagiline
    • Risperidone
    • Rizatriptan
    • Saquinavir
    • Sematilide
    • Sertindole
    • Sertraline
    • Sibutramine
    • Sodium Phosphate
    • Sodium Phosphate, Dibasic
    • Sodium Phosphate, Monobasic
    • Solifenacin
    • Sorafenib
    • Sotalol
    • Spiramycin
    • Sulfamethoxazole
    • Sultopride
    • Sumatriptan
    • Sunitinib
    • Tapentadol
    • Tedisamil
    • Telavancin
    • Telithromycin
    • Tetrabenazine
    • Toremifene
    • Tramadol
    • Trazodone
    • Trifluoperazine
    • Trimethoprim
    • Trimipramine
    • Tryptophan
    • Valproic Acid
    • Vandetanib
    • Vardenafil
    • Vasopressin
    • Vemurafenib
    • Venlafaxine
    • Vilanterol
    • Vinflunine
    • Voriconazole
    • Vortioxetine
    • Ziprasidone
    • Zolmitriptan
    • Zotepine

    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
    • Bethanidine
    • Carbamazepine
    • Cimetidine
    • Diazepam
    • Dicumarol
    • Fluvoxamine
    • Fosphenytoin
    • Galantamine
    • Guanethidine
    • Phenprocoumon
    • Phenytoin
    • Rifapentine
    • Ritonavir
    • S-Adenosylmethionine
    • St John’s Wort
    • Topiramate
    • Warfarin

    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 is usually not recommended, 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.

    • Tobacco

    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.
    • Diabetes or
    • Glaucoma or
    • Heart disease or
    • Overactive thyroid or
    • Schizophrenia or
    • Seizures, history of or
    • Urinary retention (trouble urinating), history of – Use with caution. May make these conditions worse.
    • Liver disease – Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use of Amitriptyline (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 comes with a medication guide. Read and follow the instructions in the guide 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 forms (tablets):

      • For depression:

        • Adults – At first, 75 milligrams (mg) per day given in divided doses, or 50 to 100 mg at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day, unless you are in the hospital. Some hospitalized patients may need higher doses.
        • Teenagers and Older adults – 10 milligrams (mg) three times a day, and 20 mg at bedtime. Your doctor may adjust your dose as needed.
        • Children younger than 12 years of age – 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.

    Amitriptyline 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 or your caregiver notice any of these adverse effects, tell your doctor right away.

    Do not take amitriptyline if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 5 days of stopping amitriptyline. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

    Do not take other medicines unless they have been discussed with your doctor. Using this medicine together with cisapride (Propulsid®), may increase the chance of having serious side effects.

    Do not suddenly 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 CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

    Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking amitriptyline together with medicines used during surgery may increase the risk of side effects.

    This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

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

    Side Effects of Amitriptyline (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:

    Incidence not known

    1. Abdominal or stomach pain
    2. agitation
    3. black, tarry stools
    4. bleeding gums
    5. blood in urine or stools
    6. blurred vision
    7. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    8. change in consciousness
    9. changes in patterns and rhythms of speech
    10. chest pain or discomfort
    11. chills
    12. cold sweats
    13. coma
    14. confusion
    15. confusion about identity, place, and time
    16. continuing ringing, buzzing, or other unexplained noise in ears
    17. convulsions
    18. cool, pale skin
    19. cough or hoarseness
    20. dark urine
    21. decrease in frequency of urination
    22. decrease in urine volume
    23. decreased urine output
    24. difficulty in breathing
    25. difficulty in passing urine (dribbling)
    26. difficulty in speaking
    27. disturbance of accommodation
    28. disturbed concentration
    29. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    30. double vision
    31. drooling
    32. dry mouth
    33. excitement
    34. fainting
    35. false beliefs that cannot be changed by facts
    36. fast, slow, or irregular heartbeat
    37. fear or nervousness
    38. fever with or without chills
    39. flushed, dry skin
    40. fruit-like breath odor
    41. general feeling of tiredness or weakness
    42. headache
    43. hearing loss
    44. high fever
    45. high or low blood pressure
    46. hostility
    47. inability to move arms, legs, or facial muscles
    48. inability to speak
    49. increased hunger
    50. increased need to urinate
    51. increased ocular pressure
    52. increased sweating
    53. increased thirst
    54. increased urination
    55. irritability
    56. lack of coordination
    57. lethargy
    58. light-colored stools
    59. lip smacking or puckering
    60. loss of appetite
    61. loss of balance control
    62. loss of bladder control
    63. loss of consciousness
    64. lower back or side pain
    65. mental depression or anxiety
    66. muscle spasm or jerking of all extremities
    67. muscle tightness
    68. muscle trembling, jerking, or stiffness
    69. muscle twitching
    70. nausea and vomiting
    71. nightmares or unusually vivid dreams
    72. overactive reflexes
    73. painful or difficult urination
    74. passing urine more often
    75. pinpoint red spots on skin
    76. poor coordination
    77. pounding in the ears
    78. puffing of cheeks
    79. rapid or worm-like movements of tongue
    80. rapid weight gain
    81. restlessness
    82. seeing, hearing, or feeling things that are not there
    83. seizures
    84. severe muscle stiffness
    85. shakiness and unsteady walk
    86. shivering
    87. shortness of breath
    88. shuffling walk
    89. sleeplessness
    90. slow speech
    91. slurred speech
    92. sore throat
    93. sores, ulcers, or white spots on lips or in mouth
    94. stiffness of limbs
    95. stupor
    96. sudden loss of consciousness
    97. sweating
    98. swelling of face, ankles, or hands
    99. swelling or puffiness of face
    100. swollen glands
    101. talking or acting with excitement you cannot control
    102. trouble in speaking
    103. trouble sleeping
    104. troubled breathing
    105. twisting movements of body pain or discomfort in arms, jaw, back, or neck
    106. unable to sleep
    107. uncontrolled chewing movements
    108. uncontrolled movements, especially of arms, face, neck, back, and legs
    109. unexplained weight loss
    110. unpleasant breath odor
    111. unsteadiness, trembling, or other problems with muscle control or coordination
    112. unusual bleeding or bruising
    113. unusual tiredness or weakness
    114. unusually pale skin
    115. upper right abdominal pain
    116. vomiting of blood
    117. weakness in arms, hands, legs, or feet
    118. weight gain or loss
    119. yellow eyes and skin

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

    Symptoms of Overdose

    1. Clumsiness
    2. drowsiness
    3. low body temperature
    4. muscle aches
    5. muscle weakness
    6. sleepiness
    7. tiredness
    8. weak or feeble pulse

    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:

    Incidence not known

    1. Bigger, dilated, or enlarged pupils (black part of eye)
    2. black tongue
    3. bloating
    4. breast enlargement in females
    5. constipation
    6. decreased interest in sexual intercourse
    7. diarrhea
    8. hair loss, thinning of hair
    9. hives or welts
    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 eyes to light
    14. loss in sexual ability, desire, drive, or performance
    15. loss of sense of taste
    16. redness or other discoloration of skin
    17. severe sunburn
    18. skin rash
    19. swelling of testicles
    20. swelling of the breasts or breast soreness in males
    21. swelling of the parotid glands
    22. swelling or inflammation of the mouth
    23. 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.