Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Vivactil

Descriptions


Protriptyline is used to treat the symptoms of mental depression. 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

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 protriptyline 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 protriptyline in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose for patients receiving protriptyline .

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
  • Grepafloxacin
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Ranolazine
  • Selegiline
  • Sparfloxacin
  • 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.

  • Alfuzosin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Aprindine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Buserelin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonidine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Deslorelin
  • Desvenlafaxine
  • Dextromethorphan
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Enflurane
  • Epinephrine
  • Erythromycin
  • Escitalopram
  • Etilefrine
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Histrelin
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indacaterol
  • Iobenguane I 123
  • Iproniazid
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levalbuterol
  • Levofloxacin
  • Levothyroxine
  • Lopinavir
  • Lorcainide
  • Lumefantrine
  • Mefloquine
  • Meperidine
  • Methadone
  • Methoxamine
  • Midodrine
  • Mifepristone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Naratriptan
  • Nefopam
  • Nilotinib
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olodaterol
  • Ondansetron
  • Oxilofrine
  • Oxymorphone
  • Paliperidone
  • Pargyline
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Phenylephrine
  • Posaconazole
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Quetiapine
  • Quinidine
  • Quinine
  • Rasagiline
  • Risperidone
  • Salmeterol
  • Saquinavir
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sultopride
  • Sumatriptan
  • Sunitinib
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Umeclidinium
  • 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
  • Cannabis
  • Carbamazepine
  • Dicumarol
  • Flecainide
  • 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.

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 .

Proper Use

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 form (tablets):
    • For depression:
      • Adults—At first, 15 to 40 milligrams (mg) a day divided into three or four doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Teenagers and Older Adults—At first, 5 milligrams (mg) three times a day. Your doctor may increase your dose as needed.
      • 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 .

Protriptyline 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 protriptyline 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 protriptyline. 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 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 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 protriptyline 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

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. actions that are out of control
  3. agitation
  4. anxiety
  5. black, tarry stools
  6. bleeding and bruising
  7. bleeding gums
  8. blood in urine or stools
  9. blurred vision
  10. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  11. chest pain or discomfort
  12. clay-colored stools
  13. cold sweats
  14. coma
  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. depression
  25. difficulty in passing urine (dribbling)
  26. difficulty in speaking
  27. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  28. double vision
  29. drooling
  30. dry mouth
  31. false beliefs that cannot be changed by facts
  32. fast, pounding, or irregular heartbeat or pulse
  33. fear or nervousness
  34. feeling of warmth
  35. feeling, seeing, or hearing things that are not there
  36. feeling that others can hear your thoughts
  37. feeling that others are watching you or controlling your behavior
  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. hostility
  45. hyperventilation
  46. inability to move arms, legs, or facial muscles
  47. inability to speak
  48. increased hunger
  49. increased need to urinate
  50. increased thirst
  51. increased urination
  52. irritability
  53. itching
  54. lack of coordination
  55. lethargy
  56. loss of appetite
  57. loss of balance control
  58. lower back or side pain
  59. mood or mental changes
  60. muscle spasm or jerking of all extremities
  61. muscle trembling or twitching
  62. nausea
  63. nightmares
  64. pain or discomfort in arms, jaw, back, or neck
  65. painful or difficult urination
  66. panic
  67. passing urine more often
  68. perspiration
  69. pinpoint red or purple spots on skin
  70. pounding in the ears
  71. rapid weight gain
  72. rash
  73. redness of the face, neck, arms, and occasionally, upper chest
  74. restlessness
  75. seizures
  76. shakiness and unsteady walk
  77. shortness of breath
  78. shuffling walk
  79. sleeplessness
  80. slow speech
  81. slurred speech
  82. sore throat
  83. sores, ulcers, or white spots on lips or in mouth
  84. stiffness of limbs
  85. stupor
  86. sudden loss of consciousness
  87. sweating
  88. swelling of face, ankles, or hands
  89. swollen glands
  90. talking, feeling, and acting with excitement
  91. trouble in holding or releasing urine
  92. trouble sleeping
  93. twisting movements of body uncontrolled movements, especially of face, neck, and back
  94. unable to sleep
  95. unpleasant breath odor
  96. unsteadiness or awkwardness
  97. unsteadiness, trembling, or other problems with muscle control or coordination
  98. unusual behavior
  99. unusual bleeding or bruising
  100. unusual tiredness or weakness
  101. vomiting of blood
  102. weakness in arms, hands, legs, or feet
  103. weight gain or loss
  104. yellow eyes or skin

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

Symptoms of Overdose

  1. Change in consciousness
  2. clumsiness
  3. decreased awareness or responsiveness
  4. difficulty sleeping
  5. disorientation
  6. disturbed concentration
  7. drowsiness to profound coma
  8. enlarged pupils
  9. increased or excessive unconscious or jerking movements
  10. loss of consciousness
  11. low body temperature
  12. muscle aches
  13. muscle tightness
  14. muscle weakness
  15. shivering
  16. severe sleepiness
  17. trouble breathing
  18. 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. Abdominal cramps
  2. bigger, dilated, or enlarged pupils (black part of eye)
  3. black tongue
  4. bloating
  5. decreased interest in sexual intercourse
  6. diarrhea
  7. difficulty having a bowel movement (stool)
  8. disturbance of accommodation
  9. enlargement of the breasts
  10. hair loss, thinning of hair
  11. heartburn
  12. hives or welts
  13. inability to have or keep an erection
  14. increased in sexual ability, desire, drive, or performance
  15. increased interest in sexual intercourse
  16. increased sensitivity of eyes to light
  17. increased sensitivity of skin to sunlight
  18. increased urge to urinate during the night
  19. loss in sexual ability, desire, drive, or performance
  20. pain or discomfort in chest, upper stomach, or throat
  21. peculiar taste
  22. redness or other discoloration of skin
  23. severe sunburn
  24. small red or purple spots on skin
  25. swelling of testicles
  26. swelling of the breasts or breast soreness in both females and males
  27. swelling or inflammation of the mouth
  28. swollen, painful, or tender lymph glands on side of face or neck
  29. unexpected or excess milk flow from breasts
  30. waking to urinate at night

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.