Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Tofranil
  2. Tofranil-PM

Descriptions


Imipramine 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).

Imipramine tablets are also used to treat enuresis (bedwetting) in children.

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

This product is available in the following dosage forms:

  • Tablet
  • Capsule

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 imipramine capsules in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of imipramine tablets in children with enuresis (bedwetting) under 6 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 imipramine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving imipramine.

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
  • Dronedarone
  • Furazolidone
  • Grepafloxacin
  • Iproniazid
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Ranolazine
  • Rasagiline
  • 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
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Aprindine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bretylium
  • Bupropion
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Clarithromycin
  • Clomipramine
  • Clonidine
  • Crizotinib
  • Cyclobenzaprine
  • Darifenacin
  • Dasatinib
  • Desipramine
  • Desvenlafaxine
  • Dextromethorphan
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Enflurane
  • Epinephrine
  • Erythromycin
  • Etilefrine
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Ibutilide
  • Iloperidone
  • Indacaterol
  • Iobenguane I 123
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Lapatinib
  • Levalbuterol
  • Levofloxacin
  • Levomilnacipran
  • Levothyroxine
  • Lidoflazine
  • Lorcainide
  • Lorcaserin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Methoxamine
  • Midodrine
  • Mifepristone
  • Moricizine
  • Moxifloxacin
  • Nefopam
  • Nilotinib
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxilofrine
  • Paliperidone
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Phenylephrine
  • Pixantrone
  • Posaconazole
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Risperidone
  • Saquinavir
  • Sematilide
  • Sertindole
  • Sertraline
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Sunitinib
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimethoprim
  • Tryptophan
  • 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
  • Alprazolam
  • Arbutamine
  • Atomoxetine
  • Butalbital
  • Cannabis
  • Carbamazepine
  • Cimetidine
  • Citalopram
  • Dicumarol
  • Fenfluramine
  • Fluvoxamine
  • Fosphenytoin
  • Mibefradil
  • Paroxetine
  • Phenindione
  • Phenprocoumon
  • Phenytoin
  • Ritonavir
  • 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 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, history of 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.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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 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 (capsules):
    • For depression:
      • Adults—At first, 75 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day, unless you are in the hospital. Some hospitalized patients may need higher doses.
      • Teenagers and Older Adults—At first, 25 to 50 milligrams (mg) per day using the tablets. Your doctor may adjust your dose as needed and switch you to the capsule form. However, the dose is usually not more than 100 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For depression:
      • Adults—At first, 75 milligrams (mg) per day. Your doctor may adjust your dose as needed. However the dose is usually not more than 200 mg per day. Some hospitalized patients may need higher doses.
      • Teenagers and Older Adults—30 to 40 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For enuresis (bedwetting):
      • Children 6 years of age and older—At first, 25 milligrams (mg) once a day, taken one hour before bedtime. Your doctor may adjust the dose as needed.
      • Children below 6 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.

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

Do not keep outdated medicine or medicine no longer needed.

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. Blood tests may be needed to check for any unwanted effects. Check with your doctor right away if you start having a fever or sore throat while taking this medicine.

Imipramine 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 imipramine 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 5 days of stopping imipramine. 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 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.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking imipramine 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 make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

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

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 burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  10. chest pain or discomfort
  11. clay-colored stools
  12. cold sweats
  13. coma
  14. confusion about identity, place, and time
  15. continuing ringing or buzzing or other unexplained noise in ears
  16. convulsions
  17. cool, pale skin
  18. cough or hoarseness
  19. dark urine
  20. decrease in frequency of urination
  21. decreased urine output or volume
  22. depression
  23. difficulty in passing urine (dribbling)
  24. difficulty in speaking
  25. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  26. double vision
  27. drooling
  28. dry mouth
  29. false beliefs that cannot be changed by facts
  30. fast, pounding, or irregular heartbeat or pulse
  31. fear or nervousness
  32. feeling of warmth
  33. feeling, seeing, or hearing things that are not there
  34. feeling that others are watching you or controlling your behavior
  35. feeling that others can hear your thoughts
  36. fever with or without chills
  37. flushed, dry skin
  38. fruit-like breath odor
  39. general feeling of tiredness or weakness
  40. headache
  41. hearing loss
  42. hostility
  43. hyperventilation
  44. inability to move arms, legs, or facial muscles
  45. inability to speak
  46. increased hunger
  47. increased need to urinate
  48. increased thirst
  49. increased urination
  50. irritability
  51. itching
  52. lack of coordination
  53. lethargy
  54. loss of appetite
  55. loss of balance control
  56. lower back or side pain
  57. mood or mental changes
  58. muscle spasm or jerking of all extremities
  59. muscle trembling, jerking, or stiffness
  60. muscle twitching
  61. nausea
  62. nightmares
  63. pain or discomfort in arms, jaw, back, or neck
  64. painful or difficult urination
  65. passing urine more often
  66. perspiration
  67. pinpoint red or purple spots on skin
  68. pounding in the ears
  69. rapid weight gain
  70. rash
  71. redness of the face, neck, arms, and occasionally, upper chest
  72. restlessness
  73. seizures
  74. shakiness and unsteady walk
  75. shortness of breath
  76. shuffling walk
  77. sleeplessness
  78. slow speech
  79. slurred speech
  80. sore throat
  81. sores, ulcers, or white spots on lips or in mouth
  82. stiffness of limbs
  83. stupor
  84. sudden loss of consciousness
  85. sweating
  86. swelling of face, ankles, legs, or hands
  87. swollen glands
  88. talking, feeling, and acting with excitement
  89. trouble in holding or releasing urine
  90. trouble sleeping
  91. twisting movements of body
  92. unable to sleep
  93. uncontrolled movements, especially of face, neck, and back
  94. unpleasant breath odor
  95. unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
  96. unusual behavior
  97. unusual bleeding or bruising
  98. unusual tiredness or weakness
  99. vomiting of blood
  100. weakness in arms, hands, legs, or feet
  101. weight gain or loss
  102. yellow eyes or skin

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

Symptoms of overdose

  1. Bluish color of fingernails, lips, skin, palms, or nail beds
  2. change in consciousness
  3. cold clammy skin
  4. confusion
  5. decreased awareness or responsiveness
  6. difficult or troubled breathing
  7. difficulty sleeping
  8. disorientation
  9. drowsiness to profound coma
  10. fast, weak pulse
  11. hallucination increased or excessive unconscious or jerking movements
  12. irregular, fast, slow, or shallow breathing
  13. lethargy
  14. loss of consciousness
  15. mood or other mental changes
  16. muscle stiffness or tightness
  17. pale or blue lips, fingernails, or skin
  18. severe sleepiness

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 breast
  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.