Tofranil-PM (Oral)

Imipramine is used to treat depression. It is part of a group of medicines called tricyclic antidepressants (TCA). These medicines are believed to work by boosting the activity of a chemical called serotonin in the brain.

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

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

It is very important for your doctor to monitor your progress during regular visits. This allows for any necessary changes in your dose and to check for side effects. Blood tests may be needed to look for any unwanted effects. Contact your doctor immediately if you develop a fever or sore throat while taking this medicine.

Do not take imipramine with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not start imipramine within 2 weeks after stopping a MAO inhibitor, and wait 2 weeks after stopping imipramine before starting a MAO inhibitor. If you take them together or do not wait 2 weeks, you may experience confusion, agitation, restlessness, stomach or intestinal issues, a sudden high body temperature, extremely high blood pressure, or severe seizures.

Imipramine may cause some teenagers and young adults to feel agitated, irritable, or show other unusual behaviors. It may also lead some individuals to have suicidal thoughts or become more depressed. Some people may have difficulty sleeping, become easily upset, experience a significant increase in energy, or act recklessly. If you, your child, or your caregiver notice any of these side effects, inform your doctor or your child's doctor immediately. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has attempted suicide.

Imipramine can lead to a serious condition called serotonin syndrome if taken with certain medicines. Do not use imipramine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St. John's wort, or some pain or migraine medications (for example, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Always check with your doctor before taking any other medicines with imipramine.

Do not stop taking this medicine suddenly without first consulting your doctor. Your doctor may suggest gradually reducing your dose before stopping completely. This will reduce the chance of experiencing withdrawal symptoms such as agitation, breathing issues, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

This medicine will enhance the effects of alcohol and other central nervous system (CNS) depressants (medications that cause drowsiness). Examples of CNS depressants include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medications, prescription pain medications or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Consult your doctor before taking any of the above while using this medicine.

Before any surgery, inform the medical doctor in charge that you are taking this medicine. Combining imipramine with medications used during surgery may increase the risk of side effects.

This medicine may affect blood sugar levels. If you notice changes in your blood or urine sugar test results, or if you have any questions, consult your doctor.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when outdoors and avoid sunlamps and tanning beds.

This medicine may cause drowsiness or reduced alertness. Make sure you know how this medicine affects you before driving, using machines, or doing anything that could be dangerous if you are drowsy or not alert.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other drugs. Additionally 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 to treat depression 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) younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of imipramine in the elderly. Nevertheless, elderly patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and an adjustment in the dose for patients receiving imipramine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medicine while breastfeeding.

Interactions with Drugs

Although certain medicines should not be used together at all, in other cases two different drugs 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 using this drug, it is especially important that your healthcare professional know if you are using 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 drugs is not advised. Your physician may decide not to treat you with this medicine or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Furazolidone
• Grepafloxacin
• Iproniazid
• Isocarboxazid
• Levoketoconazole
• Levomethadyl
• Linezolid
• Mesoridazine
• Methylene Blue
• Metoclopramide
• Moclobemide
• Pargyline
• Phenelzine
• Pimozide
• Piperaquine
• Potassium Citrate
• Procarbazine
• Ranolazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using this drug with any of the following medicines is typically 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.

• Abiraterone Acetate
• Acecainide
• Aceclofenac
• Acemetacin
• Adagrasib
• Albuterol
• Alfentanil
• Alfuzosin
• Almotriptan
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Benzhydrocodone
• Benzphetamine
• Bretylium
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Carisoprodol
• Celecoxib
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clonidine
• Clonixin
• Clothiapine
• Clozapine
• Cobicistat
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darifenacin
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diclofenac
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Droxicam
• Duloxetine
• Efavirenz
• Encorafenib
• Enflurane
• Entrectinib
• Epinephrine
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Fedratinib
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Formoterol
• Foscarnet
• Fostemsavir
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Indomethacin
• Inotuzumab Ozogamicin
• Iobenguane I 123
• Iobenguane I 131
• Isoflurane
• Isradipine
• Ivabradine
• Ivosidenib
• Ketoprofen
• Ketorolac
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Leuprolide
• Levalbuterol
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lofexidine
• Lorcainide
• Lorcaserin
• Lornoxicam
• Loxapine
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Meperidine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methylphenidate
• Metronidazole
• Mifepristone
• Milnacipran
• Mirtazapine
• Mobocertinib
• Moricizine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nabumetone
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nefopam
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norepinephrine
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Parecoxib
• Paroxetine
• Pasireotide
• Pazopanib
• Peginterferon Alfa-2b
• Pentamidine
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Pixantrone
• Ponesimod
• Posaconazole
• Pranoprofen
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Relugolix
• Remifentanil
• Revefenacin
• Ribociclib
• Risperidone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Scopolamine
• Secretin Human
• Selpercatinib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sulindac
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tapentadol
• Tedisamil
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tiaprofenic Acid
• Tiotropium
• Tolfenamic Acid
• Tolmetin
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Triptorelin
• Tryptophan
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vortioxetine
• Zolmitriptan
• Zolpidem
• Zotepine
• Zuclopenthixol

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

• Acenocoumarol
• Arbutamine
• Atomoxetine
• Carbamazepine
• Cimetidine
• Desogestrel
• Dicumarol
• Dienogest
• Drospirenone
• Ethinyl Estradiol
• Ethynodiol
• Fosphenytoin
• Gestodene
• Levonorgestrel
• Mestranol
• Mibefradil
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Phenindione
• Phenprocoumon
• Phenytoin
• Ritonavir
• 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 additionally 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 advised, but may be unavoidable in some cases. If used together, your physician 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 drug with any of the following may cause an increased risk of certain adverse effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

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

• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Diabetes or
• Glaucoma (angle-closure type), or
• Heart or blood vessel disease or
• Hyperthyroidism (overactive thyroid) or
• Mania, history of or
• Schizophrenia (mental illness) or
• Seizures, history of or
• Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.

• Heart attack, recent—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the drug from the body.

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

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

Incidence not known

• Abdominal or stomach pain
• agitation
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• clay-colored stools
• cold sweats
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• dark urine
• decrease in the frequency of urination
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dry mouth
• false beliefs that cannot be changed by facts
• fast, pounding, or irregular heartbeat or pulse
• feeling, seeing, or hearing things that are not there
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• fever with or without chills
• flushed, dry skin
• general feeling of tiredness or weakness
• hearing loss
• hostility
• hyperventilation
• inability to move the arms, legs, or facial muscles
• irritability
• itching or rash
• lack of coordination
• lethargy
• loss of balance control
• lower back or side pain
• mood or mental changes
• muscle spasm or jerking of all extremities
• muscle trembling, jerking, or stiffness
• nightmares
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• pinpoint red or purple spots on the skin
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• seizures
• shakiness and unsteady walk
• slow speech
• sore throat
• stiffness of the limbs
• stupor
• sweating
• swelling of the face, ankles, legs, or hands
• talking, feeling, and acting with excitement
• trouble sleeping
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual behavior
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet
• yellow eyes or skin

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

Symptoms of overdose

• Bluish color of fingernails, lips, skin, palms, or nail beds
• cold, clammy skin
• decreased awareness or responsiveness
• difficult or troubled breathing
• disorientation
• fast, weak pulse
• hallucinations
• irregular, fast, slow, or shallow breathing
• 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

• Bigger, dilated, or enlarged pupils (black part of the eye)
• black tongue
• decreased interest or ability in sexual intercourse
• difficulty having a bowel movement (stool)
• enlargement of the breast
• hives or welts
• increase in sexual ability, desire, drive, or performance
• increased sensitivity of the eyes to light
• increased urge to urinate during the night
• peculiar taste
• redness or other discoloration of the skin
• severe sunburn
• swelling of the testicles
• swelling of the breasts or breast soreness in both females and males
• swollen, painful, or tender lymph glands on the side of the face or neck
• unexpected or excess milk flow from the breasts
• 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.

In the U.S.

• Tofranil
• Tofranil-PM

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

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 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 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 1 hour before bedtime. Your doctor may adjust the dose as needed. Children younger than 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.

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.

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