Generic Name: imipramine (im-IP-ra-meen)
Brand Name: Tofranil-PM
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Tofranil-PM outweigh the risks.
Family and caregivers must closely watch patients who take Tofranil-PM. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Tofranil-PM is not approved for use in children. Talk with the doctor.
Tofranil-PM is used for:
Treating depression. It may also be used for other conditions as determined by your doctor.
Tofranil-PM is a tricyclic antidepressant. It works by increasing the activity of certain chemicals in the brain that help elevate mood.
Do NOT use Tofranil-PM if:
- you are allergic to any ingredient in Tofranil-PM or to similar medicines
- you have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
- you are recovering from a recent heart attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tofranil-PM:
Some medical conditions may interact with Tofranil-PM. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you drink alcohol or have a history of alcohol abuse
- if you take thyroid medicine or you have a history of an overactive thyroid, glaucoma or increased pressure in the eye, heart problems, kidney or liver problems, diabetes, seizures, the blood disease porphyria, or difficulty urinating
- if you have a history of suicidal thoughts or behavior, bipolar disorder, or any other mental disorders; you are undergoing electroshock therapy; or you are scheduled to have any surgery
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with Tofranil-PM. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Buspirone, cimetidine, fentanyl, flecainide, lithium, methylphenidate, phenothiazines (eg, chlorpromazine), propafenone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, tramadol, or tryptophan because they may increase the risk of Tofranil-PM's side effects
- Linezolid or MAOIs (eg, phenelzine) because the risk of high blood pressure or serious heart problems (eg, irregular heartbeat) may be increased
- Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Tofranil-PM's effectiveness
- Anticholinergics (eg, benztropine) or sympathomimetics (eg, phenylephrine) because the risk of their side effects may be increased by Tofranil-PM
- Clonidine, guanethidine, or guanfacine because their effectiveness may be decreased by Tofranil-PM
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tofranil-PM may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tofranil-PM:
Use Tofranil-PM as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tofranil-PM comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tofranil-PM refilled.
- Take Tofranil-PM by mouth with or without food.
- Taking Tofranil-PM at bedtime may help reduce side effects (eg, daytime drowsiness). Discuss this possibility with your doctor.
- It may take 1 to 3 weeks before you notice the effect of Tofranil-PM. Continue to use Tofranil-PM even if you feel well. Do not miss any doses.
- If you miss a dose of Tofranil-PM, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.
Ask your health care provider any questions you may have about how to use Tofranil-PM.
Important safety information:
- Tofranil-PM may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tofranil-PM with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tofranil-PM; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Tofranil-PM may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not become overheated in hot weather or while you are being active; heatstroke may occur.
- Children, teenagers, and young adults who take Tofranil-PM may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch all patients who take Tofranil-PM closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Tofranil-PM. Your risk may be greater if you take Tofranil-PM with certain other medicines (eg, triptans, MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Tofranil-PM may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tofranil-PM. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Some people may be at risk for eye problems from Tofranil-PM. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
- Tell your doctor or dentist that you take Tofranil-PM before you receive any medical or dental care, emergency care, or surgery.
- Diabetes patients - Tofranil-PM may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- You may need to have an electrocardiogram (ECG) checked before starting Tofranil-PM and while you take it. Talk with the doctor.
- Use Tofranil-PM with caution in the ELDERLY, especially those with cardiac disease; they may be more sensitive to its effects.
- Tofranil-PM should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Tofranil-PM can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tofranil-PM while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Tofranil-PM.
If you stop taking Tofranil-PM suddenly, you may have WITHDRAWAL symptoms. These may include headache, nausea, and tiredness.
Possible side effects of Tofranil-PM:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Tofranil-PM:
Store Tofranil-PM at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly sealed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tofranil-PM out of the reach of children and away from pets.
- If you have any questions about Tofranil-PM, please talk with your doctor, pharmacist, or other health care provider.
- Tofranil-PM is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Tofranil-PM or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tofranil-PM. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tofranil-PM. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Tofranil-PM.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.