Imipramine (Oral Route)

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

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.

• Bepridil


• Cisapride


• Clorgyline


• Grepafloxacin


• Isocarboxazid


• Levomethadyl


• Linezolid


• Mesoridazine


• Metoclopramide


• Moclobemide


• Phenelzine


• Pimozide


• 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


• Ajmaline


• Amiodarone


• Amisulpride


• Amprenavir


• Aprindine


• Arsenic Trioxide


• Astemizole


• Atazanavir


• Azimilide


• Bretylium


• Chloral Hydrate


• Chloroquine


• Clarithromycin


• Clonidine


• Darifenacin


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Enflurane


• Epinephrine


• Erythromycin


• Etilefrine


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iproniazid


• Isoflurane


• Isradipine


• Lidoflazine


• Lorcainide


• Lumefantrine


• Methoxamine


• Midodrine


• Moxifloxacin


• Nefopam


• Nialamide


• Norepinephrine


• Octreotide


• Oxilofrine


• Pargyline


• Pentamidine


• Phenylephrine


• Pirmenol


• Prajmaline


• Procainamide


• Procarbazine


• Prochlorperazine


• Propafenone


• Quetiapine


• Quinidine


• Rasagiline


• Risperidone


• Sematilide


• Sertindole


• Sertraline


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Tapentadol


• Tedisamil


• Telithromycin


• Toloxatone


• Tramadol


• Trifluoperazine


• Trimethoprim


• Vasopressin


• Venlafaxine


• 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


• Mibefradil


• Paroxetine


• Phenindione


• Phenprocoumon


• Phenytoin


• Quinidine


• 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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, recenta€”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 ofa€”Use with caution. May make these conditions worse.

• Kidney disease or


• Liver diseasea€”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:
    
    
    
    • Adultsa€”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 Adultsa€”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.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

• For oral dosage form (tablets):
  
  
  
  • For depression:
    
    
    
    • Adultsa€”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 Adultsa€”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.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For enuresis (bedwetting):
    
    
    
    • Children 6 years of age and oldera€”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 agea€”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 [MarplanA®], phenelzine [NardilA®], selegiline [EldeprylA®, or tranylcypromine [ParnateA®]) 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

• Abdominal or stomach pain


• Actions that are out of control


• Agitation


• Anxiety


• Black, tarry stools


• Bleeding and bruising


• Bleeding gums


• Blood in urine or stools


• Blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain or discomfort


• Clay-colored stools


• Cold sweats


• Coma


• Confusion about identity, place, and time


• Continuing ringing or buzzing or other unexplained noise in ears


• Convulsions


• Cool, pale skin


• Cough or hoarseness


• Dark urine


• Decrease in frequency of urination


• Decreased urine output or volume


• Depression


• Difficulty in passing urine (dribbling)


• Difficulty in speaking


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Double vision


• Drooling


• Dry mouth


• False beliefs that cannot be changed by facts


• Fast, pounding, or irregular heartbeat or pulse


• Fear or nervousness


• Feeling of warmth


• 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


• Fruit-like breath odor


• General feeling of tiredness or weakness


• Headache


• Hearing loss


• Hostility


• Hyperventilation


• Inability to move arms, legs, or facial muscles


• Inability to speak


• Increased hunger


• Increased need to urinate


• Increased thirst


• Increased urination


• Irritability


• Itching


• Lack of coordination


• Lethargy


• Loss of appetite


• 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


• Muscle twitching


• Nausea


• Nightmares


• Pain or discomfort in arms, jaw, back, or neck


• Painful or difficult urination


• Passing urine more often


• Perspiration


• Pinpoint red or purple spots on skin


• Pounding in the ears


• Rapid weight gain


• Rash


• Redness of the face, neck, arms, and occasionally, upper chest


• Restlessness


• Seizures


• Shakiness and unsteady walk


• Shortness of breath


• Shuffling walk


• Sleeplessness


• Slow speech


• Slurred speech


• Sore throat


• Sores, ulcers, or white spots on lips or in mouth


• Stiffness of limbs


• Stupor


• Sudden loss of consciousness


• Sweating


• Swelling of face, ankles, legs, or hands


• Swollen glands


• Talking, feeling, and acting with excitement


• Trouble in holding or releasing urine


• Trouble sleeping


• Twisting movements of body


• Unable to sleep


• Uncontrolled movements, especially of face, neck, and back


• Unpleasant breath odor


• Unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination


• Unusual behavior


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting of blood


• Weakness in arms, hands, legs, or feet


• Weight gain or loss


• 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


• Change in consciousness


• Cold clammy skin


• Confusion


• Decreased awareness or responsiveness


• Difficult or troubled breathing


• Difficulty sleeping


• Disorientation


• Drowsiness to profound coma


• Fast, weak pulse


• Hallucination increased or excessive unconscious or jerking movements


• Irregular, fast, slow, or shallow breathing


• Lethargy


• Loss of consciousness


• Mood or other mental changes


• Muscle stiffness or tightness


• Pale or blue lips, fingernails, or skin


• 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

• Abdominal cramps


• Bigger, dilated, or enlarged pupils (black part of eye)


• Black tongue


• Bloating


• Decreased interest in sexual intercourse


• Diarrhea


• Difficulty having a bowel movement (stool)


• Disturbance of accommodation


• Enlargement of the breast


• Hair loss, thinning of hair


• Heartburn


• Hives or welts


• Inability to have or keep an erection


• Increased in sexual ability, desire, drive, or performance


• Increased interest in sexual intercourse


• Increased sensitivity of eyes to light


• Increased sensitivity of skin to sunlight


• Increased urge to urinate during the night


• Loss in sexual ability, desire, drive, or performance


• Pain or discomfort in chest, upper stomach, or throat


• Peculiar taste


• Redness or other discoloration of skin


• Severe sunburn


• Small red or purple spots on skin


• Swelling of testicles


• Swelling of the breasts or breast soreness in both females and males


• Swelling or inflammation of the mouth


• Swollen, painful, or tender lymph glands on side of face or neck


• Unexpected or excess milk flow from 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.