ETNOFRIL 25 MG TABLET
USES: This medication is used to treat depression. It is also used with other therapies for the treatment of nighttime bed-wetting (enuresis) in children. Using this medication to treat depression may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. Imipramine can help your child control nighttime bed-wetting. Imipramine belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (neurotransmitters such as norepinephrine) in the brain. For bed-wetting, this medication may work by blocking the effect of a certain natural substance (acetylcholine) on the bladder.
Indications : anxiety, panic disorder, bulimia nervosa, depression, nocturnal enuresis, cataplexy with associated narcolepsy
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used for anxiety and panic disorders.
SIDE EFFECTS: See also Warning section. Dry mouth, blurred vision, headache, drowsiness, dizziness, constipation, nausea, vomiting, loss of appetite, diarrhea, stomach cramps, weight gain/loss, and increased sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, depression, memory problems), enlarged/painful breasts, unusual breast milk production, irregular/painful menstrual periods, muscle stiffness, restlessness, ringing in the ears, sexual problems (e.g., decreased sexual ability, changes in desire), shakiness (tremors), numbness/tingling of the hands/feet, pain/redness/swelling of arms or legs, trouble urinating, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, dark urine, yellowing of eyes/skin. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. Get medical help right away if you have any very serious side effects, including: chest pain, slow/fast/irregular heartbeat, fainting, seizures, trouble speaking, weakness on one side of the body, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking imipramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually 1 to 4 times daily. If you have daytime drowsiness, your doctor may direct you to take the entire dose once daily at bedtime. Dosage is based on your medical condition and response to therapy. In children, dosage may also be based on body weight. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. When used by children for bed-wetting, imipramine should be taken one hour before bedtime. If your child usually wets the bed early in the night, the drug may be given earlier in separate doses (e.g., one dose in the afternoon and one dose at bedtime). Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. This medication does not work right away. It may take up to 3 weeks before you experience the full benefits if you are taking this medication for depression. Keep taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased. When used for an extended period in children for bed-wetting, this medication may not work as well and may require different dosing. Talk with the doctor if this medication stops working well. Inform your doctor if your condition persists or worsens.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as desipramine, amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic bronchitis), personal or family history of glaucoma (angle-closure type), diabetes, eating disorders (such as bulimia), heart problems (such as arrhythmias, coronary artery disease, heart attack), liver problems, kidney problems, personal or family history of other mental/mood conditions (such as bipolar disorder, schizophrenia), seizures, overactive thyroid (hyperthyroidism), trouble urinating (such as due to enlarged prostate), any condition that may increase your risk of seizures (including alcohol/sedative dependency, use of electroconvulsive therapy, brain injury/disease such as stroke), certain types of tumors (such as pheochromocytoma, neuroblastoma). Imipramine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using imipramine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using imipramine safely. Before having surgery, tell your doctor or dentist that you are taking this medication. This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). To decrease dizziness and lightheadedness, get up slowly when rising from a seated or lying position. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. If you have diabetes, this drug may make it harder to control your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Older adults may be more sensitive to the side effects of this drug, especially dizziness (more likely when standing up), drowsiness, constipation, trouble urinating, mental/mood changes (such as confusion, agitation) and heart effects such as QT prolongation (see above). Dizziness, drowsiness, and confusion can increase the risk of falling. Children may be more sensitive to the side effects of this drug, especially heart effects. During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken similar medications during pregnancy may have symptoms such as trouble urinating, prolonged sleepiness, shaking, and seizures. Discuss the risks and benefits with your doctor. Since untreated mental/mood problems (such as depression, anxiety, panic disorders) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: anticholinergics (for example atropine, belladonna alkaloids, scopolamine), certain drugs for high blood pressure (such as clonidine, guanadrel, guanethidine), digoxin, disopyramide, thyroid supplements, valproic acid. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Other medications can affect the removal of imipramine from your body, which may affect how imipramine works. Examples include barbiturates (such as phenobarbital), cimetidine, cisapride, haloperidol, certain drugs for heart rhythm (such as flecainide, propafenone), halofantrine, certain HIV protease inhibitors (such as fosamprenavir), phenothiazines (such as thioridazine), pimozide, certain anti-seizure drugs (such as phenytoin), terbinafine, trazodone, among others. Many drugs besides imipramine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. Before using imipramine, report all medications you are currently using to your doctor or pharmacist. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-containing ingredients or decongestants that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking. Imipramine is very similar to desipramine. Do not take medications containing desipramine while using imipramine.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fast/irregular heartbeat, fainting, hallucinations, seizures.