Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.
There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.Who should not take Etrafon Forte 4-25?
This medication is used to treat depression occurring with other mental/mood disorders (such as anxiety, agitation, schizophrenia). This medication is a combination of a tricyclic antidepressant (amitriptyline) and an antipsychotic medication (perphenazine). Together, they restore the balance of certain natural chemicals in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin). This medication helps you to have a better mood and sense of well-being, think more clearly, and feel less nervous, so that you can take part in everyday life.
Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Dosage is based on your medical condition and response to treatment. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects (such as drowsiness, dry mouth, muscle spasms). Follow your doctor's directions carefully. The manufacturer recommends that you do not take more than 16 milligrams of perphenazine or 200 milligrams of amitriptyline per day.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Do not stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Muscle aches, headaches, and trouble sleeping may also occur. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.
This medication may not work right away. You may see some benefit within a week. However, it may take up to 4 weeks before you see the full effect. Tell your doctor if your condition persists or worsens (such as increased anxiety, your feelings of sadness get worse, or you have thoughts of suicide).
See also Warning section.
Drowsiness, dizziness, dry mouth, blurred vision, constipation, tiredness, weight gain, or trouble urinating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
To relieve dry mouth, suck on hard candy or ice chips, chew gum, drink water, or use a saliva substitute.
Perphenazine may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor right away if you notice any of the following side effects: drooling/trouble swallowing, mask-like expression of the face, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up).
Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, persistent heartburn.
Perphenazine may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.
In rare cases, perphenazine may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: signs of stroke (such as weakness on one side of the body, slurred speech, confusion), eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night), signs of pneumonia from aspiration (such as cough, fever, trouble breathing), chest/jaw/left arm pain, severe dizziness/fainting, black stools, vomit that looks like coffee grounds, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
See also Warning section.
Before taking amitriptyline with perphenazine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as nortriptyline); or to other phenothiazines (such as chlorpromazine, fluphenazine); 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: bleeding problems, decreased bone marrow function, breathing problems (such as asthma, emphysema), liver problems, low blood pressure, recent heart attack, breast cancer, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), personal or family history of glaucoma (angle-closure type), personal or family history of bipolar disorder, alcohol/substance abuse, family history of suicide, seizures, diabetes, conditions that may increase your risk of seizures (such as head injury, drug/alcohol withdrawal), a certain severe reaction to other medications (neuroleptic malignant syndrome), a certain adrenal gland tumor (pheochromocytoma), restless legs syndrome, Parkinson's disease.
Perphenazine/amitriptyline 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 perphenazine/amitriptyline, 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, vomiting, or eating disorders (such as bulimia). Talk to your doctor about using perphenazine/amitriptyline safely.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having any surgery, procedure, or imaging (such as X-ray, CT-scan), tell your doctor or dentist about this medication and all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen (SPF 30 or greater) and wear protective clothing when outdoors.
Caution is advised during hot weather because the perphenazine in this product can reduce sweating, increasing your risk for a severe reaction to too much heat (heatstroke). Drink plenty of fluids. Avoid strenuous exercise in hot weather. If you become overheated, promptly seek cooler shelter and/or stop exercising. Seek immediate medical attention if your body temperature is above normal or if you have mental/mood changes, headache, or dizziness.
Avoid exposure to certain chemicals used in gardening (organic phosphate insecticides). Seek immediate medical attention if you are exposed to garden chemicals and have an unusual headache, heavy sweating, or difficulty breathing.
If you have diabetes, this drug may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms such as increased thirst/urination, shakiness, unusual sweating, or hunger. Your anti-diabetic medication or diet may need to be adjusted.
Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, confusion, bleeding, constipation, difficulty urinating, uncontrolled movements, and QT prolongation (see above). Dizziness, drowsiness, and confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.
Since untreated mental/mood problems (such as depression, schizophrenia) 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.
See also Precautions section.
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:
anticholinergic/antispasmodic medications (such as belladonna alkaloids, dicyclomine, scopolamine), certain antihypertensive medications (such as clonidine, guanabenz, methyldopa), other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin), disulfiram, levodopa, lithium, thyroid supplements.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, 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.
Other medications can affect the removal of perphenazine/amitriptyline from your body, which may affect how this medication works. Examples include cimetidine, azole antifungals (such as ketoconazole, itraconazole), drugs to treat irregular heartbeat (such as amiodarone, flecainide, propafenone, quinidine), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), anti-HIV drugs (such as fosamprenavir, ritonavir), SSRI antidepressants (such as fluoxetine, paroxetine), St. John's wort, among others.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
Many drugs besides perphenazine/amitriptyline may affect the heart rhythm (QT prolongation). Examples include amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.
Also report the use of drugs that might increase seizure risk when combined with this medication, such as isoniazid (INH), phenothiazines (such as thioridazine), or theophylline among others. Consult your doctor or pharmacist for details.
Check the labels on all your medicines (such as antacids, allergy, or cough-and-cold products) because they may contain cimetidine, decongestants, or ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
Amitriptyline is very similar to nortriptyline. Do not use medications containing nortriptyline while using amitriptyline.
If overdose is suspected, contact a poison control center or emergency room 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: extreme drowsiness, hallucinations, fast/irregular heartbeat, fainting, slow/shallow breathing, seizures.
Do not share this medication with others.
Laboratory and/or medical tests (such as complete blood count, liver tests, EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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