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Duo-Vil 2-10

Generic Name: amitriptyline/perphenazine (AM-i-TRIP-ti-leen/per-FEN-a-zeen)
Brand Name: Duo-Vil 2-10

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 Duo-Vil 2-10 outweigh the risks.

Families and caregivers must closely watch patients who take Duo-Vil 2-10. 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.

Duo-Vil 2-10 contains an antipsychotic, which may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Duo-Vil 2-10 is not approved to treat mental problems caused by dementia.

Duo-Vil 2-10 is not approved for use in children. Talk with the doctor.

Duo-Vil 2-10 is used for:

Treating anxiety and/or agitation in certain patients with depression.

Duo-Vil 2-10 is a phenothiazine and tricyclic antidepressant combination. It works by altering the levels of naturally occurring chemicals in the brain.

Do NOT use Duo-Vil 2-10 if:

  • you are allergic to any ingredient in Duo-Vil 2-10 or to another phenothiazine (eg, chlorpromazine)
  • you have certain types of brain damage
  • you have severe drowsiness, blood problems, liver damage, decreased bone marrow function, or a recent heart attack
  • you have drowsiness caused by drinking alcohol or taking certain medicines, such as barbiturates (eg, phenobarbital), narcotic pain medicines (eg, codeine), or antihistamines (eg, diphenhydramine)
  • you are taking astemizole, cabergoline, cisapride, metoclopramide, pergolide, terfenadine, or tramadol
  • you have taken furazolidone, linezolid, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Duo-Vil 2-10:

Some medical conditions may interact with Duo-Vil 2-10. 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 have developed severe side effects (eg, blood problems, yellowing of the skin or eyes) while taking another phenothiazine (eg, thioridazine)
  • if you have a history of heart problems (eg, angina, mitral valve problems), high or low blood pressure, blood problems (eg, anemia), bone marrow problems (eg, low white blood cell count), diabetes, kidney problems, tardive dyskinesia (TD), an enlarged prostate gland, seizures, trouble urinating, liver problems (eg, cirrhosis), neuroleptic malignant syndrome (NMS), or an adrenal gland tumor (pheochromocytoma)
  • if you have asthma, a lung infection, or other lung or breathing problems (eg, emphysema); an overactive thyroid; or increased pressure in the eyes or glaucoma, or if you are at risk for glaucoma
  • if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome
  • if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer
  • if you have a history of mental or mood problems (eg, bipolar disorder, depression) or suicidal thoughts or attempts, or a family history of suicide, bipolar disorder, or depression
  • if you will be having surgery or if you are undergoing electroshock therapy (ECT)
  • if you are in poor health or are regularly exposed to extreme heat or certain insecticides (organophosphorus insecticides)
  • if you have a history of alcohol abuse, drink alcohol, or are in alcohol withdrawal
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
  • if you are taking a medicine that contains methylene blue

Some MEDICINES MAY INTERACT with Duo-Vil 2-10. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, irregular heartbeat, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach or bowel problems, overactive bladder), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Duo-Vil 2-10. Ask your doctor if you are unsure if any of your medicines may interact with Duo-Vil 2-10

This may not be a complete list of all interactions that may occur. Ask your health care provider if Duo-Vil 2-10 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 Duo-Vil 2-10:

Use Duo-Vil 2-10 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Duo-Vil 2-10 comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Duo-Vil 2-10 refilled.
  • Take Duo-Vil 2-10 by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Do not suddenly stop taking Duo-Vil 2-10. You may have an increased risk of side effects. If you need to stop Duo-Vil 2-10, your doctor will gradually lower your dose.
  • If you miss a dose of Duo-Vil 2-10, 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.

Ask your health care provider any questions you may have about how to use Duo-Vil 2-10.

Important safety information:

  • Duo-Vil 2-10 may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Duo-Vil 2-10 with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Do not drink alcohol while you are taking Duo-Vil 2-10.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Duo-Vil 2-10; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Duo-Vil 2-10 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.
  • Duo-Vil 2-10 may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Duo-Vil 2-10. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Duo-Vil 2-10 may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Children, teenagers, and young adults who take Duo-Vil 2-10 may be at increased risk for suicidal thoughts or actions. Watch all patients who take Duo-Vil 2-10 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.
  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Duo-Vil 2-10. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take Duo-Vil 2-10 may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Duo-Vil 2-10 in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Duo-Vil 2-10.
  • Duo-Vil 2-10 may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
  • Diabetes patients - Duo-Vil 2-10 may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Tell your doctor or dentist that you take Duo-Vil 2-10 before you receive any medical or dental care, emergency care, or surgery.
  • Duo-Vil 2-10 may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.
  • Duo-Vil 2-10 may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Duo-Vil 2-10.
  • Lab tests, including liver and kidney function, complete blood cell counts, and eye exams, may be performed while you use Duo-Vil 2-10. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Duo-Vil 2-10 with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion; constipation; dizziness or light-headedness, especially upon standing; drowsiness; fainting; trouble urinating; and uncontrolled muscle movements.
  • Duo-Vil 2-10 should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Duo-Vil 2-10 while you are pregnant. Taking Duo-Vil 2-10 during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor: Duo-Vil 2-10 is found in breast milk. Do not breast-feed while taking Duo-Vil 2-10.

If you stop taking Duo-Vil 2-10 suddenly, you may have WITHDRAWAL symptoms. These may include headache, nausea, and unusual tiredness.

Possible side effects of Duo-Vil 2-10:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; enlarged pupils; flushing; headache; jitteriness; loss of appetite; nausea; stuffy nose; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling; changes in behavior; chest pain; confusion; difficulty sleeping; difficulty urinating; drooling; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; loss of bladder control; mask-like face; muscle rigidness or stiffness; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness,); nightmares; numbness of the arms and legs; one-sided weakness; prolonged or painful erection; ringing in the ears; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; slurred speech; sudden shortness of breath or vomiting; suicidal thoughts or attempts; swelling of the hands, ankles, legs, or feet; symptoms of high prolactin levels (eg, decreased sexual ability, enlarged breast size, missed menstrual period, nipple discharge); symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite, yellowing of the skin or eyes); tremors; twitching or twisting movements; uncontrolled muscle movements (eg, loss of balance; trouble speaking, breathing, or swallowing; twitching of the face or tongue; uncontrolled movements of arms or legs); unusual bruising or bleeding; unusual eye movements or inability to move your eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).

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. Symptoms may include agitation; concentration problems; confusion; dilated pupils; fainting; fast or irregular heartbeat; fever; hallucinations; light-headedness; muscle rigidity; seizures; severe or persistent dizziness or drowsiness; trouble breathing; twitching or twisting movements; uncontrolled muscle movements; vomiting.

Proper storage of Duo-Vil 2-10:

Store Duo-Vil 2-10 at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Duo-Vil 2-10 out of the reach of children and away from pets.

General information:

  • If you have any questions about Duo-Vil 2-10, please talk with your doctor, pharmacist, or other health care provider.
  • Duo-Vil 2-10 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 Duo-Vil 2-10 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 Duo-Vil 2-10. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Duo-Vil 2-10. 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 Duo-Vil 2-10.

Issue Date: June 3, 2015