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    Tramadol HCL

    COMMON BRAND NAME(S): Ultram

    GENERIC NAME(S): Tramadol

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    WARNINGS:

    Tramadol has a risk for abuse and addiction, which can lead to overdose and death. Tramadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tramadol that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

    The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of tramadol from your body, which may affect how tramadol works. Be sure you know how to take tramadol and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

    Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

    Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

    Children younger than 12 years should not use products that contain tramadol. Children between 12 and 18 years old should not use tramadol after certain surgeries (including tonsil/adenoid removal). Also, tramadol use is not recommended for children between 12 and 18 years old who are obese or have breathing problems. Some children are more sensitive to tramadol and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.

    Who should not take Tramadol HCL?
    See More

    Uses

    See also Warning section.

    This medication is used to help relieve moderate to moderately severe pain. Tramadol is similar to opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

    How to use Tramadol HCL

    Read the Medication Guide provided by your pharmacist before you start taking tramadol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    Take this medication by mouth as directed by your doctor, usually every 4 to 6 hours as needed for pain relief. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

    The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. The maximum recommended dose is 400 milligrams per day. If you are older than 75 years, the maximum recommended dose is 300 milligrams per day. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

    Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

    If you have ongoing pain (such as due to arthritis), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using tramadol safely with other drugs.

    This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

    When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

    Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

    Tell your doctor if your pain persists or worsens.

    Side Effects

    See also Warning section.

    Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

    To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

    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: mental/mood changes (such as agitation, hallucinations), severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

    Get medical help right away if any of these rare but seriousfainting, seizure.

    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.

    Tramadol is changed into a strong opioid drug in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms: 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.

    Precautions

    Before taking tramadol, tell your doctor or pharmacist if you are allergic to it; 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: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, suicidal thoughts), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis), obesity.

    This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    Some children may be more sensitive to very serious side effects of tramadol, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)

    Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

    During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

    This medication passes into breast milk and may rarely have undesirable effects on a nursing infant, such as unusual sleepiness, difficulty feeding, or trouble breathing. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

    Interactions

    See also Warning 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: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.

    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, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before 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 tramadol from your body, which may affect how tramadol works. Examples include quinidine, azole antifungals (such as itraconazole), HIV drugs (such as ritonavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), drugs used to treat seizures (such as carbamazepine), among others.

    The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

    Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

    This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, 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: slow breathing, slow/irregular heartbeat, coma, seizure.

    Notes

    Do not share this medication with others. It is against the law.

    This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

    Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

    Missed Dose

    Not applicable.

    Storage

    Store at room temperature away from light and moisture. Keep all medications 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.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.

    Images

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    APO, TR 50
    tramadol 50 mg tablet
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    Identification

    color
    white
    shape
    oval
    imprint
    93, 58
    This medicine is a white, oval, film-coated, tablet imprinted with "93" and "58".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    oval
    imprint
    TV, 58
    This medicine is a white, oval, film-coated, tablet imprinted with "TV" and "58".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    round
    imprint
    M, T7
    This medicine is a white, round, tablet imprinted with "M" and "T7".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    round
    imprint
    319
    This medicine is a white, round, film-coated, tablet imprinted with "319".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    round
    imprint
    AN 627
    This medicine is a white, round, film-coated, tablet imprinted with "AN 627".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    377
    This medicine is a white, oblong, film-coated, tablet imprinted with "377".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    N024
    This medicine is a white, oblong, coated, tablet imprinted with "N024".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    N024
    This medicine is a white, oblong, coated, tablet imprinted with "N024".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    377
    This medicine is a white, oblong, film-coated, tablet imprinted with "377".
    tramadol 50 mg tablet
    tramadol 50 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    APO, TR 50
    This medicine is a white, oblong, scored, film-coated, tablet imprinted with "APO" and "TR 50".

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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