Celecoxib and tramadol (oral route)


    Brand Name

    US Brand Name

    Seglentis


    Description

    Celecoxib and tramadol combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

    Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to side effects when you suddenly stop taking the medicine. Since this medicine is only used for short-term relief of pain, mental and physical dependence will probably not occur.

    This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

    This product is available in the following dosage forms:

    • Tablet

    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 celecoxib and tramadol combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

    This medicine should not be used to relieve pain after surgery removal of tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of celecoxib and tramadol combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, stomach, or lung problems which may require caution and an adjustment in the dose for patients receiving celecoxib and tramadol combination.

    Breastfeeding

    Substance Name

    Celecoxib

    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.

    Substance Name

    Tramadol

    Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    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.

    • Isocarboxazid
    • Ketorolac
    • Linezolid
    • Mavorixafor
    • Methylene Blue
    • Moclobemide
    • Naltrexone
    • Ozanimod
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Safinamide
    • Samidorphan
    • Selegiline
    • 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.

    • Abciximab
    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Acepromazine
    • Aclidinium
    • Alfentanil
    • Almotriptan
    • Alprazolam
    • Amantadine
    • Amifampridine
    • Amiloride
    • Amineptine
    • Amiodarone
    • Amitriptyline
    • Amitriptylinoxide
    • Amobarbital
    • Amoxapine
    • Amphetamine
    • Amprenavir
    • Amtolmetin Guacil
    • Anagrelide
    • Anileridine
    • Apalutamide
    • Apixaban
    • Aprepitant
    • Ardeparin
    • Argatroban
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Armodafinil
    • Asciminib
    • Asenapine
    • Aspirin
    • Atazanavir
    • Atomoxetine
    • Atropine
    • Avacopan

    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.

    • Acebutolol
    • Atenolol
    • Azilsartan
    • Azilsartan Medoxomil
    • Benazepril
    • Betaxolol
    • Bisoprolol
    • Candesartan
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Enalapril
    • Enalaprilat
    • Eprosartan
    • Esmolol
    • Fosinopril
    • Irbesartan
    • Labetalol
    • Levobunolol
    • Lisinopril
    • Losartan
    • Metipranolol
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Olmesartan
    • Oxprenolol
    • Penbutolol
    • Perindopril
    • Pindolol
    • Propranolol
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril
    • Telmisartan
    • Timolol
    • Trandolapril

    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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, 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
    • Grapefruit Juice

    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:

    • Adrenal problems or
    • Alcohol abuse, or history of or
    • Brain tumor or
    • Depression, history of or
    • Diabetes or
    • Drug dependence, especially narcotic abuse or dependence, or history of or
    • Head injuries or
    • Increased pressure in the head or
    • Lung or breathing problems (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
    • Mental illness (eg, suicidal ideation), history of or
    • Obesity (overweight) or
    • Seizures, history of or
    • Stomach problems, severe—Use with caution. May increased risk for more side effects.
    • Anemia or
    • Bleeding problems or
    • Congestive heart failure or
    • Edema (fluid retention or body swelling) or
    • Heart attack, history of or
    • Heart disease or
    • Hypertension (high blood pressure) or
    • Kidney disease or
    • Pancreatitis (swelling of the pancreas) or
    • Stroke, history of—Use with caution. May make these conditions worse.
    • Aspirin-sensitive asthma, history of or
    • Aspirin sensitivity, history of or
    • Asthma, acute or severe or
    • Lung or breathing problems, severe or
    • Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
    • Certain genetic conditions (poor CYP2C9 (a liver enzyme) metabolizers) or
    • Liver disease, mild or moderate—Use with caution. You may need a reduced dose of this medicine.
    • Dehydration or
    • Hypovolemia—Must be corrected first before using this medicine.
    • Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—This medicine should not be used to relieve pain right before or after the surgery.
    • Kidney disease, severe or
    • Liver disease, moderate to severe—Use is not recommended in patients with these conditions.

    Proper Use

    For safe and effective use of this medicine, 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 is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may increase the chance of unwanted effects, may become habit-forming (causing mental or physical dependence), or cause an overdose.

    It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of celecoxib and tramadol combination. This medicine should come with a Medication Guide. Read and follow the 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 (tablets):
      • For acute pain:
        • Adults—2 tablets every 12 hours as needed.
        • Children 12 years of age and older—Use and dose must be determined by your doctor.
        • Children younger than 12 years of age—Should not be used in these patients.

    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.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm


    Precautions

    It is very important that your doctor check your or your child's progress at regular visits, especially within the first 24 to 72 hours of treatment, to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

    Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

    Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

    Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] within the past 14 days. Do not use this medicine together with other products containing celecoxib or tramadol.

    Do not change the dose or suddenly 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 worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble sleeping.

    This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

    This medicine may cause some people to become drowsy, dizzy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

    Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Seglentis® may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

    Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

    This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

    If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

    This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

    This medicine may cause bleeding in your stomach or bowels. These problems can happen without warning signs. This is more likely if you or your child have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or using certain other medicines (eg, steroids or a blood thinner).

    Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product (O-desmethyltramadol) more quickly than others. These individuals are called "ultra-rapid metabolizers of tramadol". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of tramadol." As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:

    • Children younger than 12 years of age.
    • Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
    • Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

    If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.

    For nursing mothers using this medicine

    • Talk to your doctor if you have any questions about taking tramadol or about how this medicine may affect your baby.
    • Call your doctor if you become extremely tired and have difficulty caring for your baby.
    • Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
    • Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

    This medicine 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. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also, tell your doctor if you have any sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has tried to commit suicide.

    Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.

    This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

    Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

    This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

    Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    Tell your doctor if you or your child have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

    Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

    Serious skin reactions, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

    This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.

    Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).

    This medicine may cause a delay in ovulation for women and may affect their ability to have children. Talk with your doctor before using this medicine if you plan to have children.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    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

    • Agitation
    • anxiety
    • bigger, dilated, or enlarged pupils (black part of eye)
    • black, tarry stools
    • blistering, peeling, or loosening of the skin
    • bloating of the stomach
    • bloody or cloudy urine
    • blurred vision
    • chest pain, discomfort, or tightness
    • chills
    • cold sweats
    • coma
    • confusion
    • confusion as to time, place, or person
    • constricted, pinpoint, or small pupils (black part of eye)
    • cool, pale skin
    • cough or hoarseness
    • dark urine
    • darkening of the skin
    • depression
    • diarrhea
    • difficulty in speaking
    • difficulty swallowing
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fainting
    • fast heartbeat
    • fever
    • greatly decreased frequency of urination or amount of urine
    • hallucinations
    • headache, sudden or severe
    • heartburn
    • hives, itching, skin rash
    • holding false beliefs that cannot be changed by fact
    • increased hunger
    • increased sensitivity of the eyes to light
    • increased sensitivity to pain
    • increased thirst
    • indigestion
    • irregular or slow heart rate
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • light-colored stools
    • loss of appetite
    • loss of sense of smell or taste
    • lower back or side pain
    • mental depression
    • muscle pain or cramps
    • nausea
    • nervousness
    • nightmares
    • numbness or tingling in the hands, feet, or lips
    • overactive reflexes
    • pain, redness, or swelling in the arm or leg
    • painful or difficult urination
    • pain or discomfort in the arms, jaw, back, or neck
    • pale or blue lips, fingernails, or skin
    • poor coordination
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red irritated eyes
    • red skin lesions, often with a purple center
    • seizures
    • shakiness
    • shivering
    • slurred speech
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • stiff neck or back
    • stomach cramps or pain
    • sweating
    • swelling of the face, ankles, or hands
    • swelling of the feet or lower legs
    • swollen glands
    • talking or acting with excitement you cannot control
    • trouble breathing
    • twitching
    • unpleasant breath odor
    • unusual bleeding or bruising
    • unusual excitement, nervousness, or restlessness
    • unusual or incomplete body or facial movements
    • unusual tiredness or weakness
    • vomiting
    • vomiting of blood or material that looks like coffee grounds
    • weakness or heaviness of the legs
    • weight gain
    • worsening of pain
    • yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Black, tarry stools
    • dark urine
    • depression
    • disorientation
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drowsiness to profound coma
    • fever
    • headache
    • irregular, fast or slow, or shallow breathing
    • lightheadedness
    • loss of appetite
    • mood or other mental changes
    • nausea
    • pale or blue lips, fingernails, or skin
    • seeing, hearing, or feeling things that are not there
    • stomach pain
    • trouble sleeping
    • unpleasant breath odor
    • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
    • vomiting of blood
    • yellow eyes or skin

    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.






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