Mylan-Celecoxib

Celecoxib belongs to the group of medications called selective COX-2 inhibitors, which is a kind of nonsteroidal anti-inflammatory drug (NSAID). NSAIDs work by reducing a substance in the body that leads to inflammation (swelling) and pain.

Celecoxib is used to treat the symptoms of osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis in adults.

It is also used to treat moderate-to-severe pain for a short-term period (less than 7 days), such as pain due to surgery, sprains, or tooth extractions.

Celecoxib will only treat symptoms and decrease inflammation as long as you are taking the medication. It will not change the progress of the disease causing the pain and inflammation.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The amount of celecoxib and how long it is taken varies according to the condition being treated. It should be used at the lowest dose possible for the shortest possible length of time to achieve pain relief.

Osteoarthritis: The usual recommended daily dose is 200 mg taken as a single dose or as 100 mg twice daily.

Ankylosing spondylitis: The usual recommended daily dose is 200 mg taken as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The usual recommended starting dose is 100 mg twice daily. This may be increased to 200 mg twice daily as directed by your doctor.

Moderate-to-severe pain: The usual recommended dose is 400 mg as a single dose on the first day, followed by 200 mg once daily. Treatment should not exceed 7 days. The maximum recommended dose is 400 mg a day.

Celecoxib may be taken with or without food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not take this medication if you:

• are allergic to celecoxib or any ingredients of the medication
• are allergic to sulfonamides (sulfa medications; e.g., sulfamethoxazole)
• are breast-feeding or planning to breast-feed
• are in the third trimester of pregnancy (28 weeks or more)
• are planning to have or recently have had heart surgery
• have an active stomach or intestinal ulcer or active gastrointestinal (stomach and intestines) bleeding
• have bleeding in the brain
• have experienced asthma, hives, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs (e.g., naproxen, ibuprofen, diclofenac, meloxicam)
• have high blood potassium levels
• have inflammatory bowel disease
• have severe, uncontrolled heart failure
• have severely decreased kidney function or kidney function that is getting worse
• have severely decreased liver function or active liver disease
• Do not give this medication to children and adolescents less than 18 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• dizziness
• drowsiness
• dry mouth
• hair loss
• headache
• heartburn
• increased gas
• menstrual problems
• mouth sores
• muscle pain
• nausea
• spinning sensation
• sweating
• taste disorder
• thirst
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision or other vision changes
• confusion
• difficulty concentrating
• digestive system problems (e.g., vomiting, ongoing indigestion, nausea, stomach pain, or diarrhea)
• fatigue
• headaches or stiff neck
• hearing changes
• increased blood pressure
• memory problems
• pain or difficulty urinating
• signs of bleeding (e.g., unusual bruising or bleeding, bloody nose, blood in urine, coughing blood, cuts that won't stop bleeding)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of lung problems (e.g., trouble breathing, dry cough, wheezing, shortness of breath, irregular heartbeat, chest tightness)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• skin rash
• swelling of the legs or feet
• symptoms of congestive heart failure (e.g., shortness of breath, fatigue, weakness, swelling in ankles, legs and feet, cough, lack of appetite, nausea, rapid or irregular heartbeat, decreased exercise tolerance)
• symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching) 

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; or swelling of the lips, throat, or tongue)
• symptoms of a severe skin reaction (e.g., high fever; rash, sores, or painful blisters on the skin, mouth, or eyes; or skin peeling off)
• symptoms of bleeding in the stomach or intestines (e.g., dark and tarry stools, blood coming from rectum, vomiting blood or material that looks like coffee grounds, fast heartbeat, weakness or fainting)
• symptoms of a heart attack (e.g., shoulder, chest, jaw or left arm pressure or squeezing pain; shortness of breath; dizziness; light-headedness; clammy skin; sweating; indigestion; anxiety; irregular heartbeat)
• symptoms of a stroke (e.g., sudden numbness, weakness or tingling of the face, arm or leg on one side of the body; blurred vision; sudden headache; difficulty swallowing or speaking; fainting; vomiting; problems with walking or balance)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: Some people who are allergic to sulfonamide medications such as certain antibiotics also experience allergic reactions to celecoxib. Before you take celecoxib, inform your doctor about any previous adverse reactions you have had to medications, especially sulfonamides and acetylsalicylic acid (ASA, e.g., Aspirin®) or other anti-inflammatories. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Blood counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. Contact your doctor immediately if you notice an increased occurrence of signs of infection (e.g., fever, chills, or sore throat), feel unusually tired, lack energy, or experience unusual bleeding or bruising.

Drowsiness/reduced alertness: Celecoxib may cause drowsiness, dizziness or, sometimes, blurred vision. Avoid driving, operating machinery, or engaging in other activities that require alertness and coordination if you find that celecoxib affects you in this way.

Fertility: As with other NSAIDs, taking celecoxib may make it more difficult to conceive . Stopping the medication allows the body's chemistry to return to normal which often resolves this issue.

Fluid retention: Celecoxib may cause fluid retention and swelling, possibly worsening high blood pressure, congestive heart failure, or decreased heart function. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Consult your doctor immediately if you develop shortness of breath, fatigue, excessive weight gain, chest pain, or swelling of the legs, feet, or ankles while taking this medication.

Heart attack and stroke: The use of selective COX-2 inhibitor NSAIDs, including celecoxib, is associated with an increased risk of cardiovascular events such as heart attack and stroke, similar to the risk associated with most traditional NSAIDs (e.g., ibuprofen, diclofenac, naproxen). The risk is increased with higher total daily doses and when taking the medication over long periods of time. Due to this increased risk, people with the following conditions or risk factors should be closely monitored by their doctor if they use celecoxib:

• congestive heart failure
• diabetes
• heart attack
• heart disease
• high blood pressure
• high cholesterol
• impaired kidney function
• poor circulation
• smoking
• stroke

Hypersensitivity reaction: Rarely, people taking celecoxib have reported severe allergic reactions have been reported by people taking celecoxib. These rare reactions often start with a skin reaction, such as a severe rash. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) may occur. This reaction can include symptoms such as fever, swollen glands, yellowing of the skin or eyes, flu-like symptoms with skin rash or blistering or other organ involvement. These reactions are medical emergencies. Get immediate medical attention if you have symptoms of a severe allergic reaction. If you experience any unusual symptoms, contact your doctor.

Kidney disease: Like other NSAIDs, celecoxib may cause decreased kidney function and is not recommended for people with advanced kidney disease. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience signs of kidney problems, such as blood in your urine or decreased urine production, contact your doctor as soon as possible.

Liver function: Decreased liver function or liver disease may cause celecoxib to build up in the body, causing side effects. Celecoxib may also worsen liver disease. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Meningitis: On rare occasions, people taking NSAIDs such as celecoxib experience symptoms of inflammation of the tissues surrounding the brain (meningitis). This appears to be more likely for people who have an autoimmune disorder. If you experience symptoms of meningitis not caused by infection, such as stiff neck, severe headache, nausea, vomiting, or changes in consciousness and awareness, contact your doctor immediately.

Potassium levels: Celecoxib may increase the risk of high potassium levels in the blood, especially for seniors, people who have conditions such as diabetes or kidney failure, or people taking certain other types of medications. Your doctor may order blood tests periodically during long-term treatment to monitor the amount of potassium in your blood. People who have been diagnosed with having high potassium levels in their blood should not take this medication.

Stomach problems: Celecoxib may cause stomach problems such as ulcers or bleeding. If you have stomach problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using acetylsalicylic acid (ASA) at the same time as celecoxib increases the risk of stomach ulcers and bleeding.

Urinary tract problems: Some people experience ongoing symptoms of urinary problems. If you experience bladder pain, pain when urinating, or increased frequency of urination, stop taking this medication and contact your doctor.

Pregnancy: The safety of using this medication during pregnancy has not been established. If celecoxib is taken during the earlier stages of pregnancy, there is also an increased risk of miscarriage.

Use of celecoxib at 20 weeks or later in pregnancy may increase the risk of kidney damage and complications due to low amniotic fluid in the developing baby. This medication should not be used during pregnancy unless the benefits outweigh the risks, and it should be avoided during the last trimester of pregnancy (after 28 weeks of pregnancy). Using celecoxib, as with any NSAID, late in pregnancy may cause labour to be prolonged. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are breast-feeding and are taking celecoxib, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children and adolescents under 18 years old.

Seniors: Seniors are more likely to experience side effects of celecoxib. Discuss the risks and benefits of using this medication with your doctor.

There may be an interaction between celecoxib and any of the following:

• 5-ASA medications (e.g., mesalamine, olsalazine, sulfasalazine)
• acetylsalicylic acid (ASA) and other salicylate medications
• alcohol
• aliskiren
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• angiotensin-converting enzyme inhibitors (ACEIs; e.g., captopril, enalapril, ramipril)
• angiotensin II receptor blockers (ARBs; e.g., losartan, irbesartan)
• apixaban
• benzydamine
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• bisphosphonates (e.g., alendronate, risedronate, zoledronic acid)
• cholestyramine
• colesevelam
• colestipol
• corticosteroids taken by mouth (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• dabigatran
• dapsone
• deferasirox
• desmopressin
• digoxin
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• doxepin
• edoxaban
• elagolix
• enzalutamide
• eplerenone
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• fluconazole
• fondaparinux
• herbal medications (e.g., garlic, ginger, gingko, ginseng)
• heparin
• hexylresorcinol
• hydralazine
• latanoprost
• lithium
• low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• lumacaftor and ivacaftor
• metformin
• methotrexate
• mifepristone
• other NSAID medications (e.g., diclofenac, ibuprofen, ketorolac, naproxen)
• potassium supplements
• pramoxine
• prostaglandin eye drops (e.g., bimatoprost, latanoprost)
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin)
• rifampin
• rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs, e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
• sodium phosphate
• spironolactone
• tacrolimus
• tenofovir
• tetracaine
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• vaccines
• vancomycin
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Mylan-Celecoxib