Elyxyb 120 mg/4.8 mL (25 mg/mL) oral solution

Generic name:
Celecoxib solution - oral

Pronunciation
(SEL-e-KOX-ib)

Brand name(s)
Elyxyb

Nonsteroidal anti-inflammatory drugs (including celecoxib) may rarely increase the risk of a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG).

Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect.

Stop taking celecoxib and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.

Talk to your doctor or pharmacist about the benefits and risks of taking this drug.

This medication is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor. It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using celecoxib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, at the first sign of a migraine. The dosage is based on your medical condition. Take this medication only when needed. Do not take more than one dose in a 24-hour period.

This medication comes in a bottle. The amount of medication in the bottle is usually used for one dose. If instructed to take all the medication in the bottle, drink the medication directly from the bottle. If instructed to only use half the amount of medication per dose, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Discard any unused medication after taking your dose. Do not save the unused medication left in the bottle for later use.

After taking the medication, you may drink up to a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise.

If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.

See also Warning section.

Changes in the sense of taste may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• pain/swelling/warmth in the groin/calf
• signs of kidney problems (such as change in the amount of urine)
• difficult/painful swallowing
• symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

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

• fever
• swollen lymph nodes
• 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 celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen); 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:

• asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs)
• blood disorders (such as anemia, bleeding/clotting problems)
• growths in the nose (nasal polyps)
• liver disease
• stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn)
• heart disease (such as previous heart attack)
• high blood pressure
• stroke
• swelling (edema, fluid retention)

Kidney problems can sometimes occur with the use of NSAID medications, including celecoxib. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

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

Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breastfeeding.

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 are:

• aliskiren
• ACE inhibitors (such as captopril, lisinopril)
• angiotensin II receptor blockers (such as valsartan, losartan)
• cidofovir
• lithium
• "water pills" (diuretics such as furosemide)

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as naproxen or ibuprofen). These drugs are similar to celecoxib and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe stomach pain, slow/shallow breathing, or loss of consciousness.

Do not share this medication with others.

Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these "triggers" may help lessen migraine attacks. Consult your doctor for more details.

Lab and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable.

Store at room temperature. Do not refrigerate or freeze. 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.