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COXANTO is a prescription medicine that contains oxaprozin (a nonsteroidal anti-inflammatory drug [NSAID]).
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What is the most important information I should know about COXANTO, and medicines called nonsteroidal anti-inflammatory drugs (NSAIDs)?
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| COXANTO may cause serious side effects, including: |
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Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
- with increasing doses of NSAIDs
- with longer use of NSAIDs
Do not take COXANTO right before or after a heart surgery called a "coronary artery bypass graft (CABG)".
Avoid taking COXANTO after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take COXANTO after a recent heart attack.
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Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
- anytime during use
- without warning symptoms
- that may cause death
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The risk of getting an ulcer or bleeding increases with:
- history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
- taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "selective serotonin reuptake inhibitors (SSRIs)", "serotonin norepinephrine reuptake inhibitors (SNRIs)"
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- increasing doses of NSAIDs
- longer use of NSAIDs
- smoking
- drinking alcohol
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- older age
- poor health
- advanced liver disease
- bleeding problems
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COXANTO should only be used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
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| What is COXANTO? |
COXANTO is a prescription medicine used:
• for relief of the signs and symptoms of osteoarthritis
• for relief of the signs and symptoms of rheumatoid arthritis
• for relief of the signs and symptoms of juvenile rheumatoid arthritis.
It is not known if COXANTO is safe and effective in children below 6 years of age. |
| Do not take COXANTO: |
- if you are allergic to oxaprozin or to any of the ingredients in COXANTO. See the end of this Medication Guide for a complete list of ingredients in COXANTO.
- if you have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs. Severe allergic reactions that have sometimes led to death have happened in people with a history of allergic reactions to NSAIDs.
- right before or after heart bypass surgery.
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Before taking COXANTO, tell your healthcare provider about all of your or your child’s medical conditions, including if you:
• have heart problems
• have bleeding problems
• have or have had ulcers
• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Taking COXANTO at about 20 weeks of pregnancy or later may harm your unborn baby.
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If you need to take COXANTO for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take COXANTO after about 30 weeks of pregnancy.
- COXANTO may cause fertility problems in females, which may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
• are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with COXANTO.
Tell your healthcare provider about all of the medicines you or your child take, including prescription or over-the-counter medicines, vitamins or herbal supplements.
COXANTO and some other medicines can interact with each other and cause serious side effects.
Do not start taking any new medicine without talking to your healthcare provider first. |
How should I take COXANTO?
• Take COXANTO exactly as your healthcare provider tells you to take it.
• If you take too much COXANTO, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away. |
| What are the possible side effects of COXANTO? |
| COXANTO may cause serious side effects, including: |
| See "What is the most important information I should know about COXANTO, and medicines called nonsteroidal anti-inflammatory drugs (NSAIDs)?" |
- liver problems including liver failure
- new or worse high blood pressure
- heart failure
- kidney problems including kidney failure
- increase in blood potassium level (hyperkalemia)
- life-threatening allergic reactions
- asthma attacks in people who have asthma
- serious skin reactions, including life-threatening skin reactions
- low red blood cells (anemia)
- skin sensitivity to sunlight
Other side effects of COXANTO include: constipation, diarrhea, indigestion, nausea, and rash. |
| Get emergency help right away if you get any of the following symptoms: |
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- shortness of breath or trouble breathing
- chest pain
- weakness in one part or side of your body
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- slurred speech
- swelling of the face or throat
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| Stop taking COXANTO and call your healthcare provider right away if you get any of the following symptoms: |
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- nausea
- more tired or weaker than usual
- diarrhea
- itching
- your skin or eyes look yellow
- indigestion or stomach pain
- flu-like symptoms
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- vomit blood
- there is blood in your bowel movement or it is black and sticky like tar
- unusual weight gain
- skin rash or blisters with fever
- swelling of the arms, legs, hands and feet
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| These are not all the possible side effects of COXANTO. |
| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| Other information about NSAIDs |
- Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
- Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs.
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How should I store COXANTO?
• Store COXANTO at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the COXANTO bottles tightly closed.
• Protect the bottle from light.
Keep COXANTO and all medicines out of the reach of children.
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| General information about the safe and effective use of COXANTO. |
| Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use COXANTO for a condition for which it was not prescribed. Do not give COXANTO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about COXANTO that is written for health professionals. |
What are the ingredients in COXANTO?
Active ingredient: oxaprozin
Inactive ingredients: microcrystalline cellulose, pregelatinized corn starch, hypromellose 2910, sodium starch
glycolate, stearic acid, and silicon dioxide. |
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Manufactured for and Distributed by:
Solubiomix, LLC
Madisonville, LA 70447
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| For more information, call 1-844-551-9911. |