Naproxen and Esomeprazole Delayed Release

1. What Dinovo is and what it is used for?
Dinovo is a fixed dose combination of the proton pump inhibitor esomeprazole magnesium with the non-steroidal anti-inflammatory drug (NSAID) naproxen in a single tablet.
Dinovo is specially indicated for the relief of sign and symptom of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcer in patients at risk of developing NSAID associated gastric ulcer.

2. Before you take Dinovo
Do not take this medicine and tell your doctor if:

  • If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID
  • For pain right before or after heart bypass surgery
  • If you are allergic to any of the ingredients in Dinovo or any other proton pump inhibitor (PPI) medicine
  • If you are in the late stages of pregnancy (third trimester)

Take special care with Dinovo
Check with your doctor before taking this medicine if:

  • All of your medical conditions, including kidney or liver problems
  • All of the medicines you take, even over-the-counter medications. NSAIDs and some other medicines can interact with each other and cause serious side effects
  • If you have been told that you have low magnesium levels in your blood
  • If you are pregnant, plan to become pregnant, or are breastfeeding. NSAIDs should not be used by pregnant women late in their pregnancy
  • If you have ulcerative colitis or Crohn's disease (inflammatory bowel disease, or IBD)

Taking other medicines
Several studies conducted with naproxen and esomeprazole combination have shown no interaction between the two components.

Pregnancy and breast-feeding
FDA pregnancy category D. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects.
Naproxen can pass into breast milk and may harm a nursing baby.

3. How to take Dinovo?
The dosage is one tablet twice daily of Dinovo® 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Dinovo® is to be taken at least 30 minutes before meals.

If you forget to take Dinovo
If you forget to take a dose of Dinovo, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take two doses at one time to make up for a missed dose

If you stop taking Dinovo
Do not stop taking this medicine without talking to your doctor. You should not stop taking Dinovo just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist

4. Possible side effects
The most common side effects with Dinovo include

  • Inflammation of the lining of the stomach
  • Indigestion
  • Diarrhea
  • Stomach ulcers
  • Abdominal pain
  • Nausea

5. How to store Dinovo?
Store Dinovo at room temperature between 68° F to 77° F (20° C to 25° C)
Keep out of reach of children

Dinovo Prescribing Information

Located in: Muscloskeletal