Drug Detail:Vimovo (Esomeprazole and naproxen [ ee-soe-mep-ra-zole-and-na-prox-en ])
Generic Name: Naproxen 375mg, Esomeprazole Magnesium 20mg
Dosage Form: tablet, delayed release
Drug Class: Nonsteroidal anti-inflammatory drugs
Important Administration Instructions
- Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].
- Carefully consider the potential benefits and risks of VIMOVO and other treatment options before deciding to use VIMOVO.
- VIMOVO does not allow for administration of a lower daily dose of esomeprazole magnesium. If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered.
- Swallow VIMOVO tablets whole with liquid. Do not split, chew, crush or dissolve the tablet. Take VIMOVO at least 30 minutes before meals.
- Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
- Antacids may be used while taking VIMOVO.
Recommended Dosage
The recommended dosage of VIMOVO by indication is shown in the table:
Indication | Patient Population | Recommended Dosage |
---|---|---|
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis | Adults | One VIMOVO tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole |
Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age and Older and Weighing at Least 38 kg | Greater than 50 kg | |
38 kg to less than 50 kg | One VIMOVO tablet twice daily of: 375 mg naproxen/20 mg of esomeprazole |
Use in Renal Impairment or Hepatic Impairment
Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance less than 30 mL/min) [see Warnings and Precautions (5.6), Use in Specific Populations (8.7)].
Hepatic Impairment
Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of VIMOVO.
VIMOVO should be avoided in patients with severe hepatic impairment [see Warnings and Precautions (5.3), Use in Specific Populations (8.6)].