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U.S. Department of Health and Human Services

Safety

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Arthrotec (diclofenac sodium/misoprostol) oral tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2014

Summary View

CONTRAINDICATIONS

  • add contraindication for patients with active gastrointestinal bleeding

WARNINGS

  • add that the use of diclofenac/misoprostol with concomitant NSAIDs including COX-2 inhibitors should be avoided.

expand Skin Reactions subsection

PRECAUTIONS

  • remove statement that nursing mothers should not take Arthrotec
Drug Interactions
  • revise statement about renal function in Ace Inhibitors subsection
  • add Tacrolimus subsection
  • add data to Nursing Mothers subsection

ADVERSE REACTIONS

add the following subsections:

  • Pregnancy, puerperium and perinatal conditions
  • Congenital, familial and genetic disorders
  • expand upon the following subsections:
  • Body as Whole
  • Female Reproductive Disorders
  • Hemic and lymphatic system subsection
  • Metabolic and nutritional subsection
  • Skin and appendages subsection
  • Urinary subsection

PATIENT INFORMATION

  • Clarify that caution should be exercised in nursing mothers
  • Add that broken tablets should not be taken

 

March 2013

Summary View

Drug Interactions

CYP2C9 inhibitors
  • Use caution when dosing diclofenac with CYP2C9 inhibitors (e.g. voriconazole). Concomitant use of CYP2C9 inhibitors may enhance toxicity of diclofenac due to an increase in systemic exposure to diclofenac. When concomitant use of CYP2C9 inhibitors is necessary, the total daily dose of  diclofenac should not exceed the lowest recommended dose of ARTHROTEC 50 twice daily (see DOSAGE AND ADMINISTRATION).
Voriconazole:
  • In a published study, single dose diclofenac (50 mg) was coadministered with the last dose of voriconazole (400 mg every 12 hours on Day 1, followed by 200 mg every 12 hours on Day 2). The mean Cmax and AUC of diclofenac were increased by 2.1-fold and 1.8-fold respectively when coadministered with voriconazole compared to diclofenac alone.
CYP2C9 inducers
  • Use caution when dosing diclofenac with CYP2C9 inducers (e.g. rifampin). Concomitant use of CYP2C9 inducers may lead to compromised efficacy due to a decrease in systemic exposure to diclofenac. The separate products of misoprostol and diclofenac should be used if a higher dose of diclofenac is deemed necessary.
     

 

 

December 2010

Summary View

 

PRECAUTIONS

Voriconazole
  • In a published study, single dose diclofenac (50 mg) was coadministered with the last dose of voriconazole (400 mg every12 hours on Day 1, followed by 200 mg every 12 hours on Day 2). The mean Cmax and AUC of diclofenac were increased by 2.1-fold and 1.8- fold respectively when coadministered with voriconazole compared to diclofenac alone.