This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: August 2022
What is the most important information I should know about ARTHROTEC?
What is the most important information I should know about medicines containing Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
Do not take NSAID containing medicines right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
The risk of getting an ulcer or bleeding increases with:
NSAID containing medicines should only be used:
What is ARTHROTEC?
ARTHROTEC is a prescription medicine used to treat:
It is not known if ARTHROTEC is safe and effective for use in children.
Who should not take ARTHROTEC?
Before taking ARTHROTEC, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. NSAIDs 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.
What are the possible side effects of NSAIDs?
Get emergency help right away if you get any of the following symptoms:
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
If you take too much of your NSAID, call your healthcare provider or get medical help right away.
Other information about NSAIDs
General information about the safe and effective use of NSAIDs
Active ingredients: diclofenac sodium, misoprostol.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, families, or their caregivers of the following information before initiating therapy with ARTHROTEC and periodically during the course of ongoing therapy.
Uterine Rupture, Abortion, Premature Birth, or Birth Defects with Misoprostol and Embryo-Fetal Toxicity with NSAIDs
- Advise females that ARTHROTEC is contraindicated in pregnant women. Use of misoprostol, a component of ARTHROTEC during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects. Use of diclofenac may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
- Advise patients not to give ARTHROTEC to others.
- Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with ARTHROTEC. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)].
Advise females of reproductive potential that ARTHROTEC may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women [see Use in Specific Populations (8.3)].
Cardiovascular Thrombotic Events
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions (5.2)].
Gastrointestinal Bleeding, Ulceration, and Perforation
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.3)].
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop ARTHROTEC and seek immediate medical therapy [see Warnings and Precautions (5.4)].
Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.6)].
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions (5.8)].
Serious Skin Reactions, including DRESS
Advise patients to stop taking ARTHROTEC immediately if they develop any type of rash or fever and contact their healthcare provider as soon as possible [see Warnings and Precautions (5.10, 5.11)].
Avoid Concomitant Use of NSAIDs
Inform patients that the concomitant use of ARTHROTEC with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.3) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia.
Use of NSAIDS and Low-Dose Aspirin
Inform patients not to use low-dose aspirin concomitantly with ARTHROTEC until they talk to their healthcare provider [see Drug Interactions (7)].
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For medical information about Arthrotec, please visit www.pfizermedinfo.com or call 1‑800‑438-1985