(misoprostol, diclofenac sodium)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ARTHROTEC safely and effectively. See full prescribing information for ARTHROTEC.

ARTHROTEC® (diclofenac sodium and misoprostol delayed-release tablets), for oral use
Initial U.S. Approval:1997

WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

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Administration of misoprostol, a component of ARTHROTEC, to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or an abortion. (4, 5.1, 8.1)
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ARTHROTEC is contraindicated in pregnancy and is not recommended in women of childbearing potential. Patients must be advised of the abortifacient property and warned not to give the drug to others. (5.1, 8.3)
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Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. (5.2)
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ARTHROTEC is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.2)
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Increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal and can occur at any time and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk. (5.3)

RECENT MAJOR CHANGES

Warnings and Precautions, Serious Skin Reactions (5.10)

11/2024

INDICATIONS AND USAGE

ARTHROTEC is a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. (1)

DOSAGE AND ADMINISTRATION

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Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1)
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Osteoarthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three times daily. A dosage of diclofenac higher than 150 mg/day is not recommended. (2.2)
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Rheumatoid Arthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three or four times daily A dosage of diclofenac higher than 200 mg/day is not recommended. (2.3)
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For dosage modifications due to intolerance, see the full Prescribing Information. (2.2, 2.3)

DOSAGE FORMS AND STRENGTHS

Delayed-release tablets:

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50 mg diclofenac sodium and 200 mcg misoprostol (3)
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75 mg diclofenac sodium and 200 mcg misoprostol (3)

CONTRAINDICATIONS

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Pregnancy (4)
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In the setting of CABG surgery (4)
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Active gastrointestinal bleeding (4)
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History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
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Known hypersensitivity to diclofenac sodium, misoprostol, or any components of the drug product (4)

WARNINGS AND PRECAUTIONS

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Embryo-Fetal Toxicity with NSAIDs: Use of NSAIDs, including diclofenac in women at about 20 weeks gestation and later in pregnancy may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. (4, 5.1, 8.1)
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Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. (5.4)
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Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. (5.5, 7)
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Heart Failure and Edema: Avoid in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. (5.6)
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Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. (5.7)
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Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. (5.8)
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Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). (5.9)
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Serious Skin Reactions: Discontinue at first appearance of skin rash or other signs of hypersensitivity. (5.10)
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Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. (5.11)
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Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. (5.12, 7)

ADVERSE REACTIONS

Most common adverse reactions (>2%) are: abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, dizziness, alanine aminotransferase increased, hematocrit decreased (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See full prescribing information for a list of clinically important drug interactions. (7)

USE IN SPECIFIC POPULATIONS

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Reversible Infertility: Consider withdrawal in women who have difficulties conceiving. (8.3)
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Geriatric Patients: Avoid use in patients with cardiovascular and/or renal risk factors. (8.5)
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Renal Impairment: Avoid use in patients with advanced renal disease. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2024

Medication Guide

MEDICATION GUIDE

MEDICATION GUIDE
Medication Guide for
ARTHROTEC (ARTH' roe-tek)
(diclofenac sodium and misoprostol delayed- release tablets) for oral use

What is the most important information I should know about ARTHROTEC?
ARTHROTEC contains diclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) and misoprostol, and can cause uterus to tear (uterine rupture), abortion, premature birth, or birth defects. The risk of uterine rupture increases as your pregnancy advances, if you have given birth to 5 or more children, and if you have had surgery on the uterus, such as a cesarean delivery.

Do not take ARTHROTEC if you are pregnant.

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Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ARTHROTEC. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ARTHROTEC. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with ARTHROTEC.

What is the most important information I should know about medicines containing Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can 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:
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with increasing doses of NSAIDs
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with longer use of NSAIDs

Do not take NSAID containing medicines right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
Avoid taking NSAID containing medicines 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 NSAIDs 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:
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anytime during use
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without warning symptoms
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that may cause death

The risk of getting an ulcer or bleeding increases with:

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past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
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taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "SSRIs", or "SNRIs"
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increasing doses of NSAIDs
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longer use of NSAIDs
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smoking
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drinking alcohol
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older age
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poor health
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advanced liver disease
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bleeding problems

NSAID containing medicines should only be used:

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exactly as prescribed
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at the lowest dose possible for your treatment
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for the shortest time needed

What is ARTHROTEC?
ARTHROTEC contains 2 medicines:

1.
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
2.
Misoprostol is a medicine used to protect the lining of the esophagus, stomach and intestines while taking diclofenac.

ARTHROTEC is a prescription medicine used to treat:

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symptoms of osteoarthritis or rheumatoid arthritis in adults at high risk of developing stomach (gastric) and intestinal (duodenal) ulcers while taking NSAIDs.

It is not known if ARTHROTEC is safe and effective for use in children.

What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis.

Who should not take ARTHROTEC?
Do not take ARTHROTEC:

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if you are pregnant.
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right before or after heart bypass surgery.
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if you currently have bleeding in your stomach (gastrointestinal bleeding).
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if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
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if you are allergic to diclofenac sodium and misoprostol, other prostaglandins or any other ingredients in ARTHROTEC. See the end of this Medication Guide for a list of ingredients in ARTHROTEC.

Before taking ARTHROTEC, tell your healthcare provider about all of your medical conditions, including if you:

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have liver or kidney problems.
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have high blood pressure.
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have heart problems, including a history of heart failure or heart attack.
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have asthma.
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are pregnant or plan to become pregnant. See "Who should not take ARTHROTEC?"
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are breastfeeding or plan to breast feed.

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?
NSAIDs can cause serious side effects, including:
See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

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new or worse high blood pressure
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heart failure
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liver problems including liver failure
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kidney problems including kidney failure
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low red blood cells (anemia)
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life-threatening skin reactions
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life-threatening allergic reactions
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asthma attacks in people who have asthma
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Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness

Get emergency help right away if you get any of the following symptoms:

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shortness of breath or trouble breathing
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chest pain
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weakness in one part or side of your body
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slurred speech
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swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

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nausea
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more tired or weaker than usual
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diarrhea
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itching
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your skin or eyes look yellow
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indigestion or stomach pain
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flu-like symptoms
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vomit blood
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there is blood in your bowel movement or it is black and sticky like tar
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unusual weight gain
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skin rash or blisters with fever
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swelling of the arms, legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.
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

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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.
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Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

Active ingredients: diclofenac sodium, misoprostol.
Inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone (polyvidone) K-30, sodium hydroxide, starch (corn), talc, triethyl citrate.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For more information, go to www.pfizer.com or call 1-800-438-1985.
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LAB: 0793-9.0

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: November 2024

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