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ARTHROTEC®(misoprostol, diclofenac sodium)

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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 abortion, premature birth, birth defects, and the uterus...

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 abortion, premature birth, birth defects, and the uterus to tear (uterine rupture). 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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What is the most important information I should know about medicines containing Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:
  • ...

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

NSAIDs can cause serious side effects, including:
  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of NSAIDs
    • 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
  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death
The risk of getting an ulcer or bleeding increases with:
  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "SSRIs", or "SNRIs"
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems
NSAID containing medicines should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
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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...

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:
  • symptoms of osteoarthritis or rheumatoid arthritis in people at high risk of developing stomach (gastric) and intestinal (duodenal) ulcers while taking NSAIDs.
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What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.
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Who should not take Arthrotec?

Do not take Arthrotec:
  • if you are allergic to diclofenac, misoprostol or any other ingredients in Arthrotec. See the end of this Medication...

Who should not take Arthrotec?

Do not take Arthrotec:
  • if you are allergic to diclofenac, misoprostol or any other ingredients in Arthrotec. See the end of this Medication Guide for a list of ingredients in Arthrotec.
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
  • if you are pregnant.
  • If you currently have bleeding in your stomach (gastrointestinal bleeding).
Before taking Arthrotec, tell your healthcare provider about all of your medical conditions, including if you:
  • have liver or kidney problems.
  • have high blood pressure.
  • have asthma.
  • are pregnant or plan to become pregnant. See " Who should not take Arthrotec?"
  • are breastfeeding or plan to breast feed.
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or 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.
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What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:See "...

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)?
  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • 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:
  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • 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:
  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • 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
  • 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.
  • 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.
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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...

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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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...

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.

Embryo-Fetal Toxicity

  • 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 abortion, premature birth, birth defects and uterine rupture. Use of diclofenac may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus [see

    Infertility

    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

    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

    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

    Hepatotoxicity

    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

    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

    Anaphylactic Reactions

    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

    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

    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

    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)].

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Full Patient Information

...

Full Patient Information

Medication Guide for Arthrotec
A combination of diclofenac a Nonsteroidal Anti-inflammatory Drug (NSAID) and misoprostol a GI mucosal protective prostaglandin E1 analog
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: August 2021    
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 abortion, premature birth, birth defects, and the uterus to tear (uterine rupture). 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.

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

NSAIDs can cause serious side effects, including:
  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of NSAIDs
    • 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
  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death
The risk of getting an ulcer or bleeding increases with:
  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "SSRIs", or "SNRIs"
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems
NSAID containing medicines should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
What is Arthrotec?
Arthrotec contains 2 medicines:
  1. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). See " What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take Arthrotec?

Do not take Arthrotec:
  • if you are allergic to diclofenac, misoprostol or any other ingredients in Arthrotec. See the end of this Medication Guide for a list of ingredients in Arthrotec.
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
  • if you are pregnant.
  • If you currently have bleeding in your stomach (gastrointestinal bleeding).
Before taking Arthrotec, tell your healthcare provider about all of your medical conditions, including if you:
  • have liver or kidney problems.
  • have high blood pressure.
  • have asthma.
  • are pregnant or plan to become pregnant. See " Who should not take Arthrotec?"
  • are breastfeeding or plan to breast feed.
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or 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 "

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.

Embryo-Fetal Toxicity

  • 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 abortion, premature birth, birth defects and uterine rupture. Use of diclofenac may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus [see

    Infertility

    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

    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

    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

    Hepatotoxicity

    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

    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

    Anaphylactic Reactions

    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

    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

    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

    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)].

Read more
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