Brand Name

Arthrotec {Pfizer}

Generic Name

diclofenac and misoprostol, pronounced dye KLOE fen ak and mye so PROSTole

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Arthrotec?

Arthrotec is used to treat patients with osteoarthritis and rheumatoid arthritis, particularlythose people at a high risk for developing stomach or intestinal ulcers. The diclofenac inArthrotec is a medication to help relieve pain and inflammation in your body, and is anonsteroidal anti-inflammatory drug (NSAID). The misoprostol helps to reduce stomach acid andreplace protective substances in your stomach that may be reduced by taking NSAIDs.

You may be prescribed Arthrotec for purposes not listed in this medication guide

Key Facts About Arthrotec

The misoprostol in Arthrotec can cause birth defects, miscarriage, premature labor, or arupture of the uterus if this medication is taken during pregnancy. Diclofenac can cause birthdefects if it is taken during the last 3 months of pregnancy. You should not take Arthrotec ifyou are pregnant. Tell your doctor immediately if you become pregnant during treatment withArthrotec and be sure to use an effective form of birth control while you are using thismedication. Arthrotec is in FDA pregnancy category X. You should not breast-feed while takingArthrotec. You will need to have a pregnancy test within 2 weeks of starting treatment withArthrotec.

The use of Arthrotec may cause heart or circulation problems, which can be life threatening.These problems may include heart attack or stroke, particularly if you use Arthrotec on along-term basis.

You should not use Arthrotec before or after heart bypass surgery.

Rarely , Arthrotec may cause serious intestinal or stomach bleeding or perforations(forming of holes). These conditions are more likely to happen to older adults, and they can
occur without warning and be fatal. You should contact your doctor immediately if you experiencesymptoms which may indicate intestinal bleeding, like tarry or bloody stools, or if you cough orvomit blood or a substance that looks like coffee grounds.

You should not drink alcohol while taking Arthrotec. You increase your risk of stomachbleeding if you drink alcohol while taking Arthrotec.

Arthrotec may also be used for purposes not listed in this medication guide.

Before You Take Arthrotec

If you are allergic to diclofenac or misoprostol you should not take Arthrotec.

If you have an allergy or a history of allergic reactions to diclofenac (Cataflam) misoprostol(Cytotec), aspirin, sulfa drugs, or other NSAIDs you should not take Arthrotec.

Tell your doctor if you have a history of heart attack, stroke, blood clots, heart disease,congestive heart failure or high blood pressure.

Before starting treatment with Arthrotec tell your physician if you have a history of stomachulcers or bleeding, liver disease, kidney disease or asthma.

If you have polyps in your nose, porphyria or a bleeding or blood clotting disorder you shouldtell your doctor.

Inform your doctor if you smoke or drink more than three alcoholic beverages a day.

Ask your doctor before you take any cold, allergy, or pain medications, as many of these maybe similar to Arthrotec especially those that are combination treatments.

You should not take other NSAID’s (non-steroidal anti-inflammatory drugs) like aspirin,ibuprofen, ketoprofen, or naproxen while you are taking Arthrotec.

Arthrotec Drug Interactions

You should inform your doctor if you are taking any of the following:

• ACE inhibitors such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil,
  Zestril), quinapril (Accupril), or ramipril (Altace)
• aspirin
• blood thinners like warfarin (Coumadin)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze)
• digoxin (Lanoxin)
• diuretics (water pills)
• etodolac (Lodine)
• ibuprofen (Motrin, Advil)
• indomethacin (Indocin)
• insulin or diabetes medications (oral)
• lithium (Eskalith, Lithobid)
• meloxicam (Mobic)
• methotrexate (Rheumatrex, Trexall)
• naproxen (Aleve, Naprosyn, Naprelan, Treximet)
• phenobarbital (Luminal, Solfoton)
• steroids like prednisone

Other drugs you take that are not listed may interact with Arthrotec. You should tell yourdoctor about all of the medications you use. This includes prescription drugs, vitamins,supplements and herbal products, and over the counter medications. You should not begin taking anew medication without telling your doctor first.

Directions for Taking Arthrotec

Arthrotec may be taken with or without food. If you are concerned that Arthrotec may upsetyour stomach you may take it with food or milk to lessen any potential stomach upset.

You should take Arthrotec exactly as prescribed by your doctor. Do not take Arthrotec inlarger or smaller amounts, or for shorter or longer than recommended. Follow the directions onyour prescription label.

Swallow Arthrotec whole. Do not break, chew or crush the tablet.

You should avoid taking antacids unless your doctor tells you to do so. Use only the type ofantacid your doctor recommends. There are some antacids that can make it harder for your body toabsorb Arthrotec

Your doctor may want to have your blood tested often if you take Arthrotec long-term.

You should avoid direct sunlight while taking Arthrotec, as well as tanning beds. Arthroteccan make you sunburn more easily. Wear protective clothing outside and use a sunscreen of SPF 30or higher.

Arthrotec needs to be stored at room temperature, and away from light, moisture and heat.

If you miss a dose of Arthrotec you should attempt to take the missed dose as soon as youremember. However, if it is almost time for your next scheduled dose do not take the missed dosein addition to your regular dose.

Arthrotec Side Effects

If you experience any of the following adverse effects you should stop taking Arthrotec andseek emergency medical help immediately:

• allergic reaction such as breathing difficulties, hives, swelling of your face., throat ortongue
• bloody, black or tarry stools
• bruising or bleeding
• clay-colored stools
• chest pain
• coughing up blood, or vomit, that looks like coffee grounds
• itching and skin rash
• jaundice (yellowing of your skin)
• loss of appetite
• muscle pain
• nausea
• neck stiffness with chills, increased sensitivity to light and purple spots on your skin
• numbness or tingling
• problems with balance or vision
• rapid weight gain
• seizures or convulsions
• shortness of breath
• skin pain, flowed by a purple or red rash which spread, mostly in your face or upper body, andcauses blistering or peeling
• slurred speech
• swelling of your face, tongue, extremities
• upper stomach pain
• urinating less than normal or not at all
• weakness

Less serious side effects of Arthrotec may include:

• bloating
• diarrhea
• dizziness
• drowsiness
• gas
• headache
• nausea
• ringing in your ears
• upset stomach
• vaginal bleeding that is unusual

It should be noted that this is not a complete list of possible side effects of Arthrotec. Youshould contact your physician for a complete list and medical advice regarding these effects.

Arthrotec Description and Dosing

Arthrotec oral tablets are white to off-white, round, biconvex, and approximately 11 mm indiameter. Each tablet consists of an enteric-coated core containing 50 mg (Arthrotec 50) or 75 mg(Arthrotec 75) diclofenac sodium surrounded by an outer mantle containing 200 mcg of misoprostol.The 50 mg/200 mcg dosage strength is a round, biconvex, white to off-white and imprinted withfour “A’s” encircling a “50” in the middle on one side and “SEARLE” and “1411” on the other side.The 75 mg/200 mcg dosage strength is a round, biconvex, white to off-white and imprinted withfour “A’s” encircling a “75” in the middle on one side and “SEARLE” and “1421” on the otherside.

You should consult your doctor for specific dosing pertaining to you regarding Arthrotec. Donot attempt to alter or change your dose without your physician’s consent.

If you suspect that you have overdosed with Arthrotec you should seek emergency helpimmediately.

Ingredients in Arthrotec

The primary active ingredients in Arthrotec are diclofenac and misoprostol. Inactiveingredients in Arthrotec include colloidal silicon dioxide, crospovidone, hydrogenated castoroil, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, microcrystallinecellulose, povidone (polyvidone) K-30, sodium hydroxide, starch (corn), talc and triethylcitrate.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.