Arthrotec

DRUG DESCRIPTION

ARTHROTEC (diclofenac sodium/misoprostol) is a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog. ARTHROTEC (diclofenac sodium, misoprostol) oral tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (ARTHROTEC (diclofenac sodium, misoprostol) 50) or 75 mg (ARTHROTEC (diclofenac sodium, misoprostol) 75) diclofenac sodium surrounded by an outer mantle containing 200 mcg misoprostol.

Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are:

C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt.

Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are:

C22H38O5 [M.W. = 382.54] () methyl 11?,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in ARTHROTEC (diclofenac sodium, misoprostol) include: 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.

What are the possible side effects of diclofenac and misoprostol (Arthrotec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • ...

Read All Potential Side Effects and See Pictures of Arthrotec

What are the precautions when taking diclofenac sodium, misoprostol (Arthrotec)?

Before taking diclofenac/misoprostol, tell your doctor or pharmacist if you are allergic to either of these drugs; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG), certain liver problem (hepatic porphyria).

Before using this medication, tell your doctor or pharmacist your...

Read All Potential Precautions of Arthrotec


Arthrotec Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea and upset stomach may occur within a few weeks after you start taking this medication, and usually last for about 1 week. See How to Use for ways to reduce diarrhea.

Nausea, heartburn, gas, stomach pain, constipation, headache, tiredness, drowsiness, and dizziness may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, diarrhea can become so severe and persistent that it may lead to a large loss of your body's water and minerals (dehydration). Be sure to drink plenty of fluids and get enough minerals/electrolytes to prevent dehydration. Tell your doctor immediately if you develop any of the following signs: severe/persistent diarrhea, stomach cramps, severe dizziness, decreased amount of urine, muscle weakness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., depression), fast/pounding heartbeat, persistent/severe headache, fainting, unusual/heavy vaginal bleeding, menstrual problems/irregular periods.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, seizures.

This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking diclofenac/misoprostol and tell your doctor immediately: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diclofenac/misoprostol, tell your doctor or pharmacist if you are allergic to either of these drugs; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG), certain liver problem (hepatic porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, inflammatory bowel disease), heart disease (e.g., congestive heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), a severe loss of body water (dehydration), blood disorders (e.g., anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Diclofenac may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

The elderly may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney effects.

This medication must not be used during pregnancy. It can harm the unborn baby and mother. Use reliable forms of birth control to prevent pregnancy while taking this medication. If you become pregnant or think you may be pregnant, inform your doctor immediately. See Warning section.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Arthrotec Patient Information Including Side Effects

Brand Names: Arthrotec

Generic Name: diclofenac and misoprostol (Pronunciation: dye KLOE fen ak and mye so PROST ole)

  • What is diclofenac and misoprostol (Arthrotec)?
  • What are the possible side effects of diclofenac and misoprostol (Arthrotec)?
  • What is the most important information I should know about diclofenac and misoprostol (Arthrotec)?
  • What should I discuss with my healthcare provider before taking diclofenac and misoprostol (Arthrotec)?
  • How should I take diclofenac and misoprostol (Arthrotec)?
  • What happens if I miss a dose (Arthrotec)?
  • What happens if I overdose (Arthrotec)?
  • What should I avoid while taking diclofenac and misoprostol (Arthrotec)?
  • What other drugs will affect diclofenac and misoprostol (Arthrotec)?
  • Where can I get more information?

What is diclofenac and misoprostol (Arthrotec)?

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.

The combination of diclofenac and misoprostol is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Diclofenac and misoprostol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of diclofenac and misoprostol (Arthrotec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness; or
  • neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

  • mild stomach pain, nausea, diarrhea, bloating, gas;
  • dizziness, drowsiness, headache;
  • blurred vision, ringing in your ears; or
  • unusual vaginal bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about diclofenac and misoprostol (Arthrotec)?

Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy.

Do not use diclofenac and misoprostol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking diclofenac and misoprostol. Alcohol can increase the risk of stomach bleeding caused by diclofenac.

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