- that what I am providing is NOT meant in any way to replace the conversation between you, your doctor, or your pharmacist
- please do not self-diagnose or make medical decisions about this drug without talking with qualified professionals
- the information provided here is the reference sheet you would find at WebMD. During my journey I found this site to be helpful in providing support. All credit for this information belongs to them. I copied it right from their website and I have removed the hyper-links. Please visit their site if you would like to read further.
For this installment, I have chosen Arthrotec 50
GENERIC NAME(S): DICLOFENAC SODIUM/MISOPROSTOL
Uses
Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding).
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks or ankylosing spondylitis in people at a high risk of stomach bleeding or an ulcer.
**Please read this information carefully**
If you have any questions about what is provided here....talk with your doctor or pharmacist please.
GENERIC NAME(S): DICLOFENAC SODIUM/MISOPROSTOL
WARNINGS: This medication is a combination of 2 drugs: diclofenac and misoprostol. Do not take this medication if you are pregnant or think that you may be pregnant. Misoprostol may cause loss of pregnancy, premature birth, or birth defects. In rare cases, serious problems (such as uterine rupture) have occurred when misoprostol was used to start labor or used in combination with another drug to end pregnancy after the eighth week. These problems have caused harm to the mother and unborn baby.
Avoid pregnancy while taking this medication and for at least one month or one complete menstrual cycle after you have stopped treatment. If you become pregnant while taking this medication, contact your doctor right away.
If you are of a woman of childbearing age, do not use this medication unless you need a nonsteroidal anti-inflammatory drug (NSAID) such as diclofenac and you are at high risk of having an ulcer or ulcer complications from NSAID treatment.
Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within 2 weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking this medication only on the second or third day of the next normal menstrual period.
This medication must not be shared with others.
Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).
Also, diclofenac may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect.
Stop taking this medication and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.
Talk to your doctor or pharmacist about the benefits and risks of taking this drug.
Uses
Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding).
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks or ankylosing spondylitis in people at a high risk of stomach bleeding or an ulcer.
How to use Arthrotec 50
Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication.
Swallow the tablets whole. Do not crush, chew, or dissolve the tablets. Doing so can increase the risk of side effects. Do not take tablets that are broken.
Take this medication with food to prevent stomach upset and to reduce the chances of diarrhea. Avoid taking antacids that contain magnesium while using this medication because they may worsen diarrhea. If you need an antacid, consult your doctor or pharmacist to help you choose a product.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. For ongoing conditions such as arthritis, keep taking this medication as directed. Discuss the risks and benefits with your doctor or pharmacist.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take up to 2 weeks of taking this drug regularly before you get the full benefit.
Tell your doctor if your condition does not get better or if it gets worse.
Side Effects
See also Warning section.
Diarrhea and stomach/abdominal pain may occur within a few weeks after you start taking this medication, and usually last for about one week. Nausea, heartburn, gas, upset stomach, drowsiness, and dizziness may also occur. If any of these effects last or get worse, tell 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.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Diarrhea that is severe or doesn't stop may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.
Tell your doctor right away if you have any serious side effects, including: difficult/painful swallowing, swelling of the ankles/feet/hands, sudden/unexplained weight gain, hearing changes (such as ringing in the ears), mental/mood changes (such as depression), easy bruising/bleeding, unusual tiredness, unusual/heavy vaginal bleeding, menstrual problems/irregular periods.
Get medical help right away if you have any very serious side effects, including: change in amount of urine, unexplained stiff neck, seizures.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Arthrotec 50 side effects by likelihood and severity
The following side effects are associated with Arthrotec 50:
Common side effects of Arthrotec 50:
Chronic Trouble Sleeping Less Severe
Diarrhea Less Severe
Feel Like Throwing Up Less Severe
Head Pain Less Severe
Incomplete or Infrequent Bowel Movements Less Severe
Indigestion Less Severe
Stomach Cramps Less Severe
Throwing Up Less Severe
Infrequent side effects of Arthrotec 50:
Abnormal Liver Function Tests Severe
Itching Severe
Rash Severe
Ringing in the Ears Severe
Stomach or Intestinal Ulcer Severe
Swelling of the Abdomen Severe
Ulcer from Stomach Acid Severe
Ulcers of Esophagus Severe
Visible Water Retention Severe
Water Retention Severe
Dizzy Less Severe
Gas Less Severe
Rare side effects of Arthrotec 50:
A Rupture in the Wall of the Stomach or Intestine Severe
Abnormal Heart Rhythm Severe
Acquired Decrease of All Cells in the Blood Severe
Acute Inflammation of the Pancreas Severe
Anemia Severe
Black Tarry Stools Severe
Bleeding Not Related to Menstrual Period Severe
Bleeding of the Stomach or Intestines Severe
Blood Clot Severe
Bloody Urine Severe
Bronchospasm Severe
Chronic Heart Failure Severe
Decreased Blood Platelets Severe
Decreased White Blood Cells Severe
Deficiency of Granulocytes a Type of White Blood Cell Severe
Elevation of Proteins in the Urine Severe
Erythema Multiforme Severe
Giant Hives Severe
Hearing Problem Severe
Heart Attack Severe
Hemolytic Anemia Severe
Hemorrhage Severe
Hepatitis Severe
High Blood Pressure Severe
Hives Severe
Increased Eosinophils in the Blood Severe
Inflammation of Skin caused by an Allergy Severe
Inflammation of the Esophagus Severe
Inflammation of the Large Intestine Severe
Inflammation of the Skin with Blisters Severe
Interstitial Nephritis Severe
Kidney Damage Severe
Kidney Disease Severe
Kidney Failure Severe
Kidney Problems Causing a Decreased Amount of Urine to be Passed Severe
Life Threatening Allergic Reaction Severe
Liver Tissue Death Severe
Loss of Memory Severe
Low Blood Counts due to Bone Marrow Failure Severe
Meningitis Not Caused by an Infection Severe
Nephrotic Syndrome Severe
Nosebleed Severe
Obstruction of a Blood Vessel by a Blood Clot Severe
Red Blood in Bowel Movement Severe
Renal Papillary Necrosis Severe
Seizures Severe
Skin Rash with Sloughing Severe
Stevens-Johnson Syndrome Severe
Stroke Severe
Tearing of the Uterus while Pregnant Severe
Throwing Up Blood Severe
Toxic Epidermal Necrolysis Severe
Trouble Breathing Severe
Yellowing of Skin or Eyes from Liver Problems Severe
Abnormally Low Blood Pressure Less Severe
Acute Infection of the Nose, Throat or Sinus Less Severe
Anxious Less Severe
Breast Tenderness Less Severe
Change in Appetite Less Severe
Chest Pain Less Severe
Chills Less Severe
Confused Less Severe
Depression Less Severe
Difficult or Painful Urination Less Severe
Difficulty Swallowing Less Severe
Drowsiness Less Severe
Dry Mouth Less Severe
Easily Angered or Annoyed Less Severe
Excess Urination Less Severe
Excessive Sweating Less Severe
Fast Heartbeat Less Severe
Feeling Faint Less Severe
Feeling Weak Less Severe
Fever Less Severe
Hair Loss Less Severe
Heart Throbbing or Pounding Less Severe
Hemorrhage of Blood Under the Skin Less Severe
Inability to have an Erection Less Severe
Inflammation of a Vein Less Severe
Inflammation of the Gums Less Severe
Involuntary Quivering Less Severe
Large Purple or Brown Skin Blotches Less Severe
Loss of Skin Color Less Severe
Low Energy Less Severe
Muscle Pain Less Severe
Painful Periods Less Severe
Painful, Red or Swollen Mouth Less Severe
Pink Eye Less Severe
Problem with Periods Less Severe
Problems with Eyesight Less Severe
Skin Inflammation Less Severe
Sun-Sensitive Skin Less Severe
Taste Problems Less Severe
Temporary Redness of Face and Neck Less Severe
Uterine Cramps Less Severe
Weight Loss Less Severe
Precautions
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to diclofenac or misoprostol; or to aspirin or other NSAIDs (such as 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers), heart disease (such as previous heart attack), high blood pressure, stroke, swelling (edema, fluid retention), blood disorders (such as anemia), bleeding/clotting problems, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps).
Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.
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, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.
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.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney problems.
This medication must not be used during pregnancy. It may harm the mother and unborn baby. Use reliable forms of birth control to prevent pregnancy while taking this medication and for at least one month or one completed menstrual cycle after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.
This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Interactions
See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, corticosteroids (such as dexamethasone, prednisone), lithium, methotrexate, "water pills" (diuretics such as furosemide).
This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should keep taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
Overdose
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: diarrhea that doesn't stop, severe stomach pain, severe drowsiness, slow/shallow breathing, seizures.
Notes
Do not share this medication with others.
Lab and/or medical tests (such as complete blood count, liver/kidney function, blood pressure) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Lifestyle changes (such as weight loss if needed, strengthening/conditioning exercises) may help improve your flexibility and joint function. Consult your doctor for specific instructions.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised November 2015. Copyright(c) 2015 First Databank, Inc.