Cataflam® (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. Cataflam is available as immediate-release tablets of 50 mg (light brown) for oral administration.
Cataflam (diclofenac potassium) is a non steroidal anti inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain inflammation.
Cataflam is used to treat mild to moderate pain and to treat the signs and symptoms of rheumatoid arthritis and osteoarthritis. Cataflam is also used to treat cramping pain in the lower abdomen associated with menstruation.
Cataflam may also be used for purposes not listed in this medication guide.
Cataflam Immediate-Release Tablets is used for:
Treating rheumatoid arthritis, osteoarthritis, menstrual pain, or mild to moderate pain. It may also be used for other conditions as determined by your doctor.
Cataflam Immediate-Release Tablets is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
Cataflam has been licensed for the following uses:
Pain relief. Cataflam relieves pain caused by straining a muscle or inflammation in a tendon (tendonitis) or bursa (bursitis), as well as pain following a medical procedure.
Relief of osteoarthritis symptoms, including pain, stiffness, and swelling.
Relief of rheumatoid arthritis symptoms.
Treatment of painful menstrual periods.
Cataflam belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Like other NSAIDs, it works by blocking a specific enzyme known as cyclooxygenase (COX), blocking the production of various inflammatory substances in the body.
By blocking the effects of prostaglandins, Cataflam is useful at reducing fever and pain related to a number of conditions. This includes pain and joint swelling associated with different forms of arthritis and other diseases; and pain related to inflammation or bone, muscle, or tendon injury.
On occasion, your healthcare provider may recommend Cataflam for something other than the conditions discussed above. This is called an “off-label” use. Some examples of off-label uses of Cataflam include the relief of:
Juvenile rheumatoid arthritis symptoms
Fibromyalgia symptoms
Symptoms of systemic lupus erythematosus (SLE for short or lupus)
Gout symptoms
Cancer pain
Pain or inflammation caused by other conditions
Migraine headaches.
Possible side effects of Cataflam Immediate-Release Tablets:
All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation;
diarrhea;
dizziness;
drowsiness;
gas;
headache;
heartburn;
nausea;
stomach upset.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue);
bloody or black, tarry stools;
change in the amount of urine produced;
chest pain;
confusion;
dark urine;
depression;
fainting;
fast or irregular heartbeat;
fever, chills, or persistent sore throat;
mental or mood changes;
numbness of an arm or leg;
one-sided weakness;
red, swollen, blistered, or peeling skin;
ringing in the ears;
seizures;
severe headache or dizziness;
severe or persistent stomach pain or nausea;
severe vomiting;
shortness of breath;
sudden or unexplained weight gain;
swelling of hands, legs, or feet;
unusual bruising or bleeding;
unusual joint or muscle pain;
unusual tiredness or weakness;
vision or speech changes;
vomit that looks like coffee grounds;
yellowing of the skin or eyes.
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 use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.
Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac.
Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs 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 an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Do not use this medication if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take diclofenac:
a history of heart attack, stroke, or blood clot
heart disease, congestive heart failure, high blood pressure
a history of stomach ulcers or bleeding
liver or kidney disease,
asthma
polyps in your nose
a bleeding or blood clotting disorder; or
Do not give this medicine to a child without the advice of a doctor.
You must not use cataflam during pregnancy or if you are trying to become pregnant due to possible harm to the unborn baby and interference with normal labor/delivery.
This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Cardiovascular Effects
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events.
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Cataflam, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Fluid retention and edema have been observed in some patients taking NSAIDs. Cataflam should be used with caution in patients with fluid retention or heart failure.
NSAIDs, including Cataflam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Cataflam® (diclofenac potassium immediate-release tablets) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Cataflam in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Anemia is sometimes seen in patients receiving NSAIDs, including Cataflam. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Cataflam, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Cataflam who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross-reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Cataflam should not be administered to patients with this form of aspirin sensitivity and should be used with caution in all patients with preexisting asthma.
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
Cataflam, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up.
Cataflam, like other NSAIDs, can cause GI discomfort and, rarely, more serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up.
Cataflam, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
Patients should be informed of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help.
These reviews are from the WebMD's homepage, among other big internet sites.
Reviewer: kat, 45-54 Female on Treatment for less than 1 month (Patient)
Comment: Broke a tooth, hurt [very much]. Took cataflam and no more pain. PS no side effects.
Reviewer: ISABEL, 45-54 Female on Treatment for less than 1 month (Patient)
Comment: The Medication was prescribed for pain. Ordered to be taken three times per day.On day two I developed severe GI discomfort with lower abdominal pain and weakness.I discontinued taking the medication and treated my symptoms with Maalox. After reading the side effects I think this medication should be taken off the market, as the bad outweights the effectiveness.
Reviewer: teacher, 55-64 Female on Treatment for 10 years or more (Patient)
Comment: I have found that it is absolutely necessary to take this medication with a small amount of food. Never take on an empty stomach.
Reviewer: ttmils, 19-24 Female on Treatment for less than 1 month (Patient)
Comment: it caused no apparent side effects to me while doing its job. results were very satisfactory
Reviewer: 45-54 Female on Treatment for 1 to 6 months (Patient)
Comment: 3X DAILY FOR TENNIS ELBOW. WORKS WELL.
Reviewer:
Comment: I had a VERY painful toth ache....pain gone in less than 15 minutes....highly recommend
Review by Anonymous: User Rating: 9.0
Cataflam (diclofenac) for Pain: This is a great medication that is non-narcotic so you can get pain relief and still function. Works well for cramps as well as back pain.
Review by Anonymous: User Rating: 10
Cataflam (diclofenac) for Osteoarthritis: Works wonders on lower back pain but sometimes needs a narcotic pain killer or muscle relaxer for days when pain is more severe. Downside of this drug is that taking too much causes excruciating abdominal cramping and stabbing gas pains in the intestines. But it's an 8-hour pill, so pain relief usually lasts and it is not hard to space doses out since it lasts so long.
Review by jjs8334: User Rating: 9.0
Cataflam (diclofenac) for Osteoarthritis: This works great for my back. i have arthritis at l4 and l5 and DJD (RALLY THE SAME THING) When my back goes out I need a stroid pack but if I catch it early and start taking voltern the need for the steroid pack disappears. It also decrease my need for vicodin which I'm scared of getting hooked on. I also have had a history of ulsers so I take protonix every day. I haven't had any problems yet!
Review by pinks: User Rating: 8.0
Cataflam (diclofenac) for Back Pain: Finally found something to stop back pain.
Review by Anonymous: User Rating: 10
Cataflam (diclofenac) for Period Pain: This is the best medication I have ever used for painful periods. (It actually helped my sinus pain, as well.) I experienced no grogginess and no side effects, very just soothing and complete pain relief.