Pirofel Gel is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Pirofel Gel works by reducing hormones that cause inflammation and pain in the body.
Pirofel Gel is used to treat pain or inflammation caused by arthritis.
Pirofel Gel may also be used for other purposes not listed in this medication guide.
Pirofel Gel indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Carefully consider the potential benefits and risks of Pirofel Gel and other treatment options before deciding to use Pirofel Gel. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Pirofel Gel is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
How should I use Pirofel Gel?
Use Pirofel Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Pirofel Gel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pirofel Gel refilled.
Take Pirofel Gel by mouth. It may be taken with food if it upsets your stomach. This may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor if you have persistent stomach upset.
Take Pirofel Gel with a full glass (8 oz [240 mL]) of water as directed by your doctor.
If you miss a dose of Pirofel Gel and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Pirofel Gel.
Uses of Pirofel Gel in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Arthritis: Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Off Label Uses
Ankylosing spondylitis
In a systematic review and metaanalysis of trials evaluating the treatment of ankylosing spondylitis, the use of Pirofel Gel was shown to be safe and effective (Kroon 2015). The American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommend NSAIDS in the treatment of ankylosing spondylitis (Ward 2016).
Pirofel Gel description
Pirofel Gel is 4-Hydroxy-2-methyl-N-2-pyridinyl-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide, an oxicam. Members of the oxicam family are not carboxylic acids, but they are acidic by virtue of the enolic 4-hydroxy substituent. Pirofel Gel occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohols and in aqueous alkaline solution. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8).
It has a molecular formula of C15H13N3O4S and molecular weight of 331.35.
Pirofel Gel dosage
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Pirofel Gel Dosage
Generic name: Pirofel Gel 10mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Carefully consider the potential benefits and risks of Pirofel Gel and other treatment options before deciding to use Pirofel Gel. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Pirofel Gel, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of Pirofel Gel, steady-state blood levels are not reached for 7–12 days. Therefore, although the therapeutic effects of Pirofel Gel are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.
Acetylsalicylic Acid: As with other NSAIDs, the use of Pirofel Gel in conjunction with acetylsalicylic acid or the concomitant use of 2 NSAIDs is not recommended because data are inadequate to demonstrate that the combination produces greater improvement than that achieved with the drug alone and the potential for adverse reactions is increased.
Studies in man have shown that the concomitant administration of Pirofel Gel and acetylsalicylic acid resulted in a reduction of plasma levels of Pirofel Gel to about 80% of the normal values.
Pirofel Gel interferes with the antiplatelet effect of low-dose aspirin, and thus may interfere with aspirins prophylactic treatment of cardiovascular disease.
Anticoagulants: Bleeding has been reported rarely when Pirofel Gel has been administered to patients on coumarin type anticoagulants. Patients should be monitored closely if Pirofel Gel and oral anticoagulants are administered together.
Pirofel Gel, like other NSAID, decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Antacids: Concomitant administration of antacids had no effect on Pirofel Gel plasma levels.
Antihypertensives Including Diuretics, Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin II Antagonists (AIIA) and β-Blockers: NSAIDs can reduce the efficacy of diuretics and other antihypertensive drugs including ACE inhibitors, AIIA and β-blockers.
In patients with impaired renal function (eg, dehydrated patients or elderly patients with the renal function compromised), the co-administration of an ACE inhibitor or an AIIA with a cyclooxygenase inhibitor can increase the deterioration of the renal function, including the possibility of acute renal failure, which is usually reversible.
The occurrence of these interactions should be considered in patients taking Pirofel Gel with an ACE inhibitor or an AIIA and/or diuretics. Therefore, the concomitant administration of these drugs should be done with caution, especially in elderly patients. Patients should be adequately hydrated and the need to monitor the renal function should be assessed in the beginning of the concomitant treatment and periodically thereafter.
Cardiac Glycosides (Digoxin and Digitoxin): NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside levels. Concomitant administration of digoxin or digitoxin had no effect on the plasma levels of Pirofel Gel or either drug.
Cimetidine: Results of 2 separate studies indicate a slight increase in the absorption of Pirofel Gel following cimetidine administration but no significant changes in elimination parameters. Cimetidine increases the AUC0-120hrs and Cmax of Pirofel Gel by approximately 13-15%. Elimination rate constants and t½ show no significant differences. The small but significant increase in absorption is unlikely to be clinically significant.
Cholestyramine: Cholestyramine has been shown to enhance the oral clearance and decrease the t½ of Pirofel Gel. To minimize this interaction, it is prudent to administer Pirofel Gel at least 2 hrs before or 6 hrs after cholestyramine.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.
Cyclosporine: Increased risk of nephrotoxicity.
Lithium and Other Protein-Bound Agents: Pirofel Gel is highly protein-bound and therefore, might be expected to displace other protein-bound drugs. The physician should closely monitor patients for change in dosage requirements when administering Pirofel Gel to patients on highly protein-bound drugs. NSAID, including Pirofel Gel, have been reported to increase steady-state plasma lithium levels. It is recommended that these levels be monitored when initiating, adjusting and discontinuing Pirofel Gel.
Methotrexate: When methotrexate is administered concurrently with NSAIDs, including Pirofel Gel, NSAIDs may decrease elimination of methotrexate resulting in increased plasma levels of methotrexate. Caution is advised, especially in patients receiving high doses of methotrexate.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Pirofel Gel is generally well tolerated. Gastrointestinal symptoms are the most commonly encountered side effects but in most instances do not interfere with the course of therapy.
Objective evaluations of gastric mucosal appearances and intestinal blood loss show that Pirofel Gel 20 mg/day administered either in single or divided daily doses is significantly less irritating to the gastrointestinal tract than acetylsalicylic acid.
Blood and Lymphatic System Disorders: Anemia, aplastic anemia, eosinophilia, hemolytic anemia, leucopenia, thrombocytopenia.
Immune System Disorders: Anaphylaxis, serum sickness.
Metabolism and Nutrition Disorders: Anorexia, hyperglycemia, hypoglycemia, fluid retention.
Hepatobiliary Disorders: Fatal hepatitis, jaundice. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash), Pirofel Gel should be discontinued.
Reproductive System and Breast Disorders: Decreased female fertility.
General Disorders and Administration Site Conditions: Edema (mainly of the ankle), local adverse reactions (burning sensation) or tissue damage (sterile abscess formation, fatty tissue necrosis) at the site of injection, malaise, transient pain upon injection.
Investigations: Positive ANA, reversible elevations of BUN and creatinine, decreases in hemoglobin and hematocrit unassociated with obvious gastrointestinal bleeding, increased serum, transaminase levels, increased and decreased weight.
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 Pirofel Gel. 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 Pirofel Gel. 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 Pirofel Gel (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 Pirofel Gel. Alcohol can increase the risk of stomach bleeding caused by Pirofel Gel.
Avoid exposure to sunlight or artificial UV rays. Pirofel Gel can make your skin more sensitive to sunlight and sunburn may result.
DailyMed. "PIROXICAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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