What is Roxifen?
Roxifen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Roxifen works by reducing hormones that cause inflammation and pain in the body.
Roxifen is used to treat pain or inflammation caused by arthritis.
Roxifen may also be used for other purposes not listed in this medication guide.
Roxifen (Feldene) is a non-steroidal anti-inflammatory drug (NSAID) indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, eg, as rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (arthrosis, degenerative joint disease), ankylosing spondylitis, acute musculoskeletal disorders, acute gout, pain after operative intervention and following acute trauma, for the treatment of primary dysmenorrhea in patients ≥12 years and for the relief of fever and pain associated with acute upper respiratory tract inflammation.
How should I use Roxifen?
Use Roxifen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Roxifen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Roxifen refilled.
- Take Roxifen 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 Roxifen with a full glass (8 oz [240 mL]) of water as directed by your doctor.
- If you miss a dose of Roxifen 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 Roxifen.
Uses of Roxifen in details
Roxifen is used to relieve swelling, stiffness and joint pain in various diseases of the joints like osteoarthritis and rheumatoid arthritis.
Roxifen 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. Roxifen 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.
Undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms.
Rheumatoid Arthritis, Osteoarthritis (Arthrosis, Degenerative Joint Disease) and Ankylosing Spondylitis: The recommended starting dose 20 mg given as a single daily dose. The majority of patients will be maintained on 20 mg daily. A relatively small group of patients may be maintained on 10 mg daily.
Acute Gout: Because of its GI safety profile, Roxifen (Feldene) should not be used in first-line treatment for acute gout when an NSAID is indicated. For same reason, it should be used to treat acute gout in patients most at risk of developing serious GI adverse events. Therapy should be initiated by a single dose of 40 mg, followed on the next 4-6 days with 40 mg daily, given in single or divided doses. Roxifen (Feldene) is not indicated for the long term management of gout.
Acute Musculoskeletal Disorders: Because of its GI safety profile, Roxifen (Feldene) should not be used in first-line treatment for acute musculoskeletal disorders when an NSAID is indicated. For the same reason, it should not be used to treat acute musculoskeletal disorders in patients most at risk of developing serious GI adverse events. Therapy should be initiated with 40 mg daily for the first two days given in single or divided doses. For the remainder of the 7 to 14 day treatment period, the dose should be reduced to 20 mg daily.
Postoperative and Post-traumatic Pain: The recommended dose is 20 mg given in a single daily dose.
Dysmenorrhea: Because of its GI safety profile, Roxifen (Feldene) should not be used in first-line treatment for dysmenorrhea when NSAID is indicated. For the same reason, it should not be used to treat dysmenorrhea in patients most at risk of developing serious GI adverse events. The treatment of primary dysmenorrhea is initiated at the earliest onset of symptoms with a recommended starting dose of 40 mg given in a single daily dose for the first two days. Treatment may be continued thereafter with a single daily dose of 20 mg for the next one to three days as necessary.
Upper Respiratory Tract Inflammation: The adult dosage is 10 mg or 20 mg once daily for five to seven days.
Juvenile Rheumatoid Arthritis (JRA): The recommended dosage for children with JRA are based on body weight as follows: Children less than or equal to 15 kg: 5 mg. 16 to 25 kg: 10 mg. 26 to 45 kg: 15 mg. Greater than or equal to 46 kg: 20 mg.
The drug should be taken once daily. The dispersible tablet may be used to obtain the exact dose required.
Oral (Capsules, Fast Dissolving): Roxifen (Feldene Flash) fast-dissolving tablets may be swallowed with water or placed on the tongue to disperse and then swallowed with saliva or water as a suspension. Roxifen (Feldene) fast-dissolving tablet dissolves almost instantly in the mouth in the presence of water or saliva.
Combined Administration: The total daily dosage of Roxifen (Feldene) administered as capsule and fast dissolving tablet should not exceed the maximum recommended daily dosage as indicated previously.
Acetylsalicylic Acid: As with other NSAIDs, the use of Roxifen 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 Roxifen and acetylsalicylic acid resulted in a reduction of plasma levels of Roxifen to about 80% of the normal values.
Roxifen 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 Roxifen has been administered to patients on coumarin type anticoagulants. Patients should be monitored closely if Roxifen and oral anticoagulants are administered together.
Roxifen, 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 Roxifen 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 Roxifen 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 Roxifen or either drug.
Cimetidine: Results of 2 separate studies indicate a slight increase in the absorption of Roxifen following cimetidine administration but no significant changes in elimination parameters. Cimetidine increases the AUC0-120hrs and Cmax of Roxifen 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 Roxifen. To minimize this interaction, it is prudent to administer Roxifen 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: Roxifen 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 Roxifen to patients on highly protein-bound drugs. NSAID, including Roxifen, have been reported to increase steady-state plasma lithium levels. It is recommended that these levels be monitored when initiating, adjusting and discontinuing Roxifen (Feldene).
Methotrexate: When methotrexate is administered concurrently with NSAIDs, including Roxifen, 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.
Roxifen side effects
Applies to Roxifen: oral capsule, oral tablet
As well as its needed effects, Roxifen may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Roxifen, check with your doctor immediately:
- bloody or black, tarry stools
- burning upper abdominal or stomach pain
- cloudy urine
- decrease in urine output or decrease in urine-concentrating ability
- itching skin or rash
- loss of appetite
- nausea or vomiting
- pale skin
- severe abdominal or stomach pain, cramping, or burning
- severe and continuing nausea
- swelling of the face, fingers, feet, or lower legs
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight changes
- Bleeding gums
- blood in the urine
- bloody nose
- blurred vision
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- clay-colored stools
- cough or hoarseness
- dark urine
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with swallowing
- dilated neck veins
- extreme fatigue
- fever or chills
- flushing or redness of the skin
- frequent urge to urinate
- increased sensitivity of the skin to sunlight
- increased thirst
- increased volume of pale, dilute urine
- large, flat, blue, or purplish patches in the skin
- lower back or side pain
- noisy breathing
- numbness or tingling in the hands, feet, or lips
- pain or burning in the throat
- peeling of the skin
- pinpoint red or purple spots on the skin
- pounding in the ears
- rapid, shallow breathing
- redness or other discoloration of the skin
- redness, swelling, or soreness of the tongue
- severe sunburn
- slow, fast, pounding, or irregular heartbeat or pulse
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stomach upset
- swelling or inflammation of the mouth
- swollen glands
- tenderness in the stomach area
- tightness in the chest
- unpleasant breath odor
- unusually warm skin
- weakness or heaviness of the legs
- yellow eyes or skin
- back or leg pains
- burning, dry, or itching eyes
- cold sweats
- cracks in the skin
- discharge or excessive tearing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- general body swelling
- general feeling of discomfort or illness
- high fever
- increased hunger
- increased urination
- inflammation of the joints
- irregular, fast or slow, or shallow breathing
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of heat from the body
- muscle aches and pains
- no blood pressure
- no breathing
- no pulse
- pain or discomfort in the arms, jaw, back, or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale or blue lips, fingernails, or skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny nose
- scaly skin
- seeing, hearing, or feeling things that are not there
- severe headache
- slurred speech
- sores, welting, or blisters
- stiff neck or back
- stomach pain, continuing
- suddenly sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble sleeping
If any of the following symptoms of overdose occur while taking Roxifen, get emergency help immediately:
Symptoms of overdose:
- muscle twitching
- pain or discomfort in the chest, upper stomach, or throat
- rapid weight gain
- swelling of the ankles or hands
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Minor Side Effects
Some Roxifen side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
- Acid or sour stomach
- continuing ringing or buzzing or other unexplained noise in the ears
- excess air or gas in the stomach or intestines
- hearing loss
- passing gas
- stomach discomfort or upset
- Feeling of constant movement of self or surroundings
- hair loss or thinning of the hair
- lack or loss of strength
- sensation of spinning
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
- Change in hearing
- changes in appetite
- inability to sit still
- mood alterations
- need to keep moving
Roxifen is contraindicated in: Patients with active peptic ulcerations.
Patients with active or history of gastrointestinal ulceration, bleeding, perforation or any gastrointestinal disorders that pre-dispose to bleeding such as Crohn’s disease, ulcerative colitis, gastrointestinal cancers or diverticulitis.
Patients with a history of previous serious allergic drug reaction of any type such as Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme.
Patients with known hypersensitivity to Roxifen or to any of the excipients, or had previous skin reaction to Roxifen, other NSAIDs or other medications. The potential exists for cross sensitivity to aspirin and other NSAIDs. Roxifen should not be given to patients in whom aspirin and other NSAIDs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.
Patients on concomitant NSAIDs or anticoagulants.
Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Patients with severe renal and hepatic failure.
Patients with severe heart failure.
Active ingredient matches for Roxifen:
Piroxicam in Philippines, Thailand.
Ceftriaxone in Philippines, Thailand.
Ceftriaxone Na in Philippines.
- DailyMed. "CEFTRIAXONE SODIUM: 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/dailymed/se... (accessed September 18, 2017).
- PubChem. "isoniazid". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).
- PubChem. "piroxicam". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).
- PubChem. "ceftriaxone". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).
ReviewsThe results of a survey conducted on ndrugs.com for Roxifen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Roxifen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
1 consumer reported price estimatesWas the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Roxifen drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
1 consumer reported age
Information checked by Dr. Sachin Kumar, MD Pharmacology