Xyron

Carefully consider the potential benefits and risks of Xyron delayed-release tablets and other treatment options before deciding to use Xyron delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Xyron delayed-release tablets are indicated:

Xyron is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, Xyron does not cure osteoarthritis and will help you only as long as you continue to use it.

Xyron topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical Xyron helps this condition is unknown.

Xyron topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.

Xyron topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

Xyron is available only with your doctor's prescription.

Carefully consider the potential benefits and risks of Xyron extended-release tablets, and other treatment options before deciding to use Xyron extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Xyron extended-release tablets the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of osteoarthritis, the recommended dosage is 100 mg daily.

For the relief of rheumatoid arthritis, the recommended dosage is 100 mg daily. In the rare patient where Xyron extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day if the benefits outweigh the clinical risks of increased side effects.

Different formulations of Xyron (Xyron enteric-coated tablets; Xyron extended-release tablets; Xyron potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

See also:
What is the most important information I should know about Xyron?

Xyron in all formulations, Xyron, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Xyron and Xyron-containing products. Xyron should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to Xyron have been reported in such patients.

Use Xyron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Xyron comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Xyron refilled.
• Do not apply Xyron to infected skin; open wounds; or red, swollen, or peeling skin.
• Wash your hands immediately before and after using Xyron.
• Wash the affected area and dry completely before using Xyron.
• To apply Xyron, dispense 10 drops at a time onto the knee or into your hand. Spread Xyron evenly around the front, back, and sides of the knee. Repeat until you have used the whole dose.
• Be sure that you cover your entire knee with your dose of Xyron. Do not use more than the recommended amount.
• Do not apply sunscreens, cosmetics, insect repellants, other topical medicines, or any other substance to the treated area until it is completely dry.
• Do not put on clothes over the treated area until it is completely dry.
• Do not wrap, bandage, or apply heat to the treated area.
• Let the treated skin dry before touching it or letting it touch anyone else's skin.
• Do not shower, bathe, or wash the treated area for at least 30 minutes after you use Xyron.
• If you miss a dose of Xyron, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xyron.

Xyron is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

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.

How to use Xyron

Read the Medication Guide provided by your pharmacist before you start using Xyron 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 drug. To prevent stomach upset, take this medication with food, milk, or an antacid.

There are different brands and forms of this medication available. Because different brands deliver different amounts of medication, do not switch brands of Xyron without your doctor's permission and directions.

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 minimize side effect risks (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For chronic conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 2 weeks of regular use before the full benefits of this drug take effect.

If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your condition worsens.

See also:
What other drugs will affect Xyron?

Aspirin: Concomitant administration of Xyron and aspirin is not recommended because Xyron is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.

Anticoagulants: While studies have not shown Xyron to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Xyron, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Xyron, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Xyron may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Xyron or who increase their Xyron dose or any other NSAID while taking digoxin, methotrexate, or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.

Lithium: Xyron decreases lithium renal clearance and increases lithium plasma levels. In patients taking Xyron and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics:

Diuretics: Xyron and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.

Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect the peak levels and AUC values of Xyron. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Xyron therapy.

Protein Binding

In vitro, Xyron interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of Xyron in human serum.

Drug/Laboratory Test Interactions

Effect on Blood Coagulation: Xyron increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. Xyron is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.

See also:
What are the possible side effects of Xyron?

Ocular

Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Xyron ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Xyron ophthalmic solution, 0.1%, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.

Systemic

The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection and vomiting.

Clinical Practice

The following reactions have been identified during postmarketing use of topical Xyron ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical Xyron ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration and epithelilal breakdown.

TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.