Diclofenac Sodium, Methyl Salicylate
FDA Drug Information • Also known as: Xiclofen
- Brand Names
- Xiclofen
- Route
- CUTANEOUS
- Dosage Form
- OINTMENT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
9. DESCRIPTION Xiclofen TM Ointment is a clear to white external ointment comprised of the active ingredient’s diclofenac sodium 1% and 5% methyl salicylate. Each tube is 85g (3 oz) which contains the active and inactive ingredient formulation. The outer unit box is imprinted with the Xiclofen TM Ointment logo. One tube and a package insert are included in each unit box. The inactive ingredients include: Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Arnica Montana Flower Extract, Ascorbic Acid, Boswellia Serrata Extract, Cetyl Alcohol, Chamomilla Recutita Flower Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid, Tetrasodium EDTA, Triethanolamine, Water.
What Is Diclofenac Sodium, Methyl Salicylate Used For?
1. INDICATIONS & USAGE Xiclofen TM Ointment is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.
Dosage and Administration
2. DOSAGE & ADMINISTRATION 2.1 General Dosing Instructions Use Xiclofen TM Ointment only on dry, intact (unbroken) skin. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Avoid contact with eyes and mucous membranes. Avoid showering or bathing for at least 1 hour after application of Xiclofen TM Ointment. Avoid concomitant use of Xiclofen TM Ointment on the treated skin site with other external products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other external medications. Do not use combination therapy with diclofenac sodium and an oral NSAID unless the benefit outweighs the risk and conduct periodic assessments. 2.2 Dosing and Instructions for Use Apply product directly to the skin, up to 4 times daily (8.5g per day). Clothing may be worn over the area of application. Wash hands with soap and water after handling Xiclofen TM Ointment. If irritation or a burning sensation occurs during application, stop use and advise your doctor. When Xiclofen TM Ointment is used concomitantly with other products containing non-steroidal anti-inflammatory agents, the amount absorbed from all formulations must be considered.
Drug Interactions
6. DRUG INTERACTIONS Drugs That Interfere with Hemostasis Monitor patients with concomitant use of diclofenac sodium external with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. Aspirin Concomitant use of diclofenac sodium external and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment. Diuretics During concomitant use of diclofenac sodium external with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects. Digoxin During concomitant use of diclofenac sodium external and digoxin, monitor serum digoxin levels. Lithium During concomitant use of diclofenac sodium external and lithium, monitor patients for signs of lithium toxicity. Methotrexate During concomitant use of diclofenac sodium external and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine During concomitant use of diclofenac sodium external and cyclosporine, monitor patients for signs of worsening renal function. Pemetrexed Concomitant use of diclofenac sodium external and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.
Contraindications
4. CONTRAINDICATIONS Xiclofen TM Ointment is contraindicated in patients with a known history of hypersensitivity to non-steroidal anti-inflammatory medications such as diclofenac sodium or methyl salicylate. History of asthma, urticaria, or allergic-type reactions after absorbing nonsteroidal anti-inflammatory drugs (NSAIDs) should also be considered.
Overdosage
8. OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. For additional information about overdose treatment, contact your poison control center.
How Supplied
12. HOW SUPPLIED / STORAGE & HANDLING 12.1 How Supplied Xiclofen TM Ointment is available as a unit box containing an 85g (3oz tube) and package insert. NDC 83295-5050-1 12.2 Storage Store unit box between 69 o -77 o F (20 o -25 o C). Excursions between 15 o -30 o C (59 o -86 o F) are allowed. Keep Xiclofen TM Ointment stored upright with the cap on. 12.3 Handling and Disposal Unintended exposure to methyl salicylate can cause severe irritation of eyes, skin, respiratory tract, and mucous membranes. Avoid contact with your eyes, nose, or mouth. Keep tube out of the reach of children and pets. Tube is not child resistant. Wash hands with soap and water after handling the ointment. If irritation or a burning sensation occurs during application, stop use and advise your doctor.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.