Xiclofen

What is Xiclofen?

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.

Uses of Xiclofen

Established uses

• 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.

How to take Xiclofen

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 formulatio

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

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 formulatio

Side effects of Xiclofen

Warnings and who should not take it

Who should NOT take Xiclofen?

• 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.

Overdose

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.

Interactions

Medicine and medicine

• 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.

Frequently asked questions