Diclofenac
Generic Name: diclofenac
Brand Names:
Xiclo
9. DESCRIPTION Xiclo™ Transdermal Patch is comprised of an adhesive material containing 1.25% diclofenac. Each patch is 2 in x 4 in (5.06 cm x 10.16 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Xiclo™ Transdermal Patch logo. 2 patches are in each pouch bag.
Overview
9. DESCRIPTION Xiclo™ Transdermal Patch is comprised of an adhesive material containing 1.25% diclofenac. Each patch is 2 in x 4 in (5.06 cm x 10.16 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Xiclo™ Transdermal Patch logo. 2 patches are in each pouch bag.
Uses
1. INDICATIONS & USAGE Xiclo™ Transdermal Patch 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
2. DOSAGE & ADMINISTRATION 2.1 General Dosing Instructions Use Xiclo™ Transdermal Patch 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 concomitant use of Xiclo™ Transdermal Patch 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 and an oral NSAID unless the benefit outweighs the risk and conduct periodic assessments. 2.2 Dosing and Instructions for Use Tear open pouch bag and remove one patch. Place remaining patches back in pouch bag and seal pouch bag closed.
Interactions
6. DRUG INTERACTIONS Drugs That Interfere with Hemostasis Monitor patients with concomitant use of diclofenac 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 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.
Warnings
5. WARNINGS, PRECAUTIONS & ADVERSE REACTIONS 5.1 Risk of Serious Cardiovascular and Gastrointestinal Events Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs, including diclofenac, can lead to new onset of hypertension, or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. 4. CONTRAINDICATIONS Xiclo™ Transdermal Patch is contraindicated in patients with a known history of hypersensitivity to non-steroidal anti-inflammatory medications such as diclofenac. Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Storage
12. HOW SUPPLIED / STORAGE & HANDLING 12.1 How Supplied Xiclo™ Transdermal Patch comes in a sealed pouch bag. Each patch is 2 in x 2 in (5.08 cm x 10.16 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, plastic film.
Frequently Asked Questions
What is Diclofenac used for?▼
1. INDICATIONS & USAGE Xiclo™ Transdermal Patch 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.
What are the important warnings for Diclofenac?▼
5. WARNINGS, PRECAUTIONS & ADVERSE REACTIONS 5.1 Risk of Serious Cardiovascular and Gastrointestinal Events Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs, including diclofenac, can lead to new onset of hypertension, or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. 4. CONTRAINDICATIONS Xiclo™ Transdermal Patch is contraindicated in patients with a known history of hypersensitivity to non-steroidal anti-inflammatory medications such as diclofenac. Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.