Clofenac Gel 1%: Topical Pain and Inflammation Relief

Clofenac Gel 1% is a topical medication designed for the local symptomatic relief of pain and inflammation associated with conditions such as rheumatoid arthritis, osteoarthritis, and general joint and muscular pains.

How Clofenac Gel Works (Mode of Action)

Clofenac Gel contains Diclofenac, a phenylacetic acid derivative that belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Diclofenac possesses potent anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) actions. Its primary mechanism involves inhibiting cyclooxygenase (COX)-1 and COX-2 enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins are chemicals in the body that contribute to inflammation, pain, and fever. By inhibiting their production, Diclofenac helps to reduce these symptoms. Additionally, it may inhibit neutrophil aggregation/activation, inhibit chemotaxis, decrease proinflammatory cytokine levels, and alter lymphocyte activity.

Key Indications & Benefits

• Rheumatoid Arthritis: Provides local relief from pain and inflammation.
• Osteoarthritis: Alleviates joint pain and swelling.
• Joint and Muscular Pains: Offers targeted relief for various aches and pains in joints and muscles.

Dosage & Administration

Clofenac Gel is for external use only. Apply to clean, dry skin. To ensure proper absorption, avoid showering or bathing until the gel is dry for at least 30 minutes after application. Always wash your hands thoroughly after use, unless your hands are the affected area. Avoid getting clothing on the treated area, especially knees, until the gel is dry.

• Adult Dose:
  • Osteoarthritis: Apply 2 g (for upper extremities) or 4 g (for lower extremities) every 6 hours. Do not exceed 8 g per day for any single joint of the upper extremities, or 16 g per day for any single joint of the lower extremities.
  • Local symptomatic relief of pain and inflammation: Apply onto the affected area 3 or 4 times daily.
• Children: The safety and efficacy of Clofenac Gel have not been established in children.

Always consult a registered physician for medication use.

Important Considerations & Warnings

It is essential to discuss your full medical history with your doctor before using Clofenac Gel.

Contraindications:

• Patients with hypersensitivity to any ingredient of the product.
• Asthmatic patients in whom attacks of asthma, urticaria (hives), or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other drugs with prostaglandin synthetase inhibitor activity.
• The gel should not be used under occlusive (airtight) dressings.

Side Effects: Common side effects include reactions at the application site:

• Dry skin
• Rash
• Contact dermatitis
• Pain at application site
• Paresthesia (numbness or tingling)
• Pruritus (itching)
• Exfoliation (peeling skin) Less common side effects (1-10%) may include hypertension, chest pain, skin ulcer, diarrhea, dyspepsia, alopecia (hair loss), photosensitivity, edema (swelling), conjunctivitis, hematuria (blood in urine), and asthma.

Precautions & Warnings:

• Gastrointestinal Bleeding/Ulceration: In rare instances, peptic ulceration or gastrointestinal bleeding may occur in patients undergoing treatment with diclofenac, even with topical use.
• Elderly Patients: Patients of advanced age should be kept under close observation.
• Avoid Contact: The gel should not come into contact with the eyes or mucous membranes. Hands should be washed properly after application.
• For External Use Only: This product is not to be taken by mouth.
• Photosensitivity: As with other NSAIDs, photosensitivity can occur; limit exposure to sunlight and artificial UV light.

Pregnancy & Lactation:

• Pregnancy Category D (after 30 weeks' gestation): Avoid using NSAIDs, including diclofenac, in pregnant women after 30 weeks' gestation due to the increased risk of premature closure of the fetal ductus arteriosus. Data on embryofetal risks during the first or second trimester are inconclusive.
• Lactation: Small amounts of oral diclofenac are reported in human milk. It is unknown if topical diclofenac is excreted in human milk, and data on effects on the breastfed infant or milk production are unavailable. Use is generally not recommended during lactation.

Interactions:

• May increase serum levels of methotrexate.
• Concomitant use with other NSAIDs or anticoagulants (e.g., warfarin) is associated with a higher risk of gastrointestinal bleeding.
• Increased risk of nephrotoxicity with cyclosporine or triamterene.
• May increase the risk of developing corneal complications in patients with significant pre-existing corneal inflammation when used concomitantly with ophthalmic preparations containing corticosteroids.
• Colestyramine and colestipol reduce the bioavailability of diclofenac (oral forms, relevance to topical unknown but caution advised).
• Decreased plasma concentration when administered after sucralfate (oral forms, relevance to topical unknown).
• Ophthalmic application of diclofenac may reduce the efficacy of ophthalmic acetylcholine and carbachol.
• May increase serum levels of lithium and digoxin.

Storage Conditions

Store as directed. Keep out of the reach of children.