VOLTAREN 1% EMULGEL 100G

Indications

Approved Uses

Local symptomatic relief of pain and inflammation in: (1) acute soft-tissue injuries (e.g., sprains, strains, contusions), (2) localized forms of soft-tissue rheumatism (e.g., tendinitis), and (3) osteoarthritis of superficial joints (e.g., knee, finger joints).

Off-Label Uses

Common off-label/real-world uses include localized tendinopathy/tennis elbow, bursitis, and other minor musculoskeletal overuse injuries where topical NSAIDs are used for symptomatic relief.

Dosage & Administration

Dosing by Condition

Apply to the affected area 4 times daily and rub in gently; use 4 g for lower extremities (foot, knee, ankle), 2 g for upper extremities (hand, wrist, elbow).

Maintenance Dose

Apply 4 g to the affected foot, knee or ankle 4 times daily; apply 2 g to the affected hand, wrist or elbow 4 times daily.

Children's Dosage

Safety and effectiveness in pediatric patients have not been established; not recommended under 18 years

Dose Adjustment Notes

No routine dose adjustment is required for topical use due to low systemic absorption; use caution/avoid excessive area or prolonged use in patients with significant renal, hepatic, or cardiovascular disease or when using other NSAIDs.

Side Effects

Common Side Effects

Common: application-site reactions such as erythema/redness, pruritus/itching, rash, burning/stinging, and dry skin; may include contact dermatitis.

Side Effect Frequency

Common (≥1%): local application-site reactions such as dermatitis/eczema, pruritus, erythema, rash, dryness, burning; Uncommon (<1%): contact dermatitis, papular/vesicular rash; Rare/very rare: photosensitivity and systemic hypersensitivity reactions (e.g., urticaria/angioedema/bronchospasm).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or excipients; history of hypersensitivity reactions to aspirin/other NSAIDs (e.g., asthma/bronchospasm, urticaria, rhinitis); third trimester of pregnancy; do not apply to broken/damaged skin, open wounds, eyes, or mucous membranes

Warnings & Precautions

External use only; avoid eyes/mucosa and broken/infected skin; do not use under occlusion; limit duration and treated surface area; stop if rash/irritation or hypersensitivity occurs; caution in NSAID-sensitive asthma; avoid excessive sun/UV on treated area; avoid in 3rd trimester; be mindful of additive risk with other NSAIDs/anticoagulants

Drug Interactions

Drug Interactions

Clinically significant interactions are unlikely with recommended topical use; caution with concomitant oral NSAIDs/aspirin (additive NSAID toxicity) and anticoagulants/antiplatelets (bleeding risk) especially with large-area/prolonged use

Food Interaction

No clinically relevant food interactions (not applicable for topical administration).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Avoid use, especially in third trimester; Category C (first and second trimesters), Category D (third trimester)

Children

Safety and effectiveness in pediatric patients have not been established; not recommended under 18 years

Liver Impairment

No adjustment needed for topical use, but use with caution in severe hepatic impairment.

Storage & Patient Advice

Patient Counseling

Apply a thin layer to clean, dry, intact skin and rub in gently; avoid eyes/mouth/nose and broken skin; wash hands after use (unless treating hands); do not use occlusive/airtight dressings and do not apply external heat; avoid sun/UV exposure on treated area; stop if rash/irritation or allergy occurs; seek medical advice if not improving within 7 days (or if needing longer use).

Monitoring Requirements

No routine monitoring required for short-term topical use

Pharmacology

Mechanism of Action

Inhibits cyclooxygenase (COX-1 and COX-2), reducing local prostaglandin synthesis and thereby decreasing inflammation, pain, and swelling at the application site.

Half-Life

Terminal plasma half-life of diclofenac is about 1-2 hours for the systemically absorbed fraction (same intrinsic half-life as oral; topical mainly reduces exposure, not half-life).

Bioavailability

Approximately 6% systemic absorption of the applied dose through intact skin (order of magnitude; varies with dose/area/skin condition).

Excretion

Elimination is mainly renal as metabolites (about two-thirds) with the remainder via biliary/fecal excretion (about one-third).

Protein Binding

>99% plasma protein binding, mainly to albumin.

Product Information

Available Dosage Forms

Topical gel (emulgel).

Composition per Dose

Each 1g of gel contains: 11.6mg of diclofenac diethylamine (equivalent to 10mg of diclofenac sodium).

Generic Availability

Yes

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.