DICLOMAX 1% EMULGEL 50G

Indications

Approved Uses

Local symptomatic relief of pain and inflammation in acute musculoskeletal conditions (e.g., sprains, strains, contusions) and localized soft-tissue rheumatism/tendinopathies; osteoarthritis of superficial joints may be included only if stated in the local label.

Dosage & Administration

Dosing by Condition

Acute localized musculoskeletal pain/soft-tissue injury: apply a thin layer to the affected area 3-4 times daily; typical self-care duration is up to 7-14 days unless advised otherwise by a clinician.

Initial Dose

Apply 4g to the affected knee(s) 4 times daily

Maintenance Dose

Apply 4g to the affected knee area up to 4 times daily

Maximum Dose

Do not exceed 32 g/day total (8 g per knee, 4 times daily)

Dose Adjustment Notes

No routine dose adjustment is required for renal/hepatic impairment with typical short-term, limited-area topical use; use the minimum effective amount for the shortest duration, and use caution/avoid large-area or prolonged use in severe renal/hepatic impairment.

How to Take

Apply a thin layer of DICLOMAX 1% Emulgel to clean, dry, intact skin over the painful area and rub in gently 3-4 times daily; wash hands after application unless the hands are being treated; avoid eyes/mucosa, broken/irritated skin, and occlusive dressings/heat over the area.

Side Effects

Common Side Effects

Application-site reactions: rash, pruritus, erythema, burning/stinging, dry skin, scaling, and contact dermatitis; photosensitivity can occur.

Side Effect Frequency

Most adverse effects are local skin reactions; commonly reported: application-site dermatitis/eczema, pruritus, erythema, rash, and dry skin; less common/uncommon: burning/irritation, contact dermatitis, and photosensitivity reactions; systemic adverse effects are rare but possible (e.g., hypersensitivity/bronchospasm in NSAID-sensitive patients).

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs (including aspirin-induced asthma/urticaria/rhinitis); do not apply to broken/non-intact skin, eyes, or mucous membranes; avoid use in late pregnancy (3rd trimester)

Warnings & Precautions

For external use only; avoid eyes/mucosa and non-intact skin; do not use under occlusion or with external heat; wash hands after use; stop if rash/irritation or hypersensitivity occurs; minimize sun/UV exposure (photosensitivity); use caution in asthma/NSAID allergy history and in renal/hepatic/cardiovascular risk patients, especially with large-area or prolonged use

Drug Interactions

Drug Interactions

Clinically relevant interactions are uncommon with topical use; use caution with concurrent systemic NSAIDs/aspirin and anticoagulants/antiplatelets (especially if large areas/prolonged use), and avoid layering other topical products on the same site

Interaction Severity

Generally LOW/clinically minor with typical topical use, but use caution with concurrent systemic NSAIDs/aspirin and anticoagulants/antiplatelets (and other bleeding-risk drugs) if used over large areas or long durations; clinically significant interactions are uncommon with limited-area topical application.

Food Interaction

No restriction

Special Populations

Elderly

Standard adult dosing; use the minimum effective amount due to increased risk of skin reactions and potential systemic effects

Kidney Impairment

No dose adjustment generally needed for topical use; use with caution/avoid extensive or prolonged use in significant renal impairment

Liver Impairment

No dose adjustment generally needed for topical use; use with caution in significant hepatic impairment

Storage & Patient Advice

Missed Dose

Apply when remembered; if it is close to the next scheduled application, skip the missed application and continue as usual; do not apply extra to make up for a missed dose.

Stopping the Medicine

Safe to stop anytime; no tapering required (stop when pain resolves or if irritation occurs)

Overdose

Topical overdose is unlikely; if excessive applied, wash off; if ingested, treat as NSAID overdose and seek medical attention/supportive care

Patient Counseling

Apply a thin layer to clean, dry, intact skin only; avoid eyes/mouth/mucosa and rinse with water if contact occurs; wash hands after application (unless treating hands); do not apply under occlusive dressings, do not apply heat, and allow to dry before covering with clothing; avoid excessive sunlight/UV exposure on treated areas; use the lowest effective amount for the shortest duration and seek medical advice if symptoms persist (commonly if needing >7-14 days) or if significant irritation/rash occurs; external use only and avoid use on broken/infected skin.

Monitoring Requirements

No routine laboratory monitoring is required for short-term, limited-area topical use; monitor for local skin reactions, and consider BP/renal function monitoring only if prolonged/high-area use or in high-risk patients (e.g., CKD, elderly, concomitant nephrotoxic/RAAS drugs).

Pharmacology

Mechanism of Action

Inhibits COX-1 and COX-2, reducing prostaglandin synthesis locally at the application site, leading to decreased inflammation, pain, and swelling.

Product Information

Available Dosage Forms

Gel (emulgel) - this SFDA-registered product is only a topical gel formulation.

Composition per Dose

Each 1 gram of gel contains: 10mg diclofenac sodium

Generic Availability

Yes

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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