RUMAFEN 1% GEL 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/tendinitis.

Off-Label Uses

Osteoarthritis pain of superficial joints (e.g., knee/hand) and other localized musculoskeletal pain syndromes (e.g., myofascial pain) where topical NSAIDs are used.

Dosage & Administration

Dosing by Condition

Musculoskeletal pain/soft-tissue injury: apply a thin layer to the affected area 3-4 times daily and rub in gently; typical duration is up to 7-14 days for acute injuries unless directed by a clinician.

Initial Dose

Apply 2-4 g (5-10 cm strip) to the affected area 3 times daily

Maintenance Dose

2-4 g applied 3-4 times daily to the affected area

Children's Dosage

Not recommended for children under 14 years of age

Dose Adjustment Notes

No routine dose adjustment is required for topical use; use the minimum effective amount for the shortest duration, and use caution/avoid large-area or prolonged use in significant renal/hepatic impairment or in the elderly.

How to Take

Apply a thin layer to clean, dry, intact skin over the affected area and rub in gently; wash hands after use (unless treating the hands). Avoid contact with eyes/mucosa, do not apply to broken/irritated skin, and do not use occlusive/airtight dressings; avoid heat sources on the area.

Side Effects

Common Side Effects

Local application-site reactions such as rash, pruritus/itching, erythema/redness, burning/stinging, dry skin, and contact dermatitis.

Side Effect Frequency

Most common adverse effects are local skin reactions (e.g., pruritus, rash/dermatitis, erythema, dry skin, burning/irritation); systemic NSAID adverse effects are uncommon/rare with topical use.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Avoid eyes/mucous membranes and broken skin; do not use under occlusive dressings; wash hands after use; stop if rash/irritation or hypersensitivity occurs; minimize duration and treated surface area to limit systemic absorption; caution in patients with NSAID/aspirin allergy or asthma; consider photosensitivity precautions.

Drug Interactions

Drug Interactions

Clinically significant interactions are unlikely with normal topical use; caution with concurrent oral NSAIDs/aspirin (additive NSAID toxicity), anticoagulants/antiplatelets (bleeding risk if systemic exposure increases), and avoid layering other topical products on the same area that may increase absorption/irritation.

Food Interaction

N/A (no clinically relevant food interactions for topical administration).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Avoid in third trimester; use with caution earlier

Children

Not recommended for children under 14 years of age

Elderly

Standard adult dosing; use minimum effective dose and duration due to increased skin sensitivity

Kidney Impairment

No routine dose adjustment for topical use; use with caution in severe renal impairment and avoid large-area/prolonged use.

Liver Impairment

No routine dose adjustment for topical use; use with caution in hepatic impairment and discontinue if signs/symptoms of liver injury occur.

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

May be stopped at any time when symptoms resolve; no tapering required.

Overdose

Overdose from topical application is unlikely; if accidentally ingested, manage as NSAID overdose (GI upset/bleeding, CNS symptoms possible) and seek urgent medical attention/supportive care.

Patient Counseling

Apply a thin layer to clean, dry, intact skin only; avoid eyes/mucosa and wash hands after use (unless treating hands); do not use with occlusive dressings or heat; allow to dry before clothing and avoid bathing soon after application; limit duration to the label (seek medical advice if symptoms persist/worsen); stop if rash/irritation occurs; avoid excessive sun/UV on treated area; be aware that systemic NSAID risks are low but possible-seek care for GI bleeding symptoms or chest pain/shortness of breath.

Monitoring Requirements

No routine monitoring is required for short-term, localized use; if prolonged use, large-area application, or high-risk patients (e.g., elderly, renal disease, on anticoagulants), monitor for NSAID adverse effects (skin reactions, GI symptoms/bleeding, blood pressure/edema, renal function as clinically indicated).

Pharmacology

Mechanism of Action

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

Onset of Action

Local analgesic effect can begin within hours of application (often within 1 hour), with maximal/clinically meaningful improvement typically over several days to 1-2 weeks depending on condition.

Duration of Effect

Analgesic effect is local and typically requires repeat application 3-4 times daily; a precise per-application duration (e.g., 4-6 hours) is not reliably established for all topical diclofenac gels.

Half-Life

Terminal plasma half-life of diclofenac is about 1-2 hours (metabolites may be longer); topical use does not materially change the intrinsic plasma half-life, but systemic levels are much lower.

Bioavailability

Systemic exposure is low; approximately up to ~10% of the systemic exposure of an equivalent oral diclofenac dose (often cited around 5-10%), varying with dose, area, and duration.

Excretion

Primarily renal excretion of metabolites, with a smaller proportion via biliary/fecal routes.

Protein Binding

>99% protein bound (mainly to albumin).

Product Information

Available Dosage Forms

Gel (topical).

Composition per Dose

Each gram of gel: 11.6 mg diclofenac diethylamine equivalent to 10 mg diclofenac sodium (1% w/w)

Generic Availability

Yes

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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