TABIFLEX COOL 1% EMULGEL 50G

Indications

Approved Uses

Local symptomatic relief of pain and inflammation in musculoskeletal conditions amenable to topical NSAID therapy (e.g., minor sprains/strains/contusions, tendinitis) and localized osteoarthritis of superficial joints.

Off-Label Uses

Localized acute musculoskeletal pain (e.g., minor strains, sprains, contusions) and other localized soft-tissue pain where a topical NSAID is appropriate.

Dosage & Administration

Dosing by Condition

Apply a thin layer to the affected area 3-4 times daily; typical adult amounts are approximately 2-4 g per application depending on area size (do not exceed label directions; reassess if not improving within ~7-14 days, and longer use for osteoarthritis should be under clinician advice).

Initial Dose

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

Maintenance Dose

2-4 g applied 3-4 times daily

Maximum Dose

Do not exceed a total of 32 g/day across all treated areas; typical per-joint limits (when using diclofenac 1% gel dosing guidance) are 16 g/day for any single lower-extremity joint and 8 g/day for any single upper-extremity joint.

Children's Dosage

Not approved 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 severe renal/hepatic impairment or in the elderly due to potential systemic NSAID effects.

How to Take

Apply a thin layer of TABIFLEX COOL diclofenac 1% gel to the affected area and gently rub in; wash hands before and after use (unless treating the hands). Avoid contact with eyes/mucosa; do not apply to broken, infected, or eczematous skin; do not use occlusive/airtight dressings; allow to dry before covering with clothing.

Side Effects

Common Side Effects

Application-site reactions such as rash, pruritus/itching, erythema/redness, dryness, burning/stinging, scaling/peeling; contact dermatitis can occur.

Side Effect Frequency

Common (1-10%): application-site reactions such as dermatitis/eczema, pruritus, erythema, rash, and dry skin; Uncommon/Rare: vesicles/bullous reactions and systemic hypersensitivity (including angioedema/bronchospasm/asthma) are very rare.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac or excipients; history of hypersensitivity reactions (e.g., asthma, urticaria, rhinitis) to aspirin/other NSAIDs; use in 3rd trimester of pregnancy; application to non-intact skin (open wounds, infected/eczema lesions) or mucous membranes/eyes; avoid use for peri-operative pain in the setting of CABG surgery.

Warnings & Precautions

External use only; avoid eyes/mucosa; do not apply to broken/damaged skin; avoid occlusive dressings/heat over treated area; wash hands after use; discontinue if rash or hypersensitivity occurs; photosensitivity-avoid sun/UV on treated area; use lowest effective amount for shortest duration; caution in patients with CV disease/risk, history of GI ulcer/bleeding, renal/hepatic impairment, asthma/NSAID sensitivity; avoid concomitant oral NSAIDs unless advised; monitor for edema/BP rise with extensive use.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically relevant mainly with extensive/prolonged topical use: concomitant oral NSAIDs/aspirin (additive NSAID toxicity); anticoagulants/antiplatelets (e.g., warfarin) (bleeding risk); SSRIs/SNRIs and systemic corticosteroids (additive GI bleeding risk); ACE inhibitors/ARBs/diuretics (possible renal function impact); cyclosporine/tacrolimus (nephrotoxicity risk).

Interaction Severity

Clinically relevant interactions are generally LOW to MODERATE with topical use: additive NSAID adverse effects with concurrent oral NSAIDs/aspirin (especially with large-area/prolonged use); increased bleeding risk with anticoagulants/antiplatelets is possible but uncommon; other systemic NSAID-type interactions (e.g., antihypertensives) are unlikely unless significant systemic absorption occurs.

Food Interaction

No restriction

Special Populations

Pregnancy

Category C (1st/2nd trimester); Contraindicated (3rd trimester)

Children

Not approved for children under 14 years of age.

Elderly

Standard adult dosing; use minimum effective dose for shortest duration due to increased risk of systemic adverse effects

Kidney Impairment

No dosage adjustment required for topical use; use with caution/avoid prolonged or large-area use in severe renal impairment and monitor if clinically indicated (not an absolute contraindication).

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; no tapering required

Patient Counseling

Apply a thin layer to clean, dry, intact skin and rub in gently; wash hands after use (unless treating hands); avoid eyes/mouth/mucosa; do not apply to broken/irritated skin; do not occlude with tight bandages or apply external heat; allow to dry before covering with clothing; avoid excessive sunlight/UV on treated area; stop and seek advice if significant rash/irritation or hypersensitivity occurs; avoid using other NSAIDs/anticoagulants without advice and do not use for prolonged periods (e.g., >1-2 weeks) without medical guidance.

Monitoring Requirements

No routine laboratory or vital-sign monitoring is required for short-term, limited-area topical use; monitor for local skin reactions, and consider monitoring blood pressure/renal function only if prolonged use over large areas or in high-risk patients (e.g., CKD, heart failure, uncontrolled hypertension).

Pharmacology

Mechanism of Action

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

Half-Life

Plasma elimination half-life of diclofenac is about 1-2 hours; after topical use, systemic half-life is similar but local tissue residence can be longer.

Bioavailability

Systemic exposure from topical diclofenac 1% is low-typically about 5-10% of the systemic exposure (AUC) seen with an oral diclofenac dose; the exact percent of applied dose absorbed varies by site and formulation.

Protein Binding

>99% plasma protein bound (mainly albumin).

Product Information

Available Dosage Forms

Topical gel (emulgel) only for this product.

Composition per Dose

Each gram of emulgel: 10 mg diclofenac sodium (1%)

Generic Availability

Yes

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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