FASTUM 2.5% GEL 50G

Indications

Approved Uses

Local symptomatic relief of pain and inflammation in musculoskeletal and soft-tissue conditions/injuries (e.g., sprains, strains, contusions) and localized rheumatic disorders (e.g., tendinitis/bursitis).

Off-Label Uses

Adjunct for localized minor sports injuries/overuse syndromes and myofascial/localized soft-tissue pain (where topical NSAIDs are used for symptomatic relief).

Dosage & Administration

Dosing by Condition

Musculoskeletal/soft-tissue pain and inflammation: apply a thin layer to the affected area 2-3 times daily and massage gently until absorbed; limit duration to the shortest necessary (commonly up to 7-14 days unless directed).

Initial Dose

Apply a 5-10 cm strip of gel to the affected area.

Maintenance Dose

Apply a 5-10 cm strip of gel to the affected area 2 to 3 times daily.

How to Take

Apply a thin layer (or an appropriate amount) to the affected area and gently massage until absorbed; wash hands after application; avoid occlusive dressings unless directed; avoid sunlight/UV exposure on treated skin and do not apply on broken/irritated skin.

Side Effects

Common Side Effects

Local application-site reactions (erythema, pruritus, burning/stinging, rash/eczema, contact dermatitis) and photosensitivity/photoallergic reactions.

Side Effect Frequency

Uncommon: local skin reactions (rash/erythema/pruritus/burning/eczema/contact dermatitis); Rare: photosensitisation/photoallergic reactions, urticaria, bullous dermatitis; systemic NSAID effects are very rare with topical use.

Safety & Warnings

Contraindications

Hypersensitivity to ketoprofen or other NSAIDs (including aspirin-induced asthma/urticaria); history of photoallergy/phototoxicity to ketoprofen; concomitant or prior photosensitivity to related agents (e.g., fenofibrate/tiaprofenic acid) or excipients; application to broken/diseased skin (e.g., eczema, open wounds, infected lesions); third trimester of pregnancy

Warnings & Precautions

Avoid sunlight/UV exposure on treated areas during use and for 2 weeks after stopping; do not apply to broken/diseased/infected skin, eyes, or mucous membranes; do not use occlusive dressings; wash hands after application; avoid octocrylene-containing sunscreens and other photosensitizing products; use caution in asthma/NSAID hypersensitivity and severe renal/hepatic impairment; stop immediately if rash or photosensitivity occurs

Driving Warning

Safe

Drug Interactions

Interaction Severity

Potential interactions are generally low but clinically relevant with extensive/prolonged use: anticoagulants/antiplatelets (possible increased bleeding risk), other NSAIDs (additive adverse effects), and increased photoallergy risk with octocrylene-containing sunscreens/cosmetics; manage by minimizing exposure and monitoring when high-risk.

Food Interaction

N/A (no clinically relevant food interaction for topical gel).

Special Populations

Breastfeeding

Caution

Elderly

Standard adult dosing. Use the lowest effective dose for the shortest duration necessary.

Kidney Impairment

No specific dose adjustment; use with caution in severe renal impairment and avoid prolonged/extensive application

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Safe to stop anytime; discontinue immediately if any rash/skin reaction or photosensitivity occurs

Overdose

Topical overdose is unlikely; if accidental ingestion occurs, manage as NSAID overdose (GI upset, drowsiness/lethargy possible) with supportive care and consider decontamination per standard toxicology guidance

Patient Counseling

Apply a thin layer to intact skin only; avoid eyes/mucosa and broken skin; wash hands after use; do not occlude with tight bandages; avoid sun/UV exposure on treated areas during use and for 2 weeks after stopping; stop and seek medical advice if rash/blistering occurs; use only for the prescribed duration (commonly up to 7-14 days unless directed).

Pharmacology

Mechanism of Action

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

Onset of Action

Approximately 30-60 minutes after application (analgesic effect may continue to build over the first few days with regular use).

Duration of Effect

Not well-defined for topical ketoprofen; analgesic benefit is typically sustained for several hours, hence repeat application 2-3 times daily.

Metabolism

Hepatic metabolism primarily via glucuronidation (minimal CYP involvement).

Product Information

Available Dosage Forms

Gel (topical).

Composition per Dose

Each gram of gel contains 25mg of ketoprofen.

OTC Alternatives

Topical diclofenac gel and topical ibuprofen gel (availability as OTC depends on local regulations; in Saudi Arabia many topical NSAIDs may be prescription-only).

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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