Systaflam

Approved and Clinically Accepted Uses:

A. Musculoskeletal and Joint Disorders

• Osteoarthritis (mild to moderate pain and stiffness)
• Rheumatoid arthritis (adjunctive localized relief)
• Ankylosing spondylitis (for localized back pain)
• Cervical spondylosis
• Lumbago and sciatica

B. Soft Tissue Injuries and Pain

• Muscle strains and sprains
• Tendonitis and bursitis
• Sports-related injuries
• Contusions and soft tissue trauma

C. Muscle Spasm and Neuromuscular Conditions

• Local muscle spasm (traumatic, inflammatory, or postural)
• Myalgia and fibrositis
• Cervical or lumbar radiculopathy-associated pain

D. Localized Inflammatory Conditions

• Neuralgia (e.g., brachial or intercostal)
• Pain associated with overuse injuries

Route: Topical (external use only)

Adults and Elderly:

• Dosage: Apply approximately 2–4 grams (cherry-sized amount) to the affected area.
• Frequency: 3 to 4 times daily.
• Method: Gently massage into the skin until completely absorbed.
• Duration: Use for up to 7–14 days unless otherwise directed by a physician.

Children:

• Not recommended for use in children under 12 years due to insufficient safety data.

Special Populations:

• Renal or Hepatic Impairment: Caution advised. Avoid application over large surface areas or prolonged use.
• Pregnancy and Lactation: Avoid use unless prescribed. (See section 5 for full details)

This combination provides multi-modal relief through synergistic actions:

• Diclofenac Diethylamine is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, which mediates inflammation, swelling, and pain.
• Mephenesin acts as a centrally acting skeletal muscle relaxant, reducing muscle tone and relieving localized muscle spasm.
• Menthol activates thermoreceptors (TRPM8), causing a cooling sensation and temporary analgesia through counterirritant action.
• Methyl Salicylate acts as a rubefacient and counterirritant, promoting vasodilation and providing a sensation of warmth that distracts from deeper musculoskeletal pain.
• Turpentine Oil has mild anti-inflammatory and vasodilatory properties, enhancing blood flow to the site and complementing the counterirritant effect.

• Absorption: Systemic absorption is minimal when applied topically. Diclofenac penetrates the skin and accumulates in underlying tissues, including muscle and synovial fluid.
• Distribution: Primarily localized at the site of application. Minimal plasma concentrations observed.
• Metabolism:
• Diclofenac: Hepatically metabolized via CYP2C9.
• Methyl Salicylate and Mephenesin: Metabolized by the liver to inactive compounds.
• Excretion: Mainly renal (as metabolites); negligible unchanged drug.
• Half-life: Diclofenac ~1–2 hours; Mephenesin ~1–2 hours. Topical half-life depends on systemic absorption, which is low.

• Pregnancy: Avoid use, especially in the third trimester. NSAIDs may cause premature closure of the ductus arteriosus. Limited safety data on topical components.
• Lactation: Use with caution. Minimal systemic absorption expected, but avoid application near the breast or areas where the infant may come into contact.
• Summary: Use only when clearly necessary under medical supervision.

• Primary Class: Topical Analgesic and Anti-inflammatory
• Subclasses:
• NSAID (Diclofenac Diethylamine)
• Skeletal Muscle Relaxant (Mephenesin)
• Counterirritants (Menthol, Methyl Salicylate, Turpentine Oil)

• Known hypersensitivity to diclofenac, salicylates, mephenesin, menthol, turpentine oil, or any excipients
• Use on broken, damaged, or infected skin
• Pregnancy (especially third trimester)
• Children under 12 years of age
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs

• Topical use only – avoid contact with eyes, mucous membranes, or open wounds.
• Systemic absorption risk – avoid prolonged use or application over large surface areas.
• High-risk patients – caution in individuals with renal impairment, hepatic disease, asthma, peptic ulcer disease, or known NSAID hypersensitivity.
• Photosensitivity – may occur; avoid direct sunlight on treated areas.
• Monitoring: Discontinue if rash, irritation, or signs of hypersensitivity occur.

Common (Local, Mild):

• Skin irritation
• Erythema
• Itching or dryness
• Mild burning or stinging sensation

Less Common / Rare:

• Allergic contact dermatitis
• Photosensitivity reaction
• Bronchospasm in aspirin-sensitive individuals
• Systemic NSAID-related adverse effects (very rare)

Systemic interactions are rare with proper topical use, but caution is advised with:

• Oral NSAIDs or Aspirin: Increased risk of cumulative toxicity.
• Anticoagulants (e.g., Warfarin): Methyl salicylate may enhance bleeding risk if absorbed in significant quantities.
• CYP2C9 inhibitors or inducers: Theoretically may alter diclofenac metabolism if systemic absorption occurs.
• Other topical agents: Avoid concurrent use with other topical NSAIDs or counterirritants to prevent skin damage or additive absorption.

• No recent FDA, EMA, or WHO safety alerts specific to this fixed combination.
• Still recommended in many clinical settings for localized musculoskeletal and joint pain.
• EMA and NICE support topical NSAID use as a safer alternative to oral NSAIDs in certain populations.

• Storage Temperature: Store below 25°C
• Humidity: Store in a dry place, away from moisture
• Light Protection: Protect from direct sunlight; keep in original container
• Handling Instructions:
• Do not freeze
• Keep container tightly closed
• For external use only
• Shelf-life: As indicated on the product label. Do not use after expiration.