VOLINAC Max

A. Approved Indications

• Musculoskeletal Disorders:
• Osteoarthritis (localized pain and inflammation)
• Rheumatoid arthritis (adjunct for joint pain and stiffness)
• Ankylosing spondylitis (localized back inflammation)
• Soft Tissue Injuries and Inflammation:
• Muscle strains, sprains, and ligament injuries
• Tendonitis and bursitis
• Contusions, trauma-induced soft tissue swelling
• Sports injuries (e.g., tennis elbow, rotator cuff pain)
• Localized Pain Syndromes:
• Cervical and lumbar spondylosis
• Lumbago and sciatica
• Myalgia and fibrositis

B. Clinically Accepted Off-label Uses

• Neuralgias (e.g., intercostal or cervical)
• Pain from repetitive strain injuries (e.g., carpal tunnel, overuse syndromes)

Route of Administration: Topical (for external use only)

Adults and Elderly:

• Apply 2–4 grams of gel/cream to the affected area.
• Frequency: 3 to 4 times daily.
• Massage gently into the skin until completely absorbed.
• Duration: Use for up to 7–14 days or as directed by a physician.

Pediatrics:

• Not recommended for children under 12 years due to lack of safety data.

Special Populations:

• Renal/Hepatic Impairment: Avoid application over large areas or long-term use. Use with caution.
• Pregnancy/Lactation: Avoid unless specifically directed by a healthcare provider (see section 5).

Precaution: Avoid contact with eyes, mucous membranes, open wounds, or damaged skin.

This combination works synergistically to provide anti-inflammatory and analgesic effects:

• Diclofenac Sodium inhibits COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation, swelling, and pain.
• Methyl Salicylate functions as a counterirritant by stimulating nerve endings, causing a warming sensation that distracts from deeper musculoskeletal pain. It also provides local anti-inflammatory effects.
• Linseed Oil (Flaxseed Oil) is rich in alpha-linolenic acid (ALA), an omega-3 fatty acid, which exerts mild anti-inflammatory properties and enhances dermal absorption of other actives.
• Menthol activates TRPM8 receptors, creating a cooling sensation and local analgesia through counterirritation, enhancing overall relief.

• Absorption: Primarily localized dermal absorption. Systemic absorption is minimal if applied as directed.
• Distribution: Limited to skin and underlying tissues; negligible systemic distribution.
• Metabolism:
• Diclofenac: If absorbed, metabolized by liver enzymes (mainly CYP2C9).
• Methyl Salicylate: Converted to salicylic acid by esterases in skin and liver.
• Menthol & Linseed Oil: Undergo hepatic metabolism if systemically absorbed.
• Excretion: Renal (as inactive metabolites), although systemic exposure is low.
• Half-life: Not clinically relevant for topical use due to localized action.

• Pregnancy:
• Avoid use during third trimester due to risk of premature closure of the ductus arteriosus (NSAID-related).
• Use in the first and second trimesters only if clearly needed under medical supervision.
• Lactation:
• No significant systemic absorption expected; however, avoid application near breast or areas where infant may contact.
• Use with caution.
• Summary: Use only when benefits outweigh risks. Avoid prolonged use or large-area application in pregnancy and breastfeeding.

• Primary Class: Topical Nonsteroidal Anti-inflammatory & Analgesic
• Subclasses:
• NSAID (Diclofenac Sodium)
• Counterirritant (Methyl Salicylate, Menthol)
• Dermal Absorption Enhancer and Anti-inflammatory (Linseed Oil)

• Known hypersensitivity to diclofenac, salicylates, menthol, linseed oil, or any excipients
• History of NSAID-induced asthma, urticaria, or allergic reactions
• Application to open wounds, eczema, or broken skin
• Children under 12 years
• Third-trimester pregnancy
• Severe renal or hepatic dysfunction

• Photosensitivity: Avoid exposure to direct sunlight on treated areas.
• Systemic Absorption Risk: Avoid prolonged use or application over large surface areas.
• Skin Reactions: Discontinue if rash, burning, or dermatitis occurs.
• Asthmatic Patients: Use with caution due to potential NSAID sensitivity.
• Avoid Occlusive Dressings: Increases risk of systemic absorption.

Common:

• Local skin irritation
• Erythema or redness
• Mild burning or tingling
• Itching or dryness at application site

Less Common:

• Contact dermatitis
• Allergic skin rash
• Photosensitivity

Rare but Serious:

• Bronchospasm (especially in NSAID-sensitive individuals)
• Systemic NSAID-related effects (rare with proper use)

• Systemic Interactions: Very rare with appropriate topical use.
• Oral NSAIDs or Aspirin: Concurrent use may increase cumulative toxicity risk.
• Anticoagulants (e.g., Warfarin): Methyl salicylate may enhance bleeding risk with excessive or large-area use.
• Other Topical Agents: Avoid use with other topical NSAIDs or irritants to prevent skin damage.
• Enzyme Involvement: Diclofenac is metabolized by CYP2C9 if absorbed systemically.

• No recent FDA or EMA regulatory changes specific to this combination.
• Clinical guidance continues to favor topical NSAID formulations as first-line therapy for localized musculoskeletal pain, especially in elderly patients to reduce systemic side effects.
• Emphasis remains on limiting use to short durations and small areas to prevent adverse effects.

• Temperature: Store below 25°C (77°F)
• Humidity: Store in a dry place; keep cap tightly closed
• Light Protection: Store in original container away from direct light
• Handling Instructions:
• Do not freeze
• For external use only
• Keep away from eyes and mucous membranes
• Wash hands after application unless used for hand pain
• Shelf-life: Use within expiry period stated on packaging