Calcium Dobesilate + Lidocaine + Dexamethasone

• Hemorrhoidal Disease: Relief of pain, inflammation, bleeding, and swelling associated with acute and chronic hemorrhoids.
• Perianal Inflammation and Pruritus: Treatment of inflammatory and painful conditions in the anal region.
• Microangiopathy and Venous Insufficiency Complications: Adjunct in management to improve microcirculation and reduce capillary fragility.
• Post-surgical or Post-procedural Analgesia and Anti-inflammatory: To reduce pain and inflammation following anorectal surgeries or invasive procedures.
• Off-label Uses:
• Local treatment of superficial skin inflammation where combined vascular protection and anti-inflammatory effect is desirable.
• Management of small venous disorders with associated pain.

• Adults: Apply topically to the affected area, usually 2-3 times daily.
• Pediatrics: Use only under specialist supervision; safety not established.
• Elderly: No specific dose adjustment; monitor for sensitivity to corticosteroids or local anesthetics.
• Special Populations: Avoid use on large damaged skin areas or mucosa to prevent systemic absorption.
• Administration:
• Topical application as a cream or gel.
• Apply a thin layer gently on the affected area after cleaning and drying.
• Duration: Typically 7-14 days depending on clinical response; prolonged use of corticosteroid component should be avoided due to risk of local and systemic side effects.

• Calcium Dobesilate: Acts as a vascular protectant by reducing capillary permeability and fragility, improving microcirculation, and exerting antioxidant effects that stabilize blood vessels.
• Lidocaine: A local anesthetic that blocks sodium channels in nerve cells, preventing initiation and conduction of nerve impulses, thereby providing analgesia.
• Dexamethasone: A potent corticosteroid that inhibits multiple inflammatory cytokines, reduces capillary permeability, and suppresses immune responses to decrease inflammation and edema.

The combination provides synergistic effects: vascular protection and microcirculatory improvement (Calcium Dobesilate), local pain relief (Lidocaine), and potent anti-inflammatory action (Dexamethasone), resulting in rapid symptom relief and tissue healing.

• Calcium Dobesilate: Poorly absorbed systemically after topical use; systemic pharmacokinetics primarily studied with oral use. Renal elimination predominates.
• Lidocaine: Absorbed through skin/mucosa after topical use; undergoes hepatic metabolism via CYP1A2 and CYP3A4 to inactive metabolites; elimination half-life ~1.5-2 hours.
• Dexamethasone: Minimal systemic absorption from topical application; when absorbed, metabolized in liver primarily by CYP3A4, excreted in urine.
• Onset of Action: Lidocaine acts within minutes; anti-inflammatory effects of dexamethasone develop over hours to days.
• Elimination: Mostly renal for all components.

• Pregnancy:
• Calcium Dobesilate: Limited data; use only if benefit justifies risk.
• Lidocaine: Category B; topical use considered low risk but avoid large areas.
• Dexamethasone: Category C; avoid unless essential due to potential fetal risk.
• Lactation:
• Limited data; caution advised. Topical use unlikely to cause significant exposure, but monitor infant for adverse effects.

• Calcium Dobesilate: Vascular protective agent (capillary stabilizer).
• Lidocaine: Local anesthetic (amide type).
• Dexamethasone: Corticosteroid, anti-inflammatory.

• Hypersensitivity to any component (Calcium Dobesilate, Lidocaine, Dexamethasone) or formulation excipients.
• Infection at application site unless concomitant antimicrobial treatment is used.
• Open wounds or large ulcerated skin areas for corticosteroid component.
• Severe hepatic or renal impairment with systemic absorption risk.
• Patients with known cardiac conduction abnormalities or arrhythmias (caution with lidocaine).

• Avoid prolonged use to prevent skin atrophy or systemic corticosteroid effects.
• Monitor for signs of local irritation, allergic reactions, or sensitization.
• Use cautiously in patients with cardiovascular diseases due to lidocaine’s potential systemic effects if absorbed in large amounts.
• Avoid use near eyes or mucous membranes unless specifically formulated for such use.
• Discontinue if worsening symptoms or infection occurs.
• Not recommended for pediatric use without specialist advice.

Common:

• Mild local irritation, burning, itching, or redness.
• Transient numbness or tingling due to lidocaine.

Uncommon/Rare:

• Allergic contact dermatitis.
• Skin atrophy or striae with prolonged corticosteroid use.
• Systemic corticosteroid effects (rare with topical use).
• Systemic lidocaine toxicity (very rare, usually with excessive application).

• Lidocaine: Additive cardiac depressant effects with antiarrhythmics, beta-blockers, or CYP3A4 inhibitors.
• Dexamethasone: Potential interaction with CYP3A4 inhibitors or inducers altering corticosteroid metabolism.
• Avoid concomitant topical products that increase skin permeability (e.g., salicylic acid) which may increase systemic absorption.
• No significant known interaction with calcium dobesilate at topical doses.

• Current guidelines emphasize short-term use of topical corticosteroid combinations for hemorrhoidal and inflammatory anorectal conditions.
• Increased caution advised regarding corticosteroid component to minimize adverse effects from overuse.
• Calcium Dobesilate recognized for improving microcirculation in vascular disorders; topical formulations are adjunctive and complementary.
• Lidocaine-containing topical agents continue to be recommended for rapid symptom relief in anorectal pain syndromes.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat, light, and moisture.
• Keep tube tightly closed when not in use.
• Avoid freezing.
• Keep out of reach of children.