Pidonex

Approved Indications:

• Recurrent respiratory tract infections (RTIs):
  Used in both children and adults to reduce frequency and severity of infections such as:
• Recurrent bronchitis
• Rhinitis
• Pharyngitis
• Tonsillitis
• Sinusitis
• Chronic obstructive pulmonary disease (COPD):
  As an adjuvant therapy to reduce the frequency of acute exacerbations.
• Community-acquired pneumonia (CAP):
  Adjunct to antibiotics for faster immune recovery and reduced relapse.
• Bronchial asthma (especially pediatric cases):
  Reduces infection-induced exacerbations.

Clinically Accepted Off-label Uses:

• Recurrent urinary tract infections (UTIs):
  As supportive therapy in immunocompromised patients.
• Mild to moderate immunodeficiency syndromes:
  To improve immune response and reduce infection rates.
• Recurrent tonsillitis and adenoiditis in children

Route: Oral
Formulations: Oral solution and tablets

Adults:

• Acute phase: 800 mg twice daily for 10–20 days
• Maintenance phase: 800 mg once daily for 30–60 days

Children (>3 years):

• Acute phase: 400 mg twice daily for 10–20 days
• Maintenance phase: 400 mg once daily for 30–60 days

Elderly:

• Use adult dose. Monitor renal function if impaired.

Renal or Hepatic Impairment:

• No specific dose adjustment established; monitor closely, especially in severe renal dysfunction due to unchanged urinary excretion.

Administration Instructions:

• Administer on an empty stomach to improve absorption.
• Oral solution may be diluted in water or juice for better taste in children.
• Duration should be customized based on clinical condition and physician judgment.

Pidotimod is a synthetic dipeptide molecule that functions as an immunostimulant. It enhances both innate and adaptive immune responses. On a cellular level, it activates T-lymphocyte proliferation, increases natural killer (NK) cell activity, and promotes the secretion of cytokines such as interleukin-2 (IL-2) and interferon-gamma (IFN-γ). Additionally, it enhances the antigen-presenting capacity of dendritic cells and the phagocytic activity of macrophages. These effects collectively boost the immune defense against bacterial and viral pathogens, especially in individuals with recurrent infections.

• Absorption: Well absorbed orally; bioavailability approximately 45%
• Time to Peak Plasma Concentration (Tmax): 2 hours after administration
• Protein Binding: Low (10–20%)
• Metabolism: Not significantly metabolized; excreted mostly unchanged
• Excretion: >90% excreted unchanged in urine
• Half-life (t½): Around 4 hours
• Accumulation: Unlikely with standard dosing; minimal accumulation

• Pregnancy:
  Human data are limited. Animal studies show no direct teratogenicity or fetal toxicity. Use only if clearly needed and prescribed by a physician.
• Lactation:
  Unknown if excreted in breast milk. Caution is advised during breastfeeding. Risk to infants is considered low but not fully excluded.
• Recommendation:
  Avoid use during pregnancy and lactation unless the potential benefit outweighs the potential risk. Consult physician before initiating treatment.

• Primary Class: Immunostimulant
• Subclass: Synthetic dipeptide immune response modulator

• Known hypersensitivity to Pidotimod or formulation components
• Patients with active or severe autoimmune diseases
• Severe renal insufficiency (due to renal route of elimination)
• Children under 3 years of age (safety not established)

• Autoimmune disorders: Use with caution; may trigger immune system activation.
• Severe renal impairment: Use with clinical monitoring due to unchanged urinary elimination.
• Children under 3 years: Not recommended due to lack of sufficient data.
• Monitoring: Watch for signs of hypersensitivity, especially in the first week of treatment.
• Immunosuppressive therapy: Avoid concurrent use as it may reduce Pidotimod's effectiveness.

Common Side Effects:

• Gastrointestinal: Nausea, vomiting, abdominal pain
• Neurological: Headache, dizziness
• Skin: Rash, itching

Uncommon Side Effects:

• Diarrhea
• Metallic taste
• Fatigue or malaise

Rare but Serious Side Effects:

• Hypersensitivity reactions (angioedema, urticaria)
• Flare-ups in autoimmune diseases (in susceptible individuals)
• Anaphylaxis (extremely rare)

Severity & Timing:

• Most adverse effects are mild and occur early during treatment.
• Usually self-limiting or resolve upon discontinuation.

• Immunosuppressants (e.g., corticosteroids, cyclosporine): May counteract the immune-stimulating effects of Pidotimod.
• Vaccines: May enhance immune response when co-administered; clinical benefit observed in some pediatric immunization programs.
• Antibiotics: Can be safely combined; no pharmacokinetic interactions reported.
• CYP450 Enzymes: Not metabolized via cytochrome P450; minimal risk of drug-drug interactions through this pathway.

• Expanded Use:
  Clinical trials and regional guidelines in Europe have endorsed its use in children with recurrent RTIs and adults with COPD as adjunct therapy.
• Immunization Synergy:
  Studies show improved vaccine responsiveness when co-administered with routine pediatric immunizations.
• Global Approvals:
  Widely approved in European, Latin American, and Asian markets; not currently FDA-approved in the United States.

• Temperature: Store below 25°C (77°F)
• Light & Humidity: Protect from direct sunlight and moisture
• Formulation Care:
• Oral solution: Shake well before use
• After opening: Discard unused portion within 30 days
• Do Not Freeze: Freezing may alter formulation stability
• Storage Container: Keep tightly closed in the original package