Uro-Vaxom

Approved Indications:

• Recurrent Urinary Tract Infections (UTIs):
  Indicated for the prophylaxis of recurrent lower urinary tract infections (e.g., cystitis) in adults and children, especially females with frequent infections.

Clinically Accepted Off-label Uses:

• Immune Support in Urogenital Tract Infections:
  Used to enhance local and systemic immune responses in individuals prone to bladder infections.
• Adjunctive Immune Modulation:
  Sometimes used in immunocompromised or elderly patients to strengthen defense against E. coli-related infections.

Adults:

• Oral Capsules (Standard Dose – 6 mg):
  One capsule daily on an empty stomach, preferably in the morning, for 90 consecutive days.

Children (≥5 years):

• One capsule daily for 90 consecutive days, under medical supervision.

Elderly:

• Same as adult dosing. Monitor response due to potential age-related immune changes.

Renal Impairment:

• No specific dose adjustment required; use with caution in severe renal impairment.

Hepatic Impairment:

• No dose adjustment generally required; monitor if chronic liver disease is present.

Route of Administration:

• Oral

Treatment Duration:

• Standard course: 3 months
• Can be repeated annually or as needed based on recurrence risk

Lyophilized bacterial lysates of E. coli contain inactivated bacterial fragments derived from pathogenic strains of Escherichia coli. When administered orally, these lysates interact with the gut-associated lymphoid tissue (GALT), particularly Peyer's patches, initiating immune responses at both local and systemic levels. They activate antigen-presenting cells such as macrophages and dendritic cells, leading to the stimulation of T lymphocytes and B cells, enhancing the production of mucosal IgA and systemic IgG. This primes the immune system to recognize and combat E. coli bacteria more effectively, thereby reducing the incidence and severity of recurrent UTIs.

As a non-systemically absorbed immunotherapeutic product, standard pharmacokinetic profiles do not apply:

• Absorption: Acts locally in the gut; not systemically absorbed
• Distribution: Stimulates mucosal and systemic immunity; no plasma distribution
• Metabolism: Broken down enzymatically in the digestive tract
• Elimination: Cleared via normal gastrointestinal metabolic and excretory pathways
• Onset of Action: Immune effects begin within the first few weeks
• Duration of Effect: Protection may persist for months after completion of therapy

• Pregnancy:
• No specific FDA pregnancy category.
• Use during pregnancy only if clearly needed and prescribed. Clinical data are limited but suggest low systemic exposure and minimal risk.
• Lactation:
• No evidence of excretion into breast milk.
• Considered safe during breastfeeding due to lack of systemic absorption. Monitor for gastrointestinal effects in infants.

• Primary Class: Immunostimulant
• Subclass: Bacterial lysate-based oral immune modulator

• Known hypersensitivity to E. coli lysates or any component of the formulation
• Acute urinary tract infection or febrile illness (postpone use until resolution)
• Autoimmune disorders (use only under specialist supervision)
• Age below 5 years (safety and efficacy not established)

• Autoimmune Diseases:
  Use cautiously in patients with systemic autoimmune conditions as immune stimulation may exacerbate symptoms.
• Active Infections:
  Do not initiate therapy during acute UTI or systemic infections. Begin only after infection is resolved.
• Immunocompromised Individuals:
  May have a reduced response; consider concurrent supportive therapy.
• Hypersensitivity Reactions:
  Though rare, allergic reactions including skin rash or gastrointestinal intolerance may occur.
• Monitoring:
  Regular assessment of UTI recurrence, symptom relief, and potential allergic responses is recommended during long-term or repeated use.

Common:

• Gastrointestinal: Nausea, flatulence, abdominal discomfort
• General: Fatigue, low-grade fever
• Skin: Mild rash, itching

Uncommon:

• Headache
• Increased urinary frequency (transient)

Rare but Serious:

• Hypersensitivity reactions, including urticaria or bronchospasm
• Exacerbation of autoimmune conditions

Timing & Severity:

• Most side effects are mild, appear during the early phase of treatment, and resolve spontaneously. Severe reactions are rare.

• Immunosuppressants (e.g., corticosteroids, methotrexate):
  May blunt the immunostimulatory effect of the bacterial lysate.
• Live Vaccines:
  Theoretical risk of interaction; spacing administration by several days is recommended.
• Antibiotics:
  Concurrent use during acute infection is acceptable, but prophylactic effect evaluation should begin after infection resolution.

CYP450 Enzyme Interaction:

• Not metabolized by CYP enzymes
• No known inhibition or induction of hepatic metabolic pathways

• Clinical Studies:
  Recent clinical trials confirm a significant reduction in UTI recurrence with 3-month courses of E. coli lysates, particularly in women with ≥3 UTIs per year.
• Guidelines:
  European urology and infectious disease guidelines recognize bacterial lysates as a non-antibiotic prophylactic option in recurrent UTI management.
• Antibiotic Stewardship:
  Highlighted in recent recommendations as a safe and effective method to reduce antibiotic overuse.

• Temperature: Store below 25°C (77°F)
• Humidity & Light: Store in a dry place, protected from light and moisture
• Handling Precautions:
• Keep capsules in original blister pack until use
• Keep out of reach of children
• Reconstitution or Refrigeration:
• Not required
• Oral capsules should be swallowed whole with water on an empty stomach