BioRenal

A. Approved and Commonly Accepted Uses

• Gastrointestinal Health Support:
• Restores and maintains normal intestinal flora.
• Prevention and treatment of antibiotic-associated diarrhea (AAD).
• Supportive management of irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).
• Aids recovery in infectious diarrhea and travelers’ diarrhea.
• Digestive Support:
• Enhances digestion and nutrient absorption.
• Reduces bloating, flatulence, and constipation.
• Bone and Cardiovascular Health:
• Vitamin K2-7 supports bone mineralization by activating osteocalcin.
• Helps prevent arterial calcification via activation of matrix Gla protein (MGP).
• Immune Function Support:
• Improves gut barrier integrity and enhances mucosal immunity.
• Helps reduce frequency of upper respiratory infections.

B. Clinically Accepted Off-label Uses

• Adjunctive therapy in Helicobacter pylori eradication regimens.
• Maintenance of gut microbiota balance in patients with metabolic disorders.
• Supportive role in osteopenia, osteoporosis, and vitamin K2 deficiency.

Route: Oral (capsules, tablets, or sachets)

Adults:

• General use: 1–2 capsules/tablets or 1 sachet daily with meals.
• During/after antibiotic therapy: 1–2 doses/day for 7–14 days.
• Bone/cardiovascular support (Vitamin K2-7): 45–120 mcg/day (as part of the combination).

Children (age >1 year):

• General GI health: Half to 1 sachet daily or age-appropriate pediatric probiotic chewables.
• Antibiotic-related diarrhea: As directed by physician, adjusted per weight.

Elderly:

• Same as adult dose; no adjustment needed.
• Monitor for response in cases of comorbid GI disorders or co-medications.

Renal or Hepatic Impairment:

• No specific dose adjustment required.
• Use cautiously if hepatic metabolism of Vitamin K2 is impaired.

Probiotics are beneficial live microorganisms (e.g., Lactobacillus, Bifidobacterium) that colonize the gut, compete with pathogenic bacteria, and restore a healthy microbiota balance. They also modulate the immune system and enhance epithelial barrier integrity. Prebiotics are non-digestible fibers (e.g., inulin, fructooligosaccharides) that selectively stimulate the growth and activity of probiotics. Vitamin K2-7 (menaquinone-7) activates vitamin K–dependent proteins like osteocalcin and matrix Gla protein (MGP), which regulate calcium deposition—promoting bone formation and preventing vascular calcification. Together, these components synergistically improve gut health, immunity, bone metabolism, and cardiovascular function.

Pharmacokinetics primarily applies to Vitamin K2-7; probiotics/prebiotics act locally.

• Probiotics & Prebiotics:
• Not absorbed into systemic circulation.
• Act within the gastrointestinal tract.
• Vitamin K2-7 (Menaquinone-7):
• Absorption: Fat-soluble; enhanced with dietary fat intake.
• Bioavailability: High; superior to Vitamin K1.
• Distribution: Deposits in liver, bone, and arterial walls.
• Metabolism: Metabolized hepatically via oxidation.
• Half-life: Approximately 60–80 hours (longer than other K vitamins).
• Elimination: Mainly via bile into feces.

• Pregnancy:
  No assigned FDA pregnancy category for this combination. Individual components are generally regarded as safe (GRAS) when taken in recommended dietary doses. Vitamin K2-7 is not teratogenic in known studies.
• Lactation:
  Safe when used at recommended doses.
  Probiotics may provide benefits for the infant by positively influencing the mother's microbiota.
• Caution:
  Consult a physician before use during pregnancy or breastfeeding, especially if on anticoagulants or immunosuppressants.

• Primary Class: Nutraceutical
• Subclasses:
• Probiotic: Live microbial dietary supplement
• Prebiotic: Fermentable non-digestible carbohydrate
• Vitamin: Fat-soluble vitamin (Vitamin K2, menaquinone-7)

• Hypersensitivity to any component of the formulation
• Critically immunocompromised states (e.g., recent organ transplant, advanced HIV)
• Patients with known vitamin K hypersensitivity
• Severe gastrointestinal barrier dysfunction (e.g., short bowel syndrome, severe colitis)
• Patients on warfarin or other vitamin K–antagonists without proper INR monitoring

• Risk of systemic infection (rare):
  Probiotics may cause bacteremia or fungemia in severely immunocompromised patients.
• Anticoagulant interaction:
  Vitamin K2-7 may counteract the effects of warfarin—INR should be monitored.
• Mild GI symptoms:
  Bloating or flatulence may occur during the first few days of use.
• Ensure product quality:
  Use clinically validated strains and formulations with proper colony-forming unit (CFU) counts.
• Not for acute treatment of infections:
  This combination supports recovery but is not a substitute for antimicrobial therapy when indicated.

Common:

• Gastrointestinal:
  Flatulence, bloating, mild abdominal discomfort, nausea
• General:
  Headache, dry mouth (occasionally reported)

Rare/Serious:

• Infectious complications (Probiotic):
  Rare bacteremia or fungemia in immunosuppressed patients
• Hypersensitivity:
  Rash, itching, urticaria (rare)
• Hypercoagulation (Vitamin K2):
  Possible in warfarin users—requires INR monitoring

• Warfarin and other vitamin K antagonists:
  Vitamin K2-7 may reduce anticoagulant effect—monitor INR regularly
• Broad-spectrum antibiotics:
  May reduce probiotic efficacy—dose probiotics 2–3 hours apart from antibiotics
• Immunosuppressive drugs (e.g., cyclosporine, corticosteroids):
  Increased risk of systemic infection from probiotics in high-risk patients
• Alcohol:
  May disrupt gut microbiota, reducing probiotic benefit

• FAO/WHO 2023 Position Statement:
  Reconfirmed safety and utility of probiotics in maintaining GI health and preventing AAD.
• Vitamin K2 Studies (2024–2025):
  New evidence supports Vitamin K2-7 in improving bone mineral density and reducing arterial stiffness in postmenopausal women.
• Clinical Nutrition Guidelines (2023):
  Recommend routine use of prebiotics and probiotics during antibiotic therapy and as supportive therapy in IBS.

• Temperature:
  Store below 25°C. Some formulations may require refrigeration (2°C to 8°C)—check label.
• Humidity & Light Protection:
  Store in a dry place, protected from moisture and direct sunlight
• Handling:
  Keep container tightly closed. Do not freeze.
• Sachets/Tablets:
  Use immediately after opening individual packaging
• Shelf Life:
  Follow manufacturer’s expiry label; ensure CFU count remains viable through shelf life