Not scheduled under Drugs and Cosmetics Rules

Oral

• Capsules: 2 billion CFU, 5 billion CFU

• Sachets: 1 billion CFU, 5 billion CFU

• Tablets: 2 billion CFU

• Suspensions/Drops (Paediatric): 1 billion CFU/mL

Note: Formulations may contain specific species such as Lactobacillus rhamnosus GG, Lactobacillus acidophilus, or Lactobacillus casei — use species-specific evidence when relevant.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Antibiotic-associated diarrhoea (AAD) – Prophylaxis and Treatment

Parameter Recommendation

Starting dose 1–2 billion CFU once daily

Titration May increase to twice daily if required

Usual maintenance dose 1–2 billion CFU twice daily

Maximum dose 5 billion CFU/day

Duration Throughout antibiotic course + 5–7 days after completion

Clinical notes Initiate within 24–48 hours of starting antibiotics for best effect

1. Clostridioides difficile-associated diarrhoea (Adjuvant therapy)

Parameter Recommendation

Starting dose 2 billion CFU twice daily

Titration Not applicable

Usual maintenance dose 2–5 billion CFU twice daily

Maximum dose 10 billion CFU/day

Duration 10–14 days alongside metronidazole or vancomycin

Clinical notes Adjuvant use only; not a replacement for standard antimicrobial therapy

1. Acute infectious diarrhoea (Viral/Bacterial including rotavirus and travellers' diarrhoea)

Parameter Recommendation

Starting dose 1 billion CFU twice daily

Titration Not applicable

Usual maintenance dose 1–2 billion CFU twice daily

Maximum dose 5 billion CFU/day

Duration 5–7 days or until diarrhoea resolves

Clinical notes May reduce duration and severity of symptoms; supportive care essential

1. Irritable Bowel Syndrome (IBS) – Diarrhoea-predominant type

Parameter Recommendation

Starting dose 2 billion CFU once daily

Titration Increase to 2 billion CFU twice daily after 1–2 weeks if tolerated

Usual maintenance dose 2–5 billion CFU/day

Maximum dose 10 billion CFU/day

Duration Trial of 4 weeks; continue only if clinically beneficial

Clinical notes L. rhamnosus GG and L. plantarum strains have better evidence

1. Pouchitis (Adjunct to standard therapy) — Specialist only

Parameter Recommendation

Starting dose 3 billion CFU once daily

Titration Not applicable

Usual maintenance dose 3–5 billion CFU once daily

Maximum dose 5 billion CFU/day

Duration As per gastroenterologist recommendation

Clinical notes L. rhamnosus GG strain has documented efficacy; specialist supervision required

Secondary Indications – Adults (Off-label)

1. Bacterial vaginosis (Adjunct to antibiotic therapy) — OFF-LABEL

• Dose: 1–2 billion CFU orally once daily ± intravaginal formulations

• Duration: During metronidazole course (5–7 days)

• Specialist only: Yes – Gynaecologist input required

• Evidence basis: Indian obstetric practice; small-scale trials showing reduced recurrence rates

1. Helicobacter pylori eradication (Adjuvant) — OFF-LABEL

• Dose: 2 billion CFU twice daily

• Duration: Throughout triple/quadruple eradication therapy (10–14 days)

• Specialist only: Gastroenterologist supervision preferred

• Evidence basis: Meta-analyses suggest reduction in antibiotic-associated GI side effects and improved eradication rates

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Prevention/Treatment of Antibiotic-associated diarrhoea

<6 months 0.25 billion CFU once daily 0.25–0.5 billion CFU once daily 0.5 billion CFU/day Paediatric drops

6 months–2 years 0.5 billion CFU once daily 0.5–1 billion CFU once or twice daily 2 billion CFU/day Sachet or drops

2–12 years 1 billion CFU once daily 1–2 billion CFU once or twice daily 4 billion CFU/day Sachet or capsule

• Duration: Throughout antibiotic course + 5–7 days after completion

• Monitoring: Stool frequency, consistency, signs of intolerance (bloating, flatulence)

1. Acute infectious diarrhoea (including rotavirus gastroenteritis)

<6 months 0.25 billion CFU once daily 0.25–0.5 billion CFU once daily 0.5 billion CFU/day

6 months–2 years 0.5 billion CFU twice daily 0.5–1 billion CFU twice daily 2 billion CFU/day

2–12 years 1 billion CFU twice daily 1–2 billion CFU twice daily 4 billion CFU/day

• Duration: 3–5 days or until diarrhoea resolves

• Monitoring: Hydration status, stool output, clinical response

Secondary Indications – Paediatrics (Off-label)

1. Necrotising enterocolitis (NEC) prophylaxis in preterm neonates — OFF-LABEL

• Dose: 0.25–1 billion CFU once daily

• Duration: Until 34–36 weeks corrected gestational age

• Specialist only: Yes – NICU protocol-based administration only

• Evidence basis: Multiple meta-analyses demonstrate reduced NEC incidence and all-cause mortality in preterm infants

⚠️ Age Restriction Statement:

Not recommended below 1 month of age outside NICU setting without specialist neonatologist input due to risk of probiotic-related sepsis in immature immune systems.

• Immunocompromised patients (chemotherapy recipients, HIV with CD4 count <200 cells/μL, solid organ transplant on immunosuppression) — risk of probiotic-related bacteraemia/fungaemia

• Presence of central venous catheter — documented risk of catheter-related bloodstream infection

• Known hypersensitivity to any Lactobacillus species or formulation excipients

• Short bowel syndrome with jejunostomy — risk of D-lactic acidosis

• Critically ill or ICU-admitted patients — use only under specialist supervision

• Prosthetic heart valves or intracardiac devices — rare case reports of Lactobacillus endocarditis

• Acute pancreatitis — avoid use (based on PROPATRIA trial showing harm)

• Gastrointestinal perforation or structural abnormalities

• Neonates and preterm infants outside NICU protocols

Parameter Information

Risk category Likely safe; no teratogenic risk documented

Preferred strains L. rhamnosus GG most studied in pregnancy

When may be used Safe throughout pregnancy for approved indications

Preferred alternatives Not applicable (no safer alternatives needed)

What to monitor Gastrointestinal tolerance; signs of systemic infection (rare)

Specialist advice Recommended for bacterial vaginosis indication only with gynaecologist input

Parameter Information

Compatible with breastfeeding Yes

Preferred strains L. rhamnosus GG, L. acidophilus

Drug levels in milk Not systemically absorbed; not relevant

What to monitor in infant Gastrointestinal tolerance (stool pattern, colic)

Additional notes Often used to improve infant gut microbiome via maternal supplementation

• Starting dose: No adjustment required; use standard adult dosing

• Titration: Standard titration applicable

• Special considerations:

• Particularly useful for preventing AAD in institutionalised elderly on frequent antibiotics

• Use with caution in frail elderly with multiple comorbidities

• Avoid in immunocompromised elderly (e.g., on long-term corticosteroids, malignancy)

• Extra risks: Monitor for sepsis symptoms in debilitated patients

Interacting Drug Effect Recommendation

Systemic antifungals (fluconazole, ketoconazole, amphotericin B) May reduce viability of yeast components in combination probiotic preparations containing Saccharomyces boulardii Avoid concurrent use of combination probiotics with active antifungal therapy

Immunosuppressive biologics (infliximab, adalimumab, rituximab) Increased risk of probiotic-related sepsis Avoid unless specialist considers benefit outweighs risk

Interacting Drug Effect Recommendation

Broad-spectrum antibiotics (fluoroquinolones, piperacillin-tazobactam, carbapenems) May inactivate Lactobacillus strains Stagger administration by at least 2 hours

Proton-pump inhibitors Altered gastric pH may reduce probiotic survival Clinical significance uncertain; no dose adjustment recommended

Antituberculosis drugs (rifampicin, isoniazid) Potential reduction in probiotic efficacy Stagger dosing; monitor clinical response

• Flatulence (most common, usually transient)

• Abdominal bloating

• Mild abdominal discomfort

• Change in stool consistency

• Increased bowel frequency initially

Generally self-limiting; dose-related; resolve within 3–5 days of continued use

Adverse Effect Clinical Features Action

Lactobacillaemia / Probiotic sepsis Fever, rigors, hypotension in immunocompromised patients Stop immediately; obtain blood cultures; initiate appropriate antibiotics

Fungaemia Occurs with mixed preparations containing Saccharomyces boulardii Discontinue; antifungal therapy as indicated

Endocarditis Fever, new murmur, embolic phenomena (extremely rare) Stop probiotic; urgent cardiology referral

Severe hypersensitivity Anaphylaxis, angioedema (rare) Discontinue permanently; supportive management

Phase Parameters

Baseline No routine laboratory investigations required for general use

During treatment Monitor stool frequency and consistency in diarrhoeal indications; clinical response

Immunocompromised patients Regular clinical assessment for sepsis symptoms (fever, tachycardia, hypotension)

NEC prophylaxis (NICU) As per institutional NICU protocol; daily clinical assessment

Long-term use Periodic assessment of clinical benefit; discontinue if no demonstrable effect

• Vizylac (Capsules, Sachets)

• Vizylac DS

• Sporlac / Sporlac DS

• Darolac / Darolac-Z (with zinc)

• Proalfa

• Lactobacil Plus

• Enterogemina (L. rhamnosus GG)

• Econorm (contains Saccharomyces boulardii — not pure Lactobacillus)

• Vibact / Vibact DS

Note: Some brands contain combinations with Bifidobacterium, Streptococcus thermophilus, or Saccharomyces boulardii — verify label for species composition

Hospital/Government supply Included in some state diarrhoea management kits under NHM

Not NPPA price-controlled; not currently on NLEM

1. Timing matters: Initiate probiotic within 24–48 hours of starting antibiotics for maximum benefit in AAD prevention

1. Heat-sensitive: Never mix with hot liquids, hot foods, or administer with hot beverages — heat inactivates live cultures

1. Strain specificity: Not all probiotics are equivalent; L. rhamnosus GG has the most robust evidence base across indications

1. CFU count matters: Ensure adequate colony-forming units; products with <1 billion CFU may have limited efficacy

1. Absolute avoidance in pancreatitis: Based on PROPATRIA trial data showing increased mortality in severe acute pancreatitis

1. Neonatal caution: Restrict use in neonates to NICU-supervised protocols only; sepsis risk is real in this population

Lactobacillus; probiotic; antibiotic-associated diarrhoea; AAD; IBS; rotavirus; gastroenterology; paediatric-use; safe-in-pregnancy; safe-in-lactation; immunocompromised-caution; NICU

RxIndia v1.0 — 08 May 2025

• CDSCO Product Information Database

• Indian Pharmacopoeia 2022

• API Textbook of Medicine, 11th Edition

• IAP Guidebook on Rational Use of Probiotics in Paediatric Practice

• ICMR-DBT Position Paper on Probiotics (2015)

• AIIMS NICU Protocols for NEC Prophylaxis

• Cochrane Reviews on Probiotics for AAD (used for off-label evidence)

• PROPATRIA Trial (reference for pancreatitis contraindication)