Usage
Bacterial lysate is prescribed for the prophylaxis of recurrent respiratory tract infections (RTIs), excluding pneumonia. It is categorized as an immunostimulant. It works by stimulating both innate and adaptive immune responses against bacterial antigens present in the lysate. This can involve activating monocytes, dendritic cells, and natural killer cells, as well as increasing IgA antibody production and modulating the Th1/Th2 immune balance.
Alternate Names
Bacterial lysates are known by various names depending on the specific product. Some examples include:
- OM-85: Marketed under brand names such as Broncho-Vaxom, Broncho-Munal, Ommunal, Imoccur, Vaxoral, and Paxoral.
- Ismigen: Also known as Immubron, Bromunyl, Respibron, and Bactovax.
- Ribomunyl
- Luivac
How It Works
Pharmacodynamics: Bacterial lysates act by stimulating the immune system. They interact with Toll-like receptors (TLRs) on immune cells (e.g. dendritic cells, monocytes/macrophages, and epithelial cells) in the respiratory tract’s mucous membranes and the gastrointestinal tract, mimicking a bacterial infection. This interaction triggers a cascade of immune responses, including:
- Activation and maturation of dendritic cells and monocytes/macrophages.
- Production of chemokines and cytokines.
- Recruitment of neutrophils and other effector cells to mucosal sites.
- Stimulation of B lymphocytes to produce specific antibodies (especially IgA) against the bacterial antigens in the lysate.
- Modulation of the Th1/Th2 immune balance.
Pharmacokinetics: Administered orally or sublingually, bacterial lysates interact with the mucosal immune system. Absorption is not completely understood, but it is thought that the bacterial fragments or their components are taken up by immune cells in the mucosal lining. Metabolism and elimination pathways are not well characterized for bacterial lysates.
Dosage
Standard Dosage
Adults:
-
OM-85: One 7 mg capsule daily on an empty stomach for 10 consecutive days per month for 3 months. For acute episodes, one capsule daily until symptoms resolve (minimum 10 days).
-
Ismigen: One 7 mg sublingual tablet daily before food for at least 10 days for acute illness or for 10 consecutive days per month for 3 months as a long-term treatment.
Children:
- OM-85: 3.5 mg daily (capsule or sachet) on an empty stomach for 10 consecutive days per month for 3 months. For acute episodes, 3.5 mg daily until symptoms resolve (minimum 10 days).
- Ribomunyl: 3 tablets or 1 sachet daily on an empty stomach, 4 times a week for 3 weeks, then for the first 4 days of each month for 2–5 months.
Special Cases:
Dosage adjustments for the elderly, patients with renal or hepatic impairment, or those with comorbid conditions are not specifically established but should be considered on a case-by-case basis. Caution is advised in these populations.
Clinical Use Cases
Bacterial lysates are primarily indicated for preventing recurrent RTIs and are not recommended for use in settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dose adjustments are not clearly defined for specific conditions. Clinical judgment should be used to determine the appropriate dose for patients with renal or hepatic dysfunction.
Side Effects
Common Side Effects
Gastrointestinal disorders (e.g., diarrhea, abdominal pain, nausea, vomiting), rash, and common cold symptoms.
Rare but Serious Side Effects
Serious immune-related reactions (very rare).
Long-Term Effects
Not well-established.
Adverse Drug Reactions (ADR)
Severe allergic reactions (rare).
Contraindications
Hypersensitivity to any component of the bacterial lysate. Caution is recommended during the first trimester of pregnancy and breastfeeding. Not recommended for children under three years old (some products have lower age limits).
Drug Interactions
No significant drug interactions are specifically documented, but caution is advised when co-administering with other medications, especially those affecting the immune system. It is unknown whether alcohol interacts with bacterial lysate.
Pregnancy and Breastfeeding
Limited data are available on the safety of bacterial lysates during pregnancy and breastfeeding. Use only if the potential benefit outweighs the risk. Not generally recommended during the first trimester of pregnancy.
Drug Profile Summary
- Mechanism of Action: Immunostimulant, activates innate and adaptive immunity, enhances IgA production.
- Side Effects: Generally well-tolerated; gastrointestinal issues and rash may occur.
- Contraindications: Hypersensitivity, caution in pregnancy (first trimester) and breastfeeding.
- Drug Interactions: Limited data, caution advised.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Varies by product; see detailed section above.
- Monitoring Parameters: Monitor for respiratory symptoms and any adverse events.
Popular Combinations
Not generally combined with other medications for RTI prevention. May be co-administered with influenza vaccines.
Precautions
Assess for allergies before administration. Exercise caution in pregnant/breastfeeding women, children, and the elderly.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bacterial Lysate?
A: Dosage varies depending on the specific product. Refer to the detailed dosage section above. Consult the prescribing information for the specific product being used.
Q2: How does Bacterial Lysate work?
A: It stimulates the immune system by mimicking bacterial infections, leading to activation of various immune cells and increased antibody production.
Q3: What are the common side effects of Bacterial Lysate?
A: Gastrointestinal upset (e.g., diarrhea, nausea), rash, and cold-like symptoms.
Q4: Is Bacterial Lysate safe during pregnancy?
A: Limited safety data are available. Use with caution only if potential benefits outweigh the risks. Generally not recommended during the first trimester.
Q5: Can Bacterial Lysate be used to treat an active respiratory infection?
A: No, it is indicated only for preventing recurrent RTIs, not treating active infections.
Q6: What is the difference between mechanical and chemical bacterial lysates?
A: They differ in the method used to lyse the bacteria during preparation. This may influence their biological activity, though more research is needed.
Q7: Are there any drug interactions I should be aware of with Bacterial Lysate?
A: Limited data on drug interactions are available. Use caution when co-administering with other drugs, especially those affecting the immune system. Consult the prescribing information.
Q8: Can children take Bacterial Lysate?
A: Yes, some bacterial lysates are indicated for children, but the age and dosage vary depending on the specific product. Consult the prescribing information.
Q9: How long does a patient typically need to take Bacterial Lysate for prophylactic benefit?
A: Typical prophylactic regimens involve taking the medication for 10 consecutive days per month for 3 months. This might vary based on the specific product.
This information is current as of February 16, 2025, and is subject to change as new research emerges. Always consult the latest prescribing information before making treatment decisions.
