Bacillus clausii: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Diarrhoea

Adult: As 2 billion spores/5 mL oral suspension or 2 billion spores/cap: 2-3 vials or capsules daily at 3- to 4-hour intervals. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: Infants and children As 2 billion spores/5 mL oral suspension: 1-2 vials daily at 3- to 4-hour intervals. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).

Contraindications

Hypersensitivity.

Special Precautions

Immunocompromised or severely ill patients. Vials for oral suspension are for oral use only, do not administer in any other way. Doses should be given between antibiotic administrations. Infants and children. Pregnancy and lactation.

Adverse Reactions

Significant: Bacteraemia, septicaemia, and sepsis (in immunocompromised or severely ill patients).
Immune system disorders: Hypersensitivity reactions (e.g. rash, hives, angioedema).

Drug Interactions

Antibiotics may decrease the therapeutic effect.

Action

Description: Bacillus clausii, a probiotic, is a spore-forming bacterium that is a part of the normal gut flora with no pathogenic properties. Its spores have high resistance to acidic conditions of the stomach and can reach the intestinal tract intact where they are transformed into metabolically active vegetative cells; they also contribute to the restoration of the balance of the intestinal bacterial flora altered by intestinal microbial imbalance of diverse origin. Furthermore, it is capable of producing vitamins, particularly the group B vitamins, which contribute to correcting the dysvitaminosis caused by using antibiotics and chemotherapeutic agents.

Storage

Oral suspension: Store below 30°C. Cap: Store below 25°C.

MIMS Class

Antidiarrheals

References

Ianiro G, Rizzatti G, Plomer M et al. Bacillus clausii for the Treatment of Acute Diarrhea in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Nutrients. 2018 Aug;10(8). doi: 10.3390/nu10081074. Accessed 11/08/2022. PMID: 30103531

Anon. Bacillus Clausii. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/08/2022.

Enterogermina (Sanofi Hong Kong Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 10/08/2022.

Enterogermina 2 billion/5 mL, Oral Suspension (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/08/2022.

Erceflora 2 billion/5 mL Oral Suspension (Sanofi-Aventis Philippines Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 10/08/2022.

TamiPRO 2 billion Spores (Prosafe Biologicals LLP). MIMS Philippines. http://www.mims.com/philippines. Accessed 11/08/2022.

Disclaimer: This information is independently developed by MIMS based on Bacillus clausii from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com