ENTEROMYCIN DRY 60 mL SYRUP
Antidiarrheal / Oral Suspension
1. Disclaimer
This information is provided for educational and reference purposes only and is not a substitute for the current official product leaflet, professional prescribing information, or advice from a qualified healthcare professional. Because Enteromycin contains older antimicrobial components, including oral clioquinol, its historical leaflet information should not automatically be interpreted as reflecting current evidence-based treatment recommendations.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
Enteromycin Dry 60 mL Syrup is an oral suspension containing alumina gel, clioquinol (iodochlorohydroxyquin), and streptomycin. Egyptian drug listings identify it as an antidiarrheal product manufactured by El Nile Company for Pharmaceuticals and Chemical Industries.
The supplied product leaflet describes the formulation as an adsorbent/astringent preparation intended for diarrhoea. However, some of those historical claims—particularly the routine use of oral clioquinol and streptomycin for diarrhoea—should not be presented as current evidence-based recommendations. WHO guidance specifically states that oral streptomycin should not be used for acute diarrhoea and that halogenated hydroxyquinolones such as clioquinol are not recommended for acute diarrhoea because of efficacy and toxicity concerns.
3. Brand Name
Enteromycin Dry 60 mL Syrup
Current Egyptian drug listings identify the product under this name.
4. Category
Antidiarrheal
This is the therapeutic classification used by Egyptian drug listings.
5. Active Ingredient
According to the available Egyptian product listings and the supplied manufacturer leaflet:
- Alumina gel, dried
- Clioquinol (iodochlorohydroxyquin / iodochloroxyquinoline)
- Streptomycin
The Egyptian Drug Index also lists Enteromycin with the combination ALUMINA GEL + CLIOQUINOL + STREPTOMYCIN.
The terminology "iodochlorohydroxy quinoline" in the supplied leaflet corresponds to clioquinol.
6. Pharmaceutical Form & Strength
Dosage form: Dry powder for preparation of an oral suspension.
Final volume: 60 mL after preparation.
The supplied leaflet states that the bottle contains 15 g of powder intended to prepare 60 mL of suspension. Egyptian listings independently identify the marketed presentation as "Enteromycin Dry 60 ml Syrup."
The supplied leaflet specifies the following composition:
- Iodochlorohydroxyquinoline — 0.1 g per 5 mL
- Dried alumina gel — 0.15 g per 5 mL
- Streptomycin base (as sulfate) — 0.05 g per 5 mL
These strengths should be regarded as leaflet-derived product information; I could not locate a current publicly accessible manufacturer/EDA document online that independently verifies a newer formulation.
7. Manufacturer & Marketing Authorization Holder
Manufacturer: The Nile Company for Pharmaceuticals and Chemical Industries (El Nile), Cairo, Egypt.
Egyptian drug directories consistently identify El Nile as the manufacturer/producer of Enteromycin Dry 60 mL Syrup.
Marketing Authorization Holder: No independently verifiable current public source located during this review clearly distinguishes the marketing authorization holder from the manufacturer. Therefore, it should not be stated separately without confirmation from the current Egyptian regulatory record or package leaflet.
8. Mechanism of Action
The formulation contains components with different pharmacological properties:
Alumina gel: The historical leaflet describes dried alumina gel as an insoluble adsorbent material capable of adsorbing substances within the intestinal contents and increasing stool bulk/consistency. These claims describe its traditional physicochemical action rather than a modern disease-modifying mechanism.
Clioquinol: Clioquinol is a halogenated 8-hydroxyquinoline derivative with antimicrobial/antiprotozoal activity. However, its historical oral use is limited by clinically important neurotoxicity.
Streptomycin: Streptomycin is an aminoglycoside that inhibits bacterial protein synthesis by binding to the bacterial 30S ribosomal subunit. It is primarily active against susceptible aerobic bacteria.
The original leaflet's statement that the three ingredients simply "act effectively to relieve diarrhoea" should therefore not be interpreted as establishing that the combination is appropriate for routine treatment of acute diarrhoea.
9. Spectrum of Activity
The original leaflet describes clioquinol as having broad antimicrobial activity and streptomycin as active against various Gram-negative and Gram-positive organisms.
This description is historical and should not be interpreted as a current clinical spectrum for treatment selection.
Streptomycin has activity against selected susceptible organisms, but its modern clinical use is limited to specific indications because many alternative antimicrobial agents are available.
Clioquinol's historical intestinal antimicrobial/antiamebic use is clinically important mainly as background information because oral use has been associated with serious neurotoxicity.
10. Pharmacokinetics
Streptomycin: Oral gastrointestinal absorption is very poor, and most orally administered drug is recovered unchanged in feces. Systemic pharmacokinetics described for parenteral streptomycin therefore should not be directly applied to this oral formulation.
Clioquinol: Human pharmacokinetic data exist, including evidence of systemic exposure after oral administration. It undergoes metabolic conjugation, including glucuronide and sulfate conjugation.
Alumina gel: The product leaflet describes dried alumina gel as essentially insoluble and acting locally within the gastrointestinal tract.
There are insufficient publicly accessible current data to provide a reliable complete pharmacokinetic profile for the combined Enteromycin formulation, so detailed absorption, distribution, metabolism, and elimination parameters for the combination should not be invented.
11. Indications
The supplied historical leaflet states:
- Symptomatic treatment of most cases of diarrhoea.
- Specific therapy for bacterial diarrhoea caused by streptomycin-sensitive organisms.
These statements should not be presented as current general treatment recommendations. Modern guidance does not support routine antimicrobial treatment for most acute diarrhoeal illnesses, and WHO specifically states that oral streptomycin should not be used for acute diarrhoea.
Therefore, the safest current description is:
Historical product indication: diarrhoea/selected intestinal infections.
Current clinical interpretation: Enteromycin should not be assumed to be appropriate for routine self-treatment of acute diarrhoea, particularly because of the presence of oral clioquinol and streptomycin.
12. Administration
Route: Oral.
The historical leaflet recommends administration before meals and states:
- Infants and young children: dosage adjusted according to weight and response; the leaflet gives a suggested initial dose of 1–2 teaspoonfuls three times daily.
- Children: 1 teaspoonful three or four times daily before meals.
- Adults: 1 tablespoonful three or four times daily.
- The leaflet states that Enteromycin suspension may be taken 0.5–1 hour before meals.
These doses are reproduced as historical leaflet information only. They should not be treated as independently verified current dosing recommendations, particularly for infants and children, because the contemporary safety status of oral clioquinol is a major concern.
13. Method of Preparation
The marketed product is supplied as a dry powder intended to be reconstituted to 60 mL of oral suspension. The supplied leaflet states that the bottle contains 15 g of powder for preparing 60 mL.
The exact volume and procedure for adding water should be taken from the current package instructions, because I could not independently verify a current official reconstitution procedure from an accessible manufacturer or Egyptian regulatory source.
Do not invent a water volume based solely on the final 60 mL presentation.
14. Contraindications
Documented/clinically relevant contraindication:
- Hypersensitivity to clioquinol, streptomycin, other aminoglycosides, or any component of the formulation.
Additional safety restrictions are important because of the individual ingredients. Oral clioquinol has a documented association with serious neurotoxicity, including subacute myelo-optic neuropathy, and its oral preparation has been banned/withdrawn in many jurisdictions.
The original leaflet's simple statement of "hypersensitivity to any component" is therefore insufficient as a modern safety description.
15. Warnings & Precautions
The original statement that "Enteromycin is a safe product that does not need any special precautions" is not scientifically appropriate and has been removed.
Important considerations include:
- Clioquinol-related neurotoxicity: Oral clioquinol has been associated with subacute myelo-optic neuropathy and other neurological toxicity.
- Acute diarrhoea: Antimicrobials should not routinely be used for uncomplicated acute diarrhoea. WHO specifically advises against oral streptomycin and halogenated hydroxyquinolones for acute diarrhoea.
- Streptomycin toxicity: Systemic aminoglycoside exposure can cause ototoxicity and nephrotoxicity. Although oral absorption is normally very low, gastrointestinal mucosal injury can increase aminoglycoside absorption.
- Children: The historical leaflet includes pediatric dosing, but the presence of oral clioquinol warrants particular caution and current professional review rather than assuming historical pediatric dosing remains appropriate.
- Persistent, severe, bloody, febrile, or dehydrating diarrhoea: These presentations require medical assessment rather than relying on an old antidiarrheal combination.
16. Drug Interactions
The supplied leaflet states that tetracyclines should not be used with Enteromycin because aluminum may form poorly soluble complexes and reduce tetracycline absorption.
This interaction is pharmacologically plausible for aluminum-containing products and orally administered tetracyclines.
However, the interaction section of the historical leaflet should not be considered exhaustive.
Other clinically important considerations include the potential for increased aminoglycoside toxicity when systemic exposure to streptomycin occurs and interactions with other nephrotoxic or ototoxic agents. The magnitude of such interactions is expected to be much lower with normally minimally absorbed oral streptomycin, but absorption can increase with severe intestinal mucosal damage.
17. Side Effects
The historical leaflet describes Enteromycin as well tolerated and mentions rare, mild, short-lived gastrointestinal distress with excessive use.
That description is incomplete by modern safety standards.
Potential adverse effects associated with the ingredients include:
- Gastrointestinal discomfort or disturbance.
- Hypersensitivity reactions.
- Neurological toxicity associated with oral clioquinol, including peripheral neurological manifestations, myelopathy, optic involvement, and the historically recognized syndrome of subacute myelo-optic neuropathy.
- Streptomycin-associated ototoxicity and nephrotoxicity when clinically significant systemic exposure occurs.
Therefore, the original statement that adverse effects are limited essentially to mild gastrointestinal distress should not be retained.
18. Use in Special Populations
Infants and children: The historical leaflet provides pediatric dosing, but current use should not be inferred from that historical dosage alone. The presence of oral clioquinol is particularly important when considering pediatric exposure.
Pregnancy: Streptomycin has recognized fetal ototoxicity concerns when systemically administered, and aminoglycosides require careful risk-benefit assessment during pregnancy.
Breastfeeding: Aminoglycosides enter breast milk but are poorly absorbed orally; nevertheless, the complete combination should be evaluated according to current product-specific information.
Renal impairment: Systemic streptomycin is renally eliminated and requires particular caution in renal impairment. Although oral absorption is normally very low, severe gastrointestinal injury can increase aminoglycoside absorption.
Pre-existing neurological or visual disease: Because of the documented neurotoxicity associated with oral clioquinol, such patients require particular caution and professional assessment.
19. Storage Conditions
The supplied material does not provide a sufficiently detailed, independently verified current storage specification for the dry powder or the reconstituted suspension.
Therefore:
Store according to the current package/leaflet instructions supplied with the product.
Do not add unsupported temperature, refrigeration, or post-reconstitution expiry statements that cannot be verified from the current official product information.
20. Additional Sections
Historical formulation information
The supplied manufacturer leaflet describes Enteromycin as containing adsorbent/astringent and antimicrobial components and historically presents it as an antidiarrheal preparation.
Important regulatory/safety context
Clioquinol is the most significant safety issue in interpreting this product. NCBI's MeSH record identifies oral clioquinol as associated with subacute myelo-optic neuropathy and notes that oral preparations were banned worldwide.
This does not by itself establish the current Egyptian regulatory status of Enteromycin. The product is nevertheless still listed in several Egyptian drug directories under its historical combination.
21. Frequently Asked Questions (FAQ)
What are the active ingredients in Enteromycin?
Enteromycin is listed in Egyptian drug references as containing alumina gel, clioquinol, and streptomycin.
Is Enteromycin an antibiotic?
It is classified as an antidiarrheal combination rather than simply as an antibiotic. However, it contains two substances with antimicrobial activity: clioquinol and streptomycin.
Is Enteromycin suitable for every case of diarrhoea?
No. The historical leaflet's broad statement that it is indicated for "most cases of diarrhoea" should not be interpreted as a current evidence-based recommendation. WHO guidance does not recommend oral streptomycin or halogenated hydroxyquinolones such as clioquinol for acute diarrhoea.
Does oral streptomycin get absorbed?
Normally, gastrointestinal absorption is very poor, with most orally administered streptomycin remaining in the intestinal tract and being recovered in feces. Absorption may increase when the gastrointestinal mucosa is severely damaged.
Is clioquinol completely harmless when taken orally?
No. Oral clioquinol has a documented history of serious neurological toxicity, including subacute myelo-optic neuropathy.
Can Enteromycin be used in children?
The historical leaflet contains pediatric dosing, but that does not establish that the historical regimen is currently appropriate or safe. Pediatric use should be determined from current professional and regulatory information.
Does Enteromycin require preparation before use?
Yes. The marketed presentation is a dry powder intended to be reconstituted to 60 mL of oral suspension. Follow the current package instructions for the exact reconstitution procedure.
22. References
- Egyptian Drug Index — Enteromycin listing: Alumina Gel + Clioquinol + Streptomycin.
- Vezeeta Pharmacy — Enteromycin Dry 60 mL Syrup — Egyptian product listing and active ingredients.
- NCBI MeSH — Clioquinol — nomenclature, historical use, and documented oral neurotoxicity/SMON.
- WHO Eastern Mediterranean Region — Guide to chemotherapy and chemoprophylaxis in bacterial infections — guidance concerning oral streptomycin and halogenated hydroxyquinolones in acute diarrhoea.
- NCBI Bookshelf — Streptomycin — mechanism, gastrointestinal absorption, pharmacokinetics, and clinical safety information.
- Clinical Pharmacogenetics Implementation Consortium (CPIC) — Aminoglycosides — enteral aminoglycoside bioavailability and circumstances that may increase absorption.
- PubMed — The toxicology of Clioquinol — historical oral use and neurotoxicity.
- Journal of Pharmaceutical Sciences — Pharmacokinetics of Iodochlorhydroxyquin in Man — human pharmacokinetic data.