THIOPHENICOL® 250 mg — Thiamphenicol Film-Coated Tablets
1- Disclaimer
This information is provided for general educational and reference purposes only and is not a substitute for diagnosis, medical advice, prescribing information, or individualized treatment by a qualified healthcare professional. Thiophenicol (thiamphenicol) is a prescription antibacterial medicine and should be used only under appropriate medical supervision.
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.
Product formulations, approved indications, manufacturers, registration status, availability, dosing instructions, contraindications, and safety information may change. The current Egyptian Drug Authority information, the latest official package insert supplied with the medicine, and the treating physician or pharmacist should take precedence over general drug summaries.
2- Summary
THIOPHENICOL® 250 mg is an oral antibacterial medicine containing thiamphenicol, a synthetic amphenicol antibiotic structurally related to chloramphenicol. It inhibits bacterial protein synthesis and has historically been used against susceptible bacterial infections.
The Egyptian Drug Authority (EDA) antimicrobial formulary lists thiamphenicol as an antibacterial agent with oral, intramuscular, and intravenous routes and includes 250 mg oral formulations and a 750 mg powder for injection among dosage forms listed in Egypt. It also emphasizes renal dose adjustment and monitoring of the complete blood count and kidney function.
Thiamphenicol should not be used for viral infections. Its use should be guided by the suspected or proven bacterial pathogen, antimicrobial susceptibility, local resistance patterns, and current treatment guidelines.
3- Brand Name
Brand name: THIOPHENICOL®
Generic name: Thiamphenicol
Country discussed: Egypt
The 250 mg product is listed in Egyptian drug references as a film-coated tablet containing thiamphenicol 250 mg, associated with Sanofi Aventis Egypt.
4- Category
Pharmacological category: Systemic antibacterial antibiotic
Antibiotic class: Amphenicol
ATC code: J01BA02 – Thiamphenicol
The Egyptian Drug Authority formulary categorizes thiamphenicol under antibacterials related to chloramphenicol and lists it within the Access Group in its antimicrobial formulary.
5- Active Ingredient
Each 250 mg tablet contains:
Thiamphenicol 250 mg
Thiamphenicol is a synthetic analogue of chloramphenicol in which structural modification of the parent molecule produces important differences in metabolism and elimination.
6- Pharmaceutical Form & Strength
For the THIOPHENICOL product discussed here:
Film-coated tablet: 250 mg thiamphenicol
A commonly listed Egyptian presentation contains 16 tablets.
The Egyptian Drug Authority antimicrobial formulary also lists the following thiamphenicol dosage forms/strengths in its Egyptian database:
- Capsules: 250 mg
- Tablets: 250 mg
- Oral solution: 250 mg
- Powder for solution for injection: 750 mg
Routes listed by EDA include oral, intramuscular, and intravenous administration.
Availability of an individual brand or dosage form at pharmacies should not be assumed solely from its appearance in a formulary.
7- Manufacturer & Marketing Authorization Holder
The Egyptian 250 mg THIOPHENICOL film-coated tablet is listed in drug directories under Sanofi Aventis Egypt, while Egyptian product information has identified the product as produced by SANOFI Egypt s.a.e. under license from sanofi-aventis/France.
Historical Egyptian governmental pharmaceutical documentation also lists both THIOPHENICOL tablets 250 mg and THIOPHENICOL vial 750 mg under Sanofi.
Because corporate structures and marketing authorizations can change, the manufacturer and current marketing authorization holder printed on the latest Egyptian pack or recorded in the current EDA registration should be considered definitive.
8- Mechanism of Action
Thiamphenicol inhibits bacterial protein synthesis.
Like other amphenicols, it acts principally on the 50S bacterial ribosomal subunit, interfering with the peptidyl-transferase stage of protein synthesis and preventing normal elongation of the bacterial peptide chain. Experimental studies demonstrate inhibition of peptidyl-transferase activity on bacterial 70S ribosomes.
Its antibacterial effect is generally considered predominantly bacteriostatic, although the clinical effect may depend on the organism, drug concentration, and site of infection.
9- Spectrum of Activity
Thiamphenicol has historically been described as a broad-spectrum antibacterial agent, with activity against a range of Gram-positive and Gram-negative organisms.
Published studies have demonstrated in-vitro activity against organisms including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and the atypical respiratory pathogen Mycoplasma pneumoniae. Evidence concerning Chlamydia pneumoniae includes studies of thiamphenicol derivatives, notably thiamphenicol glycinate acetylcysteinate; those findings should not automatically be extrapolated to oral thiamphenicol base.
However, antibacterial susceptibility changes over time and varies geographically. Historical spectrum descriptions must therefore not be interpreted as proof that a current clinical isolate is susceptible.
Whenever clinically appropriate, culture and antimicrobial-susceptibility results should guide treatment.
Thiamphenicol has no activity against viral infections such as influenza or the common cold.
10- Pharmacokinetics
Thiamphenicol is absorbed after oral administration and distributes into body tissues.
Human pharmacokinetic data indicate relatively rapid absorption, with peak plasma concentrations occurring approximately 2 hours after oral administration in studied regimens.
Protein binding is relatively low, reported at approximately 10% or less, which facilitates tissue distribution. Unlike chloramphenicol, thiamphenicol undergoes little hepatic glucuronidation and is eliminated largely through the kidneys in unchanged form. The reported plasma elimination half-life in humans is commonly around 2–3 hours after conventional dosing, but it varies with dose and renal function and is prolonged in renal impairment.
Renal impairment can significantly prolong elimination and cause drug accumulation; consequently, dose reduction is required when renal function is impaired.
11- Indications
The Egyptian Drug Authority formulary describes thiamphenicol for the treatment of susceptible bacterial infections, including certain sexually transmitted infections, and specifically records gonorrhoea among its listed indications.
Product information has also historically described use for susceptible bacterial infections involving sites such as the respiratory, gastrointestinal, and urogenital systems.
Important modern clinical context: the presence of an indication in older or existing labeling does not necessarily mean the medicine remains the preferred treatment today.
For example, thiamphenicol should not be presented as current standard empirical treatment for gonorrhoea. WHO currently identifies ceftriaxone as the preferred treatment because antimicrobial resistance has substantially changed gonorrhoea management.
Likewise, thiamphenicol should not be considered routine modern empirical treatment for acute bacterial meningitis. Current WHO guidance recommends intravenous ceftriaxone or cefotaxime for initial empirical treatment, with additional agents when clinically indicated.
Treatment should therefore be based on the current diagnosis, susceptibility data, contemporary guidelines, and physician judgment.
12- Administration
Route for THIOPHENICOL 250 mg tablets: Oral.
The EDA formulary reports a usual adult oral thiamphenicol dose of 1.5 g daily in divided doses, with doses up to 3 g daily having been used initially in severe infections. A maximum daily dose of 1 g has been suggested for elderly patients. These are formulary reference doses and are not a substitute for an individual prescription.
Pediatric treatment requires weight-, age-, infection-, and formulation-specific medical assessment. EDA describes pediatric daily doses ranging from 30 to 100 mg/kg according to age and infection severity; the 250 mg tablet should not be given to a child who cannot safely swallow tablets.
Renal impairment: dose reduction is important. The EDA formulary provides, for oral administration, suggested regimens including 500 mg twice daily when creatinine clearance is approximately 30–60 mL/minute and 500 mg once daily when creatinine clearance is approximately 10–30 mL/minute. Individual dosing must be determined by the treating physician.
No routine dosage reduction is generally considered necessary solely because of hepatic impairment according to the EDA formulary.
13- Method of Preparation
250 mg film-coated tablets: No preparation or reconstitution is required. Take the medicine exactly as prescribed and swallow the tablet with an appropriate amount of water.
750 mg injectable preparation: This is a separate parenteral dosage form and must be prepared and administered by a healthcare professional. The exact diluent, reconstitution volume, concentration, route, and administration technique must follow the current manufacturer package insert. These details should not be inferred from information for the oral tablet.
14- Contraindications
Do not use thiamphenicol in patients with known hypersensitivity to thiamphenicol, related phenicols, or any component of the particular formulation. Hypersensitivity is the contraindication specifically listed in the EDA antimicrobial formulary.
According to the product information for THIOPHENICOL 250 mg, the medicine should also not be used in patients with a history of bone-marrow insufficiency or severe renal insufficiency, and breastfeeding is contraindicated during treatment.
The EDA generic thiamphenicol monograph lists hypersensitivity as its formal contraindication and separately provides dose-reduction guidance for renal impairment. This difference means that the current product-specific package insert should take precedence for the individual THIOPHENICOL product.
Any additional contraindications appearing in the current Egyptian package insert for the specific THIOPHENICOL product should be followed.
15- Warnings & Precautions
Bone-marrow suppression is the major safety concern. Thiamphenicol may cause dose-related, generally reversible suppression of bone-marrow function. Red blood cells, white blood cells, and platelets can be affected. The risk is especially important with repeated or high exposure and in patients in whom the medicine accumulates, particularly those with renal impairment or advanced age.
A complete blood count (CBC) and assessment of renal function are recommended when clinically appropriate, particularly during repeated treatment, higher-dose therapy, or treatment in patients with impaired renal function. EDA specifically identifies CBC and kidney-function monitoring.
Thiamphenicol is generally considered less strongly associated than chloramphenicol with the classic delayed, dose-independent, often irreversible aplastic anemia syndrome. The EDA formulary states that thiamphenicol is not usually associated with aplastic anaemia. Nevertheless, dose-dependent reversible marrow suppression is well documented, and published case reports describe reversible marrow aplasia/bone-marrow insufficiency during thiamphenicol treatment. It should therefore not be described as free from serious hematologic toxicity.
Do not prolong therapy, repeat courses, or increase the dose without medical supervision.
As with other antibiotics, inappropriate use promotes antimicrobial resistance and can permit overgrowth of non-susceptible organisms.
16- Drug Interactions
Published clinical interaction information for thiamphenicol is relatively limited.
The EDA antimicrobial formulary notes that although thiamphenicol is not substantially metabolized by the liver, it has been reported to inhibit hepatic microsomal enzymes and may consequently alter the metabolism of other medicines.
Particular caution is appropriate when thiamphenicol is combined with medicines capable of causing bone-marrow suppression, because hematologic toxicity may become more clinically significant.
Patients should tell their physician or pharmacist about all prescription medicines, over-the-counter medicines, vitamins, and herbal products they use before starting treatment.
17- Side Effects
The clinically important adverse effect is dose-dependent, generally reversible bone-marrow suppression. Laboratory abnormalities may include anemia, leukopenia, thrombocytopenia, or broader cytopenias. Recovery usually occurs after withdrawal, although normalization can take time.
Other reported adverse effects may include gastrointestinal symptoms such as nausea, abdominal discomfort, or diarrhea, as well as hypersensitivity reactions and skin rash.
Peripheral neurologic toxicity has also been reported with thiamphenicol, particularly in association with significant exposure.
Seek medical attention promptly if unusual bruising or bleeding, persistent fever, marked weakness, pallor, signs of infection, severe rash, breathing difficulty, or other serious symptoms occur during treatment.
18- Use in Special Populations
Pregnancy: Human pregnancy data for thiamphenicol are limited. Thiamphenicol crosses the human placenta and has been detected in cord blood, amniotic fluid, and embryonal/fetal tissues. First-trimester research has also demonstrated placental and fetal uptake and effects on mitochondrial protein synthesis. These findings do not establish a defined rate of human teratogenicity, but they support a cautious approach. The EDA formulary records the older designation Pregnancy Category C, but the former letter-category system should not be interpreted as a modern quantitative measure of fetal risk. The product information for THIOPHENICOL advises that use during pregnancy is not recommended unless the treating physician considers it necessary.
Breastfeeding: Thiamphenicol passes into human milk. A human study following single and repeated oral administration documented milk transfer, and the authors concluded that thiamphenicol use was contraindicated in lactating mothers. The product information for THIOPHENICOL likewise contraindicates breastfeeding during treatment. If systemic treatment is considered necessary, the treating physician should determine whether an alternative antibiotic can be used or whether breastfeeding should be interrupted.
Children: Use only under medical supervision with an age-appropriate formulation and weight-based regimen. Young children who cannot safely swallow tablets should receive an appropriate alternative dosage form when treatment is justified.
Elderly patients: Reduced renal function can increase exposure and marrow toxicity. EDA notes that a maximum daily dose of 1 g has been suggested in elderly patients.
Renal impairment: Dosage reduction is required and renal function should be monitored.
Hepatic impairment: Thiamphenicol undergoes little hepatic metabolism, and EDA indicates that routine dose reduction solely for hepatic impairment is generally not necessary.
19- Storage Conditions
For the 250 mg tablet formulation:
Store at a temperature not exceeding 30°C and in a dry place, unless the current package insert specifies otherwise.
Do not use after the expiry date printed on the package.
Keep the medicine in its original packaging where possible and keep all medicines out of the sight and reach of children.
Storage requirements for injectable thiamphenicol preparations may differ and must follow the specific manufacturer's package insert.
20- Additional Sections
Excipients: The Egyptian 250 mg coated-tablet formulation has been described as containing excipients including calcium hydrogen phosphate, microcrystalline cellulose, acacia, sucrose, magnesium stearate, hypromellose, glycerol, and talc. Exact excipients should always be checked on the current pack because formulations can change.
Sucrose: Patients with relevant hereditary disorders of sugar metabolism should consult their physician or pharmacist before using a sucrose-containing formulation.
Antibiotic stewardship: Thiamphenicol should be taken only when prescribed for a bacterial infection. Do not use leftover tablets for a future illness, share antibiotics with another person, alter the dose independently, or discontinue treatment contrary to the prescriber's instructions.
Current Egyptian dosage-form status: The current EDA website continues to list the 2023 Egyptian National Antimicrobial Formulary as its antimicrobial formulary while newer formularies cover other therapeutic categories. That formulary includes 250 mg thiamphenicol tablets and 750 mg powder for injection.
The 250 mg THIOPHENICOL tablet also continues to appear in current Egyptian drug directories under Sanofi Aventis Egypt.
The 750 mg THIOPHENICOL vial has uncertain current commercial availability. The 750 mg powder for injection remains documented in the EDA antimicrobial formulary, but a formulary or database listing does not by itself prove that a specific Sanofi presentation is currently being manufactured or stocked in Egyptian pharmacies. Current market availability should therefore be verified from the latest EDA registration information, the manufacturer, or an authorized pharmacy.
21- Frequently Asked Questions (FAQ)
Is THIOPHENICOL the same as chloramphenicol?
No. Thiamphenicol is a structurally related amphenicol antibiotic, but it differs from chloramphenicol in metabolism, renal elimination, and some aspects of toxicity.
Can THIOPHENICOL treat colds or influenza?
No. It is an antibacterial medicine and does not treat viral infections.
Is thiamphenicol currently a first-line treatment for gonorrhoea?
No. Although gonorrhoea appears among historical and EDA-listed thiamphenicol indications, modern WHO recommendations favor ceftriaxone because of current antimicrobial-resistance patterns.
Is it a standard treatment for bacterial meningitis?
No. Current WHO guidance recommends ceftriaxone or cefotaxime as empirical therapy for suspected acute bacterial meningitis, with additional antibiotics when indicated by patient-specific risk factors and resistance patterns.
Why are blood tests sometimes needed?
Thiamphenicol can suppress bone-marrow production of blood cells. CBC monitoring helps detect clinically important decreases in red cells, white cells, or platelets.
Can patients with kidney disease take thiamphenicol?
Possibly, but the dose generally needs to be reduced because thiamphenicol is predominantly eliminated through the kidneys and can accumulate when renal function is impaired. A physician should determine the regimen.
Can it be used during pregnancy or breastfeeding?
Pregnancy requires medical assessment because human safety data are limited and thiamphenicol crosses the placenta; the THIOPHENICOL product information advises against use during pregnancy unless the treating physician considers it necessary. Breastfeeding is contraindicated during treatment because thiamphenicol passes into human milk.
Should a patient stop treatment when symptoms improve?
The patient should follow the duration prescribed by the treating physician and should not independently shorten, extend, or repeat an antibiotic course.
22- References
- Egyptian Drug Authority (EDA). Egyptian National Antimicrobial Formulary, Version 1.0, 2023 — Thiamphenicol monograph. The monograph lists Egyptian dosage forms, routes, indications, dosing information, renal adjustment, adverse effects, monitoring, interactions, pregnancy information, and precautions.
- Egyptian Drug Authority — Egyptian Drug Formulary portal. The current EDA formulary page continues to list the 2023 Egyptian National Antimicrobial Formulary alongside later formularies for other therapeutic areas.
- Ferrari V. Salient features of thiamphenicol: review of clinical pharmacokinetics and toxicity. Sexually Transmitted Diseases. 1984;11(4 Suppl):336–339.
- Cannon M, Harford S, Davies J. A comparative study on the inhibitory actions of chloramphenicol, thiamphenicol and some fluorinated derivatives. Journal of Antimicrobial Chemotherapy. 1990;26(3):307–317.
- Grassi C, De Benedetto F. Recent clinical evidence of the efficacy and safety of thiamphenicol derivatives. Journal of Chemotherapy. 2002;14(3):279–284.
- WHO — Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis and syphilis, 2024, together with current WHO gonorrhoea information. These sources reflect contemporary management and antimicrobial-resistance concerns.
- World Health Organization. WHO guidelines on meningitis diagnosis, treatment and care, 2025, supplemented by the WHO practical implementation material published in 2026.
- European Medicines Agency (EMA). Thiamphenicol — Summary Report (2). Human pharmacokinetic data summarized in the report describe rapid oral absorption and distribution, plasma-protein binding of approximately 10% or less, limited hepatic glucuronidation, an elimination half-life of approximately 2–3 hours, and predominantly unchanged renal elimination.
- Plomp TA, Thiery M, Maes RA. The passage of thiamphenicol and chloramphenicol into human milk after single and repeated oral administration. Veterinary and Human Toxicology. 1983;25(3):167–172.
- Nau H, Welsch F, Ulbrich B, Bass R, Lange J. Thiamphenicol during the first trimester of human pregnancy: placental transfer in vivo, placental uptake in vitro, and inhibition of mitochondrial function. Toxicology and Applied Pharmacology. 1981;60(1):131–141.
- Becq-Giraudon B, Poupet JY, Sudre Y. Spontaneously reversible bone-marrow aplasia during treatment with thiamphenicol. Sem Hôp. 1978;54(4):251–252.
- Antimicrobial activity of thiamphenicol glycinate acetylcysteinate and other drugs against Chlamydia pneumoniae. PubMed PMID: 11304944. This study concerns a thiamphenicol derivative and should not be automatically extrapolated to oral thiamphenicol base.
THIOPHENICOL® and all antibiotics should be used only on the advice of an appropriately qualified healthcare professional and in accordance with the current locally approved product information and antimicrobial-treatment guidelines.