BACTICURE — Sulfamethoxazole/Trimethoprim
1. Disclaimer
This information is provided for educational and reference purposes only and is not a substitute for the current official product information, prescribing information, or advice from a qualified healthcare professional. Drug indications, contraindications, formulations, availability, and regulatory status may vary by country and may change over time.
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.
The information below describes sulfamethoxazole/trimethoprim and the historical product information supplied for BACTICURE. Product-specific details that could not be independently verified from a current official BACTICURE source are explicitly identified rather than assumed.
2. Summary
BACTICURE is identified in the supplied product text as an oral antibacterial combination containing sulfamethoxazole and trimethoprim. The supplied formulation contains the two components in the conventional 5:1 sulfamethoxazole-to-trimethoprim dose ratio: 400 mg/80 mg per tablet and 200 mg/40 mg per 5 mL suspension.
Sulfamethoxazole and trimethoprim inhibit two consecutive steps of bacterial folate metabolism. The combination is used against selected susceptible bacterial infections and is also an important treatment and prophylactic agent for Pneumocystis jirovecii pneumonia in appropriate patients. Modern prescribing emphasizes susceptibility, local resistance patterns, and antimicrobial stewardship rather than treating every infection historically listed for the combination.
3. Brand Name
BACTICURE
The supplied historical text identifies the product as “BACTICURE Tablets & suspension.”
The currently marketed status, availability, and exact current formulation of this specific BACTICURE product could not be independently verified from a current official manufacturer/authority source.
4. Category
- Therapeutic class: Antibacterial
- Drug class: Sulfonamide antibacterial + dihydrofolate-reductase inhibitor
- Generic combination: Sulfamethoxazole + trimethoprim
- Common generic name: Co-trimoxazole
- Route of the supplied formulations: Oral
5. Active Ingredient
The active ingredients are:
- Sulfamethoxazole
- Trimethoprim
The supplied BACTICURE formulation uses the conventional 1:5 trimethoprim:sulfamethoxazole ratio.
The historical product text states:
- Each tablet: sulfamethoxazole 400 mg + trimethoprim 80 mg
- Each 5 mL suspension: sulfamethoxazole 200 mg + trimethoprim 40 mg
These strengths correspond to standard single-strength co-trimoxazole formulations.
6. Pharmaceutical Form & Strength
According to the supplied product text:
Tablets
- Sulfamethoxazole 400 mg
- Trimethoprim 80 mg
Oral suspension
- Sulfamethoxazole 200 mg per 5 mL
- Trimethoprim 40 mg per 5 mL
The suspension therefore contains 240 mg total active antibacterial ingredients per 5 mL.
No current official BACTICURE source was located that independently confirms whether these formulations and strengths remain commercially marketed today.
7. Manufacturer & Marketing Authorization Holder
The supplied historical text states:
Produced by: PHARAONIA PHARMACEUTICALS
and includes:
PHARO PHARMA – For M.O.H & P.
However, I could not independently verify from a current authoritative regulatory or manufacturer source that Pharaonia Pharmaceuticals is still the current manufacturer or that the named entity is the present Marketing Authorization Holder (MAH) for BACTICURE.
Therefore:
- Manufacturer stated on supplied historical text: Pharaonia Pharmaceuticals
- Current MAH: Not independently verified
- Current regulatory status: Not independently verified
This distinction is important because “manufacturer” and “marketing authorization holder” are not necessarily the same legal entity.
8. Mechanism of Action
Sulfamethoxazole and trimethoprim produce sequential blockade of bacterial folate synthesis.
Sulfamethoxazole is structurally similar to para-aminobenzoic acid (PABA) and competitively inhibits dihydropteroate synthase, reducing bacterial synthesis of dihydrofolic acid.
Trimethoprim inhibits bacterial dihydrofolate reductase, preventing conversion of dihydrofolate to tetrahydrofolate.
Blocking these consecutive steps interferes with the production of folate-dependent metabolites required for bacterial nucleic-acid synthesis and other cellular processes.
9. Spectrum of Activity
The combination has activity against a range of susceptible Gram-positive and Gram-negative organisms, but susceptibility varies substantially by organism, geography, resistance mechanisms, and clinical setting.
Documented susceptible organisms in current labeling include, among others:
- Escherichia coli
- Klebsiella spp.
- Enterobacter spp.
- Haemophilus influenzae
- Morganella morganii
- Proteus mirabilis
- Proteus vulgaris
- Shigella flexneri
- Shigella sonnei
- Streptococcus pneumoniae
- Pneumocystis jirovecii
Resistance is common in some organisms and regions. Modern susceptibility information should therefore be considered when appropriate.
The combination should not be described as universally active against “various types of bacteria.” Important organisms with intrinsic or clinically important resistance include Pseudomonas aeruginosa, while organisms such as Mycoplasma, Mycobacterium tuberculosis, and Treponema pallidum are not reliably susceptible.
10. Pharmacokinetics
Following oral administration, both components are rapidly absorbed.
- Peak plasma concentrations generally occur approximately 1–4 hours after administration.
- Mean serum half-life is approximately 10 hours for sulfamethoxazole and 8–10 hours for trimethoprim.
- Approximately 70% of sulfamethoxazole and 44% of trimethoprim are plasma-protein bound.
- Sulfamethoxazole undergoes extensive metabolism, including N4-acetylation.
- Trimethoprim undergoes oxidative metabolism.
- Both components are eliminated predominantly through the kidneys, by glomerular filtration and tubular secretion.
- Renal impairment can increase the half-lives of both components and may require dosage adjustment.
Both components distribute into several body fluids and tissues and cross the placenta; both are also excreted into human milk.
11. Indications
Current indications for sulfamethoxazole/trimethoprim depend on the specific product, country, organism susceptibility, and clinical circumstances.
Well-established indications include selected susceptible:
- Urinary tract infections
- Acute otitis media in appropriately selected pediatric patients
- Acute exacerbations of chronic bronchitis in adults
- Shigellosis when antibacterial treatment is indicated
- Treatment and prophylaxis of Pneumocystis jirovecii pneumonia
- Traveler’s diarrhea due to susceptible enterotoxigenic E. coli in appropriate adults
Co-trimoxazole is also used in some current international labeling for conditions such as toxoplasmosis and nocardiosis, depending on the specific product and clinical context.
The historical BACTICURE text additionally listed gonorrhea, cholera, typhoid/paratyphoid fever, bronchiectasis, sinusitis, pharyngitis, tonsillitis, and various respiratory and gastrointestinal infections. These should not be presented as universally current indications because resistance patterns, modern treatment guidelines, and product labeling have changed.
12. Administration
BACTICURE is identified as an oral formulation.
The supplied historical label states:
- Adults and children over 12 years: 2 tablets every 12 hours
- Children 6–12 years: 10 mL or 1 tablet every 12 hours
- Children 3–5 years: 5 mL every 12 hours
However, these historical product-specific doses should not be treated as a universal current dosing schedule. Contemporary dosing of sulfamethoxazole/trimethoprim is dependent on the infection, patient age and weight, renal function, and indication; pediatric dosing is commonly weight-based.
The medication should be administered exactly according to the current product labeling or prescription. Adequate fluid intake is generally recommended during treatment to reduce the risk of crystalluria.
13. Method of Preparation
No reliably verifiable current BACTICURE-specific preparation instructions were located.
The supplied text describes the product as a “suspension” but does not establish whether the historical suspension was supplied ready-to-use or required reconstitution.
Therefore, no specific volume of water or reconstitution procedure should be inferred.
If the current product is a suspension, the current package instructions should be followed. Oral suspensions should generally be shaken well before administration unless the current product labeling states otherwise.
14. Contraindications
Important contraindications for sulfamethoxazole/trimethoprim products include:
- Known hypersensitivity to trimethoprim, sulfonamides, or product excipients
- Previous drug-induced immune thrombocytopenia associated with trimethoprim or sulfonamides
- Significant/severe hepatic impairment
- Severe renal insufficiency when renal function or drug monitoring cannot be adequately performed
- Certain serious folate-deficiency states, depending on the applicable product labeling
- Pediatric age below the minimum specified in the applicable product labeling
- Concomitant use with dofetilide in U.S. labeling because of the risk of increased dofetilide exposure and serious arrhythmia
Pregnancy should not simply be described as an absolute contraindication for every circumstance. Trimethoprim is a folate antagonist, and use during pregnancy—particularly early pregnancy—requires careful benefit-risk assessment.
15. Warnings & Precautions
Important precautions include:
- Serious hypersensitivity reactions can occur.
- Severe cutaneous adverse reactions including Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), DRESS, AGEP, and other serious reactions have been reported.
- Treatment should be discontinued promptly if significant skin rash or signs of a serious hypersensitivity reaction develop.
- Hematological abnormalities, including thrombocytopenia, agranulocytosis, aplastic anemia, and other blood dyscrasias, may occur.
- Hepatic injury, including severe hepatic necrosis, has been reported.
- Hemolysis may occur in individuals with G6PD deficiency.
- Hyperkalemia and, less commonly, clinically significant hyponatremia may occur, particularly in susceptible patients.
- Renal impairment requires particular caution and may require dosage adjustment.
- Patients with folate deficiency or conditions predisposing to folate deficiency require caution.
- Prolonged or repeated therapy may warrant appropriate blood-count, renal-function, electrolyte, and other laboratory monitoring according to clinical circumstances.
- Antibiotic-associated Clostridioides difficile diarrhea can occur.
- Sulfonamides should not be relied upon for treatment of Group A streptococcal pharyngitis because they do not reliably eradicate the organism or prevent rheumatic fever.
16. Drug Interactions
Clinically important interactions include:
- Warfarin: may increase anticoagulant effect; INR/prothrombin time should be monitored.
- Phenytoin: sulfamethoxazole/trimethoprim can inhibit phenytoin metabolism and increase exposure.
- Dofetilide: concomitant use is contraindicated in applicable labeling.
- Certain diuretics: increased risk of thrombocytopenia has been reported, particularly in older adults.
- CYP2C8 substrates: trimethoprim inhibits CYP2C8.
- CYP2C9 substrates: sulfamethoxazole inhibits CYP2C9.
- OCT2 substrates: trimethoprim inhibits OCT2.
- Other clinically important interactions may occur with drugs affecting potassium balance, folate metabolism, or bone marrow function.
The historical statement that the effects of “oral anticoagulants, phenytoin and sulphonylurea” are simply “potentiated” is therefore incomplete and should not be retained as the complete interaction description.
17. Side Effects
Common or relatively frequent adverse effects can include:
- Nausea
- Vomiting
- Diarrhea
- Abdominal/gastrointestinal discomfort
- Skin rash
Less common but clinically important reactions include:
- Severe hypersensitivity
- SJS/TEN/DRESS and other severe cutaneous reactions
- Blood dyscrasias and thrombocytopenia
- Hepatotoxicity
- Hyperkalemia
- Hyponatremia
- Renal adverse effects
- Hemolysis, particularly in susceptible individuals such as some patients with G6PD deficiency
- Antibiotic-associated C. difficile diarrhea
- Serious pulmonary hypersensitivity or other pulmonary reactions
The original statement that adverse effects are limited mainly to mild gastrointestinal symptoms and rash is therefore incomplete and potentially misleading.
18. Use in Special Populations
Pregnancy:
Sulfamethoxazole and trimethoprim cross the placenta. Trimethoprim interferes with folate metabolism, and epidemiological data have raised concerns regarding congenital malformations following exposure, particularly during the first trimester. Near delivery, sulfamethoxazole may theoretically increase the risk of neonatal hyperbilirubinemia, particularly in susceptible infants. Use therefore requires individualized benefit-risk assessment.
Breast-feeding:
Both components are excreted in human milk. Use requires consideration of the infant's age and risk factors, particularly hyperbilirubinemia and prematurity.
Children:
Age restrictions vary by formulation and regulatory labeling. Pediatric dosing is generally based on indication and body weight rather than simply age bands. Very young infants should not receive the drug unless specifically directed under appropriate medical supervision.
Older adults:
Older patients may have reduced renal clearance and increased susceptibility to adverse effects, including hematological abnormalities and electrolyte disturbances.
Renal impairment:
Renal function is clinically important because both components are predominantly eliminated by the kidneys. Dose adjustment or avoidance may be necessary depending on renal function and the indication.
Hepatic impairment:
Significant hepatic impairment requires particular caution, and severe hepatic impairment is a contraindication in several current product labels.
19. Storage Conditions
The supplied historical BACTICURE text states:
“Keep at a temperature (15–30°C). Keep out of reach of children.”
I could not independently verify a current official BACTICURE storage specification. Therefore, 15–30°C should be regarded as the storage instruction appearing in the supplied historical product information, not as a independently verified current manufacturer specification.
The current package label should take precedence, particularly for the suspension formulation.
20. Additional Sections
Antimicrobial stewardship:
Sulfamethoxazole/trimethoprim should be used only when a bacterial infection is proven or strongly suspected to be susceptible to the combination, or when an appropriate prophylactic indication exists. Unnecessary use promotes antimicrobial resistance.
Resistance:
Resistance patterns vary considerably by organism and geographic region. Laboratory susceptibility testing and local epidemiology can be important when selecting therapy.
Product-specific verification:
The historical BACTICURE text provides useful information regarding its former formulation, but several product-specific details—including current marketing authorization, current availability, current packaging, and current suspension preparation instructions—could not be independently verified from an authoritative current BACTICURE source.
Historical packaging stated in the supplied text:
10, 20, 500, or 1000 tablets; suspension bottles of 60, 100, or 120 mL. These package sizes are retained here only as historical information from the supplied text and have not been independently verified as current.
21. Frequently Asked Questions (FAQ)
What is BACTICURE?
BACTICURE is identified in the supplied historical product information as an oral combination of sulfamethoxazole and trimethoprim.
What are the active ingredients?
Sulfamethoxazole and trimethoprim, in a conventional 5:1 sulfamethoxazole-to-trimethoprim ratio.
Is BACTICURE an antibiotic?
Yes. It is an antibacterial combination.
How does it work?
The two components block consecutive steps in bacterial folate metabolism, thereby interfering with essential bacterial nucleic-acid synthesis.
Can it be used for any bacterial infection?
No. Its usefulness depends on the organism, susceptibility, infection site, patient factors, and current treatment guidance.
Is the original BACTICURE indication list still fully current?
Not necessarily. Several infections listed in the historical text are no longer appropriate to present as routine general indications without qualification because treatment recommendations and resistance patterns have changed.
Can it be used during pregnancy?
Pregnancy is not appropriately summarized as an automatic contraindication in every circumstance. However, particularly during the first trimester and near delivery, significant risks and precautions must be considered.
What should happen if a rash develops?
A new rash can be an early sign of a serious hypersensitivity reaction. Current labeling recommends prompt discontinuation and medical assessment when rash or other signs of serious reaction appear.
Does it interact with warfarin or phenytoin?
Yes. Both interactions are clinically important and may require monitoring or adjustment.
Is the exact current BACTICURE manufacturer confirmed?
No. The supplied historical text names Pharaonia Pharmaceuticals, but a current authoritative source confirming the present manufacturer and MAH was not located.
22. References
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DailyMed / U.S. National Library of Medicine — Sulfamethoxazole and Trimethoprim Tablets, updated June 6, 2025. Current labeling covering indications, mechanism, pharmacokinetics, contraindications, warnings, precautions, interactions, and adverse reactions.
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Electronic Medicines Compendium (emc) — Co-Trimoxazole 80/400 mg and 160/800 mg Summary of Product Characteristics. Current UK product information covering indications, contraindications, pregnancy, lactation, pharmacokinetics, spectrum, and dosing principles.
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DailyMed — Sulfamethoxazole and Trimethoprim pharmacokinetic information. Supporting data on absorption, protein binding, metabolism, half-lives, tissue distribution, and renal elimination.
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Electronic Medicines Compendium — Co-Trimoxazole antibacterial spectrum and susceptibility information. Supporting information on susceptible, variably susceptible, and intrinsically resistant organisms and the importance of local resistance patterns.
Verification status: The pharmacological and safety information above was cross-checked against current authoritative generic co-trimoxazole labeling. Product-specific BACTICURE claims that could not be independently verified from a current authoritative source have been explicitly identified rather than presented as confirmed current facts.