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Sulfamethoxazole | CAS No: 723-46-6 | GMP-certified suppliers
A medication that supports treatment of susceptible urinary, respiratory, and gastrointestinal infections as well as Pneumocystis pneumonia and certain region-specific bacterial illnesses.
Therapeutic categories
Primary indications
- Sulfamethoxazole is indicated in combination with trimethoprim, in various formulations, for the following infections caused by bacteria with documented susceptibility: urinary tract infections, acute otitis media in pediatric patients (when clinically indicated), acute exacerbations of chronic bronchitis in adults, enteritis caused by susceptible _Shigella_, prophylaxis and treatment of _Pneumocystis jiroveci_ pneumonia, and travelers' diarrhea caused by enterotoxigenic _E
- Coli_
- In Canada, additional indications include the adjunctive treatment of cholera, treatment of bacillary dysentery, nocardiosis, and second-line treatment of brucellosis in combination with [gentamicin] or [rifampicin]
Product Snapshot
- Sulfamethoxazole is an oral and parenteral small‑molecule antibacterial API supplied in multiple solid and liquid dosage forms
- Its primary uses are bacterial infections treated in combination with trimethoprim, including UTIs, respiratory and gastrointestinal infections, Pneumocystis jiroveci pneumonia, and additional indications such as cholera and nocardiosis in Canada
- It is an approved API in the US and Canada
Clinical Overview
Pharmacodynamically, sulfamethoxazole inhibits bacterial folate production by competing with para-aminobenzoic acid for dihydropteroate synthase. Trimethoprim complements this activity by inhibiting dihydrofolate reductase, blocking the downstream reduction to tetrahydrofolate. Together, these actions suppress purine and nucleic acid synthesis and reduce the likelihood of resistance compared with either agent alone.
Absorption after oral administration is generally efficient, with broad distribution into tissues and fluids. The compound undergoes hepatic metabolism, primarily via cytochrome P450 pathways, notably CYP2C9, and both the parent drug and metabolites are eliminated renally. Renal impairment can increase systemic exposure, necessitating dose adjustments when used clinically in combination formulations.
Safety considerations include hypersensitivity reactions, which may progress to severe cutaneous adverse reactions. Sulfonamides can precipitate hemolysis in patients with glucose‑6‑phosphate dehydrogenase deficiency and may contribute to folate depletion. Photosensitivity and rare hematologic toxicities have been reported. Sulfamethoxazole is also associated with potential hyperkalemia, especially when used with other agents that impair potassium homeostasis.
Sulfamethoxazole is widely known as part of trimethoprim–sulfamethoxazole combinations marketed under various global brand names. For API sourcing, suppliers should provide evidence of compliance with pharmacopeial specifications, control of polymorphic form, impurity profile qualification, and robust documentation to support regulatory submissions.
Identification & chemistry
| Generic name | Sulfamethoxazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 723-46-6 |
| UNII | JE42381TNV |
| DrugBank ID | DB01015 |
Pharmacology
| Summary | Sulfamethoxazole is a sulfonamide that inhibits bacterial folate synthesis by competitively blocking dihydropteroate synthase, preventing formation of dihydrofolic acid and downstream nucleic acids. The drug is typically combined with trimethoprim, which inhibits dihydrofolate reductase, creating sequential blockade of the folate pathway. This dual targeting produces a complementary antibacterial effect and slows the development of resistance. |
|---|---|
| Mechanism of action | Sulfamethoxazole is a sulfonamide that inhibits bacterial dihydrofolic acid synthesis due to its structural similarity to an endogenous substrate, para-aminobenzoic acid (PABA).Most bacteria meet their need for folic acid by synthesizing it from PABA, as opposed to Animalia that require exogenous folic acid sources.Sulfamethoxazole competitively inhibits dihydropteroate synthase, the enzyme responsible for bacterial conversion of PABA to dihydrofolic acid.Inhibition of this pathway prevents the synthesis of tetrahydrofolate and, ultimately, the synthesis of bacterial purines and DNA, resulting in a bacteriostatic effect. |
| Pharmacodynamics | Sulfamethoxazole is a bacteriostatic sulfonamide antibiotic that inhibits a critical step in bacterial folate synthesis. It is generally given in combination with [trimethoprim], a dihydrofolate reductase inhibitor, which inhibits the reduction of dihydrofolic acid to tetrahydrofolic acid.Studies have shown that bacterial resistance develops more slowly with the combination of the two drugs than with either trimethoprim or sulfamethoxazole alone, as together they inhibit sequential steps in the bacterial folate synthesis pathway. Sulfonamides, including sulfamethoxazole, have been implicated in hypersensitivity reactions - these agents should be discontinued at the first sign of a developing rash, as this may signal the start of a more severe reaction such as Stevens-Johnson syndrome or toxic epidermal necrolysis. Sulfamethoxazole treatment may contribute to folate deficiency and should therefore be used with caution in patients at a higher risk of developing a deficiency. Hemolysis has been observed in patients with glucose-6-phosphate dehydrogenase deficiency who are using sulfamethoxazole/trimethoprim. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dihydropteroate synthase | Escherichia coli (strain K12) | antagonist |
ADME / PK
| Absorption | Sulfamethoxazole is rapidly absorbed following oral administration and has a bioavailability of 85-90%.The T<sub>max</sub> is approximately 1-4 hours following oral administration, and the C<sub>max</sub> at steady-state is 57.4 - 68.0 μg/mL. |
|---|---|
| Half-life | The average serum half-life of sulfamethoxazole is 10 hours and may be increased in patients with severely impaired renal function. |
| Protein binding | Sulfamethoxazole is approximately 70% bound to plasma proteins,primarily to albumin. |
| Metabolism | Sulfamethoxazole metabolism is mediated primarily by arylamine N-acetyltransferase (NAT) enzymes, which are responsible for acetylation of sulfamethoxazole at its N4 position.Sulfamethoxazole may also undergo oxidation at its C5 and N4 atoms, the latter of which is catalyzed by CYP2C9.Glucuronidation of the N4 atom, likely mediated by unspecified UGT enzymes, is an additional minor route of metabolism.None of the identified metabolites of sulfamethoxazole appear to carry antimicrobial activity. The hydroxylamine metabolite of sulfamethoxazole, generated via oxidation by CYP2C9, may be further converted to a more reactive nitroso- metabolite. |
| Route of elimination | Elimination occurs primarily via glomerular filtration and tubular secretion in the kidneys, with urine concentrations generally considerably higher than plasma concentrations.Approximately 84.5% of a single oral dose of sulfamethoxazole is recovered in the urine within 72 hours, of which ~30% is free sulfamethoxazole and the remainder is the N4-acetylated metabolite. |
| Volume of distribution | The volume of distribution sulfamethoxazole following a single oral dose was found to be 13 L.Sulfamethoxazole distributes into sputum, vaginal fluid, middle ear fluid, breast milk, and the placenta. |
| Clearance | The oral and renal clearance of sulfamethoxazole have been estimated as 1.2 ± 0.2 and 0.22 ± 0.05 L/h, respectively. |
Formulation & handling
- Oral formulations may require solubility‑enhancing excipients due to the API’s low aqueous solubility and moderate polarity.
- Parenteral use typically involves solution concentrates that require controlled pH and dilution to maintain solubility and prevent precipitation.
- Solid oral forms handle well as a stable small‑molecule powder, with standard moisture control sufficient for processing and storage.
Regulatory status
| Lifecycle | Patent protection in the US and Canada is either expired or approaching the end of its term, indicating a mature stage of market availability. The API is broadly established in both markets, with competition expected to align with patent-status transitions. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for sulfamethoxazole consists of several manufacturers, with the original branded product historically associated with a single originator but now produced widely by multiple generic firms. Branded and generic formulations are established in the US and Canada, with longstanding market presence. Patent protections have long expired, and the product is fully genericized with mature competition across markets. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> of sulfamethoxazole in mice and rats is 2300 mg/kg and 6200 mg/kg, respectively. Signs or symptoms of sulfonamide overdose include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness, and unconsciousness. Less common symptoms may include pyrexia, hematuria, and crystalluria. Later manifestations of overdose may include blood dyscrasias and jaundice.Treatment should be symptomatic and supportive, and may include gastric lavage or forced emesis if applicable. Monitor patient lab work for evidence of blood dyscrasias or electrolyte imbalances. |
|---|
- Acute oral toxicity is moderate to low in rodents, with reported LD50 values of 2300 mg/kg in mice and 6200 mg/kg in rats
- Overexposure to sulfonamides may produce CNS and gastrointestinal effects (e
- G
Sulfamethoxazole is a type of Sulfonamides and trimethoprim
Sulfonamides and trimethoprim are essential pharmaceutical active ingredients (APIs) widely used in the production of antibiotics. Sulfonamides belong to a class of synthetic antimicrobial agents that inhibit the growth of bacteria by interfering with their folic acid synthesis. These drugs are highly effective against various bacterial infections, including urinary tract infections, respiratory tract infections, and certain skin infections.
Trimethoprim, on the other hand, is a synthetic antibacterial agent that belongs to the diaminopyrimidine class. It works by inhibiting the enzyme dihydrofolate reductase, which is crucial for the synthesis of DNA and RNA in bacteria. By targeting this enzyme, trimethoprim effectively prevents bacterial replication, making it a valuable component in combination therapies for bacterial infections.
The combination of sulfonamides and trimethoprim is particularly potent, as it provides a synergistic effect against a broad spectrum of bacteria. This combination therapy is commonly used to treat urinary tract infections caused by susceptible strains of bacteria, such as Escherichia coli. The two APIs work together to disrupt multiple steps in the bacterial metabolic pathway, enhancing their overall antibacterial activity.
Pharmaceutical companies produce sulfonamides and trimethoprim APIs through rigorous manufacturing processes, ensuring high quality and purity. These APIs are then used in the formulation of various antibiotic products, such as tablets, capsules, and suspensions, which are prescribed by healthcare professionals for the treatment of bacterial infections.
Overall, sulfonamides and trimethoprim are vital pharmaceutical subcategories that play a crucial role in combating bacterial infections, providing patients with effective and targeted antibiotic therapies.
Sulfamethoxazole (Sulfonamides and trimethoprim), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Sulfamethoxazole API manufacturers & distributors
Compare qualified Sulfamethoxazole API suppliers worldwide. We currently have 9 companies offering Sulfamethoxazole API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, USDMF | 250 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Indukern Chemie AG | Distributor | Switzerland | Unknown | CoA | 13 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| Shouguang Fukang | Producer | China | Unknown | CEP, CoA, FDA, USDMF, WC | 13 products |
| Southwest Synthetic Pharm... | Producer | China | China | CEP, CoA, FDA, WC | 6 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Sulfamethoxazole API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Sulfamethoxazole API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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