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Sulphadimidine Tablet are sulfonamide antibiotics in the category of antimicrobial drugs, appearing as white or slightly yellow tablets with a specification of 0.5g/tablet. Difficult to dissolve in water and ether, easily soluble in dilute acid or alkaline solutions, dissolved in hot ethanol, gradually darkens when encountering light, and needs to be stored in the dark (2-8 ℃, sealed and dried). It is structurally similar to p-aminobenzoic acid (PABA) and can competitively bind to dihydrofolate synthase in bacteria, blocking the synthesis of dihydrofolate. Tetrahydrofolate is an essential substance for bacterial synthesis of purine, thymidine, and DNA, therefore inhibiting its synthesis can block bacterial growth and reproduction.
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Sulphadimidine COA
adverse reaction
As a broad-spectrum antibacterial drug, Sulphadimidine Tablet play an important role in the treatment of mild infections caused by sensitive bacteria, such as acute simple lower urinary tract infections, acute otitis media, and skin and soft tissue infections. However, like all drugs, Sulphadimidine may also cause a series of adverse reactions. The following is a detailed summary and analysis of its adverse reactions:
Allergic reactions
Common manifestations: Allergic reactions are one of the more common adverse reactions of the product, which can manifest as drug rashes. In severe cases, exudative erythema multiforme, exfoliative dermatitis, and bullous epidermolysis atrophic dermatitis may occur. In addition, there are also serum like reactions such as photosensitivity, drug fever, joint and muscle pain, and fever. Occasionally, allergic shock occurs, which is a life-threatening severe allergic reaction.
Mechanism of occurrence: The occurrence of allergic reactions is related to an individual's allergic constitution to sulfonamide drugs. When drugs enter the body, they may act as antigens to stimulate the production of antibodies, leading to allergic reactions.
Preventive measures: Patients who are known to be allergic to sulfonamide drugs should discontinue the use of sulfonamide tablets. Before use, doctors should inquire in detail about the patient's allergy history and conduct necessary allergy tests.
Hematological system reaction
Common manifestations: Sulfate tablets may cause blood system reactions such as neutropenia or deficiency, thrombocytopenia, and aplastic anemia. Patients may present with sore throat, fever, pallor, and a tendency to bleed.
Mechanism of occurrence: The occurrence of these reactions may be related to the inhibition of bone marrow hematopoietic function by drugs. Sulfonamide drugs may interfere with the generation and maturation of blood cells in the bone marrow, leading to a decrease in the number of blood cells.
Preventive measures: During the use of it, regular blood routine tests should be performed to monitor changes in blood cell count. Once a blood system reaction occurs, the medication should be stopped immediately and appropriate treatment measures should be taken.
Common manifestations: Patients who lack glucose-6-phosphate dehydrogenase (G-6PD) are prone to hemolytic anemia and hemoglobinuria after using the product. This is more common in newborns and children than in adults.
Mechanism of occurrence: G-6PD is an important enzyme in red blood cells that participates in the metabolism of glucose. Patients lacking this enzyme are prone to rupture and dissolution of red blood cells after exposure to certain drugs or foods, leading to hemolytic anemia and hemoglobinuria.
Preventive measures: Patients known to lack G-6PD should avoid using it. Before use, doctors should inquire about the patient's family history and allergy history, and conduct necessary G-6PD activity testing.
Hyperbilirubinemia and neonatal jaundice
Common manifestations: Due to the competition for protein binding sites with bilirubin by sulfodimidine tablets, there is an increase in free bilirubin. Newborns with incomplete liver function are more prone to develop hyperbilirubinemia and neonatal jaundice, and occasionally nuclear jaundice.
Mechanism of occurrence: The liver function of newborns is not fully developed, and their ability to metabolize bilirubin is weak. When drugs compete with bilirubin for protein binding sites, it may lead to an increase in free bilirubin levels, which in turn can cause hyperbilirubinemia and jaundice. In severe cases, it can lead to nuclear jaundice, causing damage to the brain of newborns.
Preventive measures: Sulphadimidine tablet should be contraindicated for newborns and infants under 2 months old. For infection cases that require the use of antibiotics, doctors should choose drugs that are safer for newborns.
Basic Drug Information and Pharmacological Mechanism
General Profile of the Drug
The product are white or slightly yellow tablets, with Sulphadimidine as the main ingredient. It is a short‑acting sulfonamide antibacterial agent.It is rapidly and completely absorbed after oral administration, with a peak plasma concentration achieved at approximately 1–4 hours and a plasma half‑life of about 5–7 hours. The drug is widely distributed in various tissues and body fluids, can penetrate the blood‑cerebrospinal fluid barrier, and reaches effective therapeutic concentrations in cerebrospinal fluid.
It is mainly excreted by the kidneys and partially via bile.Its antibacterial spectrum is similar to that of sulfadiazine, inhibiting a variety of Gram‑positive and Gram‑negative bacteria. However, bacterial resistance has gradually increased in recent years, so clinical indications must be strictly controlled.
Core Pharmacological Mechanism
The antibacterial mechanism of Sulphadimidine is based on competitive antagonism of bacterial folic acid synthesis, which is the core principle of its therapeutic effect:
Bacterial growth and reproduction require the synthesis of tetrahydrofolic acid, and para‑aminobenzoic acid (PABA) is the substrate of bacterial dihydrofolate synthetase. Sulphadimidine is highly similar in structure to PABA and can competitively bind to bacterial dihydrofolate synthetase, blocking the involvement of PABA in dihydrofolic acid synthesis.
When dihydrofolic acid synthesis is inhibited, bacteria cannot further produce metabolically active tetrahydrofolic acid, which is an essential precursor for the synthesis of purines, thymidine, and DNA.
Ultimately, bacterial nucleic acid synthesis is impaired, inhibiting growth and reproduction. Sulphadimidine is a broad‑spectrum bacteriostatic agent, with stronger activity against bacteria in the replicative phase and weaker effects on stationary‑phase bacteria.
Main Clinical Indications and Application Scenarios
Sulphadimidine Tablets are mainly used for mild infections caused by susceptible bacteria, focusing on the urinary system, respiratory system, skin and soft tissues, and special infections, as detailed below:
Urinary Tract Infections
Acute uncomplicated lower urinary tract infectionsThis is its core indication. It is effective against cystitis and urethritis caused by susceptible bacteria such as Escherichia coli, Klebsiella spp., and Proteus spp.Clinically, patients present with frequent urination, urgency, dysuria, and lower abdominal distension. When urinalysis shows leukocytes and erythrocytes with positive urine culture, it can be the first choice. High drug concentrations in urine act directly on pathogenic bacteria in the urinary tract mucosa, rapidly relieving symptoms.
Adjuvant treatment of mild pyelonephritisFor mild pyelonephritis without high fever or systemic toxic symptoms, it can be used as part of a combination regimen to enhance antibacterial efficacy. Adequate water intake is required to avoid renal damage caused by drug crystallization.
Respiratory Tract Infections
Acute otitis mediaIndicated for acute otitis media caused by susceptible bacteria including Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes, especially for mild cases in children.The drug reaches the middle ear cavity through blood circulation, inhibits local bacterial proliferation, and relieves otalgia and otorrhea. Pediatric dosage must be strictly calculated based on body weight.
Mild acute bronchitis / pneumoniaEffective for mild lower respiratory tract infections caused by susceptible bacteria, such as non‑penicillinase‑producing Staphylococcus aureus and Streptococcus pneumoniae.For severe infections, combination with β‑lactam bactericidal agents is recommended to avoid resistance from monotherapy.
Skin and Soft Tissue Infections
Used for mild skin and soft tissue infections caused by susceptible bacteria, such as folliculitis, furuncles, early cellulitis, and superficial wound infections.Oral administration inhibits local bacterial growth; combined with local debridement and dressing changes, it effectively controls infection and prevents spread.
Other Special Infections
Intestinal infectionsEffective for mild bacterial dysentery and enteritis caused by Salmonella and Shigella spp., especially in pediatric patients unsuitable for quinolones.Due to the risk of resistance in intestinal flora, long‑term use is not recommended.
ToxoplasmosisA classic regimen in combination with pyrimethamine and calcium folinate.Sulphadimidine inhibits folic acid synthesis in Toxoplasma gondii, while pyrimethamine inhibits dihydrofolate reductase, producing synergistic effects. Calcium folinate reduces myelosuppression.It is used for toxoplasmic encephalitis, ocular toxoplasmosis in immunocompetent patients, and prophylaxis and treatment of toxoplasmosis in AIDS patients.
CoccidiosisWidely used in veterinary medicine for coccidiosis in chickens, rabbits, and other animals, effectively controlling diarrhea, hematochezia, and emaciation. It is a common drug for preventing and treating coccidiosis in livestock and poultry.
Clinical Advantages and Limitations
Advantages
Good oral absorption and wide tissue distribution; can penetrate the blood‑cerebrospinal fluid barrier, suitable for multiple types of infections.
Low cost, convenient administration, and high patient compliance.
Effective against special pathogens such as Toxoplasma gondii and coccidia; combination therapy improves efficacy.
Limitations
Increasing bacterial resistance, especially among streptococci and Enterobacteriaceae, narrowing clinical application.
Relatively frequent adverse reactions, especially hypersensitivity, hematological and renal toxicity, limiting long‑term or high‑dose use.
Only bacteriostatic; combination with bactericidal agents is necessary for severe infections, with limited efficacy as monotherapy.
Physical Properties and Solubility
Sulphadimidine API is a white or slightly yellow crystalline powder, odorless and slightly bitter in taste. It gradually darkens in color upon exposure to light or prolonged contact with air, so preparations usually require light-resistant and airtight storage.
It is very slightly soluble in water, and slightly more soluble in organic solvents such as ethanol and acetone. Since its molecule contains a sulfonamide group (‑SO₂NH‑), it can form water-soluble salts with strong bases, so it is freely soluble in dilute hydrochloric acid, sodium hydroxide solution, and ammonia solution.This amphoteric characteristic provides an important basis for its extraction, identification, assay, and salt-forming process for injection.
Acid-base Properties and Dissociation Characteristics
Sulphadimidine is an amphoteric compound:The primary amino group (‑NH₂) on the benzene ring is weakly basic and can form salts with acids.The hydrogen atom on the sulfonamide nitrogen, influenced by two adjacent strong electron-withdrawing groups (‑SO₂‑ and the pyrimidine ring), shows obvious acidity and can form salts with strong bases such as sodium hydroxide.
Its acidity is stronger than its basicity. Under physiological pH conditions, it exists mainly in anionic form, which facilitates urinary excretion. However, it tends to crystallize out at excessively high concentrations, which is the chemical basis for recommending sufficient water intake and urine alkalinization during administration.
Chemical Stability and Color Reactions
The product is relatively stable chemically and can be stored long-term under dry conditions. However, hydrolysis may occur under strong acids, strong bases, or prolonged heating, resulting in cleavage of the sulfonamide bond and reduced activity.
The free aromatic primary amino group in its structure is a key chemical recognition site:In acidic conditions, it undergoes a diazotization reaction with sodium nitrite to form a diazonium salt, which then couples with alkaline β-naphthol to produce an orange-red to scarlet precipitate. This is the official identification reaction in pharmacopoeias.This reaction is used not only for qualitative identification but also as the basis for content determination by UV-Vis spectrophotometry or dead-stop titration.
Photolability and Structural Changes
Sulphadimidine is sensitive to light. Under illumination, it undergoes oxidation, dehydrogenation, and other reactions, leading to yellowing or darkening of color accompanied by a decrease in the active ingredient.Therefore, during the production, packaging, and storage of tablets, light-resistant containers must be used to avoid direct sunlight, so as to ensure the purity and stable efficacy of the drug.
FAQ
What is the use of sulphadimidine Tablet?
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Sulphadimidine is prescribed to treat urinary tract infections, prostatitis (infection of the prostate gland) and respiratory tract infections caused by bacteria. It is capable of inhibiting the growth or reproduction of bacteria but not killing the bacteria.
What kind of infections can sulphadimidine treat?
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The main value of sulphonamides (e.g. Sulphadimidine) is in the treatment of urinary tract infections and meningococcal meningitis. Dapsone is a close chemical relative of the sulphonamides and is invaluable in the treatment of leprosy.
What is another name for sulphadimidine?
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There are non-standardized abbreviations for it as "Sulphadimidine" (abbreviated SDI and more commonly but less reliably SDD) and as "sulfamethazine" (abbreviated SMT and more commonly but less reliably SMZ). Other names include sulfadimerazine, sulfadimezine, and sulphadimethylpyrimidine.
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