Sultamicillin Tosirate Tablets

After oral administration, this product is hydrolyzed into sulbactam and ampicillin by enterolactone. When sulbactam and ampicillin exist at the same time, it not only protects ampicillin from hydrolysis and destruction by beta-lactamase, but also expands the antibacterial spectrum of ampicillin, and also has good antibacterial activity against bacteria such as enzyme-producing strains of Staphylococcus, Acinetobacter and Bacteroides fragilis. This product has antibacterial activity against Staphylococci, Streptococci, Pneumococci, Enterococci, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Fusobacterium, Peptococcus, Peptostreptococcus and Bacteroides including Bacteroides fragilis. Ampicillin is a penicillin antibiotic that acts on the active reproduction stage of cells and has a bactericidal effect by inhibiting the biosynthesis of cell wall mucopeptides. Sulbactam itself has a weak antibacterial effect and is a competitive, irreversible beta-lactamase inhibitor. When used in combination with beta-lactam antibiotics, it can achieve a good synergistic effect.

Sultamicillin Tosirate

This product is white, off-white tablets or film-coated tablets, which appear white or off-white after removing the coating.

This product is suitable for the following infections caused by sensitive bacteria: 1. Upper respiratory tract infections: sinusitis, otitis media, tonsillitis, etc. 2. Lower respiratory tract infections: bronchitis, pneumonia, etc. 3. Urinary tract infections. 4. Skin and soft tissue infections. 5. Gonorrhea.

Oral. Adults (including the elderly) and children weighing more than 30kg take 0.375-0.75g at a time, twice a day. Children weighing less than 30kg take 50mg/kg per day, divided into 2 doses. The course of treatment is generally 5 to 14 days and can be extended if necessary. For infections caused by hemolytic streptococci, the course of treatment is at least 10 days to prevent the occurrence of acute rheumatic fever or glomerulonephritis. When treating nonspecific gonorrhea, a single dose of 2.25g can be taken orally, plus 1g of probenecid to prolong the blood concentration of ampicillin and sulbactam

1 Allergic reactions: maculopapular rash, urticaria, itchy skin, occasionally exfoliative dermatitis and severe allergic reactions (anaphylactic shock), etc. 2 Gastrointestinal reactions: diarrhea, loose stools, nausea, abdominal pain, cramps, upper abdominal pain and vomiting, etc. 3 Drowsiness, sedation, fatigue, discomfort and headache, etc. 4 Anemia, thrombocytopenia, eosinophilia and other blood system abnormalities. 5 Abnormal liver function: such as increased serum aminotransferase and serum bilirubin. 6 Occasionally interstitial nephritis. 7 Double infection: Long-term or large-scale use of this product can cause infection with penicillin-resistant Staphylococcus aureus, Gram-negative bacilli or Candida albicans.

1. Patients with positive penicillin skin test reaction and those who are allergic to this product and other penicillins are contraindicated. 2. Patients with infectious mononucleosis, cytomegalovirus infection, lymphocytic leukemia, and lymphoma are contraindicated. 3. This product can pass through the placenta into the fetus. However, there is a lack of sufficient controlled studies in humans, so pregnant women generally avoid using it and only use this product when there are clear indications. 4. This product can be secreted into breast milk, which may sensitize infants and cause diarrhea, rash, Candida infection, etc. Therefore, breastfeeding women should use it with caution or suspend breastfeeding during medication. 5. Elderly patients should adjust the dosage or medication interval according to their renal function.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Not yet clear. Precautions for the elderly: Not yet clear.

1. Probenecid, aspirin, indomethacin, phenylbutazone, and sulfonamides can reduce the excretion of this product in the renal tubules, thereby increasing the blood concentration of this product, prolonging the blood elimination half-life (t1/2beta;), and the toxicity may also increase. 2. When this product is used in combination with allopurinol, the incidence of rash increases significantly, so it should be avoided. 3. This product should not be used in combination with acetaldehyde dehydrogenase inhibitors such as disulfiram. 4. When this product is used in combination with chloramphenicol for bacterial meningitis, the incidence of long-term sequelae is higher than when either is used alone. 5. This product can stimulate estrogen metabolism or reduce its enterohepatic circulation, thereby reducing the effectiveness of oral contraceptives. 6. Antibiotics such as chloramphenicol, erythromycin, tetracyclines, and antibacterial drugs such as sulfonamides can interfere with the bactericidal activity of this product, so it is not suitable to be used in combination with this product, especially in the treatment of meningitis or severe infections that urgently need bactericidal drugs. 7. This product can enhance the effect of warfarin.

Sealed, store in a dry place.

0.25 g (calculated as C25H30N4O9S2)

24 months

STAR Pharmaceutical Pte.ltd

• Founded in:

  1993-08-28

• Address:

  3rd Floor, Office Building, No. 6 Shunda Road, Jiangdong New District, Haikou City, Hainan Province

• Tax NO.:

  91469002620007633W

• Registered Funds:

  HK$50 million

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