Sparfloxacin Lactate Tablets

Pharmacological action Sparfloxacin is a broad-spectrum fluoroquinolone antibiotic, and its mechanism of action is to inhibit bacterial DNA gyrase, thereby hindering DNA replication and producing a bactericidal effect. This product is different from β-lactam antibiotics in chemical structure and mode of action. Therefore, bacteria resistant to β-lactam antibiotics are still sensitive to this product. Although cross-resistance has been found between this product and other fluoroquinolones, some microorganisms resistant to other fluoroquinolones are still sensitive to this product. Animal in vitro tests and clinical infection treatment have confirmed that this product has antibacterial activity against the following bacteria: 1. Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pneumoniae (strains sensitive to penicillin). 2. Gram-negative aerobic microorganisms: Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis. 3. Other microorganisms: Chlamydia pneumoniae, Mycoplasma pneumoniae. Although the following microorganisms have antibacterial effects in vitro, their clinical significance is still unclear: 1. Gram-positive aerobic microorganisms: Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-resistant strains), Streptococcus pyogenes, etc. 2. Gram-negative aerobic microorganisms: nitrate-negative Acinetobacter, Acinetobacter lwoffii, Citrobacter freundii, Enterobacter aerogenes, Klebsiella oxytoca, Legionella pneumophila, Morganella, Proteus mirabilis, Proteus vulgaris. Toxicological studies Genetic toxicity: This product has no mutagenic effect on most strains of Salmonella typhimurium (TA100, TA1535.TA1537), Escherichia coli WP2uvrA and Chinese hamster lung cells in the Ames test, but it has been confirmed that this product and other quinolone drugs have mutagenic effects on Salmonella typhimurium strain TA102 and induce DNA repair of Escherichia coli, which may be because these drugs inhibit bacterial DNA gyrase. This product can induce chromosomal aberrations in Chinese hamster lung cells at in vitro cytotoxic concentrations, but when this product is orally administered to mice, no increase in chromosomal aberrations or micronuclei in mouse bone marrow is observed. Reproductive toxicity: Calculated by body surface area, no teratogenic effect was observed when the oral doses of rats, rabbits and monkeys were 6.4.4.4.2.6 times the maximum human dose (the plasma concentrations of monkeys and rats were 4.5 and 6.5 times higher than that of humans, respectively). When the dose of this product in rats reached 15.4 times the maximum human dose (400 mg) (calculated by body surface area) (equivalent to 12 times the maximum human plasma concentration), there was no effect on the fertility or reproductive function of female and male animals. The above doses are significantly toxic to the mothers of rabbits and monkeys, and slightly maternally toxic to rats. When the dose that causes significant maternal toxicity (calculated by body surface area, equivalent to 9.3 times the maximum human dose) is administered to pregnant rats, dose-dependent defects in the embryonic ventricular septum can be seen. In the three animal tests, the damage was specific to rats. Carcinogenicity: No carcinogenicity was found when mice or rats were given oral administration of 3.5-6.2 times the maximum human dose (400 mg) daily for 104 consecutive weeks. Others: It has been confirmed that when minor dogs were given this product orally for 7 consecutive days at a dose of 25 mg/kg/day (calculated on the body surface area, approximately equivalent to 1.9 times the maximum human dose), it can cause joint lesions, and small-scale cartilage corrosive damage appeared in the weight-bearing joints of the dogs. Other quinolone drugs can also be seen in different types of minor animals. Such changes and other signs of joint lesions can also be seen.

Active ingredient: Sparfloxacin lactate Chemical name: 5-amino-1-cyclopropyl-7-(cis-3,5-dimethyl-1-piperazinyl)-6,8-difluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid lactate. Chemical structure: Molecular formula: C19H22F2N4O3·C3H6O3 Molecular weight: 482.49

This product is a film-coated tablet, which appears yellow after removing the film coating.

This product can be used for mild and moderate infections caused by sensitive bacteria, including: 1. Respiratory system infections: such as acute pharyngitis, acute tonsillitis, otitis media, sinusitis, bronchitis, bronchiectasis infection, pneumonia, etc. 2. Intestinal infections: such as bacterial dysentery, typhoid fever, infectious enteritis, salmonella enteritis, etc. 3. Biliary tract infections: such as cholecystitis, cholangitis, etc. 4. Urogenital system infections: such as cystitis, pyelonephritis, prostatitis, gonococcal Neisseria urethritis, non-gonococcal Neisseria urethritis, adnexitis, intrauterine infection, cervicitis, vestibular gland inflammation, etc. and urogenital tract infections caused by Ureaplasma urealyticum and Chlamydia trachomatis. 5. Skin and soft tissue infections: such as impetigo, acne vulgaris, folliculitis, furuncle, furuncle, carbuncle, erysipelas, cellulitis, lymphadenitis, lymphangitis, subcutaneous abscess, hidradenitis, mastitis, trauma and surgical wound infection, etc. 6. Oral infections: such as periodontitis, pericoronitis, palatitis, etc.

For adults, take orally 0.1-0.3g at a time, not more than 0.4g at most, once a day. The course of treatment is generally 5-10 days. The course of treatment can be appropriately increased or decreased according to the type of disease and condition.

Sparfloxacin may cause the following reactions: 1. Digestive system reactions: such as nausea, vomiting, loss of appetite, upper abdominal discomfort, soft stools, diarrhea, abdominal distension, constipation, bloody stools, stomatitis, etc.; 2. Allergic reactions (including photosensitivity reactions): such as rash, fever, local redness, edema, itching, blisters, erythema, congestion, etc.; 3. Central nervous system: headache, dizziness, irritability, insomnia, cramps, tremors, etc.; 4. Laboratory tests: This product can cause increases in AST, ALT, ALP, LDH, BUN, Cr and total bilirubin, and can also cause eosinophilia and decreases in white blood cells, red blood cells, hemoglobin and platelets; there are reports of mild QT prolongation abroad; 5. Others: occasional tendinitis, pseudomembranous colitis, interstitial pneumonia, shock, allergic syndrome

It is contraindicated for patients who are allergic to quinolones, pregnant women, lactating women and patients under 18 years of age.

Precautions for children: The safety and effectiveness of this product for patients under 18 years of age have not been established, so it is contraindicated. Precautions for pregnancy and lactation: Fluoroquinolones can pass through the blood-placental barrier and can be secreted into breast milk. Their concentration is close to the blood concentration. Precautions for pregnant and lactating women: This product is contraindicated. Precautions for the elderly: This product should be used with caution by the elderly. If used, the dosage should be appropriately reduced.

1. Like enoxacin, norfloxacin and ciprofloxacin, this product has rarely been reported to cause spasms when used in combination with non-steroidal anti-inflammatory drugs (such as fenbutyric acid, propionic acid derivatives, etc.). 2. When this product is used in combination with antacids containing aluminum, magnesium, iron and sucralfate, it can reduce the absorption of this product, thereby reducing the efficacy of the drug. If it is necessary to take it, it should be taken at an interval of 4 hours. 3. When this product is used in combination with theophylline, caffeine, warfarin and cimetidine, it does not affect the plasma concentration of the latter. 4. When used in combination with digoxin and probenecid, it does not affect the pharmacokinetics of this product. 5. Nutritional supplements containing metal ions and vitamins containing zinc, iron and calcium can be taken 4 hours after taking this product. 6. This product should not be used in combination with astemizole, terfenadine, cisapride, erythromycin, pentamidine, phenothiazines, tricyclic antidepressants, disopyramide and amiodarone.

Sealed storage

0.1 g

24 months

Suzhou Dawnrays Pharmaceutical Co., Ltd.

• Founded in:

  1995-12-08

• Address:

  No. 268, Minfeng Road, Wuzhong Economic Development Zone, Suzhou

• Tax NO.:

  913205006283933800

• Registered Funds:

  $131.5 million

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