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Sparfloxacin capsule

Product description
Approval date: August 4, 2010
 
Date of revision: November 28, 2011
 
          October 01, 2012
 
          November 30, 2015
 
Sparfloxacin capsule instruction manual
 
Please read the instructions carefully and use them under the guidance of a physician.
 
For food and feed processing
 
【Drug Name】
 
Generic name: Sparfloxacin capsule
 
English name: Sparfloxacin Capsules
 
Chinese Pinyin: Sipashaxing Jiaonang
 
[Ingredients] The main ingredient of this product is: sparfloxacin. Its chemical name is: 5-amino-1-cyclopropyl-7-(cis-3,5-dimethyl-1-piperazinyl)-6,8-difluoro-1,4-dihydro-4 - Oxoquinoline-3-carboxylic acid.
 
 
 
Molecular formula: C19H22F2N4O3
 
Molecular weight: 391.41
 
[Properties] The contents of this product are yellow granules, powder or crystalline powder.
 
[Indications] This product can be used for light and moderate infections caused by sensitive bacteria, including:
 
  1. Respiratory infections: such as acute pharyngitis, acute tonsillitis, otitis media, sinusitis, bronchitis, bronchiectasis, 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. Genitourinary infections: such as cystitis, pyelonephritis, prostatitis, Neisseria gonorrhoeae urethritis, non-gonococcal urethritis, uterine annexitis, intrauterine infection, cervicitis, vestibular gland inflammation, etc. Urogenital infection caused by ureaplasma and Chlamydia trachomatis;
 
5. Skin and soft tissue infections: such as pustular sores, acne acne, folliculitis, sputum, carbuncle, sputum, erysipelas, cellulitis, lymphadenitis, lymphangitis, subcutaneous abscess, sweat gland inflammation, mastitis, trauma and surgery Wound infection, etc.
 
6. Stomatological infections: such as periodontal tissue inflammation, periodontitis, gingivitis, etc.
 
[Specification] 0.1g
 
[Usage and Dosage] Oral, adult 0.1 ~ 0.3g each time, up to 0.4g, once a day, the course of treatment is generally 5 to 10 days, according to the disease and condition appropriate increase or decrease course of treatment. Or follow the doctor's advice.
 
[Adverse reactions] This product may cause the following reactions:
 
1. Digestive system reactions: such as nausea, vomiting, loss of appetite, upper abdominal discomfort, soft stools, diarrhea, bloating, constipation, bloody stools, stomatitis, etc.;
 
2. Allergic reactions (including light-sensitive reactions): such as rash, fever, local redness, edema, itching, blisters, erythema, congestion, etc.;
 
3. Central nervous system: headache, dizziness, irritability, insomnia, paralysis, tremors, etc.;
 
4. Laboratory tests: elevated GOT, GPT, ALP, LDH, BUN, serum creatinine and total bilirubin can also cause eosinophilia and white blood cells, red blood cells, hemoglobin and thrombocytopenia; foreign reports of QT prolongation.
 
5. Other: occasional tendonitis, pseudomembranous colitis, interstitial pneumonia, shock, allergic syndrome (dyspnea, edema, hoarseness, flushing, pruritus, etc.), ocular mucosal syndrome (Stevens-Johnson Comprehensive Signs, hypoglycemia, numbness, discomfort, tiredness, etc.
 
[Contraindications] Disabled for those who are allergic to quinolones, pregnant women, lactating women, and patients under 18 years of age.
 
【Precautions】
 
 1. Patients with photoallergy are used with caution or disabled;
 
 2. During the medication, avoid contact with sunlight and exposure as much as possible. If photoallergic symptoms occur, such as rash, itching, blisters, etc., you must stop the drug immediately and give appropriate treatment;
 
3. Patients with abnormal liver and kidney function should be used with caution or appropriate dose reduction;
 
4. Those with history of epilepsy and other central nervous system diseases should be used with caution;
 
5. Patients with prolonged QT, such as heart disease patients (arrhythmia, ischemic heart disease, etc.), hypokalemia, hypomagnesemia, taking antiarrhythmic drugs, etc., should be used with caution;
 
6. Elderly people should use this product with caution, and if appropriate, reduce the dosage;
 
7. Like enoxacin, norfloxacin, and ciprofloxacin, this product has a rare report of sputum when combined with non-steroidal anti-inflammatory drugs (such as benzophenone acid, propionic acid derivatives, etc.).
 
8. It is strictly forbidden to be used in food and feed processing.
 
[Pregnant women and lactating women] Pregnant women, lactating women are prohibited.
 
[Child medication] Patients under the age of 18 are banned.
 
[Geriatric Use]
 
There is currently no detailed research data.
 
Elderly patients should use this product with caution. Elderly patients with extended elimination half-life should pay attention to drug accumulation.
 
【medicine interactions】
 
There is currently no detailed research data.
 
When used in combination with an antacid preparation containing aluminum, magnesium or iron, the product can reduce the absorption of the product and thereby reduce the therapeutic effect.
 
[Drug overdose] There is currently no detailed research data.
 
【Pharmacology and Toxicology】
 
Pharmacological action
 
Sparfloxacin is a broad-spectrum fluoroquinolone antibiotic that acts by inhibiting bacterial DNA gyrase (a topoisomerase of bacteria that controls DNA topology and is involved in DNA replication, repair, inactivation, and transcription) Activity.
 
This product is different in chemical structure and action form from β-lactam antibiotics. Therefore, it is still effective against bacteria resistant to β-lactam antibiotics.
 
Although cross-resistance has been found between this product and other fluoroquinolone drugs, some microorganisms resistant to other fluoroquinolones are still sensitive to this product.
 
Animals in vitro and clinical infection treatment confirmed that this product has antibacterial activity against the following bacteria:
 
Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pneumoniae (strain sensitive to penicillin).
 
Gram-negative aerobic microorganisms: Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, and Moraxella catarrhalis.
 
Other microorganisms: Chlamydia pneumoniae, Mycoplasma pneumoniae.
 
Although the following microorganisms have antibacterial effects in vitro, their clinical significance is still unclear.
 
Gram-positive aerobic microorganisms: Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-resistant strain), Streptococcus pyogenes, and the like.
 
Gram-negative aerobic microorganisms: nitrate-negative Acinetobacter, Acinetobacter ruta, F. fulvus, Enterobacter aerogenes, Klebsiella oxytocin, Legionella pneumophila, Morganella, singular Proteus, common Proteus.
 
Toxicological research
     Genotoxicity: This product has no mutagenic effect on most of the Salmonella typhimurium strains (TA100, TA1535, TA1537), Escherichia coli WP2uvrA and Chinese hamster lung cells in the Ames test, but this product and other quinolones have been confirmed. Salmonella typhimurium strain TA102 has mutagenic effects and induces DNA repair in E. coli, probably because these drugs inhibit bacterial DNA gyrase. This product can induce chromosomal aberrations in Chinese hamster lung cells in vitro cytotoxic concentration, but after oral administration of this product, no chromosomal aberrations or increased micronucleus of mouse bone marrow were observed.
    Reproductive toxicity: In terms of body surface area, rats, rabbits, and monkeys were administered orally at a dose of 6.4, 4.4, and 2.6 times the maximum dose of humans (the plasma concentrations of monkeys and rats were 4.5 and 6.5 times higher than those of humans, respectively). No teratogenic effects were observed. This product has no fertility or reproductive function in female or male animals when it is administered at a dose of 15.4 times the maximum dose (400 mg) of the human body (calculated as body surface area, which is equivalent to 12 times the maximum plasma concentration of humans). influences. The above doses are markedly toxic to the mothers of rabbits and monkeys and have mild maternal toxicity in rats. A dose-dependent defect in the embryonic ventricular septum was seen when the pregnant rats were dosed at a dose that showed significant maternal toxicity (equivalent to 9.3 times the human body maximum dose). In the test of three animals, the injury was specific to the rat. Since there is no adequate and strictly controlled study in pregnant women, it can only be used during pregnancy when the trade-offs affect the fetus for more than the disadvantages.
    This product can be secreted from human milk. Because breast-feeding mothers take this product and have serious adverse reactions to the baby, after considering the importance of the drug to the mother, decide whether to stop breastfeeding or stop using the drug.
    Carcinogenicity: No carcinogenicity was observed when mice or rats were orally administered daily for 3.5 to 6.2 times (calculated as body surface area) equivalent to the maximum dose of human (400 mg).
    Others: It has been confirmed that the adult dog is orally administered with a dose of 25 mg/kg/day for 7 consecutive days (calculated as body surface area, which is equivalent to 1.9 times the highest dose of human), which can cause joint disease. The dog's weight-bearing joints show a small range of cartilage corrosive damage. Other quinolone drugs can also be seen in different types of underage animals and other signs of joint disease.
【Pharmacokinetics】
 
When a healthy adult has a single oral dose of 0.4 g of this product, about 5 hours after taking the drug, the plasma drug concentration reaches a peak value of 1.49±0.17 μg/L, and the elimination half-life is longer, about 16 hours.
    According to the literature, this product is mainly absorbed in the small intestine after oral administration, and the stomach is hardly absorbed. The plasma protein binding rate of this product is 42 to 44%. When a single person is orally administered 150 mg of this product, the plasma drug concentration peaks at 1.72 μg/mL, and the average elimination half-life is about 26 hours. This product is widely distributed in the body after oral absorption, mainly distributed in the gallbladder (about 7 times the plasma drug concentration); followed by skin, prostate, uterus, ovary, ear, nose, throat tissue, sputum, prostatic fluid, urine and In milk (about 1.5 times the concentration of plasma drug); again saliva, tears (about 0.7 to 0.8 times the concentration of plasma drug); the lowest is aqueous humor and spinal fluid.
    For 72 hours after a single oral administration of 200 mg of this product in healthy adults, 12% of the drug was excreted from the urine with a prototype drug and 29% with a glucuronic acid conjugate, and 51% was excreted from the feces by a prototype drug.
    This product and antacid (such as aluminum hydroxide gel) combined with the use of this product alone, the plasma half-life is about the same, the plasma drug concentration peak and the area under the curve decreased by 21% and 35%.
    When a healthy adult and a patient use this product together with theophylline, this product does not affect the concentration of theophylline in the plasma.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Packing] aluminum plastic packaging, 6 capsules per box; 8 capsules per box; 10 capsules per box; 12 capsules per box; 20 capsules per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H20103415
 
【manufacturer】
 
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
Postal code: 529331
 
Phone number: 0750-2789348 2783621
 
          400-8899-328 (National Service Phone)
 
Fax number: 0750-2789348 2789285
 
Website: http://www.pdpharm.com
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