Ciprofloxacin Hydrochloride for Injection

Pharmacological action: This product has a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic Gram-negative bacilli. It has good antibacterial activity against the following bacteria in vitro: most bacteria of the Enterobacteriaceae family, including Citrobacter, Enterobacter cloacae, Enterobacter aerogenes, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. It often has antibacterial activity against multi-drug resistant bacteria. It has high antibacterial activity against penicillin-resistant Neisseria gonorrhoeae, enzyme-producing influenza bacilli and Moraxella. It has antibacterial activity against most strains of Pseudomonas such as Pseudomonas aeruginosa. This product has antibacterial activity against methicillin-sensitive Staphylococcus aureus, and only moderate antibacterial activity against Streptococcus pneumoniae, hemolytic Streptococcus and Enterococcus faecalis. It has good antimicrobial activity against Chlamydia trachomatis, Mycoplasma, Legionella, and also has antibacterial activity against Mycobacterium tuberculosis and atypical mycobacteria. Poor antibacterial activity against anaerobic bacteria. Ciprofloxacin is a bactericide that acts on the A subunit of bacterial DNA helicase, inhibiting DNA synthesis and replication and causing bacterial death. Toxicological studies: Carcinogenicity and mutagenicity: Eight in vitro mutagenicity tests have been conducted on ciprofloxacin, and two of the results were positive (rat hepatocyte DNA repair test and mouse lymphoma cell reverse mutation test). However, the in vivo tests of rat hepatocyte DNA repair test, micronucleus test (mice), and dominant lethal test (mice) were all negative. Long-term in vivo carcinogenicity tests on rats and mice have been completed. After daily oral administration for 2 consecutive years, these animals did not show any carcinogenic and tumorigenic effects of ciprofloxacin. Reproductive toxicity: Reproductive studies using rats and mice taking 6 times the usual daily dose of the drug for humans have not found that ciprofloxacin is harmful to the fetus or causes fertility impairment. When ciprofloxacin is used in rabbits (30 and 100 mg/kg orally), gastrointestinal disorders occur, leading to weight loss and increased abortion in female rabbits. However, no teratogenic effects were observed at both doses. No maternal toxicity, embryotoxicity, or teratogenicity was observed after intravenous administration of up to 20 mg/kg. However, there are no adequate, well-controlled studies in pregnant women. Ciprofloxacin should be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus.

The main ingredient of this product is ciprofloxacin hydrochloride. Excipients: mannitol.

This product is white to slightly yellow loose lumps or powder

For use in cases caused by sensitive bacteria: 1. Urinary and reproductive system infections, including simple and complicated urinary tract infections, bacterial prostatitis, urethritis or cervicitis of Neisseria gonorrhoeae (including those caused by enzyme-producing strains). Since serious adverse reactions have been reported with the use of fluoroquinolones (including ciprofloxacin hydrochloride for injection), and for some patients, simple urinary tract infections are self-limiting, ciprofloxacin hydrochloride for injection should be used only when there is no other drug treatment. 2. Respiratory tract infections, including acute attacks of bronchial infections and lung infections caused by sensitive Gram-negative bacilli. Since serious adverse reactions have been reported with the use of fluoroquinolones (including ciprofloxacin hydrochloride for injection), and for some patients, acute attacks of bronchitis are self-limiting, ciprofloxacin hydrochloride for injection should be used only when there is no other drug treatment. 3. Gastrointestinal infections caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. 4. Typhoid fever. 5. Bone and joint infections. 6. Skin and soft tissue infections. 7. Systemic infections such as sepsis.

This product is for intravenous drip administration. Before use, dissolve it in 200ml 0.9% sodium chloride injection or 5% glucose injection. For any patient, the dosage should be determined according to the degree and nature of the infection, the sensitivity of the pathogen, the patient's body resistance and liver and kidney function. The general dosage for adults is 0.1g~0.2g once, intravenously drip once every 12 hours, and the drip time for each 0.2g is at least 30 minutes. For severe infection or aeruginosa infection, the dose can be increased to 0.4g once, 2 to 3 times a day. The course of treatment depends on the degree of infection. Usually the treatment lasts for 7-14 days, and it should be continued for at least 2 days after the symptoms of infection disappear. Urinary tract infection: 5-7 days for acute simple lower urinary tract infection; 7-14 days for complicated urinary tract infection; pneumonia and skin and soft tissue infection: 7-14 days; intestinal infection: 5-7 days; bone and joint infection: 4-6 weeks or longer; typhoid fever: 10-14 days.

1. Gastrointestinal reactions are more common: they may manifest as abdominal discomfort or pain, diarrhea, nausea or vomiting, indigestion, and anorexia. If severe and long-term diarrhea is found during treatment, a doctor must be consulted, as this may be a serious gastrointestinal disease, pseudomembranous colitis. Once this happens, the drug should be discontinued immediately and appropriate treatment (such as vancomycin) should be given. Drugs that inhibit gastrointestinal motility are prohibited. 2. Central nervous system reactions may include dizziness, headache, drowsiness, or insomnia. In a few cases, peripheral pain abnormalities, increased intracranial pressure, ataxia, convulsions, anxiety, confusion, depression, hallucinations, and epileptic seizures may occur. Some patients even have psychiatric reactions and self-dangerous behaviors. Some patients may experience these reactions at the first time, and the drug should be discontinued immediately to notify the doctor. 3. Allergic reactions: rash, itchy skin, drug fever, urticaria, and occasionally exudative multiforme erythema and angioneurotic edema. In some cases, laryngeal edema, dyspnea, and anaphylactic shock may occur at the first use of the drug, and anti-shock treatment should be given immediately. A small number of patients have photosensitivity reactions. 4. Occasionally, the following may occur: (1) Visual abnormalities, impaired taste, tinnitus, and hearing loss. (2) Hematuria, interstitial nephritis, hepatitis, and manifestations of liver failure. (3) Phlebitis or thrombophlebitis. (4) Crystalluria, more common when used in high doses. (5) Joint pain, muscle pain, tenosynovitis, and Achilles tendinitis. (6) Tachycardia, facial flushing, migraine, and syncope. (7) Effects on the blood system: anemia, thrombocytopenia, hematocytopenia, eosinophilia, hemolytic anemia, and coagulation changes. (8) Skin punctate hemorrhages (petechiae) and blister formation, accompanied by bleeding (blood blisters) and small nodules (papules) with crusts, Stevens-Johnson and Yell syndromes. (9) Long-term and repeated use of this product may cause infections with drug-resistant bacteria or yeast-like bacteria. 5. Abnormal laboratory data: A small number of patients may experience elevated serum aminotransferase and alkaline phosphatase, cholestatic jaundice, especially in patients with liver damage, elevated blood urea nitrogen, creatinine or bilirubin, and some patients may experience hyperglycemia, crystalluria, and hematuria. 6. Ciprofloxacin may affect the patient's ability to drive or operate machinery, especially in patients who drink alcohol at the same time. 7. Serious and other important adverse reactions (1) Disabling and potentially irreversible serious

Patients with a history of allergy to this product or any fluoroquinolone are contraindicated.

Precautions for children: The safety of this product in infants and adolescents under 18 years of age has not been established. However, this product can cause joint lesions when used in several young animals. Therefore, it is contraindicated in children and adolescents under 18 years of age. Precautions for pregnancy and lactation: Animal experiments have not confirmed that quinolones are teratogenic, but studies on the use of drugs in pregnant women have not yet reached a clear conclusion. In view of the fact that this drug can cause joint lesions in minors, it is contraindicated in pregnant women because it can pass through the placental barrier; this product can also be secreted into breast milk, so lactating women should suspend breastfeeding when using this product. Precautions for the elderly: Elderly patients often have impaired renal function, and because this product is partially excreted through the kidneys, it needs to be used in a reduced dose.

1. Urine alkalinizing agents can reduce the solubility of this product in urine, leading to crystalluria and nephrotoxicity. 2. When this product is used in combination with theophylline, competitive inhibition of the binding site of cytochrome P450 may lead to a significant reduction in the liver clearance of theophylline, a prolonged blood elimination half-life (t1/2β), an increase in blood drug concentration, and the appearance of symptoms of theophylline poisoning, such as nausea, vomiting, tremor, restlessness, excitement, convulsions, palpitations, etc. Therefore, theophylline blood drug concentration should be measured and the dose adjusted when used in combination. 3. Cyclosporine combined with this product can increase the blood drug concentration of the former. The blood concentration of cyclosporine must be monitored and the dose adjusted. 4. When this product is used in combination with the anticoagulant warfarin, it can enhance the anticoagulant effect of the latter. When used in combination, the patient's prothrombin time should be closely monitored. 5. Probenecid can reduce the secretion of this product from the renal tubules by about 50%. When used in combination, it may cause toxicity due to the increased blood concentration of this product. 6. This product interferes with the metabolism of caffeine, resulting in reduced caffeine clearance, prolonged blood elimination half-life (t1/2β), and possible central nervous system toxicity. 7. Metoclopramide can accelerate the absorption of this product, but has no effect on bioavailability. 8. Animal experiments have shown that high doses of quinolones combined with certain non-steroidal anti-inflammatory drugs can cause convulsions, and rapid intravenous injection can lead to hypotension.

Keep away from light and store in a sealed place (10-30℃).

0.4 g (as ciprofloxacin)

24 months

Hainan Herui Pharmaceutical Co., Ltd.

• Founded in:

  2009-08-14

• Address:

  Haikou National High-tech Zone Yaogu Industrial Park Phase II

• Tax NO.:

  91460100693152436R

• Registered Funds:

  149.454 million yuan

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