Ciprofloxacin extended-release tablets

The antibacterial spectrum is similar to that of norfloxacin. The minimum inhibitory concentration (MIC90) for Enterobacter, Pseudomonas aeruginosa, Haemophilus influenzae, Neisseria gonorrhoeae, Streptococcus, Legionella, Staphylococcus aureus, Bacteroides fragilis, etc. is 0.008-2mu;g/ml, which is significantly better than other similar drugs and antibiotics such as cephalosporins and aminoglycosides. It is also often effective against pathogens resistant to beta-lactams or gentamicin. /// It has a broad-spectrum antibacterial effect. Its activity against almost all bacterial species is 2-4 times stronger than that ofloxacin and enoxacin, and is equivalent to ofloxacin. Its mechanism of action is the same as that of norfloxacin.

The chemical name of ciprofloxacin is: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Molecular formula: C17H18FN3O3, molecular weight: 331.346.

This product is a white to off-white film-coated tablet, which appears white or off-white after removing the coating.

This product can be used to treat urinary tract infections caused by the following sensitive bacteria, including acute simple pyelonephritis. This product and ciprofloxacin immediate-release tablets cannot be used interchangeably. Simple urinary tract infection (acute cystitis): caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, and Staphylococcus saprophyticus. Complicated urinary tract infection: caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, and Pseudomonas aeruginosa. Acute simple pyelonephritis: caused by Escherichia coli.

This product and ciprofloxacin immediate-release tablets are not interchangeable. They should be taken orally as shown in the table below, once a day. This product must be swallowed whole and cannot be broken, crushed or chewed before taking. Simple urinary tract infection (including acute cystitis) 500mg, Q24h, 3 days of treatment. Complicated urinary tract infection 1000mg, Q24h, 7-14 days of treatment. Acute simple pyelonephritis 1000mg, Q24h, 7-14 days of treatment. Patients with urinary tract infection treated with ciprofloxacin immediate-release tablets can switch to this product under the guidance of a physician. If you are taking magnesium/aluminum-containing antacids, sucralfate, VIDEX chewable/buffered tablets or pediatric granules, calcium, iron, zinc and other highly buffered drugs at the same time, you should take it 2 hours before or 6 hours after. This product should be avoided with milk, calcium-rich juice and other foods to avoid affecting its absorption. It is recommended that there should be at least a 2-hour interval between taking this product and taking calcium-containing substances. In patients with renal insufficiency, ciprofloxacin is mainly eliminated by renal secretion, and can also be metabolized by the bile system and partially cleared by the intestine. These pathways can reduce the reduction of renal secretion and excretion caused by renal insufficiency. Patients with simple urinary tract infection do not need to adjust the dose when taking 500 mg of this product; for patients with complicated urinary tract infection and acute simple pyelonephritis, when the creatinine clearance rate is less than 30 mL/min, the dose of this product should be reduced from 1000 mg per day to 500 mg per day; for patients undergoing hemodialysis or peritoneal dialysis, this product can be taken after the dialysis process. Patients with hepatic insufficiency and stable cirrhosis do not need to adjust the dose when taking this product, but there is no sufficient data to describe the pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency.

The adverse reactions of this product mainly include: 1. Gastrointestinal reactions such as nausea, vomiting, upper abdominal discomfort, diarrhea, and decreased appetite. 2. Nervous system reactions such as dizziness, headache, emotional disturbance, and insomnia. The incidence of such reactions is lower than that of gastrointestinal reactions. 3. Allergic reactions such as rash, skin itching, angioedema, and photodermatitis. Allergic shock may occasionally occur. 4. A small number of patients may experience muscle pain, weakness, joint swelling and pain, and palpitations. 5. Laboratory tests may show transient leukopenia and slight increases in serum transaminases, blood urea nitrogen, and creatinine, which are also reversible. The above adverse reactions are mostly mild and can be tolerated by most patients. However, fluoroquinolones such as norfloxacin may occasionally cause serious adverse reactions, including: ① Changes in consciousness, convulsions, and epileptic seizures. ② Transient hallucinations, visual hallucinations, diplopia, etc.

This product is contraindicated in patients with a history of hypersensitivity to ciprofloxacin or any other quinolone.

Precautions for children: The efficacy and safety of this product for children and adolescents (under 18 years old) have not been established. Ciprofloxacin can cause arthritis in minor animals. Precautions for pregnancy and lactation: 1. Medication for pregnant women: There are no adequate and well-controlled studies on medication for pregnant women. Literature reports that the results of the trial of ciprofloxacin for pregnant women conducted by TERIS (Teratogen Information System) showed that it is unlikely to produce a substantial risk of teratogenicity at therapeutic doses during pregnancy, but the data are insufficient to show that it is harmless. A total of 200 women were included in a controlled prospective observational trial, who used fluoroquinolones during pregnancy (52.5% of them used ciprofloxacin, and 68% of them took the drug in the first 3 months of pregnancy). Intrauterine exposure to fluoroquinolones during embryogenesis did not increase the risk factor for major malformations. The rates of major congenital malformations in the fluoroquinolone group and the control group were 2.2% and 2.6%, respectively (generally 1.5%). There was no difference in the rates of spontaneous abortion, premature birth, and low birth weight between the two groups. When the child was 1 year old, no obvious clinically significant bone and muscle disorders were found. Another prospective in-depth study reported that 549 pregnant women used fluoroquinolones (93% in the first 3 months of pregnancy), and a total of 70 pregnant women took ciprofloxacin in the first 3 months of pregnancy. The malformation rates of surviving infants in the ciprofloxacin group and the fluoroquinolone group were within the range. No special congenital malformations were found. This study did not find obvious adverse reactions caused by uterine exposure to ciprofloxacin. There was no significant change in the rates of premature birth, spontaneous abortion and low birth weight in pregnant women using ciprofloxacin. However, these small post-marketing epidemiological studies (most of which were short-term studies - the first 3 months) cannot fully evaluate the hazards of non-general defects or draw authoritative conclusions that the use of ciprofloxacin in pregnant women and fetuses is safe and reliable. Pregnant women should avoid taking ciprofloxacin unless the potential significance to the mother and child is greater than the potential harm. Ciprofloxacin has been studied for premature toxicity in mice and rats, with an oral dose of 100 mg/kg (calculated by body surface area, 0.7 and 0.4 times the maximum daily dose of 1000 mg for humans, respectively). No serious harm to the fetus was found. In toxicity tests on rabbits, ciprofloxacin (oral 30 and 100 mg/kg) caused gastrointestinal disturbances, led to maternal weight loss, and increased abortion rates, but no teratogenic toxicity was found in each dose group. After intravenous administration of 20 mg/kg to rabbits, no maternal toxicity was caused, and no teratogenic toxicity or embryotoxicity was found. 2. Use in lactating women: Ciprofloxacin can be secreted through breast milk. The amount of ciprofloxacin absorbed by infants through breast milk is not yet known. Because of the potential serious harm of mothers taking ciprofloxacin to their breastfed infants, the importance of the drug to the mother should be considered to decide whether to interrupt breastfeeding or discontinue medication. Precautions for the elderly: In a large, prospective, randomized clinical study of this product for the treatment of complicated urinary tract infections, 49% (509/1035) of the patients were over 65 years old (including 65 years old), and 30% (308/1035) of the patients were over 75 years old (including 75 years old). There is no general difference in safety and efficacy between elderly patients and young patients, and clinical trials using other preparations of ciprofloxacin have not demonstrated differences between the two, but it does not rule out that some elderly patients have higher sensitivity. It is known that ciprofloxacin is mainly excreted through the kidneys, so patients with impaired renal function have a higher risk of adverse reactions. Elderly patients with normal renal function (≥65 years old) do not need to adjust their dosage. However, some elderly patients have decreased renal function as they age, so the dosage should be carefully selected and renal function monitoring can be performed.

Similar to other quinolones, ciprofloxacin can increase the serum concentration of theophylline and prolong its elimination half-life when taken with theophylline, which may increase theophylline-related adverse reactions. If co-administration is necessary, theophylline concentration must be monitored and appropriate dose adjustments must be made. Some quinolones (including ciprofloxacin) can also affect the metabolism of caffeine, thereby reducing the clearance rate of caffeine and prolonging its serum half-life. When quinolones (including ciprofloxacin) are taken with multivalent cation preparations (such as magnesium or aluminum-containing antacids), sucralfate, VIDEX chewable/buffered tablets or pediatric granules, and calcium/zinc ion preparations, the absorption of quinolones may be affected, resulting in lower serum and urine drug concentrations. This product should be taken 2 hours before or 6 hours after taking magnesium or aluminum-containing antacids, sucralfate, VIDEX chewable/buffered tablets or pediatric granules, metal cations such as iron, and vitamin preparations containing zinc. Histamine H2 receptor antagonists may not have a significant effect on the bioavailability of ciprofloxacin. When this product is co-administered with omeprazole, the absorption of ciprofloxacin is slightly reduced (20%). However, the clinical significance of this interaction has not been confirmed. When ciprofloxacin is co-administered with phenytoin, changes in the serum concentration of phenytoin (increased or decreased) have been reported in patients. When this product is co-administered with glyburide (very rare), serious allergic reactions have been reported. Some quinolones (including ciprofloxacin) may cause a transient increase in serum creatinine when co-administered with cyclosporine. Quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. When these drugs are co-administered, clotting times should be closely monitored or other appropriate coagulation tests should be performed. Probenecid can affect the secretion process of ciprofloxacin in the renal tubules and increase its blood concentration. This should be considered if the patient is taking these two drugs together.

Keep in a light-proof and airtight container.

500mg

24 months

Guangzhou Nucien Pharmaceutical Co., Ltd.

• Founded in:

  1993-09-17

• Address:

  Building 1-2, No. 196, Kaiyuan Avenue, Luogang District, Guangzhou

• Tax NO.:

  91440101618440809W

• Registered Funds:

  65.25 million yuan

• Website:

  Log in to view

• Email:

  Log in to view