Ciprofloxacin - Beauty of Taihu-Lake Medicine Uses

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What is Ciprofloxacin - Beauty of Taihu-Lake Medicine?

Ciprofloxacin - Beauty of Taihu-Lake Medicine is used to treat bacterial infections in many different parts of the body. Ciprofloxacin - Beauty of Taihu-Lake Medicine oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. Ciprofloxacin - Beauty of Taihu-Lake Medicine may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Ciprofloxacin - Beauty of Taihu-Lake Medicine extended-release tablets are only used to treat urinary tract infections, including acute uncomplicated pyelonephritis.

Proquin® XR tablets are only used to treat uncomplicated or simple urinary tract infections (acute cystitis).

Ciprofloxacin - Beauty of Taihu-Lake Medicine belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Ciprofloxacin - Beauty of Taihu-Lake Medicine will not work for colds, flu, or other virus infections.

Ciprofloxacin - Beauty of Taihu-Lake Medicine is available only with your doctor's prescription.

Ciprofloxacin - Beauty of Taihu-Lake Medicine indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.

Urinary Tract Infections

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

Chronic Bacterial Prostatitis

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Lower Respiratory Tract Infections

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Also, Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis.

Acute Sinusitis

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Skin and Skin Structure Infections

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Infectious Diarrhea

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii†,Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.

†Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

Typhoid Fever (Enteric Fever)

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of Ciprofloxacin - Beauty of Taihu-Lake Medicine in the eradication of the chronic typhoid carrier state has not been demonstrated.

Uncomplicated Cervical and Urethral Gonorrhea

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae.

Complicated Urinary Tract Infections and Pyelonephritis

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli.

Inhalational Anthrax (post-exposure)

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin - Beauty of Taihu-Lake Medicine serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for Ciprofloxacin - Beauty of Taihu-Lake Medicine for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.

Plague

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of Ciprofloxacin - Beauty of Taihu-Lake Medicine could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.

Limitation of Use

Use in Pediatric Patients

Although effective in clinical trials, Ciprofloxacin - Beauty of Taihu-Lake Medicine is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Lower Respiratory Tract Infections

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP and other antibacterial drugs, Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to Ciprofloxacin - Beauty of Taihu-Lake Medicine. Therapy with Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets USP may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Ciprofloxacin - Beauty of Taihu-Lake Medicine. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

How should I use Ciprofloxacin - Beauty of Taihu-Lake Medicine?

Use Ciprofloxacin - Beauty of Taihu-Lake Medicine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ciprofloxacin - Beauty of Taihu-Lake Medicine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ciprofloxacin - Beauty of Taihu-Lake Medicine refilled.
  • An extra patient leaflet may be available with Ciprofloxacin - Beauty of Taihu-Lake Medicine. Talk to your pharmacist if you have questions about this information.
  • Take Ciprofloxacin - Beauty of Taihu-Lake Medicine by mouth with or without food. The preferred dosing time is 2 hours after a meal.
  • Shake well before each use.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Take Ciprofloxacin - Beauty of Taihu-Lake Medicine with a full glass of water (8 oz [240 mL]).
  • Drinking extra fluids while you are taking Ciprofloxacin - Beauty of Taihu-Lake Medicine is recommended. Check with your doctor for instructions.
  • If you also take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate, do not take them within 6 hours before or 2 hours after taking Ciprofloxacin - Beauty of Taihu-Lake Medicine. Check with your doctor if you have questions.
  • If you also take sevelamer, do not take it within 4 hours before or after taking Ciprofloxacin - Beauty of Taihu-Lake Medicine. Check with your doctor if you have questions.
  • Ciprofloxacin - Beauty of Taihu-Lake Medicine works best if it is taken at the same time each day.
  • To clear up your infection completely, take Ciprofloxacin - Beauty of Taihu-Lake Medicine for the full course of treatment. Keep taking it even if you feel better in a few days.
  • Avoid taking Ciprofloxacin - Beauty of Taihu-Lake Medicine with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Ciprofloxacin - Beauty of Taihu-Lake Medicine as part of a full meal that contains milk or milk products is permitted.
  • Do not miss any doses. If you miss a dose of Ciprofloxacin - Beauty of Taihu-Lake Medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Uses of Ciprofloxacin - Beauty of Taihu-Lake Medicine in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Ciprofloxacin - Beauty of Taihu-Lake Medicine is used to treat wide range of bacterial infections including lung or respiratory tract infections, eye infection, bladder and kidney infections, reproductive tract infections, skin and soft tissue infections and bone and joint infections.

Ciprofloxacin - Beauty of Taihu-Lake Medicine description

Ciprofloxacin - Beauty of Taihu-Lake Medicine: Each 250- and 500-mg tablet contains Ciprofloxacin - Beauty of Taihu-Lake Medicine HCl 250 mg and 500 mg, respectively.

Each 50-, 100- and 200-mL vial of infusion solution contains Ciprofloxacin - Beauty of Taihu-Lake Medicine lactate 100 mg, 200 mg and 400 mg, respectively.

Ciprofloxacin - Beauty of Taihu-Lake Medicine tablet also contains microcrystalline cellulose, maize starch, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 4000 and titanium dioxide (E171) while the infusion solution also contains lactic acid, sodium chloride, concentrated hydrochloric acid and water for injections.

Ciprofloxacin - Beauty of Taihu-Lake Medicine XR: Each 500 mg tablet contains Ciprofloxacin - Beauty of Taihu-Lake Medicine HCl monohydrate 334.8 mg and Ciprofloxacin - Beauty of Taihu-Lake Medicine hydrous 253 mg, corresponding to Ciprofloxacin - Beauty of Taihu-Lake Medicine 500 mg. Each 1 g tablet contains Ciprofloxacin - Beauty of Taihu-Lake Medicine HCl monohydrate 669.4 mg and Ciprofloxacin - Beauty of Taihu-Lake Medicine hydrate 506 mg, corresponding to Ciprofloxacin - Beauty of Taihu-Lake Medicine 1000 mg.

Ciprofloxacin - Beauty of Taihu-Lake Medicine XR also contains the following excipients: Crospovidone, magnesium stearate, anhydrous colloidal silica, succinic acid, hypromellose, macrogol 3350, titanium dioxide and purified water in bulk.

Ciprofloxacin - Beauty of Taihu-Lake Medicine dosage

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Dosage

Ciprofloxacin - Beauty of Taihu-Lake Medicine XR and Ciprofloxacin - Beauty of Taihu-Lake Medicine immediate-release tablets are not interchangeable. Ciprofloxacin - Beauty of Taihu-Lake Medicine XR should be administered orally once daily (Table 1).

Patients whose therapy is started with Ciprofloxacin - Beauty of Taihu-Lake Medicine IV for UTIs may be switched to Ciprofloxacin - Beauty of Taihu-Lake Medicine XR when clinically indicated at the discretion of the physician.

Administration

Ciprofloxacin - Beauty of Taihu-Lake Medicine XR tablets should be taken whole and not split, crushed, or chewed.
Ciprofloxacin - Beauty of Taihu-Lake Medicine XR should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate), as well as sucralfate, VIDEX® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, metal cations such as iron, and multivitamin preparations with zinc.
Concomitant administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine XR with dairy products (like milk or yogurt) or with calcium-fortified products alone should be avoided since decreased absorption is possible. A 2-hour window between substantial calcium intake (greater than 800 mg) and dosing with Ciprofloxacin - Beauty of Taihu-Lake Medicine XR is recommended.

Adequate hydration of patients receiving Ciprofloxacin - Beauty of Taihu-Lake Medicine XR should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Impaired Renal Function

In patients with cUTI and acute uncomplicated pyelonephritis with a creatinine clearance of ≤ 30 mL/min, the dose of Ciprofloxacin - Beauty of Taihu-Lake Medicine XR should be reduced from 1000 mg to 500 mg daily. The use of Ciprofloxacin - Beauty of Taihu-Lake Medicine 1000 mg XR tablets is not recommended in this patient population.
For patients on hemodialysis or peritoneal dialysis, administer Ciprofloxacin - Beauty of Taihu-Lake Medicine XR after the dialysis procedure is completed (maximum dose should be Ciprofloxacin - Beauty of Taihu-Lake Medicine 500 mg XR every 24 hours). The use of Ciprofloxacin - Beauty of Taihu-Lake Medicine 1000 mg XR is not recommended in this patient population.
For patients on continuous ambulatory peritoneal dialysis (CAPD), the maximum dose should be 500 mg every 24 hours.

Ciprofloxacin - Beauty of Taihu-Lake Medicine interactions

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Caffeine

Some quinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its serum half-life.

Cyclosporine

Some quinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Glyburide

The concomitant administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with the sulfonylurea glyburide has, on rare occasions, resulted in severe hypoglycemia.

Histamine H2-receptor antagonists

Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine, potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant Ciprofloxacin - Beauty of Taihu-Lake Medicine therapy is indicated.

Multivalent Cation-Containing Products

Concurrent administration of a quinolone, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, with multivalent cation-containing products such as magnesium or aluminum antacids, sucralfate, VIDEX chewable/buffered tablets or pediatric powder, or products containing calcium, iron, or zinc may substantially decrease the absorption of Ciprofloxacin - Beauty of Taihu-Lake Medicine, resulting in serum and urine levels considerably lower than desired. Proquin XR should be administered at least 4 hours before or 2 hours after these products. This time window is different than for other oral formulations of Ciprofloxacin - Beauty of Taihu-Lake Medicine, which are usually administered 2 hours before or 6 hours after antacids.

Non-steroidal anti-inflammatory drugs (but not aspirin)

These drugs in combination with very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.

Omeprazole

The rate and extent of absorption of Ciprofloxacin - Beauty of Taihu-Lake Medicine was bioequivalent when Proquin XR was given alone or when Proquin XR was given 2 hours after omeprazole at the dose that maximally suppresses gastric acid secretion. Omeprazole should be taken as directed and Proquin XR should be taken with a main meal of the day, preferably the evening meal..

Phenytoin

Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Probenecid

Probenecid interferes with renal tubular secretion of Ciprofloxacin - Beauty of Taihu-Lake Medicine and produces an increase in the level of Ciprofloxacin - Beauty of Taihu-Lake Medicine in serum.

Theophylline

As with some other quinolones, concurrent administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Warfarin

Quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be monitored.

Ciprofloxacin - Beauty of Taihu-Lake Medicine side effects

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Tendon Effects
Exacerbation of Myasthenia Gravis
Hypersensitivity Reactions
Other Serious and Sometimes Fatal Reactions
Hepatotoxicity
Serious Adverse Reactions with Concomitant Theophylline
Central Nervous System Effects
Clostridium difficile-Associated Diarrhea
Peripheral Neuropathy
Prolongation of the QT Interval
Musculoskeletal Disorders in Pediatric Patients
Photosensitivity/Phototoxicity
Development of Drug Resistant Bacteria

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Patients

During clinical investigations with oral and parenteral Ciprofloxacin - Beauty of Taihu-Lake Medicine, 49,038 patients received courses of the drug.

The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of Ciprofloxacin - Beauty of Taihu-Lake Medicine therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

In randomized, double-blind controlled clinical trials comparing Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg to 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, Ciprofloxacin - Beauty of Taihu-Lake Medicine demonstrated a CNS adverse reaction profile comparable to the control drugs.

Pediatric Patients

Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous Ciprofloxacin - Beauty of Taihu-Lake Medicine, was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). A total of 335 Ciprofloxacin- and 349 comparator-treated patients were enrolled.

An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent). Within 6 weeks of treatment initiation, the rates of musculoskeletal adverse reactions were 9.3% (31/335) in the Ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment. Radiological evaluations were not routinely used to confirm resolution of the adverse reactions. Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients. The rate of musculoskeletal adverse reactions was consistently higher in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group compared to the control group across all age subgroups. At the end of 1 year, the rate of these adverse reactions reported at any time during that period was 13.7% (46/335) in the Ciprofloxacin-treated group versus 9.5% (33/349) in the comparator-treated patients (Table 7).

The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of Ciprofloxacin - Beauty of Taihu-Lake Medicine patients compared to 9% (31/349) of comparator patients. Serious adverse reactions were seen in 7.5% (25/335) of Ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse reaction was observed in 3% (10/335) of Ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse reactions that occurred in at least 1% of Ciprofloxacin - Beauty of Taihu-Lake Medicine patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

Short-term safety data for Ciprofloxacin - Beauty of Taihu-Lake Medicine was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 to 17 years). Sixty seven patients received Ciprofloxacin - Beauty of Taihu-Lake Medicine IV 10 mg/kg/dose every 8 hours for one week followed by Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets 20 mg/kg/dose every 12 hours to complete 10 to 21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every 8 hours for a total of 10 to 21 days. Periodic musculoskeletal assessments were conducted by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0 to 93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms. The efficacy of Ciprofloxacin - Beauty of Taihu-Lake Medicine for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.

In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.

Postmarketing Experience

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 8).

Adverse Laboratory Changes

Changes in laboratory parameters while on Ciprofloxacin - Beauty of Taihu-Lake Medicine are listed below:

Hepatic –Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.

Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.

Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.

Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.

Ciprofloxacin - Beauty of Taihu-Lake Medicine contraindications

Caution should be taken when giving Ciprofloxacin - Beauty of Taihu-Lake Medicine to epileptic patients and to those with history of central nervous system (CNS) disorders, myasthenia gravis and glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin - Beauty of Taihu-Lake Medicine may exacerbate or unmask symptoms of myasthenia gravis. If tendon pain, inflammation or rupture occurs, treatment with Ciprofloxacin - Beauty of Taihu-Lake Medicine should be discontinued.

Ciprofloxacin - Beauty of Taihu-Lake Medicine is contraindicated in children, adolescents. It was reported to cause arthralgia and degenerative changes in joints that bear weight in young animals.

Use in pregnancy & lactation: Ciprofloxacin - Beauty of Taihu-Lake Medicine is contraindicated in pregnancy. It is also excreted in breast milk. It should be used in caution when given to breastfeeding mothers as this was found to cause arthropathy in young animals.

Ciprofloxacin - Beauty of Taihu-Lake Medicine pregnancy

Contraindicated in pregnancy (safety and efficacy in women during pregnancy has not been established); Ciprofloxacin - Beauty of Taihu-Lake Medicine crosses the placenta, excreted in breast milk.

In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with Ciprofloxacin - Beauty of Taihu-Lake Medicine in doses exceeding the usual daily dose for a person 6 times, adverse effects on the fetus is not revealed. In experiments on rabbits treated with oral dose of Ciprofloxacin - Beauty of Taihu-Lake Medicine 30 and 100 mg / kg, it is shown that the drug causes disruption of the gastrointestinal tract, leading to loss of body weight in females and increase the number of miscarriages but teratogenicity not found. When IV introduction to the doses of 20 mg / kg Ciprofloxacin - Beauty of Taihu-Lake Medicine did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of Ciprofloxacin - Beauty of Taihu-Lake Medicine in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.

Category of the fetus by FDA - C.

Ciprofloxacin - Beauty of Taihu-Lake Medicine is excreted in breast milk, so the period of lactation should decide, stop taking Ciprofloxacin - Beauty of Taihu-Lake Medicine or breastfeeding based on the degree of importance of the use of drugs for the mother.

With careful use of local forms of Ciprofloxacin - Beauty of Taihu-Lake Medicine in breast-feeding (not known whether Ciprofloxacin - Beauty of Taihu-Lake Medicine is excreted in breast milk when applied topically).

Ciprofloxacin - Beauty of Taihu-Lake Medicine overdose

In the event of acute overdosage, the patient should be carefully observed and given supportive treatment, including monitoring of renal function. Adequate hydration must be maintained. Only a small amount of Ciprofloxacin - Beauty of Taihu-Lake Medicine (< 10%) is removed from the body after hemodialysis or peritoneal dialysis.

In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of Ciprofloxacin - Beauty of Taihu-Lake Medicine between 125 and 300 mg/kg.

DOSAGE AND ADMINISTRATION

Adults

Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.

The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.

Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP should be administered by intravenous infusion over a period of 60 minutes.

Conversion of I.V. to

Oral Dosing in Adults

Ciprofloxacin - Beauty of Taihu-Lake Medicine Tablets and Ciprofloxacin - Beauty of Taihu-Lake Medicine

Oral Suspension for oral administration are available.

Parenteral therapy may be switched to oral Ciprofloxacin - Beauty of Taihu-Lake Medicine when the condition warrants, at the discretion of the physician.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Adults with Impaired Renal Function

Ciprofloxacin - Beauty of Taihu-Lake Medicine is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:

Men: Creatinine clearance (mL/min) = Weight (kg) x (140-age)

72 x serum creatinine (mg/dL)

Women: 0.85 x the value calculated for men.

The serum creatinine should represent a steady state of renal function.

For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.

Pediatrics

Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP should be administered as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.

Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

Preparation of Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP for Administration

Vials (Injection Concentrate)

THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP. This should be diluted with a suitable intravenous solution to a final concentration of l-2mg/mL. The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.

If the Y-type or "piggyback" method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP. If the concomitant use of Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

Flexible Containers

Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection, USP is also available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.

Compatibility and Stability

Ciprofloxacin - Beauty of Taihu-Lake Medicine Injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2.0 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.

  • 0.9% Sodium Chloride Injection, USP
  • 5% Dextrose Injection, USP
  • Sterile Water for Injection
  • 10% Dextrose for Injection
  • 5% Dextrose and 0.225% Sodium Chloride for Injection
  • 5% Dextrose and 0.45% Sodium Chloride for Injection
  • Lactated Ringer’s for Injection

Ciprofloxacin - Beauty of Taihu-Lake Medicine precautions

General

Crystals of Ciprofloxacin - Beauty of Taihu-Lake Medicine have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline. Crystalluria related to Ciprofloxacin - Beauty of Taihu-Lake Medicine has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving Ciprofloxacin - Beauty of Taihu-Lake Medicine. Patients should be well hydrated to prevent the formation of highly concentrated urine.

Central Nervous System

Quinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, may also cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia.

Renal Impairment

Alteration of the dosage regimen is necessary for patients with impairment of renal function..

Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs (see.

As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy.

Prescribing Ciprofloxacin - Beauty of Taihu-Lake Medicine for oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be advised:

  • To contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Ciprofloxacin - Beauty of Taihu-Lake Medicine treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • That fluoroquinolones like Ciprofloxacin - Beauty of Taihu-Lake Medicine may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if they have any worsening muscle weakness or breathing problems.
  • That antibacterial drugs including Ciprofloxacin - Beauty of Taihu-Lake Medicine for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When Ciprofloxacin - Beauty of Taihu-Lake Medicine for oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ciprofloxacin - Beauty of Taihu-Lake Medicine for oral suspension or other antibacterial drugs in the future.
  • That Ciprofloxacin - Beauty of Taihu-Lake Medicine may be taken with or without meals and to drink fluids liberally. As with other quinolones, concurrent administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or with other products containing calcium, iron or zinc should be avoided. Ciprofloxacin - Beauty of Taihu-Lake Medicine may be taken two hours before or six hours after taking these products. Ciprofloxacin - Beauty of Taihu-Lake Medicine should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of Ciprofloxacin - Beauty of Taihu-Lake Medicine may be significantly reduced; however, Ciprofloxacin - Beauty of Taihu-Lake Medicine may be taken with a meal that contains these products.
  • That Ciprofloxacin - Beauty of Taihu-Lake Medicine may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
  • That photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
  • That peripheral neuropathies have been associated with Ciprofloxacin - Beauty of Taihu-Lake Medicine use, that symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, patients should immediately discontinue Ciprofloxacin - Beauty of Taihu-Lake Medicine for oral suspension and contact their physician.
  • That Ciprofloxacin - Beauty of Taihu-Lake Medicine may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
  • That Ciprofloxacin - Beauty of Taihu-Lake Medicine increases the effects of tizanidine (Zanaflex®). Patients should not use Ciprofloxacin - Beauty of Taihu-Lake Medicine if they are already taking tizanidine.
  • That Ciprofloxacin - Beauty of Taihu-Lake Medicine may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
  • That convulsions have been reported in patients receiving quinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, and to notify their physician before taking this drug if there is a history of this condition.
  • That Ciprofloxacin - Beauty of Taihu-Lake Medicine has been associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in pediatric patients (less than 18 years of age). Parents should inform their child's physician if the child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child's physician of any joint-related problems that occur during or following Ciprofloxacin - Beauty of Taihu-Lake Medicine therapy..
  • That diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Tizanidine

In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with Ciprofloxacin - Beauty of Taihu-Lake Medicine (500 mg BID for 3 days). The hypotensive and sedative effects of tizanidine were also potentiated. Concomitant administration of tizanidine and Ciprofloxacin - Beauty of Taihu-Lake Medicine is contraindicated.

Theophylline

As with some other quinolones, concurrent administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Other Xanthine Derivatives

Some quinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its serum half-life. On concurrent administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine and caffeine or pentoxifylline containing products, elevated serum concentrations of these xanthine derivatives were reported.

Chelation Complex Formation

Concurrent administration of a quinolone, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, with multivalent cation-containing products such as magnesium/aluminum antacids, polymeric phosphate binders (for example. sevelamer, lanthanum carbonate) sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or products containing calcium, iron, or zinc may substantially decrease its absorption, resulting in serum and urine levels considerably lower than desired.

Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Omeprazole

Concomitant administration of a single tablet dose of 500 mg Ciprofloxacin - Beauty of Taihu-Lake Medicine and once-daily administration of 20 mg omeprazole pretreatment for 4 days resulted in a 16%reduction of mean Cmax and mean AUC of Ciprofloxacin - Beauty of Taihu-Lake Medicine

Phenytoin

Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant Ciprofloxacin - Beauty of Taihu-Lake Medicine. To avoid the loss of seizure control associated with decreased phenytoin levels, and to prevent phenytoin overdose-related undesirable effects when Ciprofloxacin - Beauty of Taihu-Lake Medicine is discontinued in patients receiving both agents, monitoring of phenytoin therapy, including phenytoin serum concentration measurements, is recommended during and shortly after co-administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with phenytoin.

Oral Antidiabetic Agents

Hypoglycemia has been reported when Ciprofloxacin - Beauty of Taihu-Lake Medicine and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. The concomitant administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with glyburide has, on rare occasions, resulted in severe hypoglycemia. Fatalities have been reported.

Metronidazole

The serum concentrations of Ciprofloxacin - Beauty of Taihu-Lake Medicine and metronidazole were not altered when these two drugs were given concomitantly.

Cyclosporine

Some quinolones, including Ciprofloxacin - Beauty of Taihu-Lake Medicine, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Oral Anti-coagulants

Simultaneous administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with an oral anticoagulant may augment the effect of the anticoagulant. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of Ciprofloxacin - Beauty of Taihu-Lake Medicine to the increase in INR (international normalized ratio) is difficult to assess. Prothrombin time and INR should be monitored frequently during and shortly after co-administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine with an oral anticoagulant (for example, warfarin).

Probenecid

Probenecid interferes with renal tubular secretion of Ciprofloxacin - Beauty of Taihu-Lake Medicine and produces an increase in the level of Ciprofloxacin - Beauty of Taihu-Lake Medicine in the serum. This should be considered if patients are receiving both drugs concomitantly.

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant Ciprofloxacin - Beauty of Taihu-Lake Medicine therapy is indicated.

Metoclopramide

Metoclopramide significantly accelerates the absorption of oral Ciprofloxacin - Beauty of Taihu-Lake Medicine resulting in shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Duloxetine

In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in a 5-fold increase in mean AUC and a 2.5-fold increase in mean Cmax of duloxetine. Although no clinical data are available on a possible interaction with Ciprofloxacin - Beauty of Taihu-Lake Medicine, similar effects can be expected upon concomitant administration.

NSAIDs

Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.

Ropinirole

In a study conducted in 12 patients with Parkinson's disease who were administered 6 mg ropinirole once daily with 500 mg Ciprofloxacin - Beauty of Taihu-Lake Medicine twice-daily, the mean Cmax and mean AUC of ropinirole were increased by 60% and 84%, respectively. Monitoring for ropinirole-related side effects and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Lidocaine

In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with 500 mg Ciprofloxacin - Beauty of Taihu-Lake Medicine twice daily, resulted in an increase of lidocaine Cmax and AUC by 12% and 26%, respectively. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with Ciprofloxacin - Beauty of Taihu-Lake Medicine and an increase in side effects related to lidocaine may occur upon concomitant administration.

Clozapine

Following concomitant administration of 250 mg Ciprofloxacin - Beauty of Taihu-Lake Medicine with 304 mg clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Careful monitoring of clozapine associated adverse effects and appropriate adjustment of clozapine dosage during and shortly after co-administration with Ciprofloxacin - Beauty of Taihu-Lake Medicine are advised..

Sildenafil

Following concomitant administration of a single oral dose of 50 mg sildenafil with 500 mg Ciprofloxacin - Beauty of Taihu-Lake Medicine to healthy subjects, the mean Cmax and mean AUC of sildenafil were both increased approximately two-fold. Therefore, sildenafil should be used with caution when co-administered with Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Drugs Known To Prolong QT Interval

Precaution should be taken when using Ciprofloxacin - Beauty of Taihu-Lake Medicine concomitantly with drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) as Ciprofloxacin - Beauty of Taihu-Lake Medicine may have an additive effect on the QT interval.

CARCINOGENESIS, MUTAGENESIS & IMPAIRMENT OF FERTILITY

Eight in vitro mutagenicity tests have been conducted with Ciprofloxacin - Beauty of Taihu-Lake Medicine, and the test results are listed below:

Salmonella/Microsome Test (Negative)

E. coli DNA Repair Assay (Negative)

Mouse Lymphoma Cell Forward Mutation Assay (Positive)

Chinese Hamster V79 Cell HGPRT Test (Negative)

Syrian Hamster Embryo Cell Transformation Assay (Negative)

Saccharomyces cerevisiae Point Mutation Assay (Negative)

Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)

Rat Hepatocyte DNA Repair Assay (Positive)

Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:

Rat Hepatocyte DNA Repair Assay

Micronucleus Test (Mice)

Dominant Lethal Test (Mice)

Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to Ciprofloxacin - Beauty of Taihu-Lake Medicine at daily oral dose levels up to 250 and 750 mg/kg to rats and mice, respectively (approximately 1.7- and 2.5- times the highest recommended therapeutic dose based upon mg/m2).

Results from photo co-carcinogenicity testing indicate that Ciprofloxacin - Beauty of Taihu-Lake Medicine does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered Ciprofloxacin - Beauty of Taihu-Lake Medicine. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and Ciprofloxacin - Beauty of Taihu-Lake Medicine (mouse dose approximately equal to maximum recommended human dose based upon mg/m2), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumors ranged from 16 to 32 weeks in mice treated concomitantly with UVA and other quinolones.5

In this model, mice treated with Ciprofloxacin - Beauty of Taihu-Lake Medicine alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown.

Fertility studies performed in rats at oral doses of Ciprofloxacin - Beauty of Taihu-Lake Medicine up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon mg/m2) revealed no evidence of impairment.

Pregnancy

Teratogenic Effects. Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin - Beauty of Taihu-Lake Medicine should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother. An expert review of published data on experiences with Ciprofloxacin - Beauty of Taihu-Lake Medicine use during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk.9

A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to Ciprofloxacin - Beauty of Taihu-Lake Medicine and 68% first trimester exposures) during gestation.10 In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1 to 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the Ciprofloxacin - Beauty of Taihu-Lake Medicine exposed children.

Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).11 There were 70 Ciprofloxacin - Beauty of Taihu-Lake Medicine exposures, all within the first trimester. The malformation rates among live-born babies exposed to Ciprofloxacin - Beauty of Taihu-Lake Medicine and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to Ciprofloxacin - Beauty of Taihu-Lake Medicine.

No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to Ciprofloxacin - Beauty of Taihu-Lake Medicine during pregnancy.9,10 However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of Ciprofloxacin - Beauty of Taihu-Lake Medicine in pregnant women and their developing fetuses. Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to Ciprofloxacin - Beauty of Taihu-Lake Medicine. In rabbits, oral Ciprofloxacin - Beauty of Taihu-Lake Medicine dose levels of 30 and 100 mg/kg (approximately 0.4- and 1.3-times the highest recommended therapeutic dose based upon mg/m2) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level. After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon mg/m2) no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.

Nursing Mothers

Ciprofloxacin - Beauty of Taihu-Lake Medicine is excreted in human milk. The amount of Ciprofloxacin - Beauty of Taihu-Lake Medicine absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking Ciprofloxacin - Beauty of Taihu-Lake Medicine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Ciprofloxacin - Beauty of Taihu-Lake Medicine, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness.

Inhalational Anthrax (Post-Exposure)

Ciprofloxacin - Beauty of Taihu-Lake Medicine is indicated in pediatric patients for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of Ciprofloxacin - Beauty of Taihu-Lake Medicine to pediatric patients is appropriate. For information regarding pediatric dosing in inhalational anthrax (post-exposure), see and.

Complicated Urinary Tract Infection and Pyelonephritis

Ciprofloxacin - Beauty of Taihu-Lake Medicine is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, Ciprofloxacin - Beauty of Taihu-Lake Medicine is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to the controls, including events related to joints and/or surrounding tissues. The rates of these events in pediatric patients with complicated urinary tract infection and pyelonephritis within six weeks of follow-up were 9.3% (31/335) versus 6% (21/349) for control agents. The rates of these events occurring at any time up to the one year follow-up were 13.7% (46/335) and 9.5% (33/349), respectively. The rate of all adverse events regardless of drug relationship at six weeks was 41% (138/335) in the Ciprofloxacin - Beauty of Taihu-Lake Medicine arm compared to 31% (109/349) in the control arm.

Cystic Fibrosis

Short-term safety data from a single trial in pediatric cystic fibrosis patients are available. In a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5-17 years), 67 patients received Ciprofloxacin - Beauty of Taihu-Lake Medicine IV 10 mg/kg/dose q8h for one week followed by Ciprofloxacin - Beauty of Taihu-Lake Medicine tablets 20 mg/kg/dose q12h to complete 10-21 days treatment and 62 patients received the combination of ceftazidime IV 50 mg/kg/dose q8h and tobramycin IV 3 mg/kg/dose q8h for a total of 10-21 days. Patients less than 5 years of age were not studied. Safety monitoring in the study included periodic range of motion examinations and gait assessments by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0-93 days). This study was not designed to determine long term effects and the safety of repeated exposure to Ciprofloxacin - Beauty of Taihu-Lake Medicine.

Musculoskeletal adverse events in patients with cystic fibrosis were reported in 22% of the patients in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the Ciprofloxacin - Beauty of Taihu-Lake Medicine group and 11% in the comparison group. Other adverse events were similar in nature and frequency between treatment arms. One of sixty-seven patients developed arthritis of the knee nine days after a ten day course of treatment with Ciprofloxacin - Beauty of Taihu-Lake Medicine. Clinical symptoms resolved, but an MRI showed knee effusion without other abnormalities eight months after treatment. However, the relationship of this event to the patient's course of Ciprofloxacin - Beauty of Taihu-Lake Medicine can not be definitively determined, particularly since patients with cystic fibrosis may develop arthralgias/arthritis as part of their underlying disease process.

Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Ciprofloxacin - Beauty of Taihu-Lake Medicine. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Ciprofloxacin - Beauty of Taihu-Lake Medicine to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Ciprofloxacin - Beauty of Taihu-Lake Medicine and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.

In a retrospective analysis of 23 multiple-dose controlled clinical trials of Ciprofloxacin - Beauty of Taihu-Lake Medicine encompassing over 3500 Ciprofloxacin - Beauty of Taihu-Lake Medicine treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin - Beauty of Taihu-Lake Medicine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients.

In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using Ciprofloxacin - Beauty of Taihu-Lake Medicine with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia)..



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References

  1. DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "ciprofloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 17, 2018).
  4. DTP/NCI. "ciprofloxacin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  5. Wikipedia. "ciprofloxacin: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Ciprof... (accessed September 17, 2018).

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