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What is Ciprofloxacin Axapharm?
Ciprofloxacin Axapharm is used to treat bacterial infections in many different parts of the body. Ciprofloxacin Axapharm oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. Ciprofloxacin Axapharm may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
Ciprofloxacin Axapharm 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 Axapharm belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Ciprofloxacin Axapharm will not work for colds, flu, or other virus infections.
Ciprofloxacin Axapharm is available only with your doctor's prescription.
Ciprofloxacin Axapharm indications
Ciprofloxacin Axapharm 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 Axapharm 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 Axapharm 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 Axapharm 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 Axapharm 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 Axapharm tablets USP are indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis.
Ciprofloxacin Axapharm 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 Axapharm 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 Axapharm 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 Axapharm 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.
Ciprofloxacin Axapharm 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 Axapharm tablets USP are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of Ciprofloxacin Axapharm in the eradication of the chronic typhoid carrier state has not been demonstrated.
Uncomplicated Cervical and Urethral Gonorrhea
Ciprofloxacin Axapharm 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 Axapharm 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 Axapharm 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 Axapharm 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 Axapharm for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.
Ciprofloxacin Axapharm 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 Axapharm 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 Axapharm 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 Axapharm tablets USP, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.
Lower Respiratory Tract Infections
Ciprofloxacin Axapharm tablets USP are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Axapharm tablets USP and other antibacterial drugs, Ciprofloxacin Axapharm 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 Axapharm. Therapy with Ciprofloxacin Axapharm 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 Axapharm. 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 Axapharm?
Use Ciprofloxacin Axapharm as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ciprofloxacin Axapharm comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ciprofloxacin Axapharm refilled.
- An extra patient leaflet may be available with Ciprofloxacin Axapharm. Talk to your pharmacist if you have questions about this information.
- Take Ciprofloxacin Axapharm 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 Axapharm with a full glass of water (8 oz [240 mL]).
- Drinking extra fluids while you are taking Ciprofloxacin Axapharm 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 Axapharm. 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 Axapharm. Check with your doctor if you have questions.
- Ciprofloxacin Axapharm works best if it is taken at the same time each day.
- To clear up your infection completely, take Ciprofloxacin Axapharm for the full course of treatment. Keep taking it even if you feel better in a few days.
- Avoid taking Ciprofloxacin Axapharm with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Ciprofloxacin Axapharm 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 Axapharm, 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 Axapharm.
Uses of Ciprofloxacin Axapharm in details
Ciprofloxacin Axapharm 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 Axapharm description
Ciprofloxacin Axapharm: Each 250- and 500-mg tablet contains Ciprofloxacin Axapharm HCl 250 mg and 500 mg, respectively.
Each 50-, 100- and 200-mL vial of infusion solution contains Ciprofloxacin Axapharm lactate 100 mg, 200 mg and 400 mg, respectively.
Ciprofloxacin Axapharm 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 Axapharm XR: Each 500 mg tablet contains Ciprofloxacin Axapharm HCl monohydrate 334.8 mg and Ciprofloxacin Axapharm hydrous 253 mg, corresponding to Ciprofloxacin Axapharm 500 mg. Each 1 g tablet contains Ciprofloxacin Axapharm HCl monohydrate 669.4 mg and Ciprofloxacin Axapharm hydrate 506 mg, corresponding to Ciprofloxacin Axapharm 1000 mg.
Ciprofloxacin Axapharm 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 Axapharm dosage
Ciprofloxacin Axapharm XR and Ciprofloxacin Axapharm immediate-release tablets are not interchangeable. Ciprofloxacin Axapharm XR should be administered orally once daily (Table 1).
Patients whose therapy is started with Ciprofloxacin Axapharm IV for UTIs may be switched to Ciprofloxacin Axapharm XR when clinically indicated at the discretion of the physician.
- Ciprofloxacin Axapharm XR tablets should be taken whole and not split, crushed, or chewed.
- Ciprofloxacin Axapharm 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 Axapharm 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 Axapharm XR is recommended.
Adequate hydration of patients receiving Ciprofloxacin Axapharm 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 Axapharm XR should be reduced from 1000 mg to 500 mg daily. The use of Ciprofloxacin Axapharm 1000 mg XR tablets is not recommended in this patient population.
- For patients on hemodialysis or peritoneal dialysis, administer Ciprofloxacin Axapharm XR after the dialysis procedure is completed (maximum dose should be Ciprofloxacin Axapharm 500 mg XR every 24 hours). The use of Ciprofloxacin Axapharm 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 Axapharm interactions
Some quinolones, including Ciprofloxacin Axapharm, 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.
Some quinolones, including Ciprofloxacin Axapharm, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
The concomitant administration of Ciprofloxacin Axapharm 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 Axapharm.
Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin Axapharm, 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 Axapharm therapy is indicated.
Multivalent Cation-Containing Products
Concurrent administration of a quinolone, including Ciprofloxacin Axapharm, 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 Axapharm, 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 Axapharm, 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.
The rate and extent of absorption of Ciprofloxacin Axapharm 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..
Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant Ciprofloxacin Axapharm.
Probenecid interferes with renal tubular secretion of Ciprofloxacin Axapharm and produces an increase in the level of Ciprofloxacin Axapharm in serum.
As with some other quinolones, concurrent administration of Ciprofloxacin Axapharm 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.
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 Axapharm 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
- 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
- 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.
During clinical investigations with oral and parenteral Ciprofloxacin Axapharm, 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 Axapharm 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 Axapharm 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 Axapharm demonstrated a CNS adverse reaction profile comparable to the control drugs.
Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous Ciprofloxacin Axapharm, 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 Axapharm 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 Axapharm 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 Axapharm group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of Ciprofloxacin Axapharm 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 Axapharm 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 Axapharm 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 Axapharm IV 10 mg/kg/dose every 8 hours for one week followed by Ciprofloxacin Axapharm 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 Axapharm group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the Ciprofloxacin Axapharm group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the Ciprofloxacin Axapharm group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms. The efficacy of Ciprofloxacin Axapharm 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.
The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin Axapharm. 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 Axapharm 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 Axapharm contraindications
Caution should be taken when giving Ciprofloxacin Axapharm to epileptic patients and to those with history of central nervous system (CNS) disorders, myasthenia gravis and glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin Axapharm may exacerbate or unmask symptoms of myasthenia gravis. If tendon pain, inflammation or rupture occurs, treatment with Ciprofloxacin Axapharm should be discontinued.
Ciprofloxacin Axapharm 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 Axapharm 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.
Active ingredient matches for Ciprofloxacin Axapharm:
Ciprofloxacin in Switzerland.
- 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/dailymed/se... (accessed September 18, 2017).
- PubChem. "ciprofloxacin". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).
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Information checked by Dr. Sachin Kumar, MD Pharmacology