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 suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ciprofloxacin Axapharm suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ciprofloxacin Axapharm suspension refilled.
- An extra patient leaflet may be available with Ciprofloxacin Axapharm suspension. Talk to your pharmacist if you have questions about this information.
- Take Ciprofloxacin Axapharm suspension 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 suspension with a full glass of water (8 oz [240 mL]).
- Drinking extra fluids while you are taking Ciprofloxacin Axapharm suspension 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 suspension. 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 suspension. Check with your doctor if you have questions.
- Ciprofloxacin Axapharm suspension works best if it is taken at the same time each day.
- To clear up your infection completely, take Ciprofloxacin Axapharm suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
- Avoid taking Ciprofloxacin Axapharm suspension with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Ciprofloxacin Axapharm suspension 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 suspension, 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 suspension.
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 HCl 250 mg and 500 mg, respectively.
Each 50-, 100- and 200-mL vial of infusion solution contains Ciprofloxacin 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 HCl monohydrate 334.8 mg and Ciprofloxacin Axapharm hydrous 253 mg, corresponding to Ciprofloxacin Axapharm 500 mg. Each 1 g tablet contains Ciprofloxacin 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).
Uncomplicated Urinary Tract Infection (Acute Cystitis)
every 24 hours
Complicated Urinary Tract Infection and Acute Uncomplicated Pyelonephritis
every 24 hours
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
Class IA or III Antiarrhythmics: Precaution should be taken when using Ciprofloxacin Axapharm together with class IA or III antiarrhythmics as Ciprofloxacin Axapharm may have an additive effect on the QT interval.
Chelation Complex Formation: The simultaneous administration of Ciprofloxacin Axapharm (oral) and multivalent cation-containing medicinal products and mineral supplements (eg, calcium, magnesium, aluminum, iron), polymeric phosphate binders (eg, sevelamer, lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (eg, didanosine tablets) containing magnesium, aluminum or calcium reduce the absorption of Ciprofloxacin Axapharm. Consequently, Ciprofloxacin Axapharm should be administered either 1-2 hrs before or at least 4 hrs after these preparations. This restriction does not apply to antacids belonging to the class of H2-receptor blockers.
Theophylline: Concurrent administration of Ciprofloxacin Axapharm and theophylline can cause an undesirable increase in the serum theophylline concentration. This can lead to theophylline-induced side effects; in very rare cases, these side effects can be life-threatening or fatal. If concurrent use of the 2 products is unavoidable, the serum theophylline concentration should therefore be checked and the theophylline dose appropriately reduced.
Cyclosporin: A transient rise in the concentration of serum creatinine was observed when Ciprofloxacin Axapharm and cyclosporin were administered simultaneously. Therefore, it is necessary to control the serum creatinine concentrations in these patients frequently (twice a week).
Vitamin K Antagonists: Simultaneous administration of Ciprofloxacin Axapharm with a vitamin K antagonist may augment its anticoagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of Ciprofloxacin Axapharm to the increase in International Normalized Ratio (INR) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of Ciprofloxacin Axapharm with a vitamin K antagonist (eg, warfarin, acenocoumarol, phenprocoumon or fluindione).
Glibenclamide: In particular cases, concurrent administration of Ciprofloxacin Axapharm and glibenclamide containing products can intensify the action of glibenclamide (hypoglycemia).
Probenecid: Probenecid interferes with renal secretion of Ciprofloxacin Axapharm. Co-administration of probenecid and Ciprofloxacin Axapharm increases the Ciprofloxacin Axapharm serum concentrations.
Metoclopramide: Metoclopramide accelerates the absorption of Ciprofloxacin Axapharm (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of Ciprofloxacin Axapharm.
Omeprazole: Concomitant administration of Ciprofloxacin Axapharm and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of Ciprofloxacin Axapharm.
Tizanidine: In a clinical study in healthy subjects, there was an increase in tizanidine serum concentrations (Cmax increase: 7-fold, range: 4- to 21-fold; AUC increase: 10-fold, range: 6- to 24-fold) when given concomitantly with Ciprofloxacin Axapharm. Associated with the increased serum concentrations was a potentiated hypotensive and sedative effect. Tizanidine containing medicinal products must not be administered together with Ciprofloxacin Axapharm.
Other Xanthine Derivatives: On concurrent administration of Ciprofloxacin Axapharm and caffeine or pentoxifylline (oxpentifylline) containing products, raised serum concentrations of these xanthine derivatives were reported.
Methotrexate: 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-associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant Ciprofloxacin Axapharm therapy is indicated.
Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Animal studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain nonsteroidal anti-inflammatory agents (but not acetylsalicylic acid) can provoke convulsions.
Duloxetine: In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme eg, fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with Ciprofloxacin Axapharm, similar effects can be expected upon concomitant administration.
Ropinirole: It was shown in a clinical study that concomitant use of ropinirole with Ciprofloxacin Axapharm, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring ropinirole-related side effects dose adjustment as appropriate is recommended during and shortly after co-administration with Ciprofloxacin Axapharm.
Lidocaine: It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with Ciprofloxacin Axapharm, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of IV lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with Ciprofloxacin Axapharm associated with side effects may occur upon concomitant administration.
Clozapine: Following concomitant administration of Ciprofloxacin Axapharm 250 mg with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co-administration with Ciprofloxacin Axapharm are advised.
Sildenafil: Cmax and AUC of sildenafil were increased approximately 2-fold in healthy subjects after an oral dose of 50 mg given concomitantly with Ciprofloxacin Axapharm 500 mg. Therefore, caution should be used in prescribing Ciprofloxacin Axapharm concomitantly with sildenafil taking into consideration the risks and the benefits.
Ciprofloxacin Axapharm side effects
Adverse Reactions in Adult Patients
During clinical investigations with oral and parenteral Ciprofloxacin Axapharm, 49,038 patients received courses of the drug. Most of the adverse events reported were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment. Ciprofloxacin Axapharm was discontinued because of an adverse event in 1% of orally treated patients.
The most frequently reported drug related events, 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%).
Additional medically important events that occurred in less than 1% of Ciprofloxacin Axapharm patients are listed below.
Body As A Whole
headache, abdominal pain/discomfort, foot pain, pain, pain in extremities, injection site reaction (ciprofloxacin intravenous)
palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis, phlebitis, tachycardia, migraine, hypotension
Central Nervous System
restlessness, dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures (including status epilepticus), grand mal convulsion, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide), paresthesia, abnormal gait
painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis
amylase increase, lipase increase, hyperglycemia, hypoglycemia
arthralgia or back pain, joint stiffness, achiness, neck or chest pain, flare up of gout, muscle weakness
interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis, breast pain
dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, hemoptysis, bronchospasm, pulmonary embolism
allergic reaction, pruritus, urticaria, photosensitivity/phototoxicity reaction, flushing, fever, chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, sweating
blurred vision, disturbed vision (change in color perception, overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus, hearing loss, bad taste, chromatopsia
In several instances nausea, vomiting, tremor, irritability, or palpitation were judged by investigators to be related to elevated serum levels of theophylline possibly as a result of drug interaction with Ciprofloxacin Axapharm.
In randomized, double-blind controlled clinical trials comparing Ciprofloxacin Axapharm tablets (500 mg BID) to cefuroxime axetil (250 mg - 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, Ciprofloxacin Axapharm demonstrated a CNS adverse event profile comparable to the control drugs.
Adverse Reactions in Pediatric Patients
Ciprofloxacin Axapharm, administered IV and /or orally, was compared to a cephalosporin for treatment of complicated urinary tract infections (cUTI) or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety within 6 weeks of therapy and through one year of follow-up in the 335 ciprofloxacin- and 349 comparator-treated patients enrolled.
An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse events as well as all patients with an abnormal gait or abnormal joint exam (baseline or treatment-emergent). These events were evaluated in a comprehensive fashion and included such conditions as arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint. The affected joints included: knee, elbow, ankle, hip, wrist, and shoulder. Within 6 weeks of treatment initiation, the rates of these events were 9.3% (31/335) in the ciprofloxacin-treated group versus 6 % (21/349) in comparator-treated patients. The majority of these events were mild or moderate in intensity. All musculoskeletal events 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 events. The events occurred more frequently in ciprofloxacin-treated patients than control patients, regardless of whether they received IV or oral therapy. Ciprofloxacin-treated patients were more likely to report more than one event and on more than one occasion compared to control patients. These events occurred in all age groups and the rates were consistently higher in the Ciprofloxacin Axapharm group compared to the control group. At the end of
1 year, the rate of these events reported at any time during that period was 13.7% (46/335) in the ciprofloxacin-treated group versus 9.5% (33/349) comparator-treated patients.
An adolescent female discontinued Ciprofloxacin Axapharm for wrist pain that developed during treatment. An MRI performed 4 weeks later showed a tear in the right ulnar fibrocartilage. A diagnosis of overuse syndrome secondary to sports activity was made, but a contribution from Ciprofloxacin Axapharm cannot be excluded. The patient recovered by 4 months without surgical intervention.
Findings Involving Joint or Peri-articular Tissues as Assessed by the IPSC
*The study was designed to demonstrate that the arthropathy rate for the Ciprofloxacin Axapharm group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that Ciprofloxacin Axapharm group had findings comparable to the control group
The incidence rates of neurological events 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 events regardless of relationship to study drug and 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 events were gastrointestinal: 15% (50/335) of Ciprofloxacin Axapharm patients compared to 9% (31/349) of comparator patients. Serious adverse events 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 event was observed in 3% (10/335) of ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse events that occurred in at least 1% of Ciprofloxacin Axapharm patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, accidental injury 3%, rhinitis 3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.
In addition to the events reported in pediatric patients in clinical trials, it should be expected that events reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.
Postmarketing Adverse Event Reports
The following adverse events have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin Axapharm. Because these events 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. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug.
Acute generalized exanthematous pustulosis (AGEP), Agitation, agranulocytosis, albuminuria, anaphylactic reactions (including life-threatening anaphylactic shock), anosmia, candiduria, cholesterol elevation (serum), confusion, constipation, delirium, dyspepsia, dysphagia, erythema multiforme, exfoliative dermatitis, fixed eruption, flatulence, glucose elevation (blood), hemolytic anemia, hepatic failure (including fatal cases), hepatic necrosis, hyperesthesia, hypertonia, hypesthesia, hypotension (postural), International Normalized Ratio (INR) increased (in patients treated with Vitamin K antagonists), jaundice, marrow depression (life threatening), methemoglobinemia, moniliasis (oral, gastrointestinal, vaginal), myalgia, myasthenia, exacerbation of myasthenia gravis, myoclonus, nystagmus, pancreatitis, pancytopenia (life threatening or fatal outcome), peripheral neuropathy that may be irreversible, phenytoin alteration (serum), photosensitivity/phototoxicity reaction, polyneuropathy, potassium elevation (serum), prothrombin time prolongation or decrease, pseudomembranous colitis (The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.), psychosis (toxic), QT prolongation, renal calculi, serum sickness like reaction, Stevens-Johnson syndrome, taste loss, tendinitis, tendon rupture, torsade de pointes, toxic epidermal necrolysis (Lyell's Syndrome), triglyceride elevation (serum), twitching, vaginal candidiasis, vasculitis and ventricular arrhythmia.
Adverse events were also reported by persons who received Ciprofloxacin Axapharm for anthrax post-exposure prophylaxis following the anthrax bioterror attacks of October 2001..
Adverse Laboratory Changes
Changes in laboratory parameters listed as adverse events without regard to drug relationship are listed below:
Hepatic–Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase (0.8%), LDH (0.4%), serum bilirubin (0.3%).
Hematologic–Eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), elevated blood platelets (0.1%), pancytopenia (0.1%).
Renal–Elevations of serum creatinine (1.1%), BUN (0.9%), crystalluria, cylindruria, and hematuria have been reported.
Other changes occurring in less than 0.1% of courses 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/dailyme... (accessed September 17, 2018).
- PubChem. "ciprofloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 17, 2018).
- 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).
- Wikipedia. "ciprofloxacin: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Ciprof... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology