Ciprofloxacin Aurobindo Uses

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What is Ciprofloxacin Aurobindo?

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

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

Ciprofloxacin Aurobindo is available only with your doctor's prescription.

Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo tablets USP are indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis.

Acute Sinusitis

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

Uncomplicated Cervical and Urethral Gonorrhea

Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.

Plague

Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo tablets USP, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Lower Respiratory Tract Infections

Ciprofloxacin Aurobindo 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 Aurobindo tablets USP and other antibacterial drugs, Ciprofloxacin Aurobindo 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 Aurobindo. Therapy with Ciprofloxacin Aurobindo 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 Aurobindo. 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 Aurobindo?

Use Ciprofloxacin Aurobindo suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ciprofloxacin Aurobindo suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ciprofloxacin Aurobindo suspension refilled.
  • An extra patient leaflet may be available with Ciprofloxacin Aurobindo suspension. Talk to your pharmacist if you have questions about this information.
  • Take Ciprofloxacin Aurobindo 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 Aurobindo suspension with a full glass of water (8 oz [240 mL]).
  • Drinking extra fluids while you are taking Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo suspension. Check with your doctor if you have questions.
  • Ciprofloxacin Aurobindo suspension works best if it is taken at the same time each day.
  • To clear up your infection completely, take Ciprofloxacin Aurobindo suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
  • Avoid taking Ciprofloxacin Aurobindo suspension with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo suspension.

Uses of Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo description

Ciprofloxacin Aurobindo: 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 Aurobindo 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 Aurobindo XR: Each 500 mg tablet contains Ciprofloxacin HCl monohydrate 334.8 mg and Ciprofloxacin Aurobindo hydrous 253 mg, corresponding to Ciprofloxacin Aurobindo 500 mg. Each 1 g tablet contains Ciprofloxacin HCl monohydrate 669.4 mg and Ciprofloxacin Aurobindo hydrate 506 mg, corresponding to Ciprofloxacin Aurobindo 1000 mg.

Ciprofloxacin Aurobindo 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 Aurobindo dosage

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Dosage

Ciprofloxacin Aurobindo XR and Ciprofloxacin Aurobindo immediate-release tablets are not interchangeable. Ciprofloxacin Aurobindo XR should be administered orally once daily (Table 1).

Table 1: Dosage Guidelines

Indication

Dose

Frequency

Usual Duration

Uncomplicated Urinary Tract Infection (Acute Cystitis)

500 mg

every 24 hours

3 Days

Complicated Urinary Tract Infection and Acute Uncomplicated Pyelonephritis

1000 mg

every 24 hours

7–14 Days

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

Administration

Ciprofloxacin Aurobindo XR tablets should be taken whole and not split, crushed, or chewed.
Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo XR is recommended.

Adequate hydration of patients receiving Ciprofloxacin Aurobindo 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 Aurobindo XR should be reduced from 1000 mg to 500 mg daily. The use of Ciprofloxacin Aurobindo 1000 mg XR tablets is not recommended in this patient population.
For patients on hemodialysis or peritoneal dialysis, administer Ciprofloxacin Aurobindo XR after the dialysis procedure is completed (maximum dose should be Ciprofloxacin Aurobindo 500 mg XR every 24 hours). The use of Ciprofloxacin Aurobindo 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 Aurobindo interactions

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Caffeine

Some quinolones, including Ciprofloxacin Aurobindo, 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 Aurobindo, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Glyburide

The concomitant administration of Ciprofloxacin Aurobindo 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 Aurobindo.

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin Aurobindo, 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 Aurobindo therapy is indicated.

Multivalent Cation-Containing Products

Concurrent administration of a quinolone, including Ciprofloxacin Aurobindo, 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 Aurobindo, 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 Aurobindo, 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 Aurobindo 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 Aurobindo.

Probenecid

Probenecid interferes with renal tubular secretion of Ciprofloxacin Aurobindo and produces an increase in the level of Ciprofloxacin Aurobindo in serum.

Theophylline

As with some other quinolones, concurrent administration of Ciprofloxacin Aurobindo 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 Aurobindo side effects

Adverse Reactions in Adult Patients

During clinical investigations with oral and parenteral Ciprofloxacin Aurobindo, 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 Aurobindo 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 Aurobindo 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 Aurobindo patients are listed below.

Body As A Whole

headache, abdominal pain/discomfort, foot pain, pain, pain in extremities, injection site reaction (ciprofloxacin intravenous)

Cardiovascular

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

Gastrointestinal

painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis

Hemic/Lymphatic

lymphadenopathy, petechia

Metabolic/Nutritional

amylase increase, lipase increase, hyperglycemia, hypoglycemia

Musculoskeletal

arthralgia or back pain, joint stiffness, achiness, neck or chest pain, flare up of gout, muscle weakness

Renal/Urogenital

interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis, breast pain

Respiratory

dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, hemoptysis, bronchospasm, pulmonary embolism

Skin/Hypersensitivity

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

Special Senses

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 Aurobindo.

In randomized, double-blind controlled clinical trials comparing Ciprofloxacin Aurobindo 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 Aurobindo demonstrated a CNS adverse event profile comparable to the control drugs.

Adverse Reactions in Pediatric Patients

Ciprofloxacin Aurobindo, 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 Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo 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 Aurobindo group had findings comparable to the control group

Ciprofloxacin&

Comparator&

All&Patients&(within&6&weeks)&

31/335&(9.3%)&

21/349&(6%)&

95%&Confidence&Interval*&

(-0.8%,&+7.2%)&

Age&Group

≥12&months&<&24&months&

1/36&(2.8%)&

0/41&

≥&2&years&<&6&years&

5/124&(4%)&

3/118&(2.5%)&

≥6&years&<&12&years&

18/143&(12.6%)&

12/153&(7.8%)&

≥&12&years&to&17&years&

7/32&(21.9%)&

6/37&(16.2&%)&

All&Patients&(within&1&year)&

46/335&(13.7%)&

33/349&(9.5%)&

95%&Confidence&Interval*&

(-0.6%,&+&9.1%)&

The incidence rates of neurological events within 6 weeks of treatment initiation were 3% (9/335) in the Ciprofloxacin Aurobindo 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 Aurobindo group versus 31% (109/349) in the comparator group. The most frequent events were gastrointestinal: 15% (50/335) of Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo. 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 Aurobindo 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 Aurobindo contraindications

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

Ciprofloxacin Aurobindo 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 Aurobindo 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 Aurobindo:

Ciprofloxacin in Malta.


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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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