Gipro

Gipro: 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.

Gipro 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.

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

Gipro XR also contains the following excipients: Crospovidone, magnesium stearate, anhydrous colloidal silica, succinic acid, hypromellose, macrogol 3350, titanium dioxide and purified water in bulk.

Gipro is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.

Uncomplicated Urinary Tract Infections (Acute Cystitis)

Gipro is indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus.

Because fluoroquinolones, including Gipro, have been associated with serious adverse reactions and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve Gipro for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options.

Complicated Urinary Tract Infections, And Acute Uncomplicated Pyelonephritis

Gipro is indicated for the treatment of complicated urinary tract infections (cUTI) caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa and acute uncomplicated pyelonephritis (AUP) caused by Escherichia coli.

Limitations Of Use

• The safety and efficacy of Gipro in treating infections other than urinary tract infections has not been demonstrated.
• Gipro is not indicated for pediatric patients.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gipro and other antibacterial drugs, Gipro should be used only to treat 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.

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 Gipro. Therapy with Gipro 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 Gipro. 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.

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

Gipro 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).

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

Gipro is available only with your doctor's prescription.

Dosage

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

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

Administration

Adequate hydration of patients receiving Gipro should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Impaired Renal Function

See also:
What is the most important information I should know about Gipro?

You should not use this medication if you are taking tizanidine (Zanaflex), if you have a history of myasthenia gravis, or if you are allergic to Gipro or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking Gipro, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, diabetes, muscle weakness or trouble breathing, a condition called pseudotumor cerebri, a history of seizures, a history of head injury or brain tumor, low levels of potassium in your blood, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.

Do not take Gipro with dairy products such as milk or yogurt, or with calcium-fortified juice.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 6 hours before or 2 hours after you take Gipro.

Gipro may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. Stop taking Gipro and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

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

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

Use: Labeled Indications

Children and Adolescents: Treatment of complicated urinary tract infections and pyelonephritis due to E. coli. Note: Although effective, Gipro is not the drug of first choice in children.

Infants, Children, Adolescents, and Adults: Prophylaxis to reduce incidence or progression of disease following inhalation exposure to Bacillus anthracis; prophylaxis and treatment of plague (Yersinia pestis).

Adults: Treatment of the following infections when caused by susceptible bacteria: Urinary tract infections; acute uncomplicated cystitis in females, chronic bacterial prostatitis, bone and joint infections, complicated intra-abdominal infections (in combination with metronidazole), infectious diarrhea, typhoid fever (Salmonella typhi), hospital-acquired (nosocomial) pneumonia.

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve Gipro for use in patients who have no alternative treatment options for acute uncomplicated cystitis.

Off Label Uses

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax, Gipro is an effective and recommended agent for treatment of cutaneous or systemic anthrax.

Bite wound infection (animal and human bites)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Gipro, in combination with an appropriate agent for anaerobes, is an effective and recommended alternative option for prophylaxis and treatment of human or animal bite wounds, particularly in patients who are hypersensitive to beta-lactams.

Cat scratch disease, lymphadenitis (nondisseminated)

Data from a limited number of patients suggest that Gipro may be beneficial for the treatment of cat scratch disease ).

Tularemia

Data from retrospective studies and case reports/series demonstrate varied results with the use of Gipro in the management of tularemia. Guidelines created by the Infectious Diseases Society of America, Working Group on Civilian Biodefense, and the European Commission's Task Force on Biological and Chemical Agent Threats (BICHAT) recommend Gipro as an alternative in the management of mild tularemia infection. In scenarios of mass casualty management and postexposure prophylaxis, the Working Group on Civilian Biodefense considers oral Gipro and doxycycline as drugs of choice.

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What other drugs will affect Gipro?

Theophylline

As with some other quinolones, concurrent administration of Gipro with theophylline may lead to elevated serum concentrations of theophylline, which may result in an increased risk of a patient developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, serum concentrations of theophylline should be monitored and dosage adjustments made as appropriate.

Antacids and Other Products Containing Multivalent Cations

Concurrent administration of quinolones, including Gipro, 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 Gipro. Gipro (Gipro hcl) should be given either 2 hours after or at least 4 hours before these products. This time window is different than for other oral formulations of Gipro, which are usually administered 2 hours before or 6 hours after antacids.

Calcium-containing Beverages

Concomitant administration of Gipro with milk products or calcium-fortified juices alone should be avoided since decreased absorption of Gipro is possible.

Warfarin

Quinolones, including Gipro, have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be monitored if Gipro (Gipro hcl) is administered concomitantly with warfarin or other oral anticoagulants. Patients should also be monitored for evidence of bleeding.

Cyclosporine

Some quinolones, including Gipro, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly. Cyclosporine whole blood trough concentrations should be monitored when given concomitantly with Gipro (Gipro hcl).

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of Gipro, potentially leading to increased plasma concentrations of methotrexate. This might increase the risk of methotrexate toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant Gipro therapy is indicated.

Phenytoin

Altered serum concentrations of phenytoin (increased and decreased) have been reported in patients receiving concomitant Gipro. Phenytoin serum concentrations should be monitored when given concomitantly with Gipro (Gipro hcl).

Glyburide

The concomitant administration of Gipro with the sulfonylurea glyburide has, on rare occasions, resulted in severe hypoglycemia.

Non-steroidal Anti-inflammatory Drugs (NSAIDs), but not Aspirin

NSAIDs in combination with very high doses of quinolones have been shown to provoke convulsions in nonclinical studies [see Nonclinical Toxicology.

Caffeine

Some quinolones, including Gipro, have been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and prolongation of the serum half-life of caffeine.

Probenecid

Probenecid interferes with renal tubular secretion of Gipro and produces increased concentrations of Gipro in serum.

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What are the possible side effects of Gipro?

Serious and Otherwise Important Adverse Reactions

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

• Tendon Effects
• Hypersensitivity Reactions
• Other Serious and Sometimes Fatal Reactions
• Central Nervous System Effects
• Clostridium difficile-Associated Diarrhea
• Peripheral Neuropathy
• Photosensitivity/Phototoxicity
• Development of Drug Resistant Bacteria

Crystalluria and cylindruria have been reported with quinolones, including Gipro. Therefore, adequate hydration of patients receiving Gipro (Gipro hcl) should be maintained to prevent the formation of highly concentrated urine.

Clinical Trial 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.

The data described below reflect exposure to Gipro (Gipro hcl) in 524 patients in one clinical trial. The population studied had a mean age of 39 years (approximately 93.4% of the population were < 65 years of age), 100% were female, 77% were Caucasian and 7.4% were Black. Patients received Gipro (Gipro hcl) 500 mg once daily for 3 days. Patients were followed for approximately 5 weeks after the end of study drug dosing.

Discontinuation of Gipro (Gipro hcl) occurred in 1.4% of patients. Each of the discontinuations were for a different adverse reactions. Refer to Table 1.

The most common adverse reactions ( ≥ 2%) were fungal infection, nasopharyngitis, headache, and micturition urgency.

Table 1: Adverse reactions (regardless of relationship to study drug) occurring in ≥ 1% of Gipro (Gipro hcl) -treated patients (500 mg once daily for 3 days) during the entire study period compared to Gipro-immediate release tablets (250 mg twice daily for 3 days)

The incidence of adverse events (regardless of relationship to study drug) reported for at least 1% of patients treated with Gipro (Gipro hcl) during study drug treatment and up to 3 days after study drug was headache (1.5%).

Less common reactions, occurring at any time during the study in less than 1% of Gipro (Gipro hcl) -treated patients were:

• Cardiac Disorders: ventricular bigeminy.
• Immune System Disorders: hypersensitivity.
• Gastrointestinal Disorders: abdominal pain, nausea, diarrhea, dyspepsia, aggravated irritable bowel syndrome, lower abdominal pain, vomiting.
• General Disorders: suprapubic pain, fatigue, pain, rigors, tenderness.
• Infections and Infestations: urinary tract infection, fungal vaginosis, bacterial vaginitis, vaginal candidiasis, vaginal infection, vaginitis.
• Investigations: blood bilirubin increased, alanine aminotransferase increased, abdominal aortic bruit, aspartate aminotransferase increased, body temperature increased.
• Musculoskeletal and Connective Tissue Disorders: joint swelling, muscle spasms, night cramps.
• Nervous System Disorders: headache, dizziness, disturbance in attention, paresthesia.
• Renal and Urinary Disorders: micturition urgency, dysuria, urinary frequency, abnormal urine odor, hematuria.
• Reproductive System and Breast Disorders: female genital pruritus.
• Respiratory, Thoracic, and Mediastinal Disorders: dyspnea.
• Skin/Subcutaneous Tissue Disorders: rash, photosensitivity/ phototoxicity reaction, pruritus, urticaria.

Adverse Reactions Reported with Other Systemic Formulations of Gipro

In addition, to the adverse reactions reported with Gipro (Gipro hcl), the following adverse reactions have been reported during clinical trials and from worldwide post-marketing experience with other systemic formulations of Gipro (includes all dosages and indications).

Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or a causal relationship to drug exposure. Abnormal gait, achiness, acidosis, agitation, agranulocytosis, allergic reactions (ranging from urticaria to anaphylactic reactions), amylase increase, anemia, angina pectoris, angioedema, anosmia, anxiety, arrhythmia, arthralgia, ataxia, atrial flutter, bleeding diathesis, blurred vision, bronchospasm, C. difficile associated diarrhea, candidiasis (cutaneous, oral), candiduria, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, chills, cholestatic jaundice, chromatopsia, confusion, convulsion, delirium, depression, diplopia, drowsiness, dysphagia, dyspnea, edema (conjunctivae, face, hands, laryngeal, lips, lower extremities, neck, pulmonary), epistaxis, erythema multiforme, erythema nodosum, exfoliative dermatitis, fever, fixed eruptions, flushing, gastrointestinal bleeding, gout (flare up), grand mal convulsion, gynecomastia, hallucinations, hearing loss, hematuria, hemolytic anemia, hemoptysis, hemorrhagic cystitis, hepatic failure (including fatal cases), hepatic necrosis, hepatitis, hiccup, hyperesthesia, hyperpigmentation, hypertension, hypertonia, hypoesthesia, hypotension, ileus, insomnia, interstitial nephritis, intestinal perforation, jaundice, joint stiffness, lethargy, lightheadedness, lipase increase, lymphadenopathy, malaise, manic reaction, marrow depression, migraine, moniliasis (oral, gastrointestinal, vaginal), mouth dryness, myalgia, myasthenia, myasthenia gravis (possible exacerbation), myocardial infarction, myoclonus, nephritis, nightmares, nystagmus, oral ulceration, pain (arm, back, breast, chest, epigastric, eye, extremities, foot, jaw, neck, oral mucosa), palpitation, pancreatitis, pancytopenia, paranoia, paresthesia, peripheral neuropathy, perspiration (increased), petechia, phlebitis, phobia, photosensitivity/phototoxicity reaction pleural effusion, polyuria, postural hypotension, prothrombin time prolongation, pseudomembranous colitis (the onset of symptoms may occur during or after antimicrobial treatment), pulmonary embolism, purpura, renal calculi, renal failure, respiratory arrest, respiratory distress, restlessness, serum sickness-like reaction, Stevens-Johnson syndrome, sweating, syncope, tachycardia, taste loss, tendonitis, tendon rupture, tinnitus, torsade de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, twitching, unresponsiveness, urethral bleeding, urinary retention, urination (frequent), vaginal pruritus, vasculitis, ventricular ectopy, vesicles, visual acuity (decreased), visual disturbances (flashing lights, change in color perception, overbrightness of lights), weakness.

The following adverse laboratory changes, in alphabetical order, regardless of incidence or relationship to drug, have been reported in patients given Gipro (includes all formulations, all dosages, all drug-therapy durations, and all indications):

Decreases in blood glucose, BUN, hematocrit, hemoglobin, leukocyte counts, platelet counts, prothrombin time, serum albumin, serum potassium, total serum protein, uric acid.

Increases in alkaline phosphatase, ALT (SGPT), AST (SGOT), atypical lymphocyte counts, blood glucose, blood monocytes, BUN, cholesterol, eosinophils counts, LDH, platelet counts, prothrombin time, sedimentation rate, serum amylase, serum bilirubin, serum calcium, serum cholesterol, serum creatinine phosphokinase, serum creatinine, serum gamma-glutamyl transpeptidase (GGT), serum potassium, serum theophylline (in patients receiving theophylline concomitantly), serum triglycerides, uric acid.

Others: albuminuria, change in serum phenytoin, crystalluria, cylindruria, immature WBCs, leukocytosis, methemaglobinemia, pancytopenia.