Gibac

Gibac: 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.

Gibac 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.

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

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

Gibac 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)

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

Complicated Urinary Tract Infections, And Acute Uncomplicated Pyelonephritis

Gibac 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 Gibac in treating infections other than urinary tract infections has not been demonstrated.
• Gibac is not indicated for pediatric patients.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gibac and other antibacterial drugs, Gibac 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 Gibac. Therapy with Gibac 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 Gibac. 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.

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

Gibac 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).

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

Gibac is available only with your doctor's prescription.

Dosage

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

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

Administration

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

Impaired Renal Function

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What is the most important information I should know about Gibac?

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 Gibac or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking Gibac, 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 Gibac 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 Gibac.

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

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

Use: Labeled Indications

Children and Adolescents: Treatment of complicated urinary tract infections and pyelonephritis due to E. coli. Note: Although effective, Gibac 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 Gibac 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, Gibac 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), Gibac, 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 Gibac 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 Gibac 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 Gibac 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 Gibac and doxycycline as drugs of choice.

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What other drugs will affect Gibac?

Theophylline

As with some other quinolones, concurrent administration of Gibac 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 Gibac, 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 Gibac. Gibac (Gibac 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 Gibac, which are usually administered 2 hours before or 6 hours after antacids.

Calcium-containing Beverages

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

Warfarin

Quinolones, including Gibac, 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 Gibac (Gibac hcl) is administered concomitantly with warfarin or other oral anticoagulants. Patients should also be monitored for evidence of bleeding.

Cyclosporine

Some quinolones, including Gibac, 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 Gibac (Gibac hcl).

Methotrexate

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

Phenytoin

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

Glyburide

The concomitant administration of Gibac 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 Gibac, 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 Gibac and produces increased concentrations of Gibac in serum.

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What are the possible side effects of Gibac?

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 Gibac. Therefore, adequate hydration of patients receiving Gibac (Gibac 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 Gibac (Gibac 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 Gibac (Gibac hcl) 500 mg once daily for 3 days. Patients were followed for approximately 5 weeks after the end of study drug dosing.

Discontinuation of Gibac (Gibac 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 Gibac (Gibac hcl) -treated patients (500 mg once daily for 3 days) during the entire study period compared to Gibac-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 Gibac (Gibac 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 Gibac (Gibac 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 Gibac

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