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What is the most important information I should know about Qnif?
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 Qnif or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Qnif, 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 Qnif 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 Qnif.
Qnif 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 Qnif 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.
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What are the possible side effects of Qnif?
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
Crystalluria and cylindruria have been reported with quinolones, including Qnif. Therefore, adequate hydration of patients receiving Qnif (Qnif hcl) should be maintained to prevent the formation of highly concentrated urine.
Clinical Trial ExperienceBecause 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 Qnif (Qnif 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 Qnif (Qnif hcl) 500 mg once daily for 3 days. Patients were followed for approximately 5 weeks after the end of study drug dosing.
Discontinuation of Qnif (Qnif 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 Qnif (Qnif hcl) -treated patients (500 mg once daily for 3 days) during the entire study period compared to Qnif-immediate release tablets (250 mg twice daily for 3 days)
| Adverse Reaction | Qnif | Qnif-immediate release tablets |
| Nausea | 1.4 | 2.4 |
| Abdominal pain | 1.7 | 1.2 |
| Suprapubic pain | 1.4 | 0.6 |
| Urinary tract infection | 10.8 | 9.8 |
| Fungal infection | 2.7 | 1.8 |
| Upper respiratory tract infection | 1.4 | 2.9 |
| Back pain | 1.7 | 1.6 |
| Headache | 2.3 | 3.9 |
| Micturition urgency | 1.9 | 1.0 |
| Urinary frequency | 1.4 | 1.0 |
| Nasopharyngitis | 2.7 | 1.4 |
| Pharyngitis | 1.2 | 1.0 |
The incidence of adverse events (regardless of relationship to study drug) reported for at least 1% of patients treated with Qnif (Qnif 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 Qnif (Qnif hcl) -treated patients were:
In addition, to the adverse reactions reported with Qnif (Qnif hcl), the following adverse reactions have been reported during clinical trials and from worldwide post-marketing experience with other systemic formulations of Qnif (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 Qnif (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.
Qnif 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)Qnif 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 Qnif, have been associated with serious adverse reactions and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve Qnif for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options.
Complicated Urinary Tract Infections, And Acute Uncomplicated PyelonephritisQnif 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 UseTo reduce the development of drug-resistant bacteria and maintain the effectiveness of Qnif and other antibacterial drugs, Qnif 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 Qnif. Therapy with Qnif 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 Qnif. 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.
Qnif is used to treat bacterial infections in many different parts of the body. Qnif oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. Qnif may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
Qnif 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).
Qnif belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Qnif will not work for colds, flu, or other virus infections.
Qnif is available only with your doctor's prescription.
Qnif: 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.
Qnif 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.
Qnif XR: Each 500 mg tablet contains Ciprofloxacin HCl monohydrate 334.8 mg and Qnif hydrous 253 mg, corresponding to Qnif 500 mg. Each 1 g tablet contains Ciprofloxacin HCl monohydrate 669.4 mg and Qnif hydrate 506 mg, corresponding to Qnif 1000 mg.
Qnif XR also contains the following excipients: Crospovidone, magnesium stearate, anhydrous colloidal silica, succinic acid, hypromellose, macrogol 3350, titanium dioxide and purified water in bulk.
Use Qnif suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Qnif suspension.
There 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.Use: Labeled IndicationsChildren and Adolescents: Treatment of complicated urinary tract infections and pyelonephritis due to E. coli. Note: Although effective, Qnif 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 Qnif for use in patients who have no alternative treatment options for acute uncomplicated cystitis.
Off Label UsesAnthrax
Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax, Qnif 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), Qnif, 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 Qnif may be beneficial for the treatment of cat scratch disease ).
TularemiaData from retrospective studies and case reports/series demonstrate varied results with the use of Qnif 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 Qnif 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 Qnif and doxycycline as drugs of choice.
Qnif and Qnif immediate-release tablets are not interchangeable. Qnif should be administered orally once daily (Table 1).
Patients whose therapy is started with Qnif IV for UTIs may be switched to Qnif when clinically indicated at the discretion of the physician.
Administration
Adequate hydration of patients receiving Qnif 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 other drugs will affect Qnif?
As with some other quinolones, concurrent administration of Qnif 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 CationsConcurrent administration of quinolones, including Qnif, 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 Qnif. Qnif (Qnif 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 Qnif, which are usually administered 2 hours before or 6 hours after antacids.
Calcium-containing BeveragesConcomitant administration of Qnif with milk products or calcium-fortified juices alone should be avoided since decreased absorption of Qnif is possible.
WarfarinQuinolones, including Qnif, 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 Qnif (Qnif hcl) is administered concomitantly with warfarin or other oral anticoagulants. Patients should also be monitored for evidence of bleeding.
CyclosporineSome quinolones, including Qnif, 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 Qnif (Qnif hcl).
MethotrexateRenal tubular transport of methotrexate may be inhibited by concomitant administration of Qnif, 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 Qnif therapy is indicated.
PhenytoinAltered serum concentrations of phenytoin (increased and decreased) have been reported in patients receiving concomitant Qnif. Phenytoin serum concentrations should be monitored when given concomitantly with Qnif (Qnif hcl).
GlyburideThe concomitant administration of Qnif with the sulfonylurea glyburide has, on rare occasions, resulted in severe hypoglycemia.
Non-steroidal Anti-inflammatory Drugs (NSAIDs), but not AspirinNSAIDs in combination with very high doses of quinolones have been shown to provoke convulsions in nonclinical studies [see Nonclinical Toxicology.
CaffeineSome quinolones, including Qnif, 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.
ProbenecidProbenecid interferes with renal tubular secretion of Qnif and produces increased concentrations of Qnif in serum.
