Drug: Cipro XR
CIPRO XR (ciprofloxacin*) extended-release tablets contain ciprofloxacin, a synthetic antimicrobial agent for oral administration. CIPRO XR tablets are coated, bilayer tablets consisting of an immediate-release layer and an erosion-matrix type controlled-release layer. The tablets contain a combination of two types of ciprofloxacin drug substance, ciprofloxacin hydrochloride and ciprofloxacin betaine (base). Ciprofloxacin hydrochloride is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid hydrochloride. It is provided as a mixture of the monohydrate and the sesquihydrate. The empirical formula of the monohydrate is C17H18FN3O3 • HCl • H2O and its molecular weight is 385.8. The empirical formula of the sesquihydrate is C17H18FN3O3 • HCl • 1.5 H2O and its molecular weight is 394.8. The drug substance is a faintly yellowish to light yellow crystalline substance. The chemical structure of the monohydrate is as follows: Ciprofloxacin betaine is 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. As a hydrate, its empirical formula is C17H18FN3O3 • 3.5 H2O and its molecular weight is 394.3. It is a pale yellowish to light yellow crystalline substance and its chemical structure is as follows: CIPRO XR is available in 500 mg and 1000 mg (ciprofloxacin equivalent) tablet strengths. CIPRO XR tablets are nearly white to slightly yellowish, film-coated, oblong-shaped tablets. Each CIPRO XR 500 mg tablet contains 500 mg of ciprofloxacin as ciprofloxacin HCl (287.5 mg, calculated as ciprofloxacin on the dried basis) and ciprofloxacin† (212.6 mg, calculated on the dried basis). Each CIPRO XR 1000 mg tablet contains 1000 mg of ciprofloxacin as ciprofloxacin HCl (574.9 mg, calculated as ciprofloxacin on the dried basis) and ciprofloxacin† (425.2 mg, calculated on the dried basis). The inactive ingredients are crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide. * as ciprofloxacin† and ciprofloxacin hydrochloride
† does not comply with the loss on drying test and residue on ignition test of the USP monograph.
† does not comply with the loss on drying test and residue on ignition test of the USP monograph.
Source: http://www.rxlist.com
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
System Organ Class Adverse Reactions Body as a Whole Abdominal pain
Asthenia
Malaise Cardiovascular Bradycardia
Migraine
Syncope Central Nervous System Abnormal dreams
Convulsive seizures (including status epilepticus)
Depersonalization
Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide)
Hypertonia
Incoordination
Insomnia
Somnolence
Tremor
Vertigo Gastrointestinal Constipation
Dry mouth
Flatulence
Thirst Hepatobiliary Disorders Liver function tests abnormal Investigations Prothrombin decrease Metabolic Hyperglycemia
Hypoglycemia Psychiatric Disorders Anorexia Skin/Hypersensitivity Dry skin
Maculopapular rash
Photosensitivity/phototoxicity reactions
Pruritus
Rash
Skin disorder
Urticarial
Vesiculobullous rash Special Senses Diplopia
Taste perversion Urogenital Dysmenorrhea
Hematuria
Kidney function abnormal
Vaginitis Postmarketing Experience The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO XR. Because these reactions 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 (Table 3). Table 3: Postmarketing Reports of Adverse Drug Reactions
System Organ Class Adverse Reactions Cardiovascular QT prolongation
Torsade de Pointes
Vasculitis and ventricular arrhythmia Central Nervous System Hypertonia
Myasthenia
Exacerbation of myasthenia gravis
Peripheral neuropathy
Polyneuropathy
Twitching Eye Disorders Nystagmus Gastrointestinal Pseudomembranous colitis Hemic/Lymphatic Pancytopenia (life threatening or fatal outcome)
Methemoglobinemia Hepatobiliary Hepatic failure (including fatal cases) Infections and Infestations Candidiasis (oral, gastrointestinal, vaginal) Investigations Prothrombin time prolongation or decrease
Cholesterol elevation (serum)
Potassium elevation (serum) Musculoskeletal Myalgia
Myoclonus
Tendinitis
Tendon rupture Psychiatric Disorders Agitation
Confusion
Delirium
Psychosis (toxic) Skin/Hypersensitivity Acute generalized exanthematous pustulosis (AGEP)
Fixed eruption
Serum sickness-like reaction Special Senses Anosmia
Hyperesthesia
Hypesthesia
Taste loss Adverse Laboratory Changes Changes in laboratory parameters while on CIPRO are listed below: Hepatic–Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin. Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia. Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported. Other changes occurring 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. Read the Cipro XR (ciprofloxacin extended-release) Side Effects Center for a complete guide to possible side effectsLearn More »
- Tendon Effects [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Other Serious and Sometimes Fatal Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Serious Adverse Reactions with Concomitant Theophylline [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
- Clostridium Difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS]
- Musculoskeletal Disorders in Pediatric Patients [see WARNINGS AND PRECAUTIONS]
- Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS]
- Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
System Organ Class Adverse Reactions Body as a Whole Abdominal pain
Asthenia
Malaise Cardiovascular Bradycardia
Migraine
Syncope Central Nervous System Abnormal dreams
Convulsive seizures (including status epilepticus)
Depersonalization
Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide)
Hypertonia
Incoordination
Insomnia
Somnolence
Tremor
Vertigo Gastrointestinal Constipation
Dry mouth
Flatulence
Thirst Hepatobiliary Disorders Liver function tests abnormal Investigations Prothrombin decrease Metabolic Hyperglycemia
Hypoglycemia Psychiatric Disorders Anorexia Skin/Hypersensitivity Dry skin
Maculopapular rash
Photosensitivity/phototoxicity reactions
Pruritus
Rash
Skin disorder
Urticarial
Vesiculobullous rash Special Senses Diplopia
Taste perversion Urogenital Dysmenorrhea
Hematuria
Kidney function abnormal
Vaginitis Postmarketing Experience The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO XR. Because these reactions 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 (Table 3). Table 3: Postmarketing Reports of Adverse Drug Reactions
System Organ Class Adverse Reactions Cardiovascular QT prolongation
Torsade de Pointes
Vasculitis and ventricular arrhythmia Central Nervous System Hypertonia
Myasthenia
Exacerbation of myasthenia gravis
Peripheral neuropathy
Polyneuropathy
Twitching Eye Disorders Nystagmus Gastrointestinal Pseudomembranous colitis Hemic/Lymphatic Pancytopenia (life threatening or fatal outcome)
Methemoglobinemia Hepatobiliary Hepatic failure (including fatal cases) Infections and Infestations Candidiasis (oral, gastrointestinal, vaginal) Investigations Prothrombin time prolongation or decrease
Cholesterol elevation (serum)
Potassium elevation (serum) Musculoskeletal Myalgia
Myoclonus
Tendinitis
Tendon rupture Psychiatric Disorders Agitation
Confusion
Delirium
Psychosis (toxic) Skin/Hypersensitivity Acute generalized exanthematous pustulosis (AGEP)
Fixed eruption
Serum sickness-like reaction Special Senses Anosmia
Hyperesthesia
Hypesthesia
Taste loss Adverse Laboratory Changes Changes in laboratory parameters while on CIPRO are listed below: Hepatic–Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin. Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia. Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported. Other changes occurring 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. Read the Cipro XR (ciprofloxacin extended-release) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
Dosage CIPRO XR and ciprofloxacin immediate-release tablets are not interchangeable. Cipro XR should beadministered 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 CIPRO IV for UTIs may be switched to CIPRO XR when clinically indicated at the discretion of the physician. Administration
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 CIPRO IV for UTIs may be switched to CIPRO XR when clinically indicated at the discretion of the physician. Administration
- CIPRO XR tablets should be taken whole and not split, crushed, or chewed.
- CIPRO 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 [see DRUG INTERACTIONS].
- Concomitant administration of Cipro 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 CIPRO XR is recommended [see PATIENT INFORMATION].
- Adequate hydration of patients receiving CIPRO XR should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS and PATIENT INFORMATION].
- In patients with cUTI and acute uncomplicated pyelonephritis with a creatinine clearance of ≤ 30 mL/min, the dose of CIPRO XR should be reduced from 1000 mg to 500 mg daily. The use of Ciprofloxacin 1000 mg XR tablets is not recommended in this patient population.
- For patients on hemodialysis or peritoneal dialysis, administer CIPRO XR after the dialysis procedure is completed (maximum dose should be Ciprofloxacin 500 mg XR every 24 hours). The use of Ciprofloxacin 1000 mg XR is not recommended in this patient population. [See Use in Specific Populations and CLINICAL PHARMACOLOGY]
- For patients on continuous ambulatory peritoneal dialysis (CAPD), the maximum dose should be 500 mg every 24 hours.
Source: http://www.rxlist.com
Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Coadministration of CIPRO XR with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug. Table 4: Drugs That are Affected by and Affecting CIPRO
Drugs That are Affected by CIPRO Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and CIPRO XR is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see CONTRAINDICATIONS]. Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of CIPRO XR with theophylline may result in increased risk of a patient developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate. [See WARNINGS AND PRECAUTIONS] Drugs Known to Prolong QT Interval Avoid Use Cipro XR may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]. Oral antidiabetic drugs Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when CIPRO XR and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported. Monitor blood glucose when CIPRO XR is co-administered with oral antidiabetic drugs. [See ADVERSE REACTIONS] Phenytoin Use with caution Altered serum levels of phenytoin (increased and decreased) To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon CIPRO XR discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after coadministration of CIPRO XR with phenytoin. Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when CIPRO XR is co-administered with cyclosporine. Anti-coagulant drugs Use with caution (Increase in anticoagulant effect) The risk may vary with the underlying infection, age and general status of the patient so that the contribution of CIPRO XR to the increase in INR (international normalized ratio) is difficult to assess. Monitor prothrombin time and INR frequently during and shortly after co-administration of CIPRO XR with an oral anti-coagulant (for example, warfarin). Methotrexate Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant CIPRO XR therapy is indicated. Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after coadministration with CIPRO XR [see WARNINGS AND PRECAUTIONS]. Clozapine Use with caution Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with CIPRO XR are advised. NSAIDs Use with caution Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies and in postmarketing. Sildenafil Use with caution Two-fold increase in exposure Monitor for sildenafil toxicity [see Pharmacokinetics]. Duloxetine Avoid Use Five-fold increase in duloxetine exposure If unavoidable monitor, for duloxetine toxicity Caffeine/Xanthine Derivatives Use with caution Reduced clearance resulting in elevated levels and prolongation of serum half-life CIPRO XR inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust dose as necessary. Drug(s) Affecting Pharmacokinetics of CIPRO XR Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent CIPRO XR should be taken at least two hours before or six hours after Multivalent cation-containing products Decrease CIPRO XR absorption, resulting in lower serum and urine levels considerably lower than desired for concurrent administration of these agents with CIPRO XR Cations (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder; other highly buffered drugs; or products containing calcium, iron, or zinc and dairy products) administration. [See DOSAGE AND ADMINISTRATION] Probenecid Use with caution (interferes with renal tubular secretion of CIPRO XR and increases CIPRO XR serum levels) Potentiation of CIPRO XR toxicity may occur. Read the Cipro XR Drug Interactions Center for a complete guide to possible interactions Learn More »
Drugs That are Affected by CIPRO Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and CIPRO XR is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see CONTRAINDICATIONS]. Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of CIPRO XR with theophylline may result in increased risk of a patient developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate. [See WARNINGS AND PRECAUTIONS] Drugs Known to Prolong QT Interval Avoid Use Cipro XR may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]. Oral antidiabetic drugs Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when CIPRO XR and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported. Monitor blood glucose when CIPRO XR is co-administered with oral antidiabetic drugs. [See ADVERSE REACTIONS] Phenytoin Use with caution Altered serum levels of phenytoin (increased and decreased) To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon CIPRO XR discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after coadministration of CIPRO XR with phenytoin. Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when CIPRO XR is co-administered with cyclosporine. Anti-coagulant drugs Use with caution (Increase in anticoagulant effect) The risk may vary with the underlying infection, age and general status of the patient so that the contribution of CIPRO XR to the increase in INR (international normalized ratio) is difficult to assess. Monitor prothrombin time and INR frequently during and shortly after co-administration of CIPRO XR with an oral anti-coagulant (for example, warfarin). Methotrexate Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant CIPRO XR therapy is indicated. Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after coadministration with CIPRO XR [see WARNINGS AND PRECAUTIONS]. Clozapine Use with caution Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with CIPRO XR are advised. NSAIDs Use with caution Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies and in postmarketing. Sildenafil Use with caution Two-fold increase in exposure Monitor for sildenafil toxicity [see Pharmacokinetics]. Duloxetine Avoid Use Five-fold increase in duloxetine exposure If unavoidable monitor, for duloxetine toxicity Caffeine/Xanthine Derivatives Use with caution Reduced clearance resulting in elevated levels and prolongation of serum half-life CIPRO XR inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust dose as necessary. Drug(s) Affecting Pharmacokinetics of CIPRO XR Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent CIPRO XR should be taken at least two hours before or six hours after Multivalent cation-containing products Decrease CIPRO XR absorption, resulting in lower serum and urine levels considerably lower than desired for concurrent administration of these agents with CIPRO XR Cations (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder; other highly buffered drugs; or products containing calcium, iron, or zinc and dairy products) administration. [See DOSAGE AND ADMINISTRATION] Probenecid Use with caution (interferes with renal tubular secretion of CIPRO XR and increases CIPRO XR serum levels) Potentiation of CIPRO XR toxicity may occur. Read the Cipro XR Drug Interactions Center for a complete guide to possible interactions Learn More »
Source: http://www.rxlist.com
CIPRO XR 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) CIPRO XR is indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus. Complicated Urinary Tract Infections, And Acute Uncomplicated Pyelonephritis CIPRO XR 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 CIPRO XR in treating infections other than urinary tract infections has not been demonstrated.
- CIPRO XR is not indicated for pediatric patients.
Source: http://www.rxlist.com
Hypersensitivity CIPRO XR is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see WARNINGS AND PRECAUTIONS]. Tizanidine Concomitant administration with tizanidine is contraindicated [see DRUG INTERACTIONS]. Last reviewed on RxList: 2/12/2015
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum or calcium containing antacids, which can reduce the absorption of ciprofloxacin. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.
Source: http://www.rxlist.com
Dosage Forms And Strengths
This monograph has been modified to include the generic and brand name in many instances.
- 500 mg white to slightly yellowish, film-coated, oblong-shaped tablets imprinted with the word “BAYER” on one side and “C500 QD” on the other
- 1000 mg white to slightly yellowish, film-coated, oblong-shaped tablets imprinted the word “BAYER” on one side and “C1000 QD” on the other
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Tendinopathy And Tendon Rupture Fluoroquinolones, including CIPRO XR, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Inflammation and tendon rupture can occur, sometimes bilaterally, even within the first 48 hours, during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. CIPRO XR should be used with caution in patients with a history of tendon disorders. CIPRO XR should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. [See ADVERSE REACTIONS] Exacerbation Of Myasthenia Gravis Fluoroquinolones, including CIPRO XR, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid CIPRO XR in patients with known history of myasthenia gravis. [See ADVERSE REACTIONS and PATIENT INFORMATION] Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including CIPRO XR. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated. [See CONTRAINDICATIONS, ADVERSE REACTIONS and PATIENT INFORMATION] Other Serious And Sometimes Fatal Reactions Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
This monograph has been modified to include the generic and brand name in many instances.
- Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome);
- Vasculitis; arthralgia; myalgia; serum sickness;
- Allergic pneumonitis;
- Interstitial nephritis; acute renal insufficiency or failure;
- Hepatitis; jaundice; acute hepatic necrosis or failure;
- Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
- Tendon Disorders: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue CIPRO XR treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
- Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
- Hypersensitivity Reactions: Inform patients that ciprofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
- Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking ciprofloxacin. Instruct patients to inform their physician and be if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
- Convulsions: Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including Ciprofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions.
- Neurologic Adverse Effects (for example, dizziness, lightheadedness, increased intracranial pressure): Inform patients that they should know how they react to CIPRO XR before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
- Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
- Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with ciprofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, patients should immediately discontinue CIPRO XR and contact their physician.
- Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physicians if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
- Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child's physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child's physician of any joint-related problems that occur during or following ciprofloxacin therapy [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
- Tizanidine: Instruct patients not to use ciprofloxacin if they are already taking tizanidine. CIPRO XR increases the effects of tizanidine (Zanaflex®).
- Theophylline: Inform patients that ciprofloxacin may increase the effects of theophylline. Life-threatening CNS effects and arrhythmias can occur. Advise the patients to immediately seek medical help if they experience seizures, palpitations, or difficulty breathing.
- Caffeine: Inform patients that CIPRO XR may increase the effects of caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
- Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.
- Salmonella/Microsome Test (Negative)
- E. coli DNA Repair Assay (Negative)
- Mouse Lymphoma Cell Forward Mutation Assay (Positive)
- Chinese Hamster V79 Cell HGPRT Test (Negative)
- Syrian Hamster Embryo Cell Transformation Assay (Negative)
- Saccharomyces cerevisiae Point Mutation Assay (Negative)
- Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
- Rat Hepatocyte DNA Repair Assay (Positive)
- Rat Hepatocyte DNA Repair Assay
- Micronucleus Test (Mice)
- Dominant Lethal Test (Mice)
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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