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Proquin XR

Last reviewed on RxList: 6/20/2019
Proquin XR Side Effects Center

Last reviewed on RxList 6/20/2019

Proquin XR (ciprofloxacin) is a fluoroquinolone antibiotic used to treat different types of bacterial infections. Proquin XR is available in generic form. Common side effects of Proquin XR include:

The dose of Proquin XR is 500 mg tablets, taken orally once daily for 3 to 10 days with a meal, preferably the evening meal. Proquin XR may interact with blood thinners, clozapine, cyclosporine, insulin or diabetes medication you take by mouth, methotrexate, metoclopramide, phenytoin, probenecid, ropinirole, tacrine, theophylline, non-steroidal anti-inflammatory drugs (NSAIDs), or oral steroids. Tell your doctor all medications you are taking. During pregnancy, Proquin XR should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Proquin XR (ciprofloxacin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Proquin XR Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Ciprofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking this medicine and call your doctor at once if you have:

  • low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
  • nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;
  • serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
  • signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, ciprofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using ciprofloxacin and call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • the first sign of any skin rash, no matter how mild;
  • muscle weakness, breathing problems;
  • little or no urination;
  • jaundice (yellowing of the skin or eyes); or
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • vaginal itching or discharge;
  • headache; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Proquin XR (Ciprofloxacin Hcl)

QUESTION

How much urine does the average adult pass each day? See Answer
Proquin XR Professional Information

SIDE EFFECTS

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 [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Other Serious and Sometimes Fatal Reactions [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]
  • Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS]
  • Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS]

Crystalluria and cylindruria have been reported with quinolones, including ciprofloxacin. Therefore, adequate hydration of patients receiving Proquin XR (ciprofloxacin hcl) should be maintained to prevent the formation of highly concentrated urine [see DOSAGE AND ADMINISTRATION].

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 Proquin XR (ciprofloxacin 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 Proquin XR (ciprofloxacin hcl) 500 mg once daily for 3 days. Patients were followed for approximately 5 weeks after the end of study drug dosing.

Discontinuation of Proquin XR (ciprofloxacin 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 Proquin XR (ciprofloxacin hcl) -treated patients (500 mg once daily for 3 days) during the entire study period compared to ciprofloxacin-immediate release tablets (250 mg twice daily for 3 days)

Adverse Reaction Proquin XR Ciprofloxacin-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 Proquin XR (ciprofloxacin 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 Proquin XR (ciprofloxacin 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 Ciprofloxacin

In addition, to the adverse reactions reported with Proquin XR (ciprofloxacin hcl) , the following adverse reactions have been reported during clinical trials and from worldwide post-marketing experience with other systemic formulations of ciprofloxacin (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) [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], 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 [see WARNINGS AND PRECAUTIONS], 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) [see WARNINGS AND PRECAUTIONS], 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 [see WARNINGS AND PRECAUTIONS], peripheral neuropathy, perspiration (increased), petechia, phlebitis, phobia, photosensitivity/phototoxicity reaction[see WARNINGS AND PRECAUTIONS] pleural effusion, polyuria, postural hypotension, prothrombin time prolongation, pseudomembranous colitis (the onset of symptoms may occur during or after antimicrobial treatment) [see WARNINGS AND PRECAUTIONS], 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 [see BOXED WARNING and WARNINGS AND PRECAUTIONS], 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 ciprofloxacin (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.

Read the entire FDA prescribing information for Proquin XR (Ciprofloxacin Hcl)

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