Ciprofloxacin

Generic name: ciprofloxacin hydrochloride (ciprofloxacin tablets, USP) · Brand names: Cipro (Bayer HealthCare Pharmaceuticals Inc.)

Quick facts

Drug class
Ciprofloxacin is a fluoroquinolone antibacterial (an antibiotic).
Section
Highlights, Indications and Usage
Source text (exact source wording)
Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:
Rx or otc
Prescription (label is a prescribing-information label with a Medication Guide; Rx status wording not separately confirmed on label text read)
Forms and strengths
  • 250 mg tablets (white to off-white, round, film coated, score line (functional) on one side, debossed 'L 53')
  • 500 mg tablets (white to off-white, capsule shaped, film coated, score line (functional) on one side, debossed 'L 54')
  • 750 mg tablets (white to off-white, capsule shaped, film coated, debossed 'C' on one side and '93' on the other)
Generic available
Value
Yes. This label is an ANDA generic (marketing status Abbreviated New Drug Application, as shown on the DailyMed page read via WebFetch).
Source
DailyMed set ID 6a935846-3c97-4517-bc4e-2377f673285e
Common use one line
Treats certain bacterial infections, such as urinary tract, skin, bone and joint, and others listed in the label.

What it is used for

Ciprofloxacin treats infections caused by certain bacteria. These include skin, bone and joint, stomach area, diarrhea, typhoid fever, gonorrhea, anthrax exposure, plague, prostate, lung, urinary tract and sinus infections. Children can take it only for a few of these uses. It should only be used when an infection is proven or strongly suspected to be caused by bacteria.
Section
1 INDICATIONS AND USAGE (1.1 to 1.13), label text joined; footnote on Shigella species efficacy omitted from this join
Source text (exact source wording)
Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-­susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. [1.1] Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. [1.2] Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. [1.3] Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated. [1.4] Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. [1.5] Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [1.6] Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. [1.7] Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. [1.8] Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis. [1.9] Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis. [1.10] Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. Ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [1.11] Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis. [1.12] To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. [1.13]

How it works

The label says ciprofloxacin belongs to the fluoroquinolone class of antibacterial medicines. The label's 12.1 section says no more than this. Section 12.4 (Microbiology) was not read.
Section
12.1 Mechanism of Action
Source text (exact source wording)
Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)].

Dosage: adults

The dose and length of treatment depend on the infection. Most adult doses are every 12 hours. For example, urinary tract infections are 250 to 500 mg every 12 hours for 7 to 14 days, and acute uncomplicated cystitis is 250 mg every 12 hours for 3 days. Uncomplicated gonorrhea is a single 250 mg dose. Your prescriber chooses the dose for you.
Section
2.1 Dosage in Adults, Table 1
Source text (exact source wording)
Table 1: Adult Dosage Guidelines (Dose / Frequency / Usual Durations): Skin and Skin Structure: 500 to 750 mg, every 12 hours, 7 to 14 days. Bone and Joint: 500 to 750 mg, every 12 hours, 4 to 8 weeks. Complicated Intra–Abdominal: 500 mg, every 12 hours, 7 to 14 days. Infectious Diarrhea: 500 mg, every 12 hours, 5 to 7 days. Typhoid Fever: 500 mg, every 12 hours, 10 days. Uncomplicated Urethral and Cervical Gonococcal Infections: 250 mg, single dose. Inhalational anthrax (post-exposure): 500 mg, every 12 hours, 60 days. Plague: 500 to 750 mg, every 12 hours, 14 days. Chronic Bacterial Prostatitis: 500 mg, every 12 hours, 28 days. Lower Respiratory Tract Infections: 500 to 750 mg, every 12 hours, 7 to 14 days. Urinary Tract Infections: 250 to 500 mg, every 12 hours, 7 to 14 days. Acute Uncomplicated Cystitis: 250 mg, every 12 hours, 3 days. Acute Sinusitis: 500 mg, every 12 hours, 10 days. Table footnote 1: Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).

Dosage: children

For children, the label gives doses by body weight for three uses only: complicated urinary tract or kidney infection (ages 1 to 17 years), anthrax exposure, and plague. Each has a maximum dose per time. A doctor sets the dose.
Section
2.2 Dosage in Pediatric Patients, Table 3
Source text (exact source wording)
Table 3: Pediatric Dosage Guidelines (Dose / Frequency / Total Duration): Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age): 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg). Every 12 hours. 10 to 21 days. Inhalational Anthrax (Post-Exposure): 15 mg/kg (maximum 500 mg per dose), every 12 hours, 60 days. Plague: 15 mg/kg (maximum 500 mg per dose), every 8 to 12 hours, 14 days.

Dosage adjustments

Drug interaction caps
Take ciprofloxacin at least 2 hours before or 6 hours after antacids and products with calcium, iron or zinc, and the other items listed.
Section
2.4 Important Administration Instructions, With Multivalent Cations
Source text (exact source wording)
Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
Kidney
People with reduced kidney function may need a lower dose or longer time between doses, based on creatinine clearance (a kidney test). The label lists doses for 30 to 50, 5 to 29, and dialysis.
Section
2.3 Dosage Modifications in Patients with Renal Impairment, Table 4
Source text (exact source wording)
Table 4: Creatinine Clearance (mL/min) / Dose: > 50: See Usual Dosage. 30 to 50: 250 to 500 mg every 12 hours. 5 to 29: 250 to 500 mg every 18 hours. Patients on hemodialysis or Peritoneal dialysis: 250 to 500 mg every 24 hours (after dialysis). In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Liver
In stable cirrhosis the label reports no significant change in how the body handles ciprofloxacin. It has not been studied in acute liver failure.
Section
8.7 Hepatic Impairment
Source text (exact source wording)
In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.
Elderly
The label says no dose change is needed for people over 65 with normal kidney function, but older people may have reduced kidney function, so care is needed in choosing the dose.
Section
8.5 Geriatric Use
Source text (exact source wording)
No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients

Missed dose

Take a missed dose as long as it is at least 6 hours before the next dose. If less than 6 hours remain, skip it. Never take double doses.
Section
2.4 Important Administration Instructions, Missed Doses (Medication Guide has matching text)
Source text (exact source wording)
If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.

Overdose

In an overdose, kidney problems that go away have been reported. Doctors give supportive care and keep the person hydrated. Medication Guide: if you take too much, call your healthcare provider or get medical help right away. Poison control: 1-800-222-1222 (added per RxDiff rule; not from the label text).
Section
10 OVERDOSAGE; Medication Guide 'How should I take'
Source text (exact source wording)
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.

Storage

Store at room temperature, 20 to 25 degrees C (68 to 77 degrees F). Short trips between 15 and 30 degrees C (59 to 86 degrees F) are allowed. This is from the Aurobindo label; other labelers may differ.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Boxed warning

This medicine has a boxed warning, the FDA's strongest kind. Fluoroquinolones can cause serious, disabling reactions that may be permanent and can happen together: tendon swelling or rupture, nerve damage, and effects on the brain and mind. Stop it right away if any of these happen. It can make muscle weakness worse in myasthenia gravis, so it should be avoided in people with a known history. It should be saved for acute exacerbation of chronic bronchitis, acute uncomplicated cystitis and acute sinusitis only when there is no other treatment option.
Title
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
Section
Boxed Warning
Source text (exact source wording)
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)] including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2)] Peripheral neuropathy [see Warnings and Precautions (5.3)] Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)]. Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)], reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications: Acute exacerbation of chronic bronchitis [see Indications and Usage (1.10)] Acute uncomplicated cystitis [see Indications and Usage (1.11)] Acute sinusitis [see Indications and Usage (1.12)]

Contraindications

Do not take it if you have ever had an allergic reaction to ciprofloxacin, other quinolone antibiotics, or any ingredient in the tablets.
Section
4.1 Hypersensitivity
Source text (exact source wording)
Ciprofloxacin tablets are 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 (5.7)].
Do not take it together with tizanidine.
Section
4.2 Tizanidine
Source text (exact source wording)
Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7)].

Warnings and precautions

Serious reactions can affect different parts of the body at the same time. They can start within hours to weeks. Stop the medicine at the first sign.
Heading
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
Source text (exact source wording)
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4)]. Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Risk is higher if you are over 60, take corticosteroids, or have had a kidney, heart or lung transplant. Stop if you have tendon pain, swelling or inflammation.
Heading
5.2 Tendinitis and Tendon Rupture
Source text (exact source wording)
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Discontinue ciprofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.
Stop if you get pain, burning, tingling, numbness or weakness in the limbs, to lower the chance of permanent damage.
Heading
5.3 Peripheral Neuropathy
Source text (exact source wording)
Discontinue ciprofloxacin immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition.
It can cause seizures, dizziness and tremors, and can make seizures more likely.
Heading
5.4 Central Nervous System Effects
Source text (exact source wording)
Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), dizziness, and tremors. Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold.
It can worsen muscle weakness in myasthenia gravis. Avoid it with a known history.
Heading
5.5 Exacerbation of Myasthenia Gravis
Source text (exact source wording)
Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Adverse Reactions (6.2)].
Serious and sometimes fatal allergic reactions can happen, even after the first dose.
Heading
5.7 Hypersensitivity Reactions
Source text (exact source wording)
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including ciprofloxacin.
Severe liver injury has been reported. Stop it at signs such as loss of appetite, yellow skin or eyes, dark urine, itching or a tender abdomen.
Heading
5.8 Hepatotoxicity
Source text (exact source wording)
Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with ciprofloxacin. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately.
Studies report more aortic aneurysm and dissection within two months of use, especially in older people.
Heading
5.9 Risk of Aortic Aneurysm and Dissection
Source text (exact source wording)
Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients.
Antibiotics, including this one, can cause C. difficile diarrhea, from mild to fatal colitis.
Heading
5.11 Clostridioides difficile-Associated Diarrhea
Source text (exact source wording)
Clostridioides difficile (C. difficile)-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis.
It can lengthen the QT interval and cause heart rhythm problems.
Heading
5.12 Prolongation of the QT Interval
Source text (exact source wording)
Some fluoroquinolones, including ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia. Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including ciprofloxacin.
It can cause severe sunburn-like reactions. Avoid too much sun or UV light.
Heading
5.14 Photosensitivity/Phototoxicity
Source text (exact source wording)
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including ciprofloxacin after sun or UV light exposure. Therefore, avoid excessive exposure to these sources of light.
It can cause high or low blood sugar, mostly in people with diabetes who use diabetes medicine.
Heading
5.19 Blood Glucose Disturbances
Source text (exact source wording)
Fluoroquinolones, including ciprofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin.

Pregnancy and breastfeeding

Source text (exact source wording)
Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). [8.1 Pregnancy] Because of the potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies [see Use in Specific Populations (8.4), (Clinical Considerations)], for most indications a lactating woman may consider pumping and discarding breast milk during treatment with ciprofloxacin and an additional two days (five half-lives) after the last dose. Alternatively, advise a woman that breastfeeding is not recommended during treatment with ciprofloxacin and for an additional two days (five half-lives) after the last dose. [8.2 Lactation]

Side effects

Common
The most often reported side effects were nausea (2.5%), diarrhea (1.6%), abnormal liver function tests (1.3%), vomiting (1%) and rash (1%).
Threshold
Label states: most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications. The Highlights call these 'The most common adverse reactions ≥1%'.
Section
6.1 Clinical Trials Experience, Adult Patients
Source text (exact source wording)
The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).
Less common
Fewer than 1% of people had medically important reactions such as headache, dizziness, trouble sleeping, nightmares, tremor, seizures, joint pain and itching. The label gives no percentages for this table. The label has no placebo-controlled table.
Section
6.1 Clinical Trials Experience, Table 8
Source text (exact source wording)
Table 8: Medically Important Adverse Reactions That Occurred in less than 1% of Ciprofloxacin Patients (listed by system, no percentages given): Body as a Whole: Headache, Abdominal Pain/Discomfort, Pain. Central Nervous System: Restlessness, Dizziness, Insomnia, Nightmares, Hallucinations, Paranoia, Psychosis (toxic), Manic Reaction, Irritability, Tremor, Ataxia, Seizures (including Status Epilepticus), Malaise, Anorexia, Phobia, Depersonalization, Paresthesia, Abnormal Gait, Migraine. Gastrointestinal: Intestinal Perforation, Gastrointestinal Bleeding, Cholestatic Jaundice, Hepatitis, Pancreatitis. Skin/Hypersensitivity: Pruritus, Urticaria, Photosensitivity/Phototoxicity reaction, Flushing, Fever, Angioedema, Sweating. Musculoskeletal: Arthralgia, Joint Stiffness, Muscle Weakness. (Table has more systems; this is a partial copy, text in each cell unchanged.)
Serious
Serious reactions include tendon rupture, nerve damage, severe allergic reactions, liver failure, heart rhythm changes and severe colitis. See the Warnings section.
Label source text (exact source wording)
Discontinue ciprofloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions (6.1, 6.2)]. [5.6] Postmarketing (Table 10) includes: QT prolongation, Torsade de Pointes, Vasculitis and ventricular arrhythmia, Hypertonia, Myasthenia, Exacerbation of myasthenia gravis, Peripheral neuropathy, Polyneuropathy, Pseudomembranous colitis, Pancytopenia (life threatening or fatal outcome), Hepatic failure (including fatal cases), Tendinitis, Tendon rupture, Acute generalize exanthematous pustulosis (AGEP). [6.2 Postmarketing Experience, partial copy of Table 10]
Medlineplus source text (exact source wording)
not retrieved (MedlinePlus page not opened in this run)

Interactions

Drugs
Contraindicated with tizanidine.
Name
Tizanidine
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Concomitant administration of tizanidine and ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2)].
Avoid use. If it cannot be avoided, theophylline levels must be monitored.
Name
Theophylline
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of ciprofloxacin 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 (5.10)].
Avoid use with drugs that lengthen the QT interval.
Name
Drugs known to prolong QT interval
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Avoid Use Ciprofloxacin 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)
Use with caution. Blood sugar can drop, sometimes severely. Monitor blood glucose.
Name
Oral antidiabetic drugs
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when ciprofloxacin 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 ciprofloxacin is co-administered with oral antidiabetic drugs
Use with caution. Blood thinner effect can increase. Monitor prothrombin time and INR.
Name
Anti-coagulant drugs (for example, warfarin)
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Use with caution (Increase in anticoagulant effect) Monitor prothrombin time and INR frequently during and shortly after co-administration of ciprofloxacin with an oral anti-coagulant (for example, warfarin).
Use with caution. Phenytoin levels can go up or down.
Name
Phenytoin
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Use with caution Altered serum levels of phenytoin (increased and decreased)
Use with caution. Monitor kidney function.
Name
Cyclosporine
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when ciprofloxacin is co-administered with cyclosporine.
Use with caution. Methotrexate side effects may be more likely.
Name
Methotrexate
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
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.
Avoid use. Duloxetine exposure rises five-fold.
Name
Duloxetine
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Avoid Use Five-fold increase in duloxetine exposure If unavoidable, monitor for duloxetine toxicity
Avoid use. Zolpidem levels may rise.
Name
Zolpidem
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Avoid Use Co-administration with ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended
These products lower how much ciprofloxacin is absorbed. Take ciprofloxacin 2 hours before or 6 hours after them.
Name
Antacids, sucralfate, multivitamins and other products containing multivalent cations
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Ciprofloxacin should be taken at least two hours before or six hours after Multivalent cation-containing products administration [see Dosage and Administration (2.4)]. Decrease ciprofloxacin absorption, resulting in lower serum and urine levels
Food and alcohol
Do not take it with milk, yogurt or calcium-fortified juice alone. It can be taken with a meal that contains them.
Name
Dairy products and calcium-fortified juices
Section
2.4 Important Administration Instructions
Source text (exact source wording)
Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.
Name
Alcohol
Section
n/a
Other
Use with caution with caffeine and related products.
Name
Caffeine / xanthine derivatives
Section
7 Drug Interactions, Table 11
Source text (exact source wording)
Use with caution Reduced clearance resulting in elevated levels and prolongation of serum half-life Ciprofloxacin inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust dose as necessary.
not applicable
Name
Liverpool HIV/HEP checkers
Section
n/a
Source text (exact source wording)
not applicable: the label's interaction table lists no antiviral drugs other than didanosine (as a multivalent cation product); checkers not consulted

Patient tips

Label medication guide
Take it with or without food, but not with milk, yogurt or calcium juice alone. Drink plenty of fluids. Finish the full course even if you feel better, unless you have a serious problem and your provider or the guide says to stop. Do not crush or chew. Do not drive until you know how it affects you. Avoid tanning beds and too much sun.
Section
Medication Guide: How should I take; What should I avoid
Source text (exact source wording)
Ciprofloxacin tablets can be taken with or without food. Ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone but may be taken with a meal that contains these products. Drink plenty of fluids while taking ciprofloxacin tablets. Do not skip any doses of ciprofloxacin tablets, or stop taking them, even if you begin to feel better, until you finish your prescribed treatment unless: you have tendon problems. ... you have nerve problems. ... you have central nervous system problems. ... you have a serious allergic reaction. ... your healthcare provider tells you to stop taking ciprofloxacin tablets. Take ciprofloxacin tablets in the morning and evening at about the same time each day. Do not crush or chew the tablet. Ciprofloxacin tablets can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin tablets affect you. Avoid sunlamps, tanning beds, and try to limit your time in the sun.
When to call
Get medical help right away for tendon pain or swelling, tingling or numbness, mood or behavior changes, or worse muscle weakness or breathing trouble.
Section
Medication Guide: What is the most important information (partial copy)
Source text (exact source wording)
Stop taking ciprofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. ... Stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: pain numbness burning weakness tingling ... Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

Alternatives

Class source
Label Highlights: 'Ciprofloxacin tablet is a fluoroquinolone antibacterial'. openFDA pharm_class_epc not checked.
Note
No recommendation made.

Frequently asked questions

Question
What is ciprofloxacin used for?
Answer
It treats infections caused by certain bacteria, such as urinary tract, skin, bone and joint, lung, sinus, prostate and stomach area infections, diarrhea, typhoid fever, gonorrhea, anthrax exposure and plague. It should only be used when an infection is proven or strongly suspected to be caused by bacteria.
Source section
1 Indications and Usage
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
Can I take ciprofloxacin with food or milk?
Answer
It can be taken with or without food. Do not take it with milk, yogurt or calcium-fortified juice alone, but it may be taken with a meal that contains these products.
Source section
Medication Guide; 2.4
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
What if I miss a dose?
Answer
Take it as long as at least 6 hours remain until the next dose. If less than 6 hours remain, skip it. Do not take 2 doses at 1 time.
Source section
2.4 Missed Doses; Medication Guide
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
What are the most common side effects?
Answer
The most often reported were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%) and rash (1%).
Source section
6.1 Clinical Trials Experience
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
Does ciprofloxacin have a serious warning?
Answer
Yes. A boxed warning says fluoroquinolones can cause disabling and potentially irreversible reactions including tendon rupture, nerve damage and central nervous system effects, and can worsen myasthenia gravis. Stop it immediately if these happen.
Source section
Boxed Warning
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
What medicines or products should I not combine with it?
Answer
It is contraindicated with tizanidine. Avoid use with theophylline, duloxetine and zolpidem, and with drugs that prolong the QT interval. Take it 2 hours before or 6 hours after antacids and products with calcium, iron or zinc.
Source section
4.2; 7 Drug Interactions; 2.4
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
Can I take it while pregnant or breastfeeding?
Answer
The label says long experience has not identified a drug-linked risk of major birth defects or miscarriage. For breastfeeding, pump and discard milk or do not breastfeed during treatment and for two more days after the last dose.
Source section
8.1; 8.2
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)
Question
Should I stop when I feel better?
Answer
The Medication Guide says not to skip doses or stop even if you begin to feel better until you finish your prescribed treatment, unless a serious problem occurs or your healthcare provider tells you to stop.
Source section
Medication Guide: How should I take
Source
Aurobindo ciprofloxacin tablets label (set ID 6a935846-3c97-4517-bc4e-2377f673285e)

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug