black box warning - JASE Medical

How Long Do My Meds Last? A Look at Ciprofloxacin

(How about over 10 years past expiration?)

Ciprofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic, it is used to treat many different types of bacterial infections, and is used to treat biological warfare agent inhalation  Anthrax as a post exposure prophylaxis.

How long does ciprofloxacin remain potent?

When stored in a cool, dry, and dark area away from sunlight and capped, ciprofloxacin can retain much of its potency well past expiration date.

Expiration dates reflect the time during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. According to the Shelf-Life Extension Program, a joint initiative of the FDA and Department of Defense that tested 122 drugs for potency after their expiration date revealed ciprofloxacin maintained its active ingredients with no deterioration in strength for up to 142 months- over 10 years!

Ciprofloxacin is listed in the World Health Organization Model List of Medications for the newly released 2023 edition:

FIRST CHOICE (From WHO 2023 list)

  • Acute invasive bacterial diarrhea /dysentery
  • Enteric fever
  • Low-risk febrile neutropenia
  • Pyelonephritis or prostatitis (mild to moderate)

SECOND CHOICE (From WHO 2023 list)

  • Cholera
  • Complicated intraabdominal infections (mild to moderate)

In addition, ciprofloxacin can be used to treat:

  • Anthrax exposure
  • Tularemia
  • Urinary tract infection

How to Take

Take ciprofloxacin dose 2 hours before or 6 hours after taking other medicines. It may be taken with or without food. Drink plenty of liquids when taking ciprofloxacin.

Side Effects

Fluoroquinolones carry black box warning

Fluoroquinolones (FQ) have been associated with increased tendon ruptures. A tendon rupture is a partial or complete tear of a tendon.

A large study reviewing retroactive patient records was conducted between 2007 and 2016 with over a million subjects from the senior population age 65 and older. This study reviewed the use of FQ against other antibiotics and even similar drugs in the FQ class to assess tendon rupture occurrence.  Only one of the FQ antibiotics displayed a significant tendency to tendon rupture- between a 16% (rotator cuff) and fourfold risk (Achilles tendon). That antibiotic was levofloxacin. Neither ciprofloxacin-one of the antibiotics found in the Jase case- or moxifloxacin- which were part of the study- was found to increase tendon rupture.

For more information, please read this post: Does Ciprofloxacin (Cipro) cause tendon rupture?

What To Avoid

  • Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice.
  • Avoid antacids that contain calcium, magnesium, or aluminum (such as Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Tums, and others).
  • Vitamin or mineral supplements that contain calcium, iron, magnesium, or zinc.
  • Ciprofloxacin can cause sun sensitivity. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Consult with your care provider before taking if you are taking any of the following:

For a more complete list of drugs that may interact with ciprofloxacin check out this site.

Make your care provider aware if you currently have (or history of)

  • Low levels of potassium in blood
  • Muscle weakness, myasthenia gravis
  • Any history of heart disease
  • Aneurysm
  • Diabetes or low blood sugar
  • You or family history of long QT syndrome
  • Brain tumor, head injury or seizures
  • Liver or kidney disease
  • Nerve problems
  • If pregnant or breastfeeding consult your primary care provider for guidance. There is evidence that ciprofloxacin can affect the fetus and enter breast milk. Ciprofloxacin carries US FDA pregnancy category C (Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks).

Common ciprofloxacin side effects may include:

  • Nausea, vomiting, diarrhea, stomach pain
  • Headache
  • Abnormal liver function tests

Seek medical attention if you experience:

  • Signs of an allergic reaction to ciprofloxacin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction
  • Low blood sugar – hunger, irritability, nausea, fast heart rate, or feeling shaky
  • Nerve damage symptoms – numbness, crawling, pins and needles or tingling, burning pain in your hands, arms, legs, or feet
  • Serious mood or behavior changes – nervousness, agitation, hallucinations, memory problems, thoughts of suicide
  • Bloody or black, tarry stools

Discontinue and seek immediate medical attention if you experience:

  • Severe pain in your chest, stomach, or back (a rare but serious side effect of ciprofloxacin) which may damage the aorta, leading to bleeding or death
  • Fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out)
  • Muscle weakness
  • Breathing problems
  • Little or no urination
  • Jaundice (yellowing of the skin or eyes)
  • Increased pressure inside the skull – severe headaches, ringing in your ears, vision problems, pain behind your eyes.

- Brooke Lounsbury, RN

Medical Content Writer

Lifesaving Medications

Everyone should be empowered to care for themselves and their loved ones during the unexpected.

Recent Posts

Keeping you informed and safe.

Join Our Newsletter

Our mission is to help you be more medically prepared. Join our newsletter and follow us on social media for health and safety tips each week!

Does Ciprofloxacin (Cipro) Cause Tendon Rupture?

There is much concern, and rightfully so about the use and overuse of antibiotics. Antibiotics can be lifesaving when used in a prudent and appropriate manner. Overuse is still a concern and one that shouldn’t be taken lightly.

What is a black box warning?

Black box warnings are required by the U.S. Food and Drug Administration for certain medications that carry serious safety risks. Often these warnings communicate potential rare but dangerous side effects, or they may be used to communicate important instructions for safe use of the drug, in 2008 the FDA issued a black box warning for fluoroquinolones (FQ).

Fluoroquinolones carry black box warning

One class of antibiotics, the fluoroquinolones (FQ) (ciprofloxacin, levofloxacin, moxifloxacin, and others) have been associated with increased tendon ruptures. A tendon rupture is a partial or complete tear of a tendon. Tendons are tough bands of tissue that attach muscles to your bones. An example of a tendon is the Achilles tendon, which attach the heel bone to the calf muscles.

- Brooke Lounsbury

Medical Content Writer

Fluoroquinolones (FQ) are among the most widely prescribed antibiotics in the outpatient setting, due to their broad-spectrum treatment of bacteria found in respiratory, urinary, joint, and skin infections.

A large study reviewing retroactive patient records was conducted between 2007 and 2016 with over a million subjects from the senior population age 65 and older. This study reviewed the use of FQ against other antibiotics and even similar drugs in the FQ class to assess tendon rupture occurrence.  Only one of the FQ antibiotics displayed a significant tendency to tendon rupture- between a 16% (rotator cuff) and fourfold risk (Achilles tendon). That antibiotic was levofloxacin. Neither ciprofloxacin-one of the antibiotics found in the Jase case- or moxifloxacin- which were part of the study- was found to increase tendon rupture.

Known risk factors for tendon ruptures

Risk factors associated with FQ-induced tendon disorders include age greater than 60 years, corticosteroid therapy, renal failure, diabetes mellitus, and a history of musculoskeletal disorders.

In addition, taking oral steroids increased the risk by 46-fold, and patients greater than 60 years of age who were recently treated with a FQ for 1 to 30 days were at a 1.5-fold and a 2.7-fold greater risk for development of tendon disorders and tendon rupture as compared to patients less than 60 years of age, respectively. Males are twice as likely to be affected as females as much as 2:1.

A study conducted with adolescents aged 12-18 from 2000-2018 which focused on the use of FQ and tendon rupture incidence concluded: The excess risk of tendon rupture associated with fluoroquinolone treatment was extremely small, and these events were rare.

Conclusion

There is much controversy and lack of reliable information on the black box warning of fluoroquinolones

From reliable studies there are a few conclusions we can draw:

  • Not all fluoroquinolones put patients at risk for tendon ruptures
  • Levofloxacin is the one FQ that does exhibit greater risk for tendon ruptures
  • Ciprofloxacin and moxifloxacin show no sign for increase in tendon ruptures
  • Risk factors for tendon ruptures include over age 60, taking corticosteroids, renal failure, diabetes, and history of musculoskeletal disorders. Males are 2x more likely to suffer tendon ruptures than females.
  • Adolescents are rarely at risk for tendon rupture when taking fluoroquinolones.

The FDA Boxed Warning

Fluoroquinolones, including, LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk 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 [SEE WARNINGS AND PRECAUTIONS (T.1)]”

Lifesaving Medications

Everyone should be empowered to care for themselves and their loved ones during the unexpected.

Recent Posts

Keeping you informed and safe.

Join Our Newsletter

Our mission is to help you be more medically prepared. Join our newsletter and follow us on social media for health and safety tips each week!

New Jase Case Add-on | Ivermectin Compounded for $30 | US Only

X