Ciprofloxacin - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of ciprofloxacin tablets.

Discontinue ciprofloxacin tablets at the first sign of skin rash, jaundice or any sign of hypersensitivity. ( 4.1, 5.6, 5.7 ) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur.

Clostridioides difficile - associated diarrhea: Evaluate if colitis occurs.

QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported.

Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. ( 5.12, 7, 8.5 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including ciprofloxacin tablets, 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 tablets.

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 tablets immediately at the first signs or symptoms of any serious adverse reaction.

In addition, avoid the use of fluoroquinolones, including ciprofloxacin tablets, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

2 Tendinitis and Tendon Rupture Fluoroquinolones, including ciprofloxacin tablets, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions and Adverse Reactions ] .

This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons.

Tendinitis or tendon rupture can occur, within hours or days of starting ciprofloxacin tablets, or as long as several months after completion of fluoroquinolone therapy.

Tendinitis and tendon rupture can occur bilaterally.

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.

Other factors 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.

Discontinue ciprofloxacin tablets immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Avoid fluoroquinolones, including ciprofloxacin tablets, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions ].

5.3 Peripheral Neuropathy Fluoroquinolones, including ciprofloxacin tablets, have been associated with an increased risk of peripheral neuropathy.

Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ciprofloxacin tablets.

Symptoms may occur soon after initiation of ciprofloxacin tablets and may be irreversible in some patients [see Warnings and Precautions and Adverse Reactions (6.1, 6.2) ] .

Discontinue ciprofloxacin tablets 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.

Avoid fluoroquinolones, including ciprofloxacin tablets, in patients who have previously experienced peripheral neuropathy [see Adverse Reactions (6.1, 6.2) ].

5.4 Central Nervous System Effects Psychiatric Adverse Reactions Fluoroquinolones, including ciprofloxacin tablets have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious behavior such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment.