Label Changes for:

Ciprofloxin

January 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

CIPRO (ciprofloxacin hydrochloride) Tablets
CIPRO (ciprofloxacin) Oral Suspension
CIPRO XR (ciprofloxacin extended-release tablets)
CIPRO I.V. (ciprofloxacin) For Intravenous Infusion
CIPRO I.V. (ciprofloxacin) in 5% Dextrose 

 

 

January 2013

 

WARNINGS

Tendinopathy and Tendon Rupture
  • added: ..... Inflammation andtendon 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 IV should be used with caution in patients with a history of tendon disorders related to fluoroquinolone treatment......
Hepatobiliary System
  • Cases of severe hepatotoxicity (including hepatic necrosis and life-threatening hepatic failure and fatal events), have been reported with ciprofloxacin. Acute liver injury is rapid in onset (range 1-39 days), and is often associated with hypersensitivity. The pattern of injury can be hepatocellular, cholestatic or mixed. Most patients with fatal outcomes were older than 55 years old. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be immediately discontinued (see ADVERSE REACTIONS).
Central Nervous System Effects
  • ..... psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, the  drug should be discontinued, patients should be advised to inform their healthcare provider immediately.....
  • .....used with caution in epileptic patients and patients with known or suspected CNS  disorders that may predispose to seizures or lower the seizure threshold (for example,  severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in....
  • CIPRO IV should only be used where the benefits of treatment exceed the risks, since  these patients are endangered because of possible undesirable CNS side effects. Cases of status epilepticus have been reported. If seizures occur, ciprofloxacin should be discontinued. (See PRECAUTIONS: General, Information for Patients, Drug Interactions and ADVERSE REACTIONS)
Peripheral Neuropathy
  • Patients treated with Cipro IV should be advised to inform their healthcare provider prior to continuing treatment if symptoms of neuropathy develop.
Prolongation of the QT Interval
  • CIPRO IV should be avoided in patients with known prolongation of the QT interval, risk  factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics). Elderly patients may also be more susceptible to drugassociated effects  on the QT interval.
Cytochrome P450 (CYP450)
  • added ..... primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine) results in .....

     

PRECAUTIONS

Drug Interactions

Phenytoin

  • Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin. To avoid the loss of seizure control associated with decreased phenytoin levels, and to prevent phenytoin overdose-related undesirable effects when ciprofloxacin is discontinued in patients receiving both agents, monitoring of phenytoin therapy, including phenytoin serum concentration measurements, is recommended during and shortly after co-administration of CIPRO IV with phenytoin.

Oral Antidiabetic Agents

  • Hypoglycemia 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 (see ADVERSE REACTIONS).

Drug Laboratory/Test Interactions

  • Ciprofloxacin in vitro potency may interfere with the Mycobacterium tuberculosis culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently receiving ciprofloxacin.
Pregnancy

Teratogenic Effects. Pregnancy Category C

  • There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother(see WARNINGS). 

     

ADVERSE REACTIONS

Central Nervous System:

  • added .....convulsive seizures (including status epilepticus), grand mal convulsion, paranoia, toxic psychosis, depression (potentially culminating in self-injurious behavior, such as suicidal  ideations/thoughts and attempted or completed suicide) .....

Postmarketing Adverse Event Reports

  • added: ..... Acute generalized exanthematous pustulosis (AGEP), International Normalized Ratio (INR) increased (in patients treated with Vitamin K antagonists),...

Overdosage

  • In the event of acute overdosage, the patient should be carefully observed and given supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria
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