Label Changes for:

Catapres-TTS (clonidine) Transdermal Therapeutic System

May 2012

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

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

 

May 2012

WARNINGS

Withdrawal
  • added...tremor

PRECAUTIONS

General
  • The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of CATAPRES-TTS transdermaltherapeutic system can be expected.
Information for Patients
  • Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.
Drug Interactions
  • If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated
Pregnancy
  • Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

 

 

November 2009 

 

PRECAUTIONS

Information for Patients
  • Patients who wear contact lenses should be cautioned that treatment with Catapres-TTS tablets may cause dryness of eyes.
Pediatric Use (reworded)
  • Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials

ADVERSE REACTIONS

Marketing Experience (rephrased)
  • The following adverse reactions have been identified during post-approval use of Catapres-TTS transdermal therapeutic system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Catapres-TTS transdermal therapeutic system.
  • Central Nervous System: delusional perception and paresthesia
  • Gastrointestinal: salivary gland pain
  • Genitourinary: erectile dysfunction (changed from impotence)
  • Ophthalmological: accommodation disorder and decreased lacrimation

 

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