Label Changes for:
Catapres-TTS (clonidine) Transdermal Therapeutic System
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)
- 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.
- If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated
- Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
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
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