Catapres-TTS
INDICATIONS
Catapres-TTS® (clonidine) transdermal therapeutic system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
DOSAGE AND ADMINISTRATION
Apply CATAPRES-TTS transdermal therapeutic system once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of CATAPRES-TTS transdermal therapeutic system should be on a different skin site from the previous location. If the system loosens during 7-day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion. There have been rare reports of the need for patch changes prior to 7days to maintain blood pressure control.
To initiate therapy, CATAPRES-TTS transdermal therapeutic system dosage should be titrated according to individual therapeutic requirements, starting with CATAPRES-TTS-1. If after one or two weeks the desired reduction in blood pressure is not achieved, increase the dosage by adding another CATAPRES-TTS-1 or changing to a larger system. An increase in dosage above two CATAPRES-TTS-3 is usually not associated with additional efficacy.
When substituting CATAPRES-TTS transdermal therapeutic system for oral clonidine or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of CATAPRES-TTS transdermal therapeutic system may not commence until 2-3 days after initial application. Therefore, gradual reduction of prior drug dosage is advised. Some or all previous antihypertensive treatment may have to be continued, particularly in patients with more severe forms of hypertension.
Renal Impairment
Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
HOW SUPPLIED
CATAPRES-TTS-1, CATAPRES-TTS-2, and CATAPRES-TTS-3 are supplied as 4 pouched systems and 4 adhesive covers per carton. See chart below.
| Programmed Delivery Clonidine in vivo | ||||
| Per Day Over 1 Week | Clonidine Content | Size | Code | |
| Catapres-TTSŪ-1(clonidine) NDC 0597-0031-34 |
0.1 mg | 2.5 mg | 3.5 cm2 | BI-31 |
| Catapres-TTSŪ-2 (clonidine) NDC 0597-0032-34 |
0.2 mg | 5.0 mg | 7.0 cm2 | BI-32 |
| Catapres-TTSŪ-3 (clonidine) NDC 0597-0033-34 |
0.3 mg | 7.5 mg | 10.5 cm2 | BI-33 |
Storage And Handling
Store below 86° F (30° C).
Manufactured by: ALZA Corporation Mountain View, CA 94043, USA. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, USA. Licensed from: Boehringer Ingelheim International GmbH. Revised: February 14, 2006. FDA rev date: 04/13/06
Generic Name: Clonidine
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Catapres-TTS
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