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Catapres-TTS (Clonidine Hydrochloride Transdermal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CATAPRES-TTS (clonidine) is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Apply CATAPRES-TTS (clonidine) once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of CATAPRES-TTS should be on a different skin site from the previous location. If the system loosens during 7-day wearing, the adhesive overlay should be applied directly over the system to ensure good adhesion. There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.

To initiate therapy, CATAPRES-TTS 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 for oral clonidine or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of CATAPRES-TTS 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 (clonidine) and CATAPRES-TTS-2 are supplied as 4 pouched systems and 4 adhesive overlays per carton, 3 cartons per shipper (NDC 0597-0031-12 and 0597-0032-12, respectively). CATAPRES-TTS-3 is supplied as 4 pouched systems and 4 adhesive overlays per carton (NDC 0597-0033-34). See chart below.

Programmed Delivery          
Clonidine in vivo
Per Day Over 1 Week
    Clonidine
Content
Size Code
Catapres-TTS® -1 (clonidine) 0.1 mg 2.5 mg 3.5 cm2 BI-31
Catapres-TTS® -2 (clonidine) 0.2 mg 5.0 mg 7.0 cm2 BI-32
Catapres-TTS® -3 (clonidine) 0.3 mg 7.5 mg 10.5 cm2 BI-33

STORAGE AND HANDLING

Store below 86° F (30° C).

Rx only

Manufactured by:

ALZA Corporation, Mountain View, California 94043 USA

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Licensed from:

Boehringer Ingelheim International GmbH

© Copyright Boehringer Ingelheim International GmbH

2003, ALL RIGHTS RESERVED

Revised October 2003

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