Clonidine Transdermal System (Page 4 of 5)

DOSAGE AND ADMINISTRATION

Apply clonidine transdermal system once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of clonidine transdermal 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 7 days to maintain blood pressure control.

To initiate therapy, clonidine transdermal system dosage should be titrated according to individual therapeutic requirements, starting with clonidine transdermal system, 0.1 mg per day for one week. If after one or two weeks the desired reduction in blood pressure is not achieved, increase the dosage by adding another clonidine transdermal system, 0.1 mg per day for one week or changing to a larger system. An increase in dosage above two clonidine transdermal systems, 0.3 mg per day for one week is usually not associated with additional efficacy.

When substituting clonidine transdermal system for oral clonidine or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of clonidine transdermal system may not commence until 2 to 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

Patients with renal impairment may benefit from a lower initial dose. 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

Clonidine transdermal systems USP, 0.1 mg per day for one week, 0.2 mg per day for one week, and 0.3 mg per day for one week are supplied as 4 pouched systems and 4 adhesive covers per carton.

Each system contains 1.97 mg, 3.94 mg, or 5.90 mg clonidine. See chart below.

Programmed DeliveryClonidine in vivo Per Day Over 1 Week ClonidineContent Size Code
Clonidine Transdermal System, USP (clonidine)NDC 0591-3508-04 0.1 mg 1.97 mg 4.1 cm2 WPI3508
Clonidine Transdermal System, USP (clonidine)NDC 0591-3509-04 0.2 mg 3.94 mg 8.2 cm2 WPI3509
Clonidine Transdermal System, USP (clonidine)NDC 0591-3510-04 0.3 mg 5.90 mg 12.3 cm2 WPI3510

STORAGE AND HANDLING

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Manufactured by:
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Address medical inquiries to Actavis at 1-888-838-2872.

Rev. A 12/2020

PATIENT INSTRUCTIONS

Clonidine Transdermal System, USP
0.1 mg*, 0.2 mg*, or 0.3 mg* clonidineper day for one week.

Rx Only

Clonidine Transdermal System , USP

*In vivo delivery of 0.1 mg, 0.2 mg, or 0.3 mg clonidine per day for one week. Each system contains 1.97 mg, 3.94 mg, or 5.90 mg clonidine.

(Read the following instructions carefully before using this medication. If you have any questions, please consult with your doctor.)

General Information

Clonidine transdermal system is a square to rectangular, tan adhesive PATCH containing an active blood-pressure-lowering medication. It is designed to deliver the drug into the body through the skin smoothly and consistently for one full week. Normal exposure to water, as in showering, bathing, and swimming, should not affect the PATCH.

The optional white to slightly yellow, round to elliptical ADHESIVE COVER should be applied directly over the PATCH, should the PATCH begin to separate from the skin. The ADHESIVE COVER ensures that the PATCH sticks to the skin. The clonidine transdermal PATCH must be replaced with a new one on a fresh skin site if the one in use significantly loosens or falls off.

Figure 1
(click image for full-size original)

Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because the clonidine transdermal PATCH contains aluminum, it is recommended to remove the system before undergoing an MRI.

How to Apply the C lonidine T ransdermal PATCH

1) Apply the square to rectangular, tan clonidine transdermal PATCH once a week, preferably at a convenient time on the same day of the week (i.e., prior to bedtime on Tuesday of week one; prior to bedtime on Tuesday of week two, etc.).

2) Select a hairless area such as on the upper, outer arm or upper chest. The area chosen should be free of cuts, abrasions, irritation, scars or calluses and should not be shaved before applying the clonidine transdermal PATCH. Do not place the clonidine transdermal PATCH on skin folds or under tight undergarments, since premature loosening may occur.

Each box of clonidine transdermal system contains two types of pouches:

0.1 mg Pouch
(click image for full-size original)

3) Wash hands with soap and water and thoroughly dry them.

4) Clean the area chosen with soap and water. Rinse and wipe dry with a clean, dry tissue.

5) Select the pouch with the blue, red or yellow colors labeled clonidine transdermal system and open it as illustrated in Figure 3. Remove the square to rectangular, tan PATCH from the pouch. Remove the translucent to clear secondary protective liner card that rests over the PATCH.

figure 3
(click image for full-size original)

6) Remove the translucent to clear protective backing from the PATCH by gently peeling it off as shown in Figure 4. Avoid prolonged touching of the sticky side of the clonidine transdermal PATCH.

Figure 4
(click image for full-size original)

7) Place the clonidine transdermal PATCH on the prepared skin site (sticky side down) by applying firm pressure over the PATCH to ensure good contact with the skin, especially around the edges (Figure 5). Discard the translucent to clear protective backing and wash your hands with soap and water to remove any drug from your hands.

Figure 5
(click image for full-size original)

8) After one week, remove the old PATCH and discard it (refer to Instructions for Disposal). After choosing a different skin site, repeat instructions 2 through 7 for the application of your next clonidine transdermal PATCH.

What to do if your clonidine transderm al PATCH becomes loose while wearing:

How to Apply the ADHESIVE COVER

Note: The white to slightly yellow, round to elliptical, ADHESIVE COVER does not contain any drug and should not be used alone. The COVER should be applied directly over the clonidine transdermal PATCH only if the PATCH begins to separate from the skin, thereby ensuring that it sticks to the skin for seven full days.

Figure 6
(click image for full-size original)

1) Wash hands with soap and water and thoroughly dry them.

2) Using a clean, dry tissue, make sure that the area around the square to rectangular, tan clonidine transdermal PATCH is clean and dry. Press gently on the clonidine transdermal PATCH to ensure that the edges are in good contact with the skin.

3) Take the white to slightly yellow, round to elliptical, ADHESIVE COVER (Figure 6) from the plain white pouch and remove the paper liner backing from the COVER.

4) Carefully center the round to elliptical, white to slightly yellow, ADHESIVE COVER over the square to rectangular, tan clonidine transdermal PATCH and apply firm pressure, especially around the edges in contact with the skin.

STORAGE AND HANDLING

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Instructions for Disposal

KEEP OUT OF REACH OF CHILDREN .

During or even after use, a PATCH contains active medication which may be harmful to infants and children if accidentally applied or ingested. After use, fold in half with the sticky sides together. Dispose of carefully out of reach of children.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 12/2020

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