Clonidine Transdermal System
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Clonidine Transdermal System – Instructions For Use

Manufacture: Actavis
Country: United States
Condition: ADHD (Attention Deficit Hyperactivity Disorder), High Blood Pressure (Hypertension), Pain
Class: Antiadrenergic agents, centrally acting
Form: Skin patch (transdermal)
Ingredients: Clonidine

(0.1 mg*, 0.2 mg*, or 0.3 mg* clonidine per day for one week)

*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 ADHESIVECOVER 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.

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 Clonidine Transdermal 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.
  3. Each box of clonidine transdermal system contains two types of pouches:

  4. Wash hands with soap and water and thoroughly dry them.
  5. Clean the area chosen with soap and water. Rinse and wipe dry with a clean, dry tissue.
  6. 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.
  7. 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.
  8. 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.
  9. 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 transdermal 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.

  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 20° to 25°C (68° to 77°F) [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.