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Secuado (Asenapine): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
3.8 mg/day, 5.7 mg/day, 7.6 mg/day
Other brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Secuado

Instructions for Use

SECUADO® (seh kue a’ doe)

(asenapine) transdermal system

Read this Instructions for Use before you start using the SECUADO transdermal system (patch) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important Information:

  • The SECUADO transdermal system (patch) is for use on the skin only (transdermal).
  • Do not cut the pouch open until you are ready to apply the patch.
  • You should apply only 1 SECUADO patch to 1 application site every 24 hours. The patch should only be worn for 24 hours. Do not wear the patch longer than 24 hours.
  • Avoid bathing or swimming while wearing the patch. Swimming or bathing may cause the patch to fall off. You may shower.
  • Avoid exposing the patch application site to direct heat sources such as hair dryers, heating pads, electric blankets, or heated water beds.
  • If your skin feels irritated or feels like it is burning after you apply the patch, remove the patch and apply a new patch to a new application site.

Applying your SECUADO patch:

  • Change (rotate) your patch application site every time you apply a new patch. Changing your application site every time you apply a patch will help to lessen your chances of developing skin irritation at the application site. Do not use the same application site 2 times in a row.
  • The application site you choose should be clean, dry, and intact. Do not apply the patch on skin that has cuts, scrapes, burns, rashes, redness, or other skin problems.
  • The application site you choose should be hairless or nearly hairless. If there is a lot of hair, use scissors to clip the hair as close to the skin as possible. Do not shave the application site.
  • Do not apply the patch on skin that has oils, lotions, or powders on it.
  • Do not apply the patch to areas of your skin where you wear tight clothing, such as waistbands, bras, or tank top straps.
Step 1.
  • Always remove the used patch before applying a new one. You should only wear 1 patch at a time.
  • Choose 1 application site to apply 1 patch.

  • The application site you may choose should be one of the approved sites listed. Apply the patch to the left or right:

    • upper arm
    • upper back
    • stomach area (abdomen)
    • hip

Step 2.

When you are ready to apply your patch, use scissors and carefully cut the protective pouch along the dashed line to open the pouch and remove the patch. Do not cut the SECUADO patch.

  • Do not use the patch if it is cut or damaged or if the seal on the pouch is broken. Throw it away and get a new one.
  • Apply the patch right away after removing it from the pouch.

Step 3.

Hold the patch with the protective liner facing you. Bend the patch along the wave-shaped line in the middle of the protective liner. Slowly peel half of the protective liner off your patch.

  • Do not touch the sticky side of the patch.

Step 4.

Holding the other half of the protective liner, apply the sticky half of the patch to the application site you chose and smooth it down with your fingers.

Step 5.

Hold the edge of the remaining half of the protective liner, then slowly peel it away and smooth the patch down onto your skin with your fingers.

Step 6.

Press and hold the patch firmly with the palm of your hand to make sure the patch and edges are sticking to your skin.

  • Check the patch regularly during the day to make sure the patch is still firmly attached to your skin, especially after showering, using the bathroom, undressing, changing clothes, sleeping, or sweating.
  • If the patch edges lift off your skin, you should smooth down edges with your fingers, press and hold the patch firmly with the palm of your hand.
  • If your patch falls off, do not reapply the same patch. Choose a new application site, and repeat Steps 1 through 7 to apply a new SECUADO patch. Then, follow your normal schedule for changing the patch.

Step 7.

Wash your hands with soap and water after applying the patch.

Removing and disposing of your used SECUADO patch:

Step 8.

After you have worn the patch for 24 hours, remove the used patch from your skin and fold it in half so that the sticky sides stick together.

  • Your used patch still has some medicine and should be folded.
  • If the patch is hard to remove from the skin, gently apply an oil-based product (petroleum jelly, olive oil, or mineral oil) to the patch edges.
  • If any adhesive (glue) remains on the skin after you remove the patch, apply an oil-based product or lotion to help with the removal.

Step 9.

Safely throw away the used folded patch in the trash right away so that children and pets cannot reach it

Step 10.

Wash your hands with soap and water after removing the patch.

How should I store SECUADO patch?

  • Store SECUADO patches at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep SECUADO patches and all medicines out of the reach of children.

Manufactured by: Hisamitsu Pharmaceutical Co., Inc., 408, Tashirodaikan-machi, Tosu, Saga, Japan ©2019-2023, Hisamitsu Pharmaceutical Co., Inc. All rights reserved.

Distributed by: Noven Therapeutics, LLC, Miami, Florida USA

SECUADO is a registered trademark of Hisamitsu Pharmaceutical Co., Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

4O134A-0

Revised: 12/2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 212268 · View the label on DailyMed

Revision date stated in the text: December 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Secuado

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Atypical Antipsychotic
Active ingredient Asenapine
Dosage form Film, extended release
Route Transdermal
Marketing status listed in the FDA NDC Directory
Company (applicant) HISAMITSU
FDA approval NDA 212268New Drug Application (NDA) Approved October 11, 2019
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
3.8 mg/day – 1 d in 1 pouch / 30 in 1 carton NDC 68968-0172-3
3.8 mg/day – 1 d in 1 pouch / 7 in 1 carton NDC 68968-0172-7
5.7 mg/day – 1 d in 1 pouch / 30 in 1 carton NDC 68968-0173-3
5.7 mg/day – 1 d in 1 pouch / 7 in 1 carton NDC 68968-0173-7
7.6 mg/day – 1 d in 1 pouch / 30 in 1 carton NDC 68968-0174-3
7.6 mg/day – 1 d in 1 pouch / 7 in 1 carton NDC 68968-0174-7

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.