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Dotti (Estradiol): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 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 - Dotti

INSTRUCTIONS FOR USE

DOTTI (dah ʹ tee)

(estradiol transdermal system)

Read this Instructions for Use before you start using DOTTI 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 menopausal symptoms or your treatment.

1. Determine Your Schedule for Your Twice-a-Week Application

  • Decide upon which 2 days you will change your patch.
  • Your DOTTI (estradiol transdermal system) individual carton contains a calendar card printed on its inner flap. Mark the 2-day schedule you plan to follow on your carton’s inner flap.
  • Be consistent.
  • If you forget to change your patch on the correct date, apply a new one as soon as you remember.
  • No matter what day this happens, stick to the schedule you have marked on the inner flap of your carton (your calendar card).

2. Where to Apply DOTTI

  • Apply patch to a dry area of the skin of the trunk of the body, including the lower abdomen, or buttocks. Avoid the waistline, since clothing may cause the patch to rub off.
  • Do not apply patch to breasts.
  • When changing your patch, based on your twice-a-week schedule, apply your new patch to a different site. Do not apply a new patch to that same area for at least 1 week.

3. Before You Apply DOTTI

Make sure your skin is:

  • Clean (freshly washed), dry and cool.
  • Free of any powder, oil, moisturizer or lotion.
  • Free of cuts or irritations (rashes or other skin problems).

4. How to Apply DOTTI

  • Each patch is individually sealed in a protective pouch.
  • Tear open the pouch at the tear notch (do not use scissors).
  • Remove the patch.
  • Apply the patch immediately after removing from the pouch.
  • Holding the patch with the rigid protective liner facing you, remove half of the liner, which covers the sticky surface of the patch.
  • Avoid touching the sticky side of the patch with your fingers.
  • Using the other half of the rigid protective liner as a handle, apply the sticky side of the patch to the selected area of the abdomen or buttocks.
  • Press the sticky side of the patch firmly into place.
  • Smooth it down.
  • While still holding the sticky side down, fold back the other half of the patch.
  • Grasp an edge of the remaining protective liner and gently pull it off.
  • Avoid touching the sticky side of the patch with your fingers.
  • Press the entire patch firmly into place with the palm of your hand.
  • Continue to apply pressure, with the palm of your hand over the patch, for approximately 10 seconds.
  • Make sure that the patch is properly adhered to your skin.
  • Go over the edges with your finger to ensure good contact around the patch.

Note:

  1. 1. Showering will not cause your patch to fall off.
  2. 2. If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area and continue to follow your original placement schedule.
  3. 3. If you stop using your DOTTI patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and recurrence of symptoms.

5. Throwing Away Your Used Patch

  1. 1. When it is time to change your patch, remove the old patch before you apply a new patch.
  2. 2. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. Used patches should not be flushed in the toilet.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 05-2024-03

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 211293 · View the label on DailyMed

Revision date stated in the text: May 2024

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 Dotti

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 Estrogen
Active ingredient Estradiol
Dosage form Patch, extended release
Route Transdermal
Marketing status listed in the FDA NDC Directory
Company (applicant) AMNEAL
FDA approval ANDA 211293Abbreviated New Drug Application (ANDA) – generic drug Approved February 5, 2019
Therapeutic equivalence (TE) code AB1Codes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Estradiol Topical Extended-Release, Lyllana, Vivelle-Dot with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.025 mg/day – 1 d in 1 pouch / 8 in 1 carton NDC 65162-989-04
0.0375 mg/day – 1 d in 1 pouch / 8 in 1 carton NDC 65162-992-04
0.05 mg/day – 1 d in 1 pouch / 8 in 1 carton NDC 65162-993-04
0.075 mg/day – 1 d in 1 pouch / 8 in 1 carton NDC 65162-995-04
0.1 mg/day – 1 d in 1 pouch / 8 in 1 carton NDC 65162-997-04

Source: FDA drug labeling via NLM DailyMed, data as of November 6, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.