Dosing & Administration | ONYDA<sup>®</sup> XR (clonidine HCI) ADHD Medication

Instructions for use - mom and son smiling

Once nightly dose with ONYDA XR

One dose at night for ADHD symptom control during the day

Take ONYDA XR (clonidine HCl) exactly as prescribed
ONYDA XR should be taken by mouth once daily before bed
ONYDA XR can be taken with or without food
ONYDA XR comes with an oral dosing dispenser to help you measure the correct amount of medication
Gently shake bottle for at least 10 seconds to avoid foaming
Keep ONYDA XR at room temperature
Do not stop taking ONYDA XR without speaking to your doctor. Your child will need to gradually reduce the dose to avoid an elevation in blood pressure

How to take ONYDA XR

Read the Instructions for Use for ONYDA XR you received from your pharmacist before taking ONYDA XR and every time you get a refill so that you have the most up-to-date instructions.

If you have any questions, talk to your healthcare provider about your or your child’s medical condition or treatment.

Step 1

Preparing to take ONYDA XR:

Wash and dry your hands (see Figure B).
Remove the ONYDA XR bottle, 1 oral dosing syringe, and 1 bottle adapter from the carton.

Tell your pharmacist right away if you are missing any supplies from the carton.

Step 2

Place the ONYDA XR bottle on a flat surface like a table or countertop and remove the child resistant cap by pressing down and turning counterclockwise (see Figure C).

Insert the bottle adapter (first time use only).

Hold the bottle firmly and insert the ridged end of the bottle adapter into the neck of the bottle.
Firmly push the bottle adapter all the way down with your thumb until the top of the adapter is aligned and flat (flush) with the top of the bottle (See Figure D).
Do not remove the bottle adapter once it has been inserted into the bottle.

Step 3

Put the cap back on the bottle and close it tightly by turning the cap clockwise (see Figure E).
Shake the bottle gently with a smooth up and down motion to avoid foaming (see Figure F).
Shake the bottle gently for at least 10 seconds before you take each dose.

Step 4

Place the ONYDA XR bottle upright on the table or countertop. Open the cap again by pressing down and turn counterclockwise to remove the cap (see Figure G).

Step 5

Check the ONYDA XR oral dosing syringe to find the right dose in milliliters (mL) that has been prescribed by the healthcare provider (see Figure H).
Make sure the oral dosing syringe is dry.

Step 6

Insert the tip of the oral dosing syringe through the adapter into the bottle (see Figure I).
Push the plunger all the way down (see Figure J).

Step 7

Measuring the dose of ONYDA XR:

With the tip of the oral dosing syringe in place in the adapter, hold the ONYDA XR bottle with 1 hand and turn the bottle upside down. Pull the plunger down until the white end of the plunger reaches the number of mL you need for the prescribed dose (see Figure K).
Push and pull the plunger a few times to make sure that there are no air bubbles.
Tap the barrel of the oral dosing syringe if needed to get rid of any air bubbles (see Figure L).

Step 8

Turn the bottle over and place it upright on a table or countertop, then remove the oral dosing syringe from the bottle adapter (see Figure M).

Step 9

Check that the correct dose in mL was pulled up into the oral dosing syringe (see Figure N).
If the dose is not correct:
- Insert the oral syringe tip back into the bottle and fully push in the plunger to the bottom of the syringe barrel so that all of the oral suspension flows back into the bottle.
- Repeat Steps 6 through 8.

Step 10

Taking the dose of ONYDA XR:

The child should be in a seated position before taking ONYDA XR.
Tilt the head slightly upwards.
Place the oral dosing syringe into the mouth and point it toward the cheek (see Figure O).
Close the mouth tightly around the oral dosing syringe and slowly push the plunger all the way down to give the ONYDA XR dose (see Figure P).
After all the medication has been taken, remove the oral dosing syringe from the mouth.

Step 11

Closing the bottle:

Put the ONYDA XR cap back on the bottle and close the cap tightly by turning the cap clockwise (see Figure Q).

Step 12

Cleaning up:

Clean the oral dosing syringe after each use by rinsing with tap water (see Figure R).
Allow the oral dosing syringe to dry and keep it in a safe place for the next use.
Wash and dry your hands.

Keep ONYDA XR and all medicines out of the reach of children.

Learn about the Unique Technology of ONYDA XR

Savings & Support

We want to make getting ONYDA XR as easy and inexpensive as possible! Learn about your options below!

Eligible patients pay $25^† per month
with the Tris Savings Program

8 out of 10 of commercially covered patients pay $25^‡

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Or text TRIS to TRIS4U (874748) for a Mobile Savings Card^§

Eligible commercially-insured patients
pay as little as $15^†

You’ll also receive free delivery, automatic refills, same-day processing, and ongoing support.

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and resources to help support your child's ADHD treatment journey.

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REFERENCES: 1. ONYDA XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ.

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APPROVED USE

ONYDA^® XR (clonidine HCI) is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), alone or with certain other ADHD medicines, in children 6 years of age and older. It is not known if ONYDA XR is safe and effective in children under 6 years of age.

Important Safety Information

Do not take ONYDA XR if you are allergic to clonidine.

Before taking ONYDA XR, tell your healthcare provider if you have kidney problems; low or high blood pressure; a history of passing out (syncope); heart problems (including slow heart rate or rhythm problems); had a stroke or stroke symptoms; or had an allergic reaction after taking clonidine through the skin (patch). Tell your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. It is not known if ONYDA XR may harm an unborn baby. ONYDA XR passes into breast milk and may cause sleepiness, floppy muscles, or breathing problems in breastfed babies. A pregnancy registry is available at 1-866-961-2388 or womensmentalhealth.org/adhdmedications.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ONYDA XR may interact with medicines for depression, ADHD, heart or blood pressure conditions, medicines that cause sleepiness, or other clonidine-containing medicines.

What to avoid while taking ONYDA XR?

Avoid dehydration and overheating, which may increase the risk of passing out.

Do not drive, operate machinery, or perform dangerous activities until you know how ONYDA XR affects you, because it may cause sleepiness and tiredness that can slow reaction times.

Avoid alcohol or other medicines that cause sleepiness or dizziness unless discussed with your healthcare provider.

Do not suddenly stop ONYDA XR. Stopping suddenly may cause rebound high blood pressure and withdrawal symptoms. Contact your healthcare provider before stopping treatment. If vomiting prevents you from taking ONYDA XR, contact your healthcare provider because rebound hypertension may occur.

Possible side effects

ONYDA XR may cause serious side effects including:

Low blood pressure and slow heart rate, which may increase the risk of passing out. Your healthcare provider should check your heart rate and blood pressure before and during treatment.

Sleepiness and tiredness that may slow reaction times.

Rebound high blood pressure and withdrawal symptoms after sudden stop (including headache, increased heart rate, nausea, flushing or warm feeling, lightheadedness, chest tightness, nervousness, or anxiety).

Allergic reactions. Stop taking ONYDA XR and seek medical help immediately if you develop rash, hives, or swelling of the eyes, face, lips, or tongue, especially if you previously had an allergic reaction to clonidine patch.

ONYDA XR may cause fertility problems in females and males, which may affect the ability to have a child. Talk to your healthcare provider if this is a concern.

Most common side effects when used alone:

Sleepiness/tiredness, nightmare, constipation, irritability, trouble sleeping, and dry mouth.

Most common side effects when used with other ADHD medicines:

Sleepiness/tiredness, decreased appetite, and dizziness.

These are not all possible side effects of ONYDA XR. Call your healthcare provider for medical advice about side effects. Report side effects to Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088.

Please see Full Prescribing Information and Patient Information, including Instructions for Use.