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DIHYDROERGOTAMINE MESYLATE spray


  1. Patient Information
  2. Do Not Use Dihydroergotamine Mesylate Nasal Spray If You:
  3. Are You Taking A Macrolide Class Of Antibiotic?
  4. In Clinical Trials, Most Migraine Patients Have Used Dihydroergotamine Mesylate Nasal Spray Without Serious Side Effects. You May Experience Some Nasal Congestion Or Irritation, Altered Sense Of Taste, Sore Throat, Nausea, Vomiting, Dizziness, And Fatigue After Using Dihydroergotamine Mesylate Nasal Spray. These Side Effects Are Temporary And Usually Do Not Require You To Stop Using Dihydroergotamine Mesylate Nasal Spray. Although The Following Reactions Rarely Occur, They Can Be Serious And Should Be Reported To Your Physician Immediately:
  5. 2. Check The Contents Of The Package:
  6. 3. Assemble The Sprayer:
  7. 4. Using The Sprayer:
  8. 5. After Completing These Instructions:
  9. Important Notes:
  10. What If I Need Help In Using My Dihydroergotamine Mesylate Nasal Spray?
  11. How Much Medication Should I Use And How Often?
  12. Why Do I Have To Prime Or Pump The Nasal Sprayer 4 Times Before Using? Am I Wasting The Medication?
  13. Can I Reuse My Dihydroergotamine Mesylate Nasal Sprayer?
  14. Can I Use Dihydroergotamine Mesylate Nasal Spray If I Have A Stuffy Nose, Cold, Or Allergies?
  15. Do I Need To Sniff The Medication When I Spray It In My Nostril?
  16. Distributed By:
  17. Manufactured By:

Patient Information 

Information for the Patient

Dihydroergotamine Mesylate Nasal Spray.

The solution used in Dihydroergotamine Mesylate Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.

Please read this information carefully before using your Dihydroergotamine Mesylate Nasal Spray for the first time. Keep this information handy for future reference. This leaflet does not contain all of the information on Dihydroergotamine Mesylate Nasal Spray. Your pharmacist and/or health care provider can provide more detailed information.

Dihydroergotamine Mesylate Nasal Spray has been evaluated in a limited number of patients long term (e.g., 1 year or longer).

Purpose of your Medication

Dihydroergotamine Mesylate Nasal Spray is intended to treat an active migraine headache. Do not try to use it to prevent a headache if you have no symptoms. Do not use it to treat common tension headache or a headache that is not at all typical of your usual migraine headache. Administration of Dihydroergotamine Mesylate Nasal Spray, should not exceed the dosing guidelines and should not be used for chronic daily administration. There have been reports of fibrosis (stiffening) in the lung or kidney areas in patients following prolonged daily use of injectable dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs (the class of drugs to which Dihydroergotamine Mesylate Nasal Spray belongs) has been associated with heart valvular fibrosis. Rare cases have also been reported in association with the use of injectable dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with heart valvular fibrosis.

Do Not Use Dihydroergotamine Mesylate Nasal Spray If You: 

Are pregnant or nursing.
have any disease affecting your heart, arteries, or circulation.
are taking certain anti-HIV medications (protease inhibitors)
are taking a macrolide antibiotic such as troleandomycin, clarithromycin or erythromycin.

Important questions to consider before using Dihydroergotamine Mesylate Nasal Spray

Please answer the following questions before you use your Dihydroergotamine Mesylate Nasal Spray. If you answer YES to any of these questions or are unsure of the answer, you should talk to your doctor before using Dihydroergotamine Mesylate Nasal Spray.

Are You Taking A Macrolide Class Of Antibiotic? 

Serious or potentially life-threatening reductions in blood flow to the brain or extremities have been reported rarely due to interactions between Dihydroergotamine Mesylate Nasal Spray and protease inhibitors or macrolide antibiotics.

REMEMBER TO TELL YOUR DOCTOR IF YOU HAVE ANSWERED YES TO ANY OF THESE QUESTIONS BEFORE YOU USE Dihydroergotamine Mesylate Nasal Spray.

Side Effects To Watch Out For

In Clinical Trials, Most Migraine Patients Have Used Dihydroergotamine Mesylate Nasal Spray Without Serious Side Effects. You May Experience Some Nasal Congestion Or Irritation, Altered Sense Of Taste, Sore Throat, Nausea, Vomiting, Dizziness, And Fatigue After Using Dihydroergotamine Mesylate Nasal Spray. These Side Effects Are Temporary And Usually Do Not Require You To Stop Using Dihydroergotamine Mesylate Nasal Spray. Although The Following Reactions Rarely Occur, They Can Be Serious And Should Be Reported To Your Physician Immediately: 

Numbness or tingling in your fingers and toes
Pain, tightness, or discomfort in your chest
Muscle pain or cramps in your arms and legs
Weakness in your legs
Temporary speeding or slowing of your heart rate
Swelling or itching

Dosing Information

Each vial contains one complete dose of Dihydroergotamine Mesylate Nasal Spray, which is 1 spray in each nostril followed in 15 minutes by an additional spray in each nostril, for a total of 4 sprays.
Studies have shown no benefit from acute doses greater than 2 mg (4 sprays) for a single administration. The safety of doses greater than 3 mg in a 24 hour period has not been established.
The safety of doses greater than 4 mg in a 7-day period has not been established.
Dihydroergotamine Mesylate Nasal Spray, should not be used for chronic daily administration.

Learn what to do in case of an Overdose

If you have used more medication than you have been instructed, contact your doctor, hospital emergency department, or nearest poison control center immediately.

How to use the Dihydroergotamine Mesylate Nasal Spray

1. Use available training materials.

Read and follow the instructions in the administration instructions which are provided with the Dihydroergotamine Mesylate Nasal Spray package before attempting to use the product.
If there are any questions concerning the use of your Dihydroergotamine Mesylate Nasal Spray, ask your doctor or pharmacist, or contact Oceanside Pharmaceuticals at 1-800-321-4576.

2. Check The Contents Of The Package: 

8 Nasal Spray Vials
8 Nasal Sprayers
Administration Instructions
Package Insert

3. Assemble The Sprayer: 

Assemble your nasal sprayer only when you are ready to use it.

Lift tab to bend back blue cover. In one piece, completely remove the blue cover and metal seal in a circular motion. Keeping the vial upright, remove rubber stopper. Set vial aside.
Remove plastic cover from the bottom of pump unit. Insert spray pump into vial and turn clockwise until securely fastened.

4. Using The Sprayer: 

Remove cap from spray unit. Holding the vial upright, point nasal sprayer away from face and pump 4 times before using. DO NOT PUMP MORE THAN 4 TIMES. (Although some medication will spray out, there is enough medication in each vial to allow you to prepare your nasal spray pump properly and still receive a full treatment of dihydroergotamine mesylate.)
Spray once into each nostril. Do not tilt head back or sniff through your nose while spraying or
immediately after. Wait 15 minutes. Spray once again into each nostril.

5. After Completing These Instructions: 

Carefully dispose of the nasal spray pump with the vial.

Important Notes: 

Once a Dihydroergotamine Mesylate Nasal Spray vial has been opened, it must be thrown away after 8 hours.

Storing Dihydroergotamine Mesylate Nasal Spray

Keep medication in a safe place away from children
Keep Dihydroergotamine Mesylate Nasal Spray away from heat and light.
Do not expose Dihydroergotamine Mesylate Nasal Spray to temperatures over 77 F.
Never refrigerate or freeze Dihydroergotamine Mesylate Nasal Spray.
Do not keep an opened Dihydroergotamine Mesylate Nasal Spray vial for more than 8 hours.
Check the expiration date printed on the vial containing medication. If the expiration date has passed, do not use it.

Answers to patients' questions about Dihydroergotamine Mesylate Nasal Spray

What If I Need Help In Using My Dihydroergotamine Mesylate Nasal Spray? 

If you have any questions or if you need help in opening, putting together, or using Dihydroergotamine Mesylate Nasal Spray, speak to your doctor or pharmacist, or contact Oceanside Pharmaceuticals at 1-800-321-4576.

How Much Medication Should I Use And How Often? 

Each vial contains one complete dose of Dihydroergotamine Mesylate Nasal Spray, which is 1 spray in each nostril, followed by an additional spray in each nostril 15 minutes later for a total of 4 sprays. Do not use more than this amount unless instructed to do so by your doctor. Dihydroergotamine Mesylate Nasal Spray is not intended for chronic daily use.

Why Do I Have To Prime Or Pump The Nasal Sprayer 4 Times Before Using? Am I Wasting The Medication? 

You have to prime the Nasal Sprayer 4 times to make sure that you get the proper amount of medication when you use it. Although you will

No. The brown (amber) glass vial containing your medication must remain unopened until you are ready to use it. It may not be fully effective if opened and not used within 8 hours.

Can I Reuse My Dihydroergotamine Mesylate Nasal Sprayer? 

No. After completing the full dose, you must carefully dispose of your Dihydroergotamine Mesylate Nasal Spray and the opened vial. You should use a new unit for your next migraine attack. Each Unit contains a new Nasal Sprayer, and a vial of Dihydroergotamine Mesylate Nasal Spray medication.

Can I Use Dihydroergotamine Mesylate Nasal Spray If I Have A Stuffy Nose, Cold, Or Allergies? 

Yes. Dihydroergotamine Mesylate Nasal Spray can be used if you have a stuffy nose, cold, or allergies. However, if you are taking any medications for your cold, or allergies, even those you can buy without a doctor's prescription, speak with your doctor before using Dihydroergotamine Mesylate Nasal Spray.

Do I Need To Sniff The Medication When I Spray It In My Nostril? 

No, you should not sniff because Dihydroergotamine Mesylate Nasal Spray should remain in the nose so that it can be absorbed into the bloodstream through the lining of the nose. If you have any other unanswered questions about Dihydroergotamine Mesylate Nasal Spray, consult your doctor or pharmacist.

*Trademark of PDR Network, LLC

Distributed By: 


Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC,
Bridgewater, NJ 08807 USA

Manufactured By: 


Mipharm S.p.A.
Milano, Italy

D.H.E. 45 is a trademark of Bausch Health Companies Inc. or its affiliates.

2019 Bausch Health Companies Inc. or its affiliates

Rev. 07/2019
9606501
USA/933554



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