What is D.H.E. 45?
D.H.E. 45 (dihydroergotamine mesylate) Injection, USP 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 D.H.E. 45 (dihydroergotamine mesylate) Injection, USP 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 D.H.E. 45 (dihydroergotamine mesylate) Injection, USP 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.
What is the most important information I should know about D.H.E. 45?
Before self-injecting D.H.E. 45 (dihydroergotamine mesylate) Injection, USP by subcutaneous administration, you will need to obtain professional instruction on how to properly administer your medication. Below are some of the steps you should follow carefully. Read this leaflet completely before using this medication.
Who should not use D.H.E. 45?
Do not use D.H.E. 45 (dihydroergotamine mesylate) Injection, USP 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.
What should I tell my healthcare provider before using D.H.E. 45?
Please answer the following questions before you use your D.H.E. 45 (dihydroergotamine mesylate) Injection, USP.
If you answer YES to any of these questions or are unsure of the answer, you should talk to your doctor before using D.H.E. 45 (dihydroergotamine mesylate) Injection, USP.
- Do you have high blood pressure?
- Do you have chest pain, shortness of breath, heart disease, or have you had any surgery on your heart arteries?
- Do you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40)?
- Do you have any problems with blood circulation in your arms or legs, fingers, or toes?
- Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you sexually active and not using birth control? Are you breastfeeding?
- Have you ever had to stop taking this or any other medication because of an allergy or bad reaction?
- Are you taking any other migraine medications, erythromycin or other antibiotics, or medications for blood pressure prescribed by your doctor, or other medicines obtained from your drugstore without a doctor's prescription?
- Do you smoke?
- Have you had, or do you have, any disease of the liver or kidney?
- Is this headache different from your usual migraine attacks?
- Are you using D.H.E. 45 (dihydroergotamine mesylate) Injection, USP nasal spray or other dihydroergotamine mesylate containing drugs on a daily basis?
- Are you taking a protease inhibitor for HIV therapy?
- 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 D.H.E. 45 (dihydroergotamine mesylate) Injection, USP and protease inhibitors or macrolide antibiotics.
Remember to tell your doctor if you have answered “yes” to any of these questions before you use D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
How should I use D.H.E. 45?
Dosage
Your doctor will have told you what dose to use for each migraine attack. Should you get another migraine attack in the same day as the attack you treated, you must not treat it with D.H.E. 45 (dihydroergotamine mesylate) Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should be injected during a 1-week period. D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is not intended to be used on a prolonged daily basis.
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 D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
1. Use Available Training Materials
- Read and follow the instructions in the patient instruction booklet which is provided with the D.H.E. 45 (dihydroergotamine mesylate) Injection, USP package before attempting to use the product.
- If there are any questions concerning the use of your D.H.E. 45 (dihydroergotamine mesylate) Injection, USP, ask your doctor or pharmacist.
2. Preparing for the Injection
- Carefully examine the ampul (glass vial) of D.H.E. 45 (dihydroergotamine mesylate) Injection, USP for any cracks or breaks, and the liquid for discoloration, cloudiness, or particles. If any of these defects are present, use a new ampul, make certain it is intact, and return the defective ampul to your doctor or pharmacy. Once you open an ampul, if it is not used within an hour, it should be thrown away.
3. Locating an Injection Site
- Administer your subcutaneous injection in the middle of your thigh, well above the knee.
4. Drawing the Medication into the Syringe
a. Wash your hands thoroughly with soap and water.
b. Check the dose of your medication.
c. Look to see if there is any liquid at the top of the ampul. If there is, gently flick the ampul with your finger to get all the liquid into the bottom portion of the ampul.
d. Hold the bottom of the ampul in one hand. Clean the ampul neck with an alcohol wipe using the other hand. To break, place the alcohol wipe around the neck of the ampul and break it open by pressing your thumb against the neck of the ampul.
e. Tilt the ampul down at a 45° angle. Insert the needle into the solution in the ampul.
f. Draw up the medication by pulling back the plunger slowly and steadily until you reach your dose.
g. Check the syringe for air bubbles. Hold it with the needle pointing upward. If there are air bubbles, tap your finger against the barrel of the syringe to get the bubbles to the top. Slowly and carefully push the plunger up so that the bubbles are pushed out through the needle and you see a drop of medication.
h. When there are no air bubbles, check the dose of the medication. If the dose is incorrect, repeat steps e, f, g, and h until you draw up the right dose.
5. Preparing the Injection Site
- With a new alcohol wipe, clean the selected injection site thoroughly with a firm, circular motion from inside to outside. Wait for the injection site to dry before injecting.
6. Administering the Injection
- Hold the syringe/needle in your right hand.
- With your left hand, firmly grasp about a 1-inch fold of skin at the injection site.
- Push the needle shaft, bevel side up, all the way into the fold of skin at a 45° to 90° angle, then release the fold of skin.
- While holding the syringe with your left hand, use your right hand to draw back slightly on the plunger.
- If you do not see any blood coming back into the syringe, inject the medication by pushing down on the plunger. If you do see blood in the syringe, that means the needle has penetrated a vein. If this happens, pull the needle/syringe out of the skin slightly and draw back on the plunger again. If no blood is seen this time, inject the medication.
- Use your right hand to pull the needle out of your skin quickly at the same angle you injected it. Immediately press the alcohol wipe on the injection site and rub.
Check the expiration date printed on the ampul containing medication. If the expiration date has passed, do not use it.
Answers to Patients' Questions About D.H.E. 45 (dihydroergotamine mesylate) Injection, USP
What if I need help in using my D.H.E. 45 (dihydroergotamine mesylate) Injection, USP?
If you have any questions or if you need help in opening, putting together, or using D.H.E. 45 (dihydroergotamine mesylate) Injection, USP, speak to your doctor or pharmacist.
How much medication should I use and how often?
Your doctor will have told you what dose to use for each migraine attack. Should you get another migraine attack in the same day as the attack you treated, you must not treat it with D.H.E. 45 (dihydroergotamine mesylate) Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of D.H.E. 45 (dihydroergotamine mesylate) Injection, USP should be injected during a 1-week period. Do not use more than this amount unless instructed to do so by your doctor. D.H.E. 45 (dihydroergotamine mesylate) Injection, USP is not intended for chronic daily use.
If you have any other unanswered questions about D.H.E. 45 (dihydroergotamine mesylate) Injection, USP, consult your doctor or pharmacist.
What are the possible side effects of D.H.E. 45?
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 legsTemporary speeding or slowing of your heart rate
- Swelling or itching
General information about the safe and effective use of D.H.E. 45
This leaflet does not contain all of the information on D.H.E. 45 (dihydroergotamine mesylate) Injection, USP. Your pharmacist and/or health care provider can provide more detailed information.
How should I store D.H.E. 45?
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Use carton to protect contents from light until used.
Do not refrigerate or freeze.
To assure constant potency, protect the ampuls from light and heat. Administer only if clear and colorless.
What are the ingredients in D.H.E. 45?
Active ingredient: Dihydroergotamine Mesylate
Inactive ingredients: Alcohol, Glycerin, Water, Methanesulfonic Acid, Sodium Hydroxide
