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D H E 45 Patient, Information, Instructions - Dihydroergotamine

PATIENT INFORMATION

To assure safe and effective use of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP, the information and instructions provided in the patient Information sheet should be discussed with patients.

Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest, temporary speeding or slowing of the heart rate, swelling, or itching. Prior to the initial use of the product by a patient the prescriber should take steps to ensure that the patient understands how to use the product as provided. (See Patient Information Sheet and product packaging, below.)

INSTRUCTION FOR PATIENTS ON SUBCUTANEOUS SELF-INJECTION

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.

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.

Purpose of your Medication

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.

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.

Important questions to consider before using D.H.E. 45® (dihydroergotamine mesylate) Injection, USP

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, diabates, 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 breast feeding?
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?

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

Side Effects To Watch Out For

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.

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 one-week period.

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

Wash your hands thoroughly with soap and water.
Check the dose of your medication
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.
Hold the bottom of the ampul in one hand. Clean the ampul neck with an alcohol wipe using your other hand. Then place the alcohol wipe around the neck of the ampul and break it open by pressing your thumb against the neck of the ampul.
Tilt the ampul down at a 45° angle. Insert the needle into the solution in the ampul.
Draw up the medication by pulling back the plunger slowly and steadily until you reach your dose.
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.
When there are no air bubbles check the dose of the medication. If the dose is incorrect, repeat steps 6 through 8 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 an 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 one-week period. Do not use more than this amount unless instructed to do so by your doctor.

If you have any other unanswered question about D.H.E. 45® (dihydroergotamine mesylate) Injection, USP, consult your doctor or pharmacist.

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