Dihydroergotamine Mesylate (Page 4 of 5)

HOW SUPPLIED/STORAGE AND HANDLING

Dihydroergotamine Mesylate Injection, USP

Available as a clear, colorless, sterile solution in single 1 mL sterile ampules containing 1 mg of dihydroergotamine mesylate per mL, in packages of 5 (NDC 61990-0411-1) and 10 (NDC 61990-0411-2).

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Use carton to protect contents from light until used.

Do not refrigerate or freeze.

To assure constant potency, protect the ampules from light and heat. Administer only if clear and colorless.

INSTRUCTION FOR PATIENTS ON SUBCUTANEOUS SELF-INJECTION

Information for the Patient

Dihydroergotamine Mesylate Injection, USP

Before self-injecting 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 Dihydroergotamine Mesylate Injection, USP . Your pharmacist and/or health care provider can provide more detailed information.

Purpose of your medication

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 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 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.

Do not use 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.

Important questions to consider before using
Dihydroergotamine Mesylate Injection, USP

Please answer the following questions before you use your 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 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 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?
Are you using 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 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 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 Dihydroergotamine Mesylate Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of Dihydroergotamine Mesylate Injection, USP should be injected during a 1-week period. 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 Dihydroergotamine Mesylate Injection, USP

1.
Use Available Training Materials
  • Read and follow the instructions in the patient instruction booklet which is provided with the Dihydroergotamine Mesylate Injection, USP package before attempting to use the product.
  • If there are any questions concerning the use of your Dihydroergotamine Mesylate Injection, USP , ask your doctor or pharmacist.
2.
Preparing for the Injection
  • Carefully examine the ampule (glass vial) of 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 ampule, make certain it is intact, and return the defective ampule to your doctor or pharmacy. Once you open an ampule, 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
  1. Wash your hands thoroughly with soap and water.
  2. Check the dose of your medication.
  3. Look to see if there is any liquid at the top of the ampule. If there is, gently flick the ampule with your finger to get all the liquid into the bottom portion of the ampule.
  4. Hold the bottom of the ampule in one hand. Clean the ampule neck with an alcohol wipe using the other hand. To break, place the alcohol wipe around the neck of the ampule and break it open by pressing your thumb against the neck of the ampule.
    Instructions for Use
    (click image for full-size original)
  5. Tilt the ampule down at a 45° angle. Insert the needle into the solution in the ampule.
  6. Draw up the medication by pulling back the plunger slowly and steadily until you reach your dose.
  7. 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.
  8. 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 ampule containing medication. If the expiration date has passed, do not use it.

Answers to Patients’ Questions About Dihydroergotamine Mesylate Injection, USP

What if I need help in using my Dihydroergotamine Mesylate Injection, USP ?

If you have any questions or if you need help in opening, putting together, or using 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 Dihydroergotamine Mesylate Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of 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. Dihydroergotamine Mesylate Injection, USP is not intended for chronic daily use.

If you have any other unanswered questions about Dihydroergotamine Mesylate Injection, USP, consult your doctor or pharmacist.

Distributed by:
Apollo Pharmaceuticals USA Inc.
Palm Beach Gardens, FL33410

Manufactured in France.

Revised: 12/2019

AP-NNAD000.01

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