Dihydroergotamine Nasal Spray

Do not take dihydroergotamine if you are taking any of the following medications: antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); or macrolide antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Erythrocin), and troleandomycin (TAO).

Dihydroergotamine is used to treat migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Dihydroergotamine is in a class of medications called ergot alkaloids. It works by tightening blood vessels in the brain and by stopping the release of natural substances in the brain that cause swelling.

Dihydroergotamine comes as a spray to use in the nose. If you are using dihydroergotamine nasal spray (Migranal) to treat migraine headache, it is given as one spray in each nostril and then after 15 minutes, an additional spray in each nostril for a total of 4 sprays. If you are using dihydroergotamine nasal spray (Trudhesa) to treat migraine headaches, it is given as one spray in each nostril. If headache continues after 1 hour, an additional dose of dihydroergotamine nasal spray (Trudhesa) can be given in each nostril. For all dihydroergotamine nasal spray products, no more than 4 sprays (2 doses) should be given in a 24-hour period or 6 sprays (3 doses) in a 7-day period. Dihydroergotamine nasal spray should be given at start of migraine symptoms but can be used at any time during the migraine. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use dihydroergotamine nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You may use your first dose of dihydroergotamine nasal spray in a doctor's office or other medical facility where you can be monitored for serious reactions.

Using dihydroergotamine nasal spray more than 10 times in a one month period may cause headaches to worsen. To help prevent this from happening, be sure to mark on a calendar or write down days when dihydroergotamine nasal spray is used.

To use the nasal spray, follow these steps:

1. Read all of the manufacturer's instructions for using the nasal spray before you use your first dose.
2. Do not assemble sprayer until you are ready to use the product.
3. Remove the blue cap, metal seal and grey rubber stopper from the vial.
4. Remove the plastic cap from the spray pump and attach vial to the bottom of the pump. Rotate clockwise until vial is securely attached to pump.
5. Holding the device upright and pointing away from you, pump the nasal spray 4 times to prime the pump. Do not spray more than 4 times.
6. Once primed, rotate the pump so it is facing you, but keeping it upright, and then insert into first nostril until comfortable and gently press down on pump to release dose into nostril. Then, repeat in the second nostril.
7. For the dihydroergotamine (Migranal) product, refrain from sniffing through the nose during or immediately following use of the nasal spray. For the dihydroergotamine (Trudhesa) product, sniffing during or after nasal spray is not needed but will not hurt you.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using dihydroergotamine nasal spray,

• tell your doctor and pharmacist if you are allergic to dihydroergotamine, other ergot alkaloids such as bromocriptine (Parlodel), ergonovine (Ergotrate), ergotamine (Cafergot, Ercaf, others), methylergonovine (Methergine), and methysergide (Sansert), or any other medications.
• do not use dihydroergotamine within 24 hours of taking ergot alkaloids such as bromocriptine (Parlodel), ergonovine (Ergotrate), ergotamine (Cafergot, Ercaf, others), methylergonovine (Methergine), and methysergide (Sansert); or other medications for migraine such as frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig). Do not use dihydroergotamine with medications that are used to raise blood pressure such as droxidopa (Northera), epinephrine (Epipen), midodrine (Orvaten), phenylephrine (Biorphen, Vazculep; in Pherazine and several over-the-counter cold products), and pseudoephedrine (Sudafed).
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: certain antifungals such as clotrimazole (Mycelex), fluconazole (Diflucan); beta blockers such as propranolol (Inderal); nefazodone (Serzone); oral contraceptives (birth control pills); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil ), and sertraline (Zoloft); saquinavir (Fortovase, Invirase); and zileuton (Zyflo). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have a family history of heart disease and if you have or have ever had high blood pressure; high cholesterol; diabetes; Raynaud's disease (a condition that affects the fingers and toes); any disease that affects your circulation or arteries; sepsis (a severe infection of the blood); surgery on your heart or blood vessels; a heart attack; or kidney, liver, lung, or heart disease. Your doctor may tell you not to take dihydroergotamine.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using dihydroergotamine, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using dihydroergotamine.
• tell your doctor if you use tobacco products. Smoking cigarettes while using this medication increases the risk of serious side effects.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.

Dihydroergotamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away.

• stuffy nose
• tingling or pain in the nose or throat
• dryness in the nose
• nosebleed
• taste changes
• upset stomach
• vomiting
• dizziness
• extreme tiredness
• weakness

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• color changes, numbness or tingling in fingers and toes
• muscle pain in arms and legs
• weakness in arms and legs
• chest pain
• speeding or slowing of heart rate
• swelling
• itching
• cold, pale skin
• slow or difficult speech
• dizziness
• faintness

Dihydroergotamine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and light. Dispose of unused nasal spray 8 hours after you open the vial.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• numbness, tingling, and pain in fingers and toes
• blue color in fingers and toes
• slowed breathing
• upset stomach
• vomiting
• fainting
• blurred vision
• dizziness
• confusion
• seizures
• coma
• stomach pain

Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body's response to dihydroergotamine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Migranal^® Nasal Spray
• Trudhesa^® Nasal Spray