Dihydroergotamine (nasal)

Dihydroergotamine (nasal) is used to treat migraine headaches with or without aura in adults. Dihydroergotamine (nasal) will only treat a headache that has already started. It will not prevent headaches or decrease the number of attacks.

Dihydroergotamine (nasal) should not be used to treat any headache that feels different from your usual migraine headaches.

Dihydroergotamine (nasal) may also be used for purposes not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Dihydroergotamine nasal spray is absorbed quickly through your nasal passages and is for use only in the nose. The nasal spray liquid should not be injected into the body.

Your first dose may be given in a medical setting where any serious side effects can be quickly treated.

You should use dihydroergotamine as soon as your headache begins, but it may be given at any time during the migraine episode.

Before your first use, prime the nasal spray device with 4 sprays into the air, away from your face.

Trudhesa: apply one spray in each nostril then another spray in each nostril 1 hour later only if your headache comes back or if you only get some relief from your headache. Use a new nasal spray device for the second dose.

Migranal: apply one spray in each nostril followed by another spray in each nostril 15 minutes later, for a total of 4 sprays.

You may need medical tests to check your heart function.

The nasal spray vial should be thrown away 8 hours after it has been opened.

Store at room temperature away from moisture, heat, and light. Do not keep this medicine in a refrigerator and do not freeze.

Tell your doctor about all your other medicines. Some drugs must not be used with dihydroergotamine.

You should not use dihydroergotamine if you are allergic to it or similar medicines (ergotamine, ergonovine, methylergonovine, and others), or if you have or have ever had:

• heart disease, angina (chest pain), blood circulation problems, coronary artery disease (clogged arteries), or a heart attack or stroke;
• uncontrolled high blood pressure;
• a serious infection called sepsis;
• vascular surgery;
• narrowing of blood vessels in the legs, arms, stomach, or kidneys (peripheral vascular disease); or
• severe liver or kidney disease.

Some drugs should not be used with dihydroergotamine. Your treatment plan may change if you also use:

• medicines that raise your blood pressure or constrict your blood vessels;
• an antibiotic such as troleandomycin, clarithromycin, or erythromycin;
• antifungal medicine such as itraconazole or ketoconazole; or
• antiviral medicine for HIV or hepatitis C.

Tell your doctor if you have ever had:

• blood circulation problems in your arms, hands, legs, or feet;
• chest pain, shortness of breath;
• risk factors for coronary artery disease (high blood pressure, high cholesterol, diabetes, menopause, smoking, family history of coronary artery disease, being overweight, being over 40 and a man); or
• liver or kidney disease.

Dihydroergotamine may cause preterm labor. Tell your doctor if you are pregnant or plan to become pregnant. Do not use dihydroergotamine if you are pregnant.

Do not breastfeed while using this medicine, and for at least 3 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dihydroergotamine may cause serious side effects. Call your doctor immediately if you have:

• numbness, cold feeling, or pale appearance of your fingers or toes;
• sudden or severe stomach pain, weight loss, nausea, vomiting, constipation, bloody diarrhea, fever;
• severe headache, blurred vision, pounding in your neck or ears;
• burning sensation in the nose, mouth, throat, and altered sense of taste;
• fast or slow heart rate;
• swelling or itching;
• signs of a blood clot—sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg; or
• heart attack symptoms—chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects of dihydroergotamine may include:

• pain, bruising, swelling, or irritation where the medicine was applied;
• drowsiness;
• dizziness;
• nausea, vomiting, diarrhea;
• runny nose;
• altered sense of taste; or
• sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Migraine:

Parenteral: Initial dose: 1 mg IM/IV/subcutaneously -Additional 1 mg dose may be given at hourly intervals as needed not to exceed daily maximumsMaximum doses: -IV: 2 mg/24 hours; 6 mg/7-day period-IM/subcutaneously: 3 mg/ 24 hours; 6 mg/ 7-day period Nasal Spray: Initial dose: 0.5 mg (1 spray) intranasally into both nostrils; repeat in 15 minutes Total dose: 2 mg (2 sprays in each nostril 15 minutes apart)-Acute doses greater than 2 mg have not been shown to provide additional benefits Maximum doses: 3 mg/24 hours; 4 mg/7-day period Comments: -This drug should only be used where a clear diagnosis of migraine headache has been established. -This drug is not intended for chronic daily administration.Use: For the acute treatment of migraine headaches with or without aura.

Usual Adult Dose for Cluster Headache:

Initial dose: 1 mg IM/IV/subcutaneously -Additional 1 mg dose may be given at hourly intervals as needed not to exceed daily maximumsMaximum doses: -IV: 2 mg/24 hours; 6 mg/7-day period-IM/subcutaneously: 2 mg/ 24 hours; 6 mg/ 7-day periodComments: -This drug is not intended for chronic daily administration.Use: For the acute treatment of cluster headache episodes.

Dihydroergotamine (nasal) is used as needed and does not have a daily dosing schedule.

• Do not use more than 2 doses of Trudhesa within 24 hours or 3 doses within 7 days.

• Do not use more than 6 sprays of Migranal within 24 hours or 8 sprays within 7 days.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow breathing, changes in blood pressure, confusion, hallucinations, agitation, convulsions, coma, nausea, vomiting, stomach pain, and pain, numbness, cold feeling, or pale appearance of your fingers or toes.

Do not use dihydroergotamine (nasal) within 24 hours before or after using another migraine headache medicine, including:

• another ergot medicine such as ergotamine, ergonovine, methylergonovine; or
• almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, or rizatriptan.

Grapefruit may interact with dihydroergotamine (nasal) and cause side effects. Avoid consuming grapefruit products.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect dihydroergotamine, especially:

• heart or blood pressure medication;
• nicotine gum or patches;
• an antidepressant; or
• medicine to treat asthma.

This list is not complete, and many other drugs may also affect dihydroergotamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are mentioned here.