Trudhesa nasal spray is used to treat migraine headaches with or without aura in adults. Dihydroergotamine will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Trudhesa nasal spray should not be used to treat any headache that seems to be different from your usual migraine headaches.

Trudhesa is a single-dose nasal spray and is supplied in a package containing 4 single-dose units.

It is not known if Trudhesa is safe and effective in children.

Tell your doctor about all your other medicines. Some drugs should not be used with Trudhesa.

Trudhesa can cause serious side effects, including problems with blood circulation to your legs and feet due to blockage of the blood vessels. Using Trudhesa with certain medicines known as CYP3A4 inhibitors may lead to a stroke and death. Example of CYP3A4 inhibitors include: ritonavir, erythromycin, ketoconazole, nelfinavir, clarithromycin, and itraconazole.

Stop treatment and get emergency medical help right away if you have any of the following symptoms: cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting. numbness, tingling, or weakness in your legs, cold feeling or color changes in 1 or both legs or feet, slurred speech, or sudden weakness.

Use Trudhesa nasal spray as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Trudhesa 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 Trudhesa nasal spray 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.

Use 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 Trudhesa nasal spray vial for the second dose.

You may need medical tests to check your heart function.

The Trudhesa 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.

Usual Adult Dose for Migraine:

After putting Trudhesa together and priming the device, spray 1 time in each nostril (a complete dose).
If your headache comes back after the first complete dose or you only get some relief from your headache, you can use a second dose 1 hour after the first complete dose. Use a new nasal spray device for the second dose.

Maximum doses: Do not use more than 2 doses within a 24-hour period or 3 doses within a 7-day period.

Using Trudhesa for 10 or more days in 1 month may make your headaches worse.

You should not use Trudhesa nasal spray if you are allergic to dihydroergotamine 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 Trudhesa. 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.

To make sure Trudhesa nasal spray is safe for you, 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 this medicine if you are pregnant.

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

Trudhesa is used when 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.

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

Overdose symptoms may include slow breathing, blood pressure changes, 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 Trudhesa nasal spray 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 and cause side effects. Avoid consuming grapefruit products.

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

Dihydroergotamine may cause serious side effects. Call your doctor at once 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 Trudhesa side effects 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.

Tell your doctor about all your current medicines. Many drugs can interact with 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 interact with dihydroergotamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.