Description
Migranal® (dihydroergotamine mesylate, USP)
Nasal Spray, is for the acute treatment of Migraine with or without
aura. Ergotamine preparations are non-triptan Migraine abortive
medications. In clinical trials, self-administration of Migranal® Nasal
Spray resulted in Migraine pain relief and a reduction in pain
intensity. Over 50% of patients in pivotal clinical trials did not need
additional medications during the 24-hour period following a single 2 mg
Migranal® treatment. Developed by Novartis Pharmaceuticals Corporation,
Migranal® was cleared for marketing by the U.S. Food and Drug
Administration on December 8, 1997.
In clinical trials, Migranal® Nasal Spray was shown to produce a
reduction in nausea and sensitivity to both light and sound at 2 and 4
hours compared with placebo. Over 50% of patients in all pivotal
clinical trials did not need additional migraine medications during the
24-hour period following a single 2 mg Migranal treatment. In addition,
the nasal spray formulation bypasses the gastrointestinal tract, making
it appropriate for patients who suffer from nausea and vomiting as a
result of migraine, and who may therefore have difficulty with oral
treatments.
Migranal® Nasal Spray is a migraine-specific serotonin agonist. It
attacks migraine at its source by selectively binding to receptors in
the brain that regulate the release of serotonin, a chemical thought to
play a major role in the development of migraine. Migranal® is also
nonnarcotic, non-habit forming, and nonsedating.
Migranal® is available only with your doctor's prescription.
Before Using This Medicine
Nasal dihydroergotamine may cause blood
vessels in the body to constrict (become narrower). This action can lead
to serious effects that are caused by a decrease in the flow of blood
(blood circulation) to many parts of the body. Be sure that you discuss
with your doctor the risks of using this medicine as well as the good it
can do. Before using Migranal, be sure to consider and discuss with your
doctor:
Allergies-
Tell your doctor if you have ever had any unusual or allergic
reaction to dihydroergotamine or any other ergot alkaloid. Also tell
your health care professional if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Pregnancy-
Use of nasal dihydroergotamine by pregnant women may cause serious
harm to the fetus. Therefore, nasal dihydroergotamine should not be used
during pregnancy.
Breast-feeding-
Use of nasal dihydroergotamine is not recommended for nursing
mothers. Nasal dihydroergotamine may pass into the breast milk and may
cause unwanted effects, such as vomiting, diarrhea, weak pulse, changes
in blood pressure, or convulsions (seizures) in nursing babies. Nasal
dihydroergotamine may also decrease the flow of breast milk.
Children-
There is no specific information comparing use of nasal
dihydroergotamine in children with use in other age groups.
Older adults-
There is no specific information comparing use of nasal
dihydroergotamine in older adults with use in other age groups.
Other medicines-
Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur. In
these cases, your doctor may want to change the dose, or other
precautions may be necessary. When you are taking nasal
dihydroergotamine, it is especially important that your health care
professional know if you are using any of the following:
Do not take frovatriptan if you have
taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan),
tranylcypromine (Parnate), or phenelzine (Nardil) within the last 14
days. The combination could cause seizures, nausea, vomiting, sweating,
flushing, and dizziness.
Do not take frovatriptan if you:
- Cocaine
- Epinephrine by injection [e.g., Epi-Pen]
- Other ergot medicines (ergoloid
mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate],
methylergonovine [e.g., Methergine], methysergide [e.g., Sansert]
- Triptans: Imitrex/sumatriptan,
Amerge/naratriptan, Maxalt/rizatriptan, Zomig/zolmitriptan, Axert/almotriptan,
Frova/frovatriptan. The chance of serious side effects caused by nasal
dihydroergotamine may be increased
- beta-blockers (which are used to
treat high blood pressure, irregular heartbeats, and other heart
conditions) such as acebutolol (Sectral), betaxolol (Kerlone),
bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg),
labetalol (Normodyne, Trandate), metoprolol (Lopressor), nadolol (Corgard),
pindolol (Visken), propranolol (Inderal), sotalol (Betapace), and
timolol (Blocadren)
- antibiotics, including erythromycin
(Ery-Tab, E.E.S., E-Mycin, Eryc, PCE, and others), clarithromycin (Biaxin),
and azithromycin (Zithromax).
Other medical problems-
The presence of other medical
problems may affect the use of Migranal. Make sure you tell your
doctor if you have any other medical problems, especially:
- Heart or blood vessel disease
- a peripheral vascular disease or
poor circulation,
- arteriosclerosis or "hardening of
the arteries"
- Hypertension (high blood pressure)
- Kidney disease
- Liver disease
- Infection—The chance of serious side
effects caused by nasal dihydroergotmine may be increased. Heart or
blood vessel disease and high blood pressure sometimes do not cause
any symptoms, so some people do not know that they have these
problems. Before deciding whether you should use nasal
dihydroergotamine, your doctor may need to do some tests to make sure
that you do not have any of these conditions.
Proper Use of This Medicine
It is important to use this
medicine properly:
- Do not use nasal dihydroergotamine
for a headache that is different from your usual migraine
- To relieve your migraine as soon as
possible, use nasal dihydroergotamine as soon as the headache begins.
Even if you get warning signals of a coming migraine (an aura), you
should wait until the headache pain starts before using nasal
dihydroergotamine.
- Lying down in a quiet, dark room for
a while after you use this medicine may help relieve your migraine.
- If you feel much better after a dose
of nasal dihydroergotamine, but your head pain comes back or gets
worse after a while, you may use more nasal dihydroergotamine.
However, use this medicine only as directed by your doctor. Do not use
more of it, and do not use it more often, than directed.
- Your doctor may direct you to take
another medicine to help prevent Migraines. It is important that you
follow your doctor's directions, even if your headaches continue to
occur. Migraine-preventing medicines may take several weeks to start
working. Even after they do start working, your headaches should occur
less often, and they should be less severe, and easier to relieve.
This can reduce the amount of nasal dihydroergotamine or other pain
medicines that you need. If you do not notice any improvement after
several weeks of Migraine-preventing treatment, check with your
doctor.
Dosing-
The dose of nasal dihydroergotamine will be different for
different patients. Follow your doctor's orders or the directions on the
label. The following information includes only the average doses of
nasal dihydroergotamine. If your dose is different, do not change it
unless your doctor tells you to do so.
- Adults—One spray (0.5 mg) in each
nostril. After 15 minutes, another spray (0.5 mg) in each nostril
should be used.
- Children—Use and dose must be
determined by your doctor.
Storage-
To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct
light.
- Do not store in the bathroom, near
the kitchen sink, or in other damp places. Heat or moisture may cause
the medicine to break down.
- Do not keep outdated medicine or
medicine no longer needed. Be sure that any discarded medicine is out
of the reach of children..
Precautions While Using This Medicine
Drinking alcoholic beverages can make
headaches worse or cause new headaches to occur. People who suffer from
severe headaches should probably avoid alcoholic beverages, especially
during a headache.
Some people feel drowsy or dizzy during or after a migraine attack, or
after taking nasal dihydroergotamine to relieve a migraine headache. As
long as you are feeling drowsy or dizzy, do not drive, use machines or
do anything else that could be dangerous if you are dizzy or are not
alert.
Side Effects of This Medicine
Along with its needed effects,
a medicine may cause some unwanted effects. Although not all of these
side effects may occur, if they do occur they may need medical
attention.
- Check with your doctor as soon as
possible if any of the following side effects occur:
- Less common or rare:
- Chest pain; cough, fever,
sneezing, or sore throat
- feeling of heaviness in chest
- irregular heartbeat
- itching of the skin
- numbness and tingling of face,
fingers, or toes
- pain in arms, legs, or lower
back
- pain in back, chest or left arm
- pale bluish-colored or cold
hands or feet
- shortness of breath or troubled
breathing
- weak or absent pulses in legs
- Other side effects may occur that
usually do not need medical attention. These side effects may go away
during treatment as your body adjusts to the medicine. However, check
with your doctor if any of the following side effects continue or are
bothersome:
- More common
- Burning or tingling sensation,
dryness, soreness, or pain in the nose
- change in sense of taste
- diarrhea
- dizziness
- dry mouth
- fatigue
- headache
- increased sweating
- nausea and or vomiting
- muscle stiffness
- runny and or stuffy nose
- sudden sweating and feelings of
warmth
- sensation of burning, warmth, or
heat
- sore throat
- sleepiness
- unexplained nose bleeds
- unusual tiredness or weakness
- Less common
- Anxiety
- blurred vision
- cold clammy skin
- confusion
- congestion in chest
- cough
- decreased appetite
- depression
- difficulty swallowing
- dizziness or lightheadedness
when getting up from a lying or sitting position
- ear pain
- eye pain
- fever
- heartburn
- increased watering of eyes
- increased watering of the mouth
- increased yawning
- muscle weakness
- nervousness
- pinpoint red spots on skin
- pounding heartbeat
- red or irritated eyes
- ringing or buzzing in ears
- skin rash
- stomach pain
- sudden fainting
- swelling of face, fingers, feet,
or lower legs
- trembling or shaking of hands or
feet
- trouble in sleeping
- unusual feeling of well being.
Other side effects not listed above may
also occur in some patients. If you notice any other effects, check with
your doctor.
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