Usual Adult Dose for Migraine

Use only after a clear diagnosis of migraine has been established

Oral:
Initial dose: 25 mg, 50 mg, or 100 mg orally, once

• If some response to first dose occurs, a second dose may be administered at least 2 hours after first dose if needed
• Oral doses of 50 and 100 mg may provide greater relief than 25 mg; however, a 100 mg dose may not provide greater effect than a 50 mg dose

Maximum dose: 200 mg per 24 hours

Subcutaneous:
Initial dose: 1 to 6 mg subcutaneously, once

• If some response to first dose occurs, a second dose may be administered at least 1 hour after first dose if needed.

Maximum dose: 12 mg per 24 hours

Intranasal:
Nasal spray: Initial dose: 5 mg, 10 mg, or 20 mg into one nostril, once

• Administer the 5 and 20 mg doses as a single spray in 1 nostril; the 10 mg dose may be administered as 5 mg into each nostril
• If some response to first dose occurs, a second dose may be administered at least 2 hours after first dose if needed

Maximum dose: 40 mg per 24 hours

Nasal capsule/powder: Initial dose: 11 mg into each nostril via Xsail (R) breath-powered delivery device once

• If symptoms have not resolved in 2 hours, or return after transient improvement a second dose may be administered at least 2 hours after the first dose

Maximum dose: 2 doses (44 mg/4 nosepieces) per 24 hours

Comments:

• Treatment should be started at the first sign of a migraine headache, or associated symptoms such as nausea, vomiting, or photophobia; this drug should not be used for migraine prophylaxis.
• Higher doses may have a greater effect, but also carry a greater risk of adverse reactions.
• The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Usual Adult Dose for Cluster Headache

Subcutaneous injection:
Initial dose: 6 mg subcutaneously, once. If symptoms recur, the dose may be repeated if at least 1 hour has elapsed since the first dose.
Maximum dose: 12 mg per 24 hours

Comments:

• Treatment should be started at the first sign of cluster headache, or associated symptoms such as nausea, vomiting, or photophobia. This drug should not be used prophylactically.
• The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

Use: For the acute treatment of cluster headache.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction:
Oral tablets: Maximum single dose of 50 mg should not be exceeded
Nasal spray: Data not available
Subcutaneous injection: No adjustment recommended

Severe liver dysfunction: Contraindicated

Dose Adjustments

Elderly:

• Dose selection for the older patient should be cautious, generally starting at the lower end of the dosing range due to a greater frequency of hepatic, renal, cardiac impairment as well as presence of concomitant disease or drug therapy.

For patients initiating therapy with subcutaneous injections:

• If migraine returns after an initial dose of subcutaneous injection, additional oral doses may be given up to 100 mg orally per day, with at least a 2 hour interval between tablet doses.

For patients initiating therapy with Xsail(R) Breath Powdered Delivery Device:

• If migraine returns after an initial intranasal dose, 1 dose of another sumatriptan product may be given as long as at least 2 hours has elapsed since intranasal administration.

Precautions

Zecuity(R) was voluntarily withdrawn from the market by the manufacturer in June 2016 due to reports of serious application site reactions associated with use of this iontophoretic transdermal system. Since marketing of the patch in September 2015, there have been a number of reports in which patients describe severe redness, cracked skin, blistering or welts, and burns or scars where the patch was worn. Many report resolution within hours to weeks, although there are reports of unresolved skin reactions, typically skin discoloration.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral tablets: Swallow whole with water or other liquids
Nasal spray: A 10 mg intranasal dose may be administered as 5 mg in each nostril.
Nasal capsule/powder: Administer using Xsail (R) breath-powered delivery device (see preparation below)
Subcutaneous injection: For subcutaneous use only; do not give IV or IM

• Preferred administration sites are the subcutaneous tissues of the lateral aspect of the thighs or the subcutaneous tissues overlying the deltoid muscles.
• An autoinjection system is available for self-administration.
• Needleless administration (Sumavel DosePro[R]) should be administered in the abdomen at least 2 inches from navel or thigh; do not give in the arm.

Preparation:
Xsail (R) Breath-Powered Delivery Device:

• Remove device cover; remove disposable nosepiece from foil pouch and insert into the device until a click is heard; fully press and release white button to pierce capsule.
• Insert nosepiece deeply into 1 nostril while rotating the device to place mouthpiece in mouth; blow forcefully through mouthpiece for 2 to 3 seconds to deliver powder into nasal cavity; vibration (e.g., a rattling noise) may be heard and this indicates the patients is blowing forcefully as directed.
• Once the first nosepiece has been administered, press the clear tab and remove the first nosepiece; check to see if the medication is gone from the capsule; discard used nosepiece and repeat with a second nosepiece in the second nostril; it is normal to see a thin white residue after use.

Storage requirements: The manufacturer's product information should be consulted.

General:

• The first dose of this drug should be administered by, or under the direct supervision of, a physician in a medically supervised setting in patients with multiple cardiovascular risk factors who have a negative cardiovascular examination.
• This drug should not be used for prophylaxis.
• If a patient has no response to treatment, reconsider diagnosis before treating any subsequent attacks.
• All patients should be counseled on proper use of product including disposal.

General monitoring:

• Cardiovascular: Signs or symptoms consistent with ischemic heart disease
• Gastrointestinal: Abdominal pain and bloody diarrhea
• Local: Injection site reactions (subcutaneous injection)
• Nervous system: Atypical headache; medication overuse headache; signs or symptoms of cerebrovascular events such as stroke, serotonin syndrome

Patient advice:

• Take this medicine as soon as possible after the onset of a migraine or cluster headache or associated symptoms such as nausea, vomiting, or photophobia.
• If you do not get relief from the first dose of this medicine, do not take a second dose without first talking to your healthcare provider.
• Use of this medicine for 10 or more days per month may exacerbate headaches; use a headache diary to record how often you have a headache and when you take this medicine.
• Follow the instruction leaflet for the correct administration of the nasal spray, nasally administered breath-powered delivery system, subcutaneous injection or autoinjector device and the safe disposal after use.
• Drowsiness may occur during a migraine or during its treatment with this drug. Do not drive or operate machinery until you know how this drug affects you.

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