Zomig

ZOMIG is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

• Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks.
• ZOMIG is not indicated for the prevention of migraine attacks.
• Safety and effectiveness of ZOMIG have not been established for cluster headache.

You should not take this medication if you are allergic to zolmitriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches.

Do not take zolmitriptan within 24 hours before or after using another migraine headache medicine, including zolmitriptan nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex, Treximet), or ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Do not take zolmitriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before taking zolmitriptan, tell your doctor if you have liver or kidney disease, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Zolmitriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a zolmitriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 10 mg of zolmitriptan in 24 hours.

Zomig is a prescription medication used to treat migraine headaches once they have started. Zomig belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

This medication comes in tablet form. Swallow Zomig tablets whole, with water.

It is also available as an orally disintegrating tablet that dissolves quickly in the mouth. It is found under the brand name Zolmig ZMT. 

Zomig is also available as a nasal spray. 

Common side effects of Zomig include dizziness, drowsiness, dry mouth, and tingling skin. 

Zomig is a prescription medication used to treat migraine headaches in adults, once they have started.

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

Do not take Zomig if you:

• Have heart disease or a history of heart disease
• Have uncontrolled high blood pressure
• Have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
• Have or had a stroke or problems with your blood circulation
• Have serious liver problems
• Have taken any of the following medicines in the last 24 hours: other “triptans” like almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), sumatriptan/naproxen (Treximet); ergotamines like Bellergal-S, Cafergot, Ergomar, Wigraine; dihydroergotamine like D.H.E. 45 or Migranal; or methysergide (Sansert). These medications have side effects similar to Zomig.
• Have taken monoamine oxidase (MAO) inhibitors such as phenelzine sulfate (Nardil) or tranylcypromine sulfate (Parnate) for depression or other conditions, or if it has been less than 2 weeks since you stopped taking a MAO inhibitor.
• Are allergic to any ingredients in Zomig. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zomig there are no specific foods that you must exclude from your diet when receiving Zomig.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Zomig falls into category C. No well-controlled studies have been done in humans. It is not known if Zomig will harm your unborn baby. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Appears to be metabolized by CYP1A2; active N-desmethyl metabolite appears to be further metabolized by MAO-A.22 23 24 26

Specific Drugs

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

There is no experience with acute overdose of Zomig. Clinical study subjects who received single 50 mg oral doses of Zomig commonly experienced sedation.

There is no specific antidote to Zomig. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.

The elimination half-life of Zomig is 3 hours [see Clinical Pharmacology (12.1)]; therefore, monitor patients after overdose with Zomig for at least 15 hours or until symptoms or signs resolve. It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan.

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

Applies to zolmitriptan: nasal spray, oral tablet, oral tablet disintegrating

Cardiovascular

Common (1% to 10%): Chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, palpitations
Uncommon (0.1% to 1%): Arrhythmias, hypertension, syncope, tachycardia
Rare (less than 0.1%): Angina pectoris, myocardial infarct, coronary vasospasm, QT prolongation, thrombophlebitis[Ref]

Rare reports of serious cardiac adverse events have been reported including acute myocardial infarction within a few hours following administration of this drug.

Chest pain/tightness/pressure and/or heaviness appear to be dose-related occurring in 2%, 3%, and 4% of patients receiving 1 mg, 2.5 mg, and 5 mg, respectively. Neck/throat/jaw pain/tightness/pressure occurred in 4%, 7%, and 10% of patients, respectively.[Ref]

Nervous system

Very Common (greater than 10%): Taste disturbances (up to 21%, inhaler)
Common (1% to 10%): Paresthesia, somnolence, dizziness, hyperesthesia
Rare (less than 0.1%): Cerebral ischemia, amnesia, convulsions, ataxia, dystonia, hyperkinesia, hypotonia, hypertonia
Frequency not reported: Serotonin syndrome[Ref]

Paresthesia appears to be a dose-related adverse event occurring in 5%, 7%, and 9% of patients receiving 1 mg, 2.5 mg, and 5 mg, respectively.[Ref]

Other

Common (1% to 10%): Warm/cold sensation, heaviness other than chest or neck, pressure/tightness/heaviness, vertigo, asthenia, chills
Uncommon (0.1% to 1%): Tinnitus, hyperacusis, ear pain[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dry mouth, dysphagia, dyspepsia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Gastroenteritis, increased thirst
Rare (less than 0.1%): Stomatitis, constipation, hematemesis, pancreatitis, melena, ulcer
Very rare (less than 0.01%): Bloody diarrhea, gastrointestinal infarction or necrosis, gastrointestinal ischemic events, ischemic colitis, splenic infarction[Ref]

General

The most common adverse reactions included neck, throat, jaw pain; dizziness; paresthesia; asthenia; somnolence; warm and cold sensation; nausea; heaviness sensation; and dry mouth. In adolescents treated with the nasal spray, the more commonly reported adverse reactions included dysgeusia, nasal discomfort, dizziness, oropharyngeal pain, and nausea.[Ref]

Hematologic

Uncommon (0.1% to 1%): ecchymosis
Rare (less than 0.1%): Thrombocytopenia, eosinophilia, leucopenia[Ref]

Metabolic

Uncommon (0.1% to 1%): Increased appetite, thirst
Rare (less than 0.1%): Anorexia, hyperglycemia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, muscle weakness
Uncommon (0.1% to 1%): Back pain, leg cramps, tenosynovitis
Rare (less than 0.1%): Arthritis, tetanus, twitching[Ref]

Respiratory

Common (1% to 10%): Disorder/discomfort of nasal cavity, throat pain, throat tightness, oropharyngeal pain
Uncommon (0.1% to 1%): Pharyngitis, rhinitis, dyspnea, sinusitis, bronchitis, increased cough, epistaxis, laryngeal edema, hiccup, laryngitis, yawn
Rare (less than 0.1%): Apnea, voice alteration[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Hypersensitivity reactions including angioedema, anaphylactic reactions and anaphylactic shock[Ref]

Ocular

Rare (less than 0.1%): Diplopia, dry eyes, lacrimation, conjunctivitis, eye pain, visual field defect[Ref]

Genitourinary

Uncommon (0.1% to 1%): Polyuria, urinary urgency, cystitis, hematuria
Rare (less than 0.1%): Urinary frequency, miscarriage, dysmenorrhea[Ref]

Dermatologic

Common (1% to 10%): Sweating, facial edema
Uncommon (0.1% to 1%): Urticaria, pruritus, rash, photosensitivity reaction
Rare (less than 0.1%): Angioedema[Ref]

Local

Common (1% to 10%): Local irritation or soreness at the site of administration of nasal spray

In clinical trials using the nasal spray approximately 3% (n=460) patients reported local irritation or soreness at the site of administration. Effects were severe in about 1% of patients and approximately 57% resolved in 1 hour. Nasopharyngeal examinations of a subset of patients failed to demonstrate any clinically significant changes with repeated use of the nasal spray.

Some side effects of Zomig may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.