Zomig Nasal Spray

DRUG DESCRIPTION

ZOMIG® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5-hydroxy- tryptamine1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino) ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure:

ZOMIG® (zolmitriptan) Structural Formula Illustration

The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG (zolmitriptan nasal spray) Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray contains 5 mg of zolmitriptan in a 100-?L unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP.

ZOMIG (zolmitriptan nasal spray) Nasal Spray is hypertonic. The osmolarity of ZOMIG (zolmitriptan nasal spray) Nasal Spray 5 mg is 420 to 470 mOsmol.

What are the possible side effects of zolmitriptan (Zomig, Zomig-ZMT)?

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

Stop taking zolmitriptan and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or...

Read All Potential Side Effects and See Pictures of Zomig Nasal Spray »

What are the precautions when taking zolmitriptan nasal spray (Zomig Nasal Spray)?

See also How to Use section.

Before using zolmitriptan, tell your doctor or pharmacist if you are allergic to it; or to other "triptan" migraine drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: heart disease (e.g., chest pain, heart attack, irregular heartbeat, coronary artery disease, vasospasm), blood flow problems in the brain (e.g., stroke, transient ischemic attack), blood vessel disease (e.g., peripheral vascular disease, ischemic bowel disease), uncontrolled high blood pressure...

Read All Potential Precautions of Zomig Nasal Spray »


Zomig Nasal Spray Consumer (continued)

SIDE EFFECTS: Unusual taste, discomfort in the nose, tingling/numbness, nausea, dry mouth, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold feeling in the hands/feet.

Pain/pressure/tightness in the chest/neck/jaw can occur shortly after using zolmitriptan. These side effects are usually not serious. However, you may not be able to tell them apart from a rare but very serious reaction related to a lack of blood flow to the heart, brain, or other parts of the body. Therefore, seek immediate medical attention if you notice any of these unlikely side effects: chest/jaw/left arm pain, fainting, irregular/pounding heartbeat, vision changes, severe nausea, weakness on one side of the body, confusion, seizures, slurred speech, sudden or severe stomach/abdominal pain, trouble swallowing, bloody diarrhea.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before using this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use section.

Before using zolmitriptan, tell your doctor or pharmacist if you are allergic to it; or to other "triptan" migraine drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: heart disease (e.g., chest pain, heart attack, irregular heartbeat, coronary artery disease, vasospasm), blood flow problems in the brain (e.g., stroke, transient ischemic attack), blood vessel disease (e.g., peripheral vascular disease, ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar migraine), severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation disorder (e.g., Raynaud's disease), kidney disease.

Before using this medication, tell your doctor or pharmacist if you have any condition that increases your risk of heart disease, including: high cholesterol level, high blood pressure, diabetes, smoking history, family history of heart disease or stroke, overweight, female after menopause, male older than 40 years.

If you are at high risk for heart disease, your doctor may want to check your heart before prescribing zolmitriptan.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Zomig Nasal Spray Patient Information Including Side Effects

Brand Names: Zomig, Zomig-ZMT

Generic Name: zolmitriptan (oral) (Pronunciation: ZOLE mi TRIP tan)

  • What is zolmitriptan (Zomig Nasal Spray)?
  • What are the possible side effects of zolmitriptan (Zomig Nasal Spray)?
  • What is the most important information I should know about zolmitriptan (Zomig Nasal Spray)?
  • What should I discuss with my healthcare provider before taking zolmitriptan (Zomig Nasal Spray)?
  • How should I take zolmitriptan (Zomig Nasal Spray)?
  • What happens if I miss a dose (Zomig Nasal Spray)?
  • What happens if I overdose (Zomig Nasal Spray)?
  • What should I avoid while taking zolmitriptan (Zomig Nasal Spray)?
  • What other drugs will affect zolmitriptan (Zomig Nasal Spray)?
  • Where can I get more information?

What is zolmitriptan (Zomig Nasal Spray)?

Zolmitriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain. Zolmitriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Zolmitriptan is used to treat migraine headaches.

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

Zolmitriptan should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Zolmitriptan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of zolmitriptan (Zomig Nasal Spray)?

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

Stop taking zolmitriptan and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fast or pounding heartbeats, dizziness;
  • sudden and severe stomach pain and bloody diarrhea;
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) - agitation, high fever, sweating, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting;

Less serious side effects may include:

  • dry mouth, upset stomach;
  • feeling of pain or pressure in your neck or throat;
  • drowsiness, weakness; or
  • feeling of warmth.

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.

What is the most important information I should know about zolmitriptan (Zomig Nasal Spray)?

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 dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

You should not take this medication if you are allergic to zolmitriptan, or if you have a history of heart disease, angina (chest pain), blood circulation problems, ischemic bowel disease, severe liver disease, uncontrolled high blood pressure, or history of a heart attack or stroke.

Do not use zolmitriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or phenelzine (Nardil) in the past 14 days.

Before taking zolmitriptan, tell your doctor if you have liver disease, high blood pressure, a heart rhythm disorder, coronary artery disease, or risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or 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).

Before taking zolmitriptan, tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), 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.

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