Relpax

DRUG DESCRIPTION

RELPAX® (eletriptan) Tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine IB/ID (5-HT1B/1D) receptor agonist. Eletriptan is chemically designated as (R)-3-[(l-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-lH-indole monohydrobromide, and it has the following chemical structure:

RELPAX®
  (eletriptan hydrobromide) Structural Formula Illustration

The empirical formula is C22H26N2O2S.HBr, representing a molecular weight of 463.40. Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water.

Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose NF, lactose NF, croscarmellose sodium NF, magnesium stearate NF, titanium dioxide USP, hypromellose, triacetin USP and FD&C Yellow No. 6 aluminum lake.

What are the possible side effects of eletriptan (Relpax)?

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 using eletriptan 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;
  • ...

Read All Potential Side Effects and See Pictures of Relpax »

What are the precautions when taking eletriptan hydrobromide (Relpax)?

See also How to Use section.

Before taking eletriptan, tell your doctor or pharmacist if you are allergic to it; or to other "triptan" migraine drugs (e.g., sumatriptan); 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...

Read All Potential Precautions of Relpax »


Relpax Consumer (continued)

SIDE EFFECTS: Tingling/numbness, nausea, 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 eletriptan. 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, 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 taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking 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 taking eletriptan, tell your doctor or pharmacist if you are allergic to it; or to other "triptan" migraine drugs (e.g., sumatriptan); 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 eletriptan.

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.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially high blood pressure.

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

This drug passes into breast milk. Consult your doctor before breast-feeding.


Relpax Patient Information Including Side Effects

Brand Names: Relpax

Generic Name: eletriptan (Pronunciation: EL e TRIP tan)

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

What is eletriptan (Relpax)?

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

Eletriptan is used to treat migraine headaches.

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

Eletriptan 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.

Eletriptan may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of eletriptan (Relpax)?

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 using eletriptan 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;
  • 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, fast or pounding heartbeats, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting.

Less serious side effects may include:

  • mild headache (not a migraine);
  • dry mouth, upset stomach, stomach pain or cramps;
  • feeling of pain or tightness in your jaw, neck, or throat;
  • pressure or heavy feeling in any part of your body;
  • dizziness, drowsiness, weakness; or
  • warmth, redness, or mild tingling under your skin.

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 eletriptan (Relpax)?

You should not take this medication if you are allergic to eletriptan, 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 eletriptan within 24 hours before or after using another migraine headache medicine, including almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use eletriptan within 72 hours after taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone (Serzone), clarithromycin (Biaxin), troleandomycin (Tao), ritonavir (Norvir), or nelfinavir (Viracept).

Before taking eletriptan, 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 eletriptan, 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).

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

After taking an eletriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 80 mg of eletriptan in 24 hours.

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