Naratriptan
Drug Info:
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Naratriptan
Brand names: Amerge®
Chemical formula:
Naratriptan Hydrochloride Oral tablet
What is this medicine?
NARATRIPTAN (NAR a trip tan) is used to treat migraines with or without aura. An aura is a strange feeling or visual disturbance that warns you of an attack. It is not used to prevent migraines.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•bowel disease or colitis
•diabetes
•family history of heart disease
•fast or irregular heart beat
•heart or blood vessel disease, angina (chest pain), or previous heart attack
•high blood pressure
•high cholesterol
•history of stroke, transient ischemic attacks (TIAs or mini-strokes), or intracranial bleeding
•kidney or liver disease
•overweight
•poor circulation
•postmenopausal or surgical removal of uterus and ovaries
•Raynaud's disease
•seizure disorder
•an unusual or allergic reaction to naratriptan, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine is taken at the first symptoms of a migraine. It is not for everyday use. If your migraine headache returns after one dose, you can take another dose as directed. You must leave at least 4 hours between doses, and do not take more than 5 mg in 24 hours. If there is no improvement at all after the first dose, do not take a second dose without talking to your doctor or health care professional. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What may interact with this medicine?
Do not take this medicine with any of the following medicines:
•amphetamine, dextroamphetamine or cocaine
•dihydroergotamine, ergotamine, ergoloid mesylates, methysergide, or ergot-type medication - do not take within 24 hours of taking naratriptan
•feverfew
•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate - do not take naratriptan within 2 weeks of stopping MAOI therapy
•other migraine medicines like almotriptan, eletriptan, sumatriptan, rizatriptan, zolmitriptan - do not take within 24 hours of taking naratriptan
•tryptophan
This medicine may also interact with the following medications:
•birth control pills
•medicines for mental depression, anxiety or mood problems
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Only take this medicine for a migraine headache. Take it if you get warning symptoms or at the start of a migraine attack. It is not for regular use to prevent migraine attacks.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness, dizziness and flushing. Avoid alcoholic drinks.
Smoking cigarettes may increase the risk of heart-related side effects from using this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•breathing problems
•changes in vision
•chest or throat pain, tightness
•fast, slow, or irregular heart beat
•hallucinations
•increased or decreased blood pressure
•problems with balance, talking, walking
•seizures
•severe stomach pain and cramping, bloody diarrhea
•tingling, pain, or numbness in the face, hands or feet
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•diarrhea
•feeling warm, flushing, or redness of the face
•muscle cramps, pain
•nausea, vomiting
•stomach upset
•unusually weak or tired
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.
Last updated: 7/1/2002
Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.
Oxford A-Z of Medicinal Drugs:
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naratriptan
A 5-hydroxytryptamine (= serotonin)1 agonist used to treat acute attacks of migraine. A single dose can relieve a migraine headache at any stage of the attack. Naratriptan is available as tablets on prescription only.
Side effects:
include sensations of tingling, heat, heaviness, pressure, or tightness; if tightness in the chest or throat is severe, treatment should be discontinued. Other side effects may include a slow or fast heart rate, disturbed vision, flushing, dizziness, and weakness.
Precautions:
naratriptan should not be taken by people with certain heart conditions, uncontrolled high blood pressure, or disease of the peripheral blood vessels or by those who have previously had a heart attack or a stroke. It should be used with caution by women who are pregnant or breastfeeding and by people with impaired liver or kidney function.
Interactions with other drugs:
Ergot alkaloids: ergotamine and methysergide should not be taken with naratriptan.
St John's wort: increases the risk of adverse effects on the central nervous system and should not be taken with naratriptan.
Proprietary preparation:
Naramig.
| naproxen, nandrolone decanoate, naltrexone hydrochloride | |
| natalizumab, nateglinide, nebivolol |
Wikipedia on Answers.com:
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Naratriptan
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| Systematic (IUPAC) name | |
| N-methyl-2-[3-(1-methylpiperidin-4-yl)-1H-indol-5-yl]ethanesulfonamide | |
| Clinical data | |
| Trade names | Amerge |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a601083 |
| Pregnancy cat. | B3 (AU) C (US) |
| Legal status | ℞ Prescription only |
| Routes | Oral |
| Pharmacokinetic data | |
| Bioavailability | 74% |
| Metabolism | Hepatic |
| Half-life | 5-8 hours |
| Excretion | Renal |
| Identifiers | |
| CAS number | 121679-13-8  |
| ATC code | N02CC02 |
| PubChem | CID 4440 |
| IUPHAR ligand | 45 |
| DrugBank | DB00952 |
| ChemSpider | 4287 |
| UNII | QX3KXL1ZA2 |
| KEGG | D08255 |
| ChEBI | CHEBI:7478 |
| ChEMBL | CHEMBL1278 |
| Chemical data | |
| Formula | C17H25N3O2S |
| Mol. mass | 335.465 g/mol |
| SMILES | eMolecules & PubChem |
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Naratriptan (trade names include Amerge and Naramig) is a triptan drug marketed by GlaxoSmithKline and is used for the treatment of migraine headaches. Naratriptan is available in 2.5 mg tablets. It is a selective 5-HT1 receptor subtype agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-( 1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide.
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Indication
Naratriptan is used for the treatment of the acute migraine attacks and the symptoms of migraine, including severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light[1].
Mechanism of Action
The causes of migraine are not clearly understood; however, the efficacy of naratriptans and other triptans is believed to be due to their activity as 5HT (serotonin) agonists.
Efficacy
A meta-analysis of 53 clinical trials has shown that all triptans are effective for treating migraine at marketed doses and that naratriptan, although less effective than sumatriptan and rizatriptan was more effective than placebo in reducing migraine symptoms at two hours[2] and efficacy was demonstrated in almost two thirds of subjects after four hours of treatment[3].
Side effects
Side effects include: dizziness, drowsiness, tingling of the hands or feet, unusual tiredness, nausea, dry mouth and unsteadiness. If these effects persist or worsen, notify your doctor promptly. Side-effects which are unlikely and which should be promptly reported include: chest pain/pressure, throat pain/pressure, unusually fast/slow/irregular pulse, one-sided muscle weakness, vision problems, cold/bluish hands or feet, stomach pain, bloody diarrhea, mental/mood changes, and fainting. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.
Exclusivity
In the United States, the Food and Drug Administration (FDA) approved naratriptan on February 11, 1998.[4] It was covered by U.S. Patent no. 4997841; the FDA lists the patent as expiring on July 7, 2010.[4][5]
In July 2010, in the wake of the patent expiration, several drug manufacturers, including Roxane Labs,[6] Sandoz[7] and Teva Pharmaceuticals,[8] announced that they were launching generic Naratriptan medications.
The drug continues to be covered by European patent 0303507 in Germany, Spain, France and the United Kingdom through March 10, 2012,[9] and by Australian patent 611469 in Australia through June 17, 2013.[9] It had previously been covered by Canadian patent 1210968; but both Sandoz and Novopharm have offered generic equivalents in Canada since that patent's expiration December 1, 2009.[9]
References
- ^ Medline Plus Drug Information for Naratriptan Accessed 6 August 2009
- ^ Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 2002 Oct;22(8):633-58.
- ^ Efficacy of naratriptan tablets in the acute treatment of migraine: A dose-ranging study. Clin Ther 2000 Aug;22(8):970-80.
- ^ a b FDA AccessData entry for Naratriptan Hydrochloride, accessed September 8, 2008
- ^ U.S. Patent no. 4997841, Alexander W. Oxford, et al., Indole Derivatives, March 5, 1991
- ^ DeArment, Alaric (2010-07-09). "Roxane launches generic Amerge, Arimidex". Drug Store News. http://drugstorenews.com/story.aspx?id=145645. Retrieved 2010-07-23.
- ^ DeArment, Alaric (2010-07-12). "Sandoz launches generic Amerge". Drug Store News. http://drugstorenews.com/story.aspx?id=145817. Retrieved 2010-07-23.
- ^ DeArment, Alaric (2010-07-14). "Teva launches generic Amerge". Drug Store News. http://drugstorenews.com/story.aspx?id=146081. Retrieved 2010-07-23.
- ^ a b c Oh, Dae (June 2010). "Drug In Focus: Naratriptan". GenericsWeb. http://www.genericsweb.com/druginfocus/Naratriptan_press_release. Retrieved 2010-12-15.
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