Zolmitriptan (zomig)

WHENEVER A MIGRAINE STRIKES… *Most adult patients (69%) said their headache pain was reduced from moderate or severe to mild or no pain with ZOMIG Nasal Spray 5 mg at 2 hours (primary measurement of the study). The recommended starting dose is 2.5 mg.

1,2 †In a clinical study, some adult patients (12%) who used a single spray of ZOMIG Nasal Spray 5 mg felt relief in as soon as 15 minutes.1 Zolmitriptan (Zomig) Zolmitriptan (Zomig) Zolmitriptan (Zomig) Zolmitriptan (Zomig) Zolmitriptan (Zomig) Zolmitriptan (Zomig) Zolmitriptan (Zomig) Zolmitriptan (Zomig) References: 1. Data on file, Impax Laboratories, LLC. 2. ZOMIG Nasal Spray [package insert].

  • heart problems, a history of heart problems, or problems with the electrical system of your heart
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider
  • narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease)
  • uncontrolled high blood pressure
  • used other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications
  • used monoamine oxidase A inhibitors (MAO-A inhibitors) or you stopped taking a MAO-Ainhibitor in the last 14 days
  • allergies to zolmitriptan or any of the ingredients in ZOMIG Nasal Spray

If you are not sure about any of the above, ask your doctor.

  • Before taking ZOMIG Nasal Spray, tell your doctor about all your medical conditions, including if you have high blood pressure, high cholesterol, diabetes, if you smoke, are overweight, are a female who has gone through menopause, have heart disease or a family history of heart disease or stroke, have liver problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. Talk to your doctor about the best way to feed your baby while using ZOMIG Nasal Spray.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines used to treat mood disorders including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors or cimetidine (reduces stomach acid production)
  • ZOMIG Nasal Spray can cause serious side effects such as heart attacks (symptoms include severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away), increases in blood pressure, stroke (symptoms include slurring of speech; or unusual weakness or numbness), life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body (symptoms include changes in color or sensation in your fingers and toes), or serious allergic reactions (symptoms include hives; tongue, mouth, lip or throat swelling; problems breathing). In extremely rare cases, patients have died from these side effects. If you experience any of the above side effects, seek emergency help or contact your doctor right away
  • ZOMIG Nasal Spray can cause dizziness, weakness, or drowsiness. If you have any of these symptoms do not drive a car, use machinery, or do anything that needs you to be alert
  • Some people who take ZOMIG Nasal Spray may have a reaction called serotonin syndrome which can be life-threatening. In particular this reaction may occur when ZOMIG Nasal Spray is used together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (confusion, seeing things that are not there (hallucinations), agitation, coma), fast heartbeat, changes in blood pressure, feeling faint, fever, sweating, muscle spasm, trouble walking, nausea, vomiting, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking ZOMIG Nasal Spray
  • The safety and effectiveness of ZOMIG Nasal Spray have not been established in patients under 12 years of age or patients over 65 years of age
  • The most common side effects reported by adult patients in clinical studies for ZOMIG Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, warm sensation, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of the nasal cavity; and dry mouth
  • The most common side effects in pediatrics (12 to 17 years of age) in clinical trials for ZOMIG Nasal Spray were unusual taste, nasal discomfort, dizziness, mouth/throat pain and nausea

These are not all of the possible side effects of ZOMIG Nasal Spray. For more information, ask your doctor

Approved Use for ZOMIG Nasal Spray

ZOMIG Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age). It is not known if ZOMIG Nasal Spray is safe and effective in children under 12 years of age. Only your doctor can determine if ZOMIG Nasal Spray is right for you.

Limitations of Use:

ZOMIG Nasal Spray should only be used where a clear diagnosis of migraine has been established.

For a given migraine attack, if you do not respond to the first dose of ZOMIG Nasal Spray, then your doctor will need to determine if you really have a migraine headache before you take another dose. ZOMIG Nasal Spray is not for the prevention of migraines.

ZOMIG Nasal Spray is not for other types of headaches, including cluster headache. ZOMIG Nasal Spray is not for people with moderate or severe liver problems (hepatic impairment).

The maximum daily dose should not exceed 10 mg in any 24-hour period.

Zomig (zolmitriptan) for Migraines: Side Effects, Dosage, Generic

What is zolmitriptan, and how does it work (mechanism of action)?

Zolmitriptan is a drug for treating migraine headaches. Migraine headaches are believed to result from dilation of the blood vessels in the brain. Zolmitriptan causes constriction of the blood vessels and thereby relieves the pain of a migraine headache.

Budete mít zájem:  Maltitol a jeho účinky na zdraví

While zolmitriptan is very effective in relieving migraine headaches, it does not prevent or reduce the number of headaches if taken prophylactically. Its mechanism of action and effectiveness are similar to those of sumatriptan (Imitrex).

Zolmitriptan was approved by the FDA in November of 1997.

What brand names are available for zolmitriptan?

Zomig, Zomig-ZMT

Is zolmitriptan available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for zolmitriptan?

Yes

What are the uses of zolmitriptan?

Zolmitriptan is used for the treatment of migraines.

What are the side effects of zolmitriptan?

  • Side effects are generally transient. Some common side effects include:
  • Rarely, allergic reactions (even shock) have been reported though usually in individuals who are highly allergic to many substances.

What is the dosage for zolmitriptan?

Dosing: The initial dose is 2.5 mg or less. The dose can be repeated after 2 hours if symptoms persist. The maximum dose is 10 mg per day. Doses less than 2.5 mg can be achieved by splitting the 2.5 mg tablet. Zolmitriptan may be taken with or without food.

Zolmitriptan (Zomig) Who suffers more frequently from migraine headaches? See Answer

Which drugs or supplements interact with zolmitriptan?

Monoamine oxidase inhibitors, for example, isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and procarbazine (Matulane)) may exaggerate the effects of zolmitriptan.

Zolmitriptan directly stimulates serotonin receptors on nerves.

Serotonin reuptake inhibitors (SSRIs) that are used for treating depression, for example, fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft), enhance the effects of serotonin by preventing its uptake by nerves.

Therefore, the combination of zolmitriptan and an SSRI may lead to exaggerated effects of serotonin, and has been reported to cause weakness, increased reflexes, and loss of coordination.

Zomig Tablets 2.5mg

This information is intended for use by health professionals

Each tablet contains 2.5 mg of zolmitriptan.

Excipient(s) with known effect

Each tablet contains 100 mg lactose anhydrous.

For the full list of excipients, see Section 6.1.

Zomig is indicated for the acute treatment of migraine with or without aura.

Posology

The recommended dose of Zomig to treat a migraine attack is 2.5 mg.

If symptoms persist or return within 24 hours, a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose.

If a patient does not achieve satisfactory relief with 2.5 mg doses, subsequent attacks can be treated with 5 mg doses of Zomig.

  • In those patients who respond, significant efficacy is apparent within 1 hour of dosing.
  • Zomig is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that Zomig is taken as early as possible after the onset of migraine headache.
  • In the event of recurrent attacks, it is recommended that the total intake of Zomig in a 24 hour period should not exceed 10 mg.
  • Zomig is not indicated for prophylaxis of migraine.
  • Paediatric population (under 12 years of age)

The safety and efficacy of Zomig tablets in children aged 0-12 years has not yet been established. No data are available. Use of Zomig in children is therefore not recommended.

Adolescents (12 – 17 years of age)

The efficacy of Zomig tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of Zomig tablets in adolescents is therefore not recommended.

  1. Elderly
  2. Safety and efficacy of Zomig in individuals aged over 65 years have not been systematically evaluated.
  3. Hepatic impairment

Metabolism is reduced in patients with hepatic impairment (see Section 5.2). Therefore for patients with moderate or severe hepatic impairment a maximum dose of 5 mg in 24 hours is recommended.

Renal impairment

No dosage adjustment required (see Section 5.2).

Method of administration

To be taken by oral administration.

• Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.

  • • Uncontrolled hypertension.
  • • Ischaemic heart disease.
  • • Coronary vasospasm/Prinzmetal's angina.
  • • A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
  • • Concomitant administration of Zomig with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.

Zomig should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions.

There are no data on the use of Zomig in hemiplegic or basilar migraine. Migraineurs may be at risk of certain cerebrovascular events.

Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists.

Zomig should not be given to patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathways.

In very rare cases, as with other 5HT 1B/1D agonists, coronary vasospasm, angina pectoris and myocardial infarction have been reported.

In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with this class of compounds, including Zomig, is recommended (see Section 4.3).

These evaluations, however, may not identify every patient who has cardiac disease, and in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

As with other 5HT 1B/1D agonists, atypical sensations over the precordium (see Section 4.8) have been reported after the administration of zolmitriptan. If chest pain or symptoms consistent with ischaemic heart disease occur, no further doses of zolmitriptan should be taken until after appropriate medical evaluation has been carried out.

As with other 5HT1B/1D agonists transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.

Budete mít zájem:  Achondroplázie – porucha růstu kostí – příznaky, příčiny a léčba

As with other 5HT1B/1D agonists, there have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving Zomig.

Zomig: Uses, Side Effects & Dosage Guide – Drugs.com

Generic Name: zolmitriptan (oral) (ZOLE mi TRIP tan)Brand Names: Zomig, Zomig-ZMT

Medically reviewed by Drugs.com. Last updated on Oct 24, 2019.

What is Zomig?

Zomig (zolmitriptan) is a headache medicine that narrows 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.

Zomig is used to treat migraine headaches in adults.

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

Zomig should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, 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.

Important information

You should not use Zomig if you have uncontrolled high blood pressure, heart problems, certain heart rhythm disorders, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Do not use Zomig if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not take Zomig 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).

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).

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

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

Before taking this medicine

You should not use Zomig if you are allergic to zolmitriptan, or if you have:

  • coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
  • a history of heart disease, heart attack, or stroke, including ‚mini-stroke‘;
  • Wolff-Parkinson-White syndrome;
  • severe or uncontrolled high blood pressure;
  • a blood vessel disorder or circulation problems that cause a lack of blood supply within the body; or
  • a headache that seems different from your usual migraines.

Do not use Zomig if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure Zomig is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, or a heart rhythm disorder;
  • epilepsy or seizures;
  • liver or kidney disease;
  • a condition for which you take cimetidine (Tagamet); 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).

Zomig disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of zolmitriptan if you have phenylketonuria (PKU).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether zolmitriptan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Zomig is not approved for use by anyone younger than 18 years old.

How should I take Zomig?

Take Zomig exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

  • Use Zomig as soon as you notice migraine symptoms.
  • Take the regular tablet whole with a full glass of water.
  • To take the orally disintegrating tablet (Zomig-ZMT):
  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
  • Use dry hands to remove the tablet and place it in your mouth.
  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet 2 hours after the first. Do not take more than 10 mg of zolmitriptan in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Call your doctor if your headache does not go away at all after taking the first Zomig tablet.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse.

Contact your doctor if you have more than four headaches in one month (30 days). Tell your doctor if this medicine seems to stop working as well in treating your migraine attacks.

Zomig can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using this medicine. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Budete mít zájem:  Pompeho choroba – příznaky, příčiny a léčba

Store at room temperature away from moisture, heat, and light.

Zomig dosing information

Usual Adult Dose for Migraine:

Zolmitriptan

This article needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed.Find sources: ‚Zolmitriptan‘ – news · newspapers · books · scholar · JSTOR (August 2009) (Learn how and when to remove this template message)

ZolmitriptanClinical dataTrade namesZomig, othersAHFS/Drugs.comMonographMedlinePlusa601129License data

  • US DailyMed: Zolmitriptan

Pregnancycategory

  • AU: B3
  • US: C (Risk not ruled out)

Routes ofadministrationBy mouth, nasal sprayATC code

  • N02CC03 (WHO)

Legal statusLegal status

  • US: ℞-only

Pharmacokinetic dataBioavailability40% (oral)Protein binding25%MetabolismLiver (CYP1A2-mediated, to active metabolite)Elimination half-life3 hoursExcretionKidney (65%) and fecal (35%)IdentifiersIUPAC name

  • (S)-4-({3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl}methyl)-1,3-oxazolidin-2-one

CAS Number

  • 139264-17-8 Y

PubChem CID

  • 60857

IUPHAR/BPS

  • 60

DrugBank

  • DB00315 Y

ChemSpider

  • 54844 Y

UNII

  • 2FS66TH3YW

KEGG

  • D00415 Y

ChEBI

  • CHEBI:10124 Y

ChEMBL

  • ChEMBL1185 Y

CompTox Dashboard (EPA)

  • DTXSID8045933

ECHA InfoCard100.158.186 Chemical and physical dataFormulaC16H21N3O2Molar mass287.363 g·mol−13D model (JSmol)

  • Interactive image

SMILES

InChI

  • InChI=1S/C16H21N3O2/c1-19(2)6-5-12-9-17-15-4-3-11(8-14(12)15)7-13-10-21-16(20)18-13/h3-4,8-9,13,17H,5-7,10H2,1-2H3,(H,18,20)/t13-/m0/s1 Y
  • Key:ULSDMUVEXKOYBU-ZDUSSCGKSA-N Y

  (verify)

Zolmitriptan, sold under the brand name Zomig among others, is a triptan used in the acute treatment of migraine attacks with or without aura and cluster headaches. It is a selective serotonin receptor agonist of the 1B and 1D subtypes.

It was patented in 1990 and approved for medical use in 1997.[1]

Medical uses

Zolmitriptan is used for the acute treatment of migraines with or without aura in adults. Zolmitriptan is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine.

Zolmitriptan is available as a swallowable tablet, an oral disintegrating tablet, and a nasal spray, in doses of 2.5 and 5 mg. People who get migraines from aspartame should not use the disintegrating tablet (Zomig ZMT), which contains aspartame.[2]

According to a study of healthy volunteers, food intake seems to have no significant effect on the effectiveness of Zolmitriptan in both men and women.[3]

Contraindications and precautions

  • Zolmitriptan should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's angina, or other significant underlying cardiovascular disease.

Zomig (Zolmitriptan): Uses, Dosage, Side Effects, Interactions, Warning

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Myocardial Ischemia, Myocardial Infarction, And Prinzmetal Angina

ZOMIG is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD).

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of ZOMIG. Some of these reactions occurred in patients without known CAD.

5-HT1 agonists including ZOMIG may cause coronary artery vasospasm (Prinzmetal Angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving ZOMIG. Do not administer ZOMIG if there is evidence of CAD or coronary artery vasospasm [see CONTRAINDICATIONS].

For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first ZOMIG dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following ZOMIG administration.

For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZOMIG.

Arrhythmias

Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT1 agonists.

Discontinue ZOMIG if these disturbances occur.

ZOMIG is contraindicated in patients with Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see CONTRAINDICATIONS].

Chest, Throat, Neck and Jaw Pain/Tightness/Pressure

As with other 5-HT1 agonists, sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with ZOMIG and is usually non-cardiac in origin.

However, perform a cardiac evaluation if these patients are at high cardiac risk.

5-HT1 agonists including ZOMIG are contraindicated in patients with CAD or Prinzmetal's variant angina [see CONTRAINDICATIONS].

Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not.

As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, exclude other potentially serious neurological conditions. ZOMIG is contraindicated in patients with a history of stroke or transient ischemic attack [see CONTRAINDICATIONS].

Other Vasospasm Reactions

5-HT1 agonists, including ZOMIG, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional ZOMIG doses [see CONTRAINDICATIONS].

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.

Medication Overuse Headache

Diskuze

Vaše emailová adresa nebude zveřejněna. Vyžadované informace jsou označeny *