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AXERT

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Overview

What is AXERT?

AXERT (almotriptan malate) Tablets contain almotriptan malate, a selective 5-hydroxytryptamine (5-HT) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine (±)-hydroxybutanedioate (1:1) and its structural formula is:

Its empirical formula is CHNOS-CHO, representing a molecular weight of 469.56. Almotriptan is a white to slightly yellow crystalline powder that is soluble in water. AXERT for oral administration contains almotriptan malate equivalent to 6.25 or 12.5 mg of almotriptan. Each compressed tablet contains the following inactive ingredients: carnauba wax, cellulose, FD&C Blue No. 2 (12.5 mg only), hypromellose, iron oxide (6.25 mg only), mannitol, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide.



What does AXERT look like?



What are the available doses of AXERT?

Tablets: 6.25 mg and 12.5 mg ()

What should I talk to my health care provider before I take AXERT?

How should I use AXERT?

AXERT is a 5HT receptor agonist (triptan) indicated for:

Important limitations:

The recommended dose of AXERT (almotriptan malate) in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. As individuals may vary in their response to different doses of AXERT, the choice of dose should be made on an individual basis.

If the headache is relieved after the initial AXERT dose but returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials. The maximum daily dose should not exceed 25 mg. The safety of treating an average of more than four migraines in a 30-day period has not been established.


What interacts with AXERT?

Sorry No Records found


What are the warnings of AXERT?

Sorry No Records found


What are the precautions of AXERT?

Sorry No Records found


What are the side effects of AXERT?

Sorry No records found


What should I look out for while using AXERT?

Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ()

Cerebrovascular syndromes (e.g., history of stroke or TIA) ()

Peripheral vascular disease (including ischemic bowel disease) ()

Uncontrolled hypertension ()

Do not use AXERT within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT agonist, e.g., another triptan (, )

Hemiplegic or basilar migraine ()

Known hypersensitivity to AXERT ()


What might happen if I take too much AXERT?


How should I store and handle AXERT?

AXERT (almotriptan malate) Tablets are available as follows:6.25 mg12.5 mgAXERT (almotriptan malate) Tablets are available as follows:6.25 mg12.5 mgAXERT (almotriptan malate) Tablets are available as follows:6.25 mg12.5 mg


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Almotriptan binds with high affinity to 5-HT, 5-HT, and 5-HT receptors. Almotriptan has weak affinity for 5-HT and 5-HTreceptors, but has no significant affinity or pharmacological activity at 5-HT, 5-HT, 5-HT, 5-HT; alpha or beta adrenergic; adenosine (A, A); angiotensin (AT, AT); dopamine (D, D); endothelin (ET, ET); or tachykinin (NK, NK, NK) binding sites.

Non-Clinical Toxicology
Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ()

Cerebrovascular syndromes (e.g., history of stroke or TIA) ()

Peripheral vascular disease (including ischemic bowel disease) ()

Uncontrolled hypertension ()

Do not use AXERT within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT agonist, e.g., another triptan (, )

Hemiplegic or basilar migraine ()

Known hypersensitivity to AXERT ()

As with all drugs, the potential for interaction by a variety of mechanisms is a possibility.

Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ()

It is strongly recommended that AXERT not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with AXERT use in the absence of known cardiovascular disease. If AXERT is considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physician's office setting ()

Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw: generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD ()

Cerebrovascular events, some fatal ()

Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g., Raynaud's syndrome) ()

Potentially life-threatening serotonin syndrome, particularly in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients for neurologic changes and gastrointestinal symptoms if concomitant treatment is clinically warranted (, )

Medication overuse headache: Detoxification may be necessary ()

Increase in blood pressure, very rarely associated with significant clinical events (, )

Use with caution in patients with a known hypersensitivity to sulfonamides ()

Serious cardiac reactions, including myocardial infarction, have occurred following the use of AXERT (almotriptan malate) Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation .

The following adverse reactions are discussed in more detail in other sections of the labeling:

Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of AXERT and 386 adult patients who received placebo. The most common adverse reactions during treatment with AXERT were nausea, somnolence, headache, paresthesia, and dry mouth. In long-term open-label studies where patients were allowed to treat multiple attacks for up to 1 year, 5% (63 out of 1347 patients) withdrew due to adverse experiences.

Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received AXERT and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with AXERT were dizziness, somnolence, headache, paresthesia, nausea, and vomiting. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to 1 year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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