ALMOTRIPTAN MALATE PDF

Axert has been approved by the FDA for the acute treatment of migraine with or without aura in adults. Axert belongs to a class of drugs known as selective serotonin receptor agonists. These drugs target serotonin receptors and act against migraine headaches by inducing the constriction of blood vessels surrounding the brain. Migraine attacks are characterized by severe unilateral head pain, which lasts between four and 72 hours. Approximately 28 million Americans suffer from migraine headaches, with women experiencing migraines at least three times more often than men.

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Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Oral serotonin agonist for migraine; similar to sumatriptan, but with a higher patient acceptability rating regarding ADRs; FDA approved in adults and pediatrics 12—17 years of age. If the headache returns, the dose may be repeated after 2 hours. Controlled trials have not adequately established the effectiveness of a second dose if the initial dose is ineffective.

Single doses more than The safety of treating more than 4 headaches in a day period has not been established. Efficacy for migraine associated symptoms such as nausea, photophobia, and phonophobia has not been established. Intermittent hemodialysis See dosage for renal impairment. It is not known whether hemodialysis removes almotriptan from plasma.

Peritoneal dialysis The effects of peritoneal dialysis on plasma concentrations of almotriptan are unknown. Avoid or use with caution with other serotonergic drugs to prevent serotonin syndrome see Drug Interactions. Generic: - Store at 77 degrees F; excursions permitted to degrees F Axert: - Store at 77 degrees F; excursions permitted to degrees F.

Almotriptan is contraindicated in patients with known hypersensitivity to almotriptan or any of its ingredients. Because the chemical structure of almotriptan contains a sulfonyl group, caution is recommended when administering almotriptan to patients with a sulfonamide hypersensitivity.

It should be noted that cross-sensitivity to almotriptan in patients allergic to sulfonamides has not been formally evaluated by the manufacturer.

Rare, but serious adverse cardiac effects, including heart attacks, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours of receiving 5-HT1 agonists.

Many of these patients had concurrent cardiovascular risk factors; therefore, it is difficult to assess causality. Almotriptan and other 5-HT1 agonists may cause coronary vasospasm, and therefore are contraindicated in patients with coronary artery disease CAD , angina pectoris, vasospastic angina such as Prinzmetal's variant angina, silent myocardial ischemia, history of myocardial infarction, or other significant underlying cardiac disease.

Patients with CAD risk factors e. Patients who are long-term users of almotriptan and who have or acquire risk factors predictive of CAD should undergo periodic cardiac evaluation.

For patients with risk factors predictive of CAD who are determined to have a satisfactory cardiac evaluation, the first dose of almotriptan should be given in a controlled setting such as a clinic or physician's office. ECG monitoring is strongly encouraged due to the possibility of asymptomatic cardiac ischemia during the time immediately following almotriptan administration in patients with risk factors. In addition, patients with cardiac arrhythmias should not receive almotriptan as rhythm disturbances have been reported with the use of 5-HT1 agonists.

Patients with symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other cardiac accessory conduction pathway disorders should not receive almotriptan because serious cardiac events have been reported within a few hours of receiving 5-HT1 agonists.

Almotriptan is contraindicated in uncontrolled hypertension. Serotonin agonists can produce an increase in blood pressure in patients with and without a history of hypertension.

Patients with controlled hypertension may experience mild and transient elevations in blood pressure. Almotriptan is contraindicated in patients with cerebrovascular disease, including stroke or history of transient ischemic attack. Intracranial hemorrhage, intracranial bleeding, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT1 agonists; some have resulted in fatal events.

In these cases, cerebrovascular events may have preceded administration of the 5-HT1 agonist. Patients with migraine may be at increased risk of certain cerebrovascular events e.

Almotriptan should be used with caution in geriatric patients with migraine. Elderly patients are more likely to have unrecognized risk factors for coronary artery disease than younger adults. Clearance of almotriptan is lower in elderly volunteers than in younger individuals, but there are no observed differences in the safety and tolerability between the two populations; however, sufficient numbers of elderly patients receiving almotriptan have not been studied.

In general, dosage selection for almotriptan should be cautious, usually starting at the lower end of the adult dosage range. Almotriptan should be used cautiously in patients with hepatic disease. Almotriptan should be used cautiously in patients with renal impairment renal disease or renal failure.

Patients with severe renal impairment require dosage reduction. Almotriptan is contraindicated in patients with peripheral vascular disease, including but not limited to ischemic bowel disease ischemic colitis.

Almotriptan may cause vasospastic reactions other than coronary artery vasospasm, such as peripheral and gastrointestinal vascular ischemia with abdominal pain and bloody diarrhea. Rare reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1-agonists. Visual disorders may also be part of a migraine attack.

Patients who experience signs or symptoms suggestive of decreased arterial flow, such as Raynaud's phenomenon or ischemic bowel syndrome, after the use of almotriptan should be further evaluated. Patients should be warned to avoid driving or operating machinery until they know how almotriptan affects them.

The safety and efficacy of almotriptan have not been established in neonates, infants, or children less than 12 years of age. Post-marketing experience with other 'triptans' include a limited number of reports that describe pediatric patients who have experienced serious adverse events that are similar in nature to rare adverse events reported in adults.

Almotriptan is classified as FDA pregnancy risk category C. There have been no adequate and well controlled studies in pregnant women; therefore, almotriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known if almotriptan crosses the placenta, but the low molecular weight and minimal protein binding of the drug suggest that placental transfer in humans is likely. In animal studies, almotriptan produced developmental toxicity increased embryolethality, fetal skeletal variations decreased ossification , and decreased offspring body weight at doses greater than those used clinically.

During administration to rats throughout gestation and lactation, gestation length was increased and litter size and offspring body weight were decreased at the highest dose. The decrease in pup weight persisted throughout lactation.

Patients should be instructed to notify their physician if they become pregnant or intend to become pregnant during treatment with almotriptan. The effects of almotriptan during labor and delivery are unknown. Use caution when administering almotriptan to a breast-feeding woman. Almotriptan is excreted into the breast milk of lactating rats, however, it is not known if almotriptan is distributed into human breast milk. In rats, concentrations of almotriptan were up to 7 times higher in breast milk compared to plasma.

During administration of almotriptan to rats throughout gestation and lactation, pup weight was decreased at the highest dose, and the decrease in weight persisted throughout lactation. Low molecular weight and low protein binding suggest the drug will be excreted into human breast milk. Pumping or expressing breast milk and discarding it after a dose would help to avoid maximum infant exposure to almotriptan.

Additionally, almotriptan is typically given as a 1 or 2 time dose, which may lessen infant risk. Sumatriptan is classified as compatible with breast-feeding by the American Academy of Pediatrics and may be considered as an alternative to almotriptan for the acute treatment of migraines in breast-feeding mothers.

Acetaminophen; Butalbital; Caffeine; Codeine: Moderate Serotonin syndrome can occur during concomitant use of opiate agonists with serotonergic drugs, such as serotonin-receptor agonists. Symptoms may occur hours to days after concomitant use, particularly after dose increases.

Serotonin syndrome may occur within recommended dose ranges. Inform patients taking this combination of the possible increased risk and monitor for the emergence of serotonin syndrome.

Discontinue all serotonergic agents and initiate symptomatic treatment if serotonin syndrome occurs. Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result.

Serotonin syndrome can be serious and consists of symptoms such as mental status changes, diaphoresis, tremor, myoclonus, hyperreflexia, and fever. Patients receiving serotonergic drugs in combination should be informed of the signs and symptoms of serotonin syndrome. Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result.

Acetaminophen; Codeine: Moderate Serotonin syndrome can occur during concomitant use of opiate agonists with serotonergic drugs, such as serotonin-receptor agonists. Acetaminophen; Dextromethorphan: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result. Acetaminophen; Dextromethorphan; Doxylamine: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result.

Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result.

Acetaminophen; Dextromethorphan; Phenylephrine: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result. Acetaminophen; Dextromethorphan; Pseudoephedrine: Moderate Dextromethorphan inhibits serotonin reuptake and therefore should be used cautiously with serotonin-receptor agonists as serotonin syndrome may result.

Acetaminophen; Hydrocodone: Moderate Serotonin syndrome can occur during concomitant use of opiate agonists with serotonergic drugs, such as serotonin-receptor agonists. Acetaminophen; Oxycodone: Moderate Serotonin syndrome can occur during concomitant use of opiate agonists with serotonergic drugs, such as serotonin-receptor agonists.

Acetaminophen; Tramadol: Moderate Caution is advised when tramadol is coadministered with serotonin-receptor agonists because of the potential for serotonin syndrome. If concomitant treatment of tramadol and a serotonin-receptor agonist is clinically warranted, careful observation of the patient is advised, especially during the initial time both drugs are used together and during a dose increase of either tramadol or the serotonin-receptor agonist. Amitriptyline: Moderate Tricyclic antidepressants TCAs should be used cautiously with drugs that also augment serotonin, like the serotonin-receptor agonists "triptans" used for the treatment of migraine.

Additive effects may occur, and the risk of serotonin syndrome may be increased. Tricyclic antidepressants inhibit norepinephrine and serotonin uptake, but rarely cause serotonin syndrome when used alone.

However, the risk may be increased when combined with other serotonergic agents, especially at times of antidepressant dose increases. Amitriptyline; Chlordiazepoxide: Moderate Tricyclic antidepressants TCAs should be used cautiously with drugs that also augment serotonin, like the serotonin-receptor agonists "triptans" used for the treatment of migraine.

Amoxicillin; Clarithromycin; Lansoprazole: Moderate The maximum recommended starting dose of almotriptan is 6. Concomitant use of almotriptan and clarithromycin should be avoided in patients with renal or hepatic impairment. Amoxicillin; Clarithromycin; Omeprazole: Moderate The maximum recommended starting dose of almotriptan is 6.

Amphetamine: Moderate Serotonin syndrome may occur during coadministration of serotonergic drugs such as amphetamines and serotonin-receptor agonists. At high doses, amphetamines can increase serotonin release, as well as act as serotonin agonists. Although unlikely to occur during monotherapy with serotonin-receptor agonists or "triptans" , serotonin syndrome may occur from combining these drugs with other medications that potentiate serotonin activity.

Inform patients taking this combination of the possible increased risk and monitor for the emergence of serotonin syndrome particularly after a dose increase or the addition of other serotonergic medications to an existing regimen.

Discontinue all serotonergic agents if serotonin syndrome occurs and implement appropriate medical management. Amphetamine; Dextroamphetamine Salts: Moderate Serotonin syndrome may occur during coadministration of serotonergic drugs such as amphetamines and serotonin-receptor agonists. Amphetamine; Dextroamphetamine: Moderate Serotonin syndrome may occur during coadministration of serotonergic drugs such as amphetamines and serotonin-receptor agonists.

Aprepitant, Fosaprepitant: Moderate Use caution if almotriptan and aprepitant, fosaprepitant are used concurrently and monitor for an increase in almotriptan-related adverse effects for several days after administration of a multi-day aprepitant regimen. Almotriptan is a CYP3A4 substrate.

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Axert (almotriptan malate) tablets

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Oral serotonin agonist for migraine; similar to sumatriptan, but with a higher patient acceptability rating regarding ADRs; FDA approved in adults and pediatrics 12—17 years of age. If the headache returns, the dose may be repeated after 2 hours. Controlled trials have not adequately established the effectiveness of a second dose if the initial dose is ineffective.

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