Treatment of the cephalalgic phase of migraine attack with or without aura

The tablet of almotriptan should be taken with water as early as possible after the onset of the migraine headache crisis but it is also effective when taken at a later stage. >

The tablet of almotriptan should not be used for prophylaxis.

The tablets may be taken with or without food.
Adult (18 to 65 years old)

The recommended dosage is one tablet of 12.5 mg of almotriptan.

If the symptoms of migraine reappear within 24 hours, a second tablet may be taken, provided that an interval of at least 2 hours between the two is taken.
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The efficacy of a second dose for the treatment of the same seizure when the first dose has not been effective has not been studied in clinical trials. Therefore, if a patient does not respond to the first dose, a second dose should not be taken for the same crisis.
The maximum recommended dose is two tablets per 24 hours.
Child and adolescent (under 18 years old)

There are no data on the use of almotriptan in children and adolescents. Therefore, its use in this age class is not recommended.

Elderly Patient (over 65 years old)

No dose adjustment is required for the elderly patient. The safety and efficacy of almotriptan have not been systematically evaluated in patients over the age of 65.
Renal impairment

No dosage adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment should not take more than one 12.5 mg tablet of almotriptan per 24 hours.
Insufficient hepatic

There are no data on the use of almotriptan in patients with hepatic impairment (see sections 4.3 and 4.4). >

Rounded, biconvex, white to whitish engraved tablet, "M" on one side and "AL2" on the other.

Antimigraine / Selective 5HT1 receptor agonists

ATC Code: N02CC05.

Mechanism of Action

Almotriptan is a selective agonist of 5HT 1B and 5HT 1D receptors. These receptors are involved in the vasoconstriction of certain blood vessels, intracranial as has been demonstrated in studies conducted on isolated human tissue preparations. >
Almotriptan also interacts with the trigeminal vascular system which inhibits the release of plasma proteins from the dura mater vessels associated with ganglion stimulation, which triggers neuronal inflammation and appears to be involved in the pathophysiology of The migraine

Almotriptan has no significant activity on other 5HT receptor subtypes nor at adrenaline binding sites: adenosine, angiotensin, dopamine, endothelin or tachykinin .

Pharmacodynamic effects

The efficacy of almotripan in the treatment of the migraine attack was established in four multi-center, placebo-controlled clinical trials including more than 700 patients administered 12.5 mg of almotriptan. The reduction in pain began 30 minutes after administration and the percentage of response (from severe to moderate to severe headache, mild to absent) after 2 hours was 57-70% with almotriptan and 32-42% with placebo. In addition, almotriptan decreased nausea, photophobia and phonophobia associated with the migraine attack.


However, as somnolence may occur during a migraine attack and has also been reported as an undesirable effect of almotriptan therapy, caution is advised in patients performing tasks requiring A certain skill.

Hypersensitivity to almotriptan or to any of the excipients listed in the section
As with other 5-hydroxytryptamine receptor agonists (5HT 1B / 1D), almotriptan should not be used in patients with a history of, symptoms or signs of ischemic heart disease ( Infectious myocardial infarction, angina pectoris, documented silent ischemia, Prinzmetal angina) or with hypertension, severe or benign or moderate uncontrolled hypertension
Almotriptan should not be used in patients with a history of stroke, stroke (CTA), ischemic stroke, transient (TIA), or in patients with peripheral vascular disease

Concomitant administration of almotriptan with ergotamine, ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine receptor agonists (5HT 1B / 1D) is contraindicated.

The administration of almotriptan is contraindicated in patients with severe hepatic impairment (see section 4.2).

Almotriptan should only be used after a certain diagnosis of migraine has been established.
It should not be used for the treatment of hemiplegic, basilar or ophthalmoplegic migraines

As with other treatments of migraine attack, before treating headaches of patients without prior diagnosis of migraine or migraine patients presenting with atypical symptoms it is necessary to exclude other pathologies, potentially severe neurological . Cerebrovascular accidents have been reported in patients treated with 5HT 1B / 1D receptor agonists. It should be noted that migraineurs may present an increased risk of occurrence of certain vascular and cerebral events (eg, stroke or TIA).


However, this assessment may not identify all patients who have cardiovascular disease and, in very rare cases, severe cardiac events have occurred in patients without disease, underlying cardio-vascular Agonist intake, 5HT 1B / 1D.

Following administration, the intake of almotriptan may be associated with transient symptoms including chest pain or an intense feeling of tightness that may extend into the throat (see also section Effects, undesirable Undesirable effects). If the symptom is suggestive of cardiac ischemia, additional doses of almotriptan should not be taken and appropriate investigations should be carried out.
Particular attention should be paid when prescribing almotriptan in patients with known hypersensitivity to sulphonamides.

A serotonergic syndrome (including mental disorders, system dysfunction, autonomic nervous system and neuromuscular abnormalities) has been reported after concomitant treatment with triptans, and selective serotonin reuptake inhibitors (SSRIs) or recapture inhibitors; Serotonin and noradrenaline (IRSN). These reactions can be severe. If concomitant treatment with almotriptan and an SSRI or SNRI is clinically justified, appropriate monitoring of the patient is advised, particularly at the initiation of treatment, increase in doses, or with the addition of another drug Serotonin (see section Interactions with other medicinal products and other forms of interactions)

It is recommended to wait at least 6 hours after administration of almotriptan to administer an ergotamine product. A delay of at least 24 hours must be respected after administration of a medicine containing ergotamine before giving almotriptan. Although an increased risk of vasospasm was not observed in the clinical trial, including 12 healthy subjects receiving oral almotriptan and ergotamine, such a risk is theoretically possible (see Also in the section Contraindications, Contra-indications)

Patients with severe renal insufficiency should not take more than one tablet at 12.5 mg of almotriptan over 24 hours.

Special attention is recommended for patients with mild to moderate hepatic insufficiency. Treatment with almotriptan is contraindicated in patients with severe hepatic impairment (see Pharmacokinetic properties, Pharmacokinetic properties).

The frequency of undesirable effects can be increased by combining triptans with preparations containing St. John's wort (Hypericum perforatum).


Drug Abuse Headache (MAC): The prolonged use of an analgesic treatment to treat headaches can lead to an aggravation of these headaches. In such cases or cases of suspicion, medical advice is required and treatment should be discontinued. The diagnosis of drug abuse headache (MAC) should be suspected in patients with frequent or daily headache, despite (or because of) regular use of an antimigraine treatment.

The maximum recommended dosage of almotriptan should not be exceeded

Interaction studies have been conducted with monoamine oxidase A inhibitors, beta-blockers, selective serotonin reuptake inhibitors, calcium channel blockers and with inhibitors of cytochrome 3A4 and 2D6 isoenzymes P450. There have been no studies and in vivo interaction studies to assess the effect of almotriptan on other drugs
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As with all 5HT1B / 1D receptor agonists, the potential risk of a serotonin syndrome due to a pharmacodynamic interaction in the concomitant treatment with MAOI is a possibility that can not be ruled out. >

Cases of patients with symptoms consistent with a serotonin syndrome (including consecutive disorders of consciousness, dysautonomia and neuromuscular disorders), the combination of selective serotonin (SSRI) inhibitors or recapture inhibitors , Noradrenaline serotonin (IRSNs) and triptans have been described (see Warnings and Precautions for Use)

Repeated administration of a calcium channel inhibitor, verapamil, the cytochrome CYP3A4 substrate, resulted in a 20% increase in C max and in the area under the almotriptan curve. This increase was not considered clinically relevant. No clinically relevant interactions were observed.

Repeated administration of propranolol did not influence the pharmacokinetics of almotriptan No clinically relevant interaction was observed


Not applicable.

No cases of overdose have been reported.
The most common adverse reaction in patients receiving 150 mg of almotriptan (the highest dose that was administered to patients) was somnolence.

The effects associated with an overdose should be treated in a manner and symptoms and vital functions should be maintained. As the half-life is about 3.5 hours, patient monitoring should be maintained for at least 12 hours or as long as symptoms or signs of overdose persist.

Pregnancy

Very limited data are available on almotriptan pregnancies. Experimental studies in animals have shown no direct or indirect deleterious effects on pregnancy, development, embryo-fetal, on childbirth or on postnatal development (see section on safety data Preclinical).

Particular attention should be paid when prescribing almotriptan during pregnancy

Breastfeeding

There are no data concerning the excretion of almotriptan in human milk. Studies in lactating spleen showed that almotriptan and / or its related metabolites were excreted in milk.


Almotriptan has been evaluated on more than 2700 patients in clinical trials up to one year. The most frequent adverse effects at the dose were: dizziness, drowsiness, nausea, vomiting and fatigue. None of these adverse reactions occurred more than 1.5%.



Frequencies are defined as follows: very common (≥1 / 10), frequent (≥1 / 100 -