Almotriptan

Talk to your doctor about drinking grapefruit juice while taking this medicine.

• Axert^®

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and  herbal supplements. Especially tell your doctor if you take:

• monoamine oxidase (MAO) inhibitors, such as phenelzine sulfate (Nardil) or tranylcypromine sulfate (Parnate) for depression or another condition, or if it has been less than two weeks since you stopped taking an MAO inhibitor.
• ketoconazole (Nizoral), itraconazole (Sporanox), ritonavir (Norvir), or erythromycin (Emycin), or if it has been less than one week since you stopped taking one of these drugs.
• selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are Celexa (citalopram HBr), Lexapro (escitalopram oxalate), Paxil (paroxetine), Prozac/Sarafem (fluoxetine), Symbyax (olanzapine/fluoxetine), Zoloft (sertraline), and fluvoxamine. Common SNRIs are Cymbalta (duloxetine) and Effexor (venlafaxine).

These medicines may affect how almotriptan works, or almotriptan may affect how these medicines work. This is not a complete list of almotriptan drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and  herbal supplements. 

Before receiving almotriptan, tell your doctor about all of your medical conditions including:

• past or present medical problems
• past or present high blood pressure, chest pain, shortness of breath, or heart disease
• liver or kidney problems
• high blood pressure
• diabetes
• high cholesterol
• overweight
• smoking
• family members with heart disease
• you are past menopause
• you are a male over 40 years old
• allergic reactions to sulfonamides, also known as sulfa drugs or other allergies

Talk to your doctor about using almotriptan if you are pregnant, planning to become pregnant, or breastfeeding.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

• When you have a migraine headache, take your medicine as directed by your doctor.
• If your headache comes back after your first dose, you may take a second dose 2 hours or more after the first dose. If your pain continues after the first dose, do not take a second dose without first checking with your doctor.
• Do not take more than two almotriptan tablets in a 24-hour period.
• If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

If you take too much almotriptan, call your local Poison Control Center or seek emergency medical attention right away.

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

Do not take almotriptan within 24 hours before or after using another migraine headache medicine.

Stop using almotriptan and get emergency medical help if you have: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating, and a light-headed feeling.

You should not take almotriptan if you are allergic to it, or if you have:

• severe or uncontrolled high blood pressure;

• past or present heart problems;

• history of coronary artery disease, angina, (chest pain), heart attack, or stroke, including "mini-stroke";

• 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 migraine headaches.

To make sure almotriptan is safe for you, tell your doctor if you have ever had:

• a sulfa drug allergy;

• liver or kidney disease;

• kidney disease;

• high blood pressure, a heart rhythm disorder; or

• risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of heart disease, or being older than 40 and a man).

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 almotriptan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 12 years old.

Since almotriptan is used as needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using almotriptan.

Almotriptan is used to treat acute migraine headaches in adults and teenagers. It is not used to prevent migraine headaches and is not used for cluster headaches. Almotriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

Almotriptan is not an ordinary pain reliever. It will not help with any kind of pain other than migraine headaches. almotriptan is usually used in people whose headaches are not helped or relieved by acetaminophen (Tylenol®), aspirin, or other pain relievers.

almotriptan is available only with your doctor's prescription.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Headache.
• Dry mouth.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about almotriptan, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about almotriptan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using almotriptan.

Review Date: October 4, 2017

Almotriptan malate tablets are available as white, film-coated, round, convex tablets in the following strengths:

6.25 mg tablet debossed with “93” on one side and “A1” on the other side

12.5 mg tablet debossed with “93” on one side and “A2” on the other side

Adults

The efficacy of Almotriptan malate was established in three multi-center, randomized, double-blind, placebo-controlled European trials. Patients enrolled in these studies were primarily female (86%) and Caucasian (more than 98%), with a mean age of 41 years (range of 18 to 72). Patients were instructed to treat a moderate to severe migraine headache. Two hours after taking one dose of study medication, patients evaluated their headache pain. If the pain had not decreased in severity to mild or no pain, the patient was allowed to take an escape medication. If the pain had decreased to mild or no pain at 2 hours but subsequently increased in severity between 2 and 24 hours, it was considered a relapse and the patient was instructed to take a second dose of study medication. Associated symptoms of nausea, vomiting, photophobia, and phonophobia were also evaluated.

In these studies, the percentage of patients achieving a response (mild or no pain) 2 hours after treatment was significantly greater in patients who received either Almotriptan 6.25 mg or 12.5 mg, compared with those who received placebo. A higher percentage of patients reported pain relief after treatment with the 12.5 mg dose than with the 6.25 mg dose. Doses greater than 12.5 mg did not lead to a significantly better response. These results are summarized in Table 3.

The estimated probability of achieving pain relief within 2 hours following initial treatment with Almotriptan malate in adults is shown in Figure 1.

Figure 1. Estimated Probability of Achieving an Initial Headache Response (Mild or no Pain) in 2 Hours in Adults

This Kaplan-Meier plot is based on data obtained in the three placebo-controlled clinical trials that provided evidence of efficacy (Studies 1, 2, and 3). Patients not achieving pain relief by 2 hours were censored at 2 hours.

For patients with migraine-associated photophobia, phonophobia, nausea, and vomiting at baseline, there was a decreased incidence of these symptoms following administration of Almotriptan malate compared with placebo.

Two to 24 hours following the initial dose of study medication, patients were allowed to take an escape medication or a second dose of study medication for pain response. The estimated probability of patients taking escape medication or a second dose of study medication over the 24 hours following the initial dose of study medication is shown in Figure 2.

Figure 2. Estimated Probability of Adult Patients Taking Escape Medication or a Second Dose of Study Medication Over the 24 Hours Following the Initial Dose of Study Treatment

This Kaplan-Meier plot is based on data obtained in the three placebo-controlled trials that provided evidence of efficacy (Studies 1, 2, and 3). Patients not using additional treatment were censored at 24 hours. Remedication was not allowed within 2 hours after the initial dose of Almotriptan malate.

The efficacy of Almotriptan malate was unaffected by the presence of aura; by gender, weight, or age of the patient; or by concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, and tricyclic antidepressants); or oral contraceptives. There were insufficient data to assess the effect of race on efficacy.

Adolescents Age 12 to 17 Years

The efficacy of Almotriptan malate in adolescent patients age 12 to 17 years was evaluated in a double-blind, randomized, placebo-controlled, study. Patients enrolled in that study had at least a 1-year history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). Patients enrolled in the study were primarily females (60%) and Caucasian (75%), while 15% of patients were black, and 10% were of other races. Patients were instructed to treat a moderate to severe migraine headache. Two hours after taking one dose of study medication, patients evaluated their headache pain. Associated symptoms of nausea, photophobia, and phonophobia were also evaluated.

In this study, the percentage of patients achieving a pain relief response (mild or no pain) 2 hours after treatment was statistically significantly greater in patients who received Almotriptan 6.25 mg or 12.5 mg compared with those who received placebo. There was no additional benefit on pain relief provided by the 12.5 mg dose. The 2-hour pain relief results are summarized in Table 4.

The estimated probability of achieving pain relief within 2 hours following initial treatment with Almotriptan malate in adolescents age 12 to 17 years is shown in Figure 3.

Figure 3. Estimated Probability of Achieving an Initial Headache Response (Mild or no Pain) in 2 Hours in the Adolescent Study

The prevalence of the migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose was not significantly different between patients who received Almotriptan 6.25 mg or 12.5 mg and those who received placebo.

May be taken without regard to meals.

1% to 10%:

Central nervous system: Drowsiness (≤5%), dizziness (≤4%), headache (≤2%)

Gastrointestinal: Nausea (1% to 3%), vomiting (≤2%), xerostomia (1%)

Neuromuscular & skeletal: Paresthesia (≤1%)

<1% (Limited to important or life-threatening): Anaphylactic shock, anaphylaxis, angina pectoris, angioedema, colitis, coronary artery vasospasm, hemiplegia, hypersensitivity reaction, hypertension, ischemic heart disease, mastalgia, myocardial infarction, neuropathy, seizure, skin rash, syncope, tachycardia, ventricular fibrillation, ventricular tachycardia

Dosage Forms & Strengths

tablet

• 6.25mg
• 12.5mg

Migraine

Indicated for acute treatment of migraine attacks in patients with a history of migraine with or without aura

Initial 6.25-12.5 mg PO at onset; may repeat once after 2 hours

Not to exceed 25 mg/day

Renal Impairment, Severe

CrCl <30 mL/min: Initial 6.25 mg PO

Not to exceed 12.5 mg/day

Hepatic Impairment

Initial: 6.25 mg PO

Not to exceed 12.5 mg/day

Dosage Forms & Strengths

tablet

• 6.25mg
• 12.5mg

Migraine

Indicated for acute treatment of migraine headache pain in adolescents with a history of migraine attacks with or without aura usually lasting ≥4 hr (when untreated)

<12 years: Safety and efficacy not established

≥12 years: 6.25-12.5 mg PO at onset of headache; may repeat once after 2 hr

Not to exceed 25 mg/day

Migraine: See adult dosing

Substance Name

Almotriptan

CAS Registry Number

154323-57-6

Drug Class

Serotonin Agonists