Almotrex

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Almotrex uses


1 INDICATIONS AND USAGE

Almotrex® is a 5HT1B/1D receptor agonist indicated for:


Important limitations:

1.1 Acute Treatment of Migraine Attacks

Adults

Almotrex® (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.

Adolescents Age 12 to 17 Years

Almotrex® is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).

1.2 Important Limitations

Almotrex® should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with Almotrex®, the diagnosis of migraine should be reconsidered before Almotrex® is administered to treat any subsequent attacks.

In adolescents age 12 to 17 years, efficacy of Almotrex® on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotrex® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine .

Safety and effectiveness of Almotrex® have not been established for cluster headache which is present in an older, predominantly male population.

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2 DOSAGE AND ADMINISTRATION

2.1 Acute Treatment of Migraine Attacks

The recommended dose of Almotrex® (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 Almotrex®, the choice of dose should be made on an individual basis.

If the headache is relieved after the initial Almotrex® 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.

2.2 Hepatic Impairment

The recommended starting dose of Almotrex® in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period .

2.3 Renal Impairment

The recommended starting dose of Almotrex® in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period .

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3 DOSAGE FORMS AND STRENGTHS

Almotrex® (almotriptan malate) Tablets are available as white, coated, circular, biconvex tablets in the following dosage strengths:

6.25 mg tablet with red code imprint "2080"

12.5 mg tablet with blue stylized imprint "A."

Tablets: 6.25 mg and 12.5 mg (3)

4 CONTRAINDICATIONS

4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease

Do not use Almotrex® (almotriptan malate) in patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or in patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina, or other significant underlying cardiovascular disease .

4.2 Cerebrovascular Syndromes

Do not use Almotrex® in patients with cerebrovascular syndromes including stroke of any type as well as transient ischemic attacks .

4.3 Peripheral Vascular Disease

Do not use Almotrex® in patients with peripheral vascular disease including (but not limited to) ischemic bowel disease .

4.4 Uncontrolled Hypertension

Because Almotrex® may increase blood pressure, do not use Almotrex® in patients with uncontrolled hypertension .

4.5 Ergotamine-Containing and Ergot-Type Medications

Do not use Almotrex® and ergotamine-containing or ergot-derived medications like dihydroergotamine, ergotamine tartrate, or methysergide within 24 hours of each other .

4.6 Concomitant Use With 5-HT1 Agonists

Almotrex® and other 5-HT1 agonists (e.g., triptans) should not be administered within 24 hours of each other .

4.7 Hemiplegic or Basilar Migraine

Do not use Almotrex® in patients with hemiplegic or basilar migraine.

4.8 Hypersensitivity

Almotrex® is contraindicated in patients with known hypersensitivity to almotriptan or any of its inactive ingredients.

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5 WARNINGS AND PRECAUTIONS

5.1 Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events

Cardiac Events and Fatalities with 5-HT1 Agonists

Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following administration of Almotrex® (almotriptan malate). Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other triptans. Considering the extent of use of triptans in patients with migraine, the incidence of these events is extremely low.

Almotrex® can cause coronary vasospasm; at least one of these events occurred in a patient with no cardiac history and with documented absence of coronary artery disease. Because of the close proximity of the events to use of Almotrex®, a causal relationship cannot be excluded. Patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of coronary artery disease (CAD) or a predisposition to Prinzmetal's variant angina before receiving additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.

Premarketing Experience with Almotrex® in Adults

Among the 3865 subjects/patients who received Almotrex® in premarketing clinical trials, one patient was hospitalized for observation after a scheduled electrocardiogram (ECG) was found to be abnormal (negative T-waves on the left leads) 48 hours after taking a single 6.25 mg dose of almotriptan. The patient, a 48-year-old female, had previously taken 3 other doses for earlier migraine attacks. Myocardial enzymes at the time of the abnormal ECG were normal. The patient was diagnosed as having had myocardial ischemia and that she had a family history of coronary disease. An ECG performed 2 days later was normal, as was a follow-up coronary angiography. The patient recovered without incident.

Postmarketing Experience with Almotrex® in Adults

Serious cardiovascular events have been reported in association with the use of Almotrex®. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to definitively determine the proportion of the reported cases that were actually caused by almotriptan or to reliably assess causation in individual cases .

Patients with Documented Coronary Artery Disease

Because of the potential of this class of compound (5-HT1 agonists) to cause coronary vasospasm, Almotrex® should not be given to patients with documented ischemic or vasospastic coronary artery disease .

Patients with Risk Factors for CAD

It is strongly recommended that Almotrex® not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, Almotrex® should not be administered .

For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of Almotrex® take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received Almotrex®. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an ECG during the interval immediately following Almotrex®, in these patients with risk factors. It is recommended that patients who are intermittent long-term users of Almotrex® and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use Almotrex®.

The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to Almotrex®. The ability of cardiac diagnostic procedures to detect all cardiovascular diseases or predisposition to coronary artery vasospasm is modest at best. Cardiovascular events associated with triptan treatment have occurred in patients with no cardiac history and with documented absence of coronary artery disease.

5.2 Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw

As with other 5-HT1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw have been reported after treatment with Almotrex®. Because 5-HT1 agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD or a predisposition to Prinzmetal's variant angina before receiving additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms occur. Patients shown to have CAD and those with Prinzmetal's variant angina should not receive 5-HT1 agonists .

5.3 Cerebrovascular Events and Fatalities

Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with other triptans and some events have resulted in fatalities. In a number of cases, it appeared possible that the cerebrovascular events were primary, the triptan 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 atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, and transient ischemic attack) .

5.4 Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and Colonic Ischemia

Triptans, including Almotrex®, may cause vasospastic reactions other than coronary artery vasospasm, such as peripheral and gastrointestinal vascular ischemia with abdominal pain and bloody diarrhea. Very rare reports of transient and permanent blindness and significant partial vision loss have been reported with the use of triptans. Visual disorders may also be part of a migraine attack. Patients who experience symptoms or signs suggestive of decreased arterial flow following the use of any triptan, such as ischemic bowel syndrome or Raynaud's syndrome, are candidates for further evaluation .

5.5 Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome may occur with triptans, including Almotrex®, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with Almotrex® and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) .

5.6 Medication Overuse Headache

Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

5.7 Increases in Blood Pressure

As with other triptans, significant elevations in systemic blood pressure have been reported on rare occasions with Almotrex® use in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events. Almotrex® is contraindicated in patients with uncontrolled hypertension . In normotensive healthy subjects and patients with hypertension controlled by medication, small, but clinically insignificant, increases in mean systolic (0.21 and 4.87 mm Hg, respectively) and diastolic (1.35 and 0.26 mm Hg, respectively) blood pressure relative to placebo were seen over the first 4 hours after oral administration of 12.5 mg of almotriptan.

An 18% increase in mean pulmonary artery pressure was seen following dosing with another triptan in a study evaluating subjects undergoing cardiac catheterization.

5.8 Hypersensitivity to Sulfonamides

Caution should be exercised when prescribing Almotrex® to patients with known hypersensitivity to sulfonamides. The chemical structure of almotriptan contains a sulfonyl group, which is structurally different from a sulfonamide. Cross-sensitivity to almotriptan in patients allergic to sulfonamides has not been systematically evaluated.

5.9 Impaired Hepatic or Renal Function

Almotrex® should be administered with caution to patients with diseases that may alter the absorption, metabolism, or excretion of drugs, such as those with impaired hepatic or renal function .

5.10 Binding to Melanin-Containing Tissues

When pigmented rats were given a single oral dose of 5 mg/kg of radiolabeled almotriptan, the elimination half-life of radioactivity from the eye was 22 days. This finding suggests that almotriptan and/or its metabolites may bind to melanin in the eye. Because almotriptan could accumulate in melanin-rich tissues over time, there is the possibility that it could cause toxicity in these tissues with extended use. However, no adverse retinal effects related to treatment with almotriptan were noted in a 52-week toxicity study in dogs given up to 12.5 mg/kg/day (resulting in exposure [AUC] to parent drug approximately 20 times that in humans receiving the maximum recommended human dose of 25 mg/day). Although no systematic monitoring of ophthalmologic function was undertaken in clinical trials, and no specific recommendations for ophthalmologic monitoring are offered, prescribers should be aware of the possibility of long-term ophthalmologic effects.

5.11 Corneal Opacities

Three male dogs (out of a total of 14 treated) in a 52-week toxicity study of oral almotriptan developed slight corneal opacities that were noted after 51 weeks, but not after 25 weeks of treatment. The doses at which this occurred were 2, 5, and 12.5 mg/kg/day. The opacity reversed after a 4-week drug-free period in the affected dog treated with the highest dose. Systemic exposure (plasma AUC) to parent drug at 2 mg/kg/day was approximately 2.5 times the exposure in humans receiving the maximum recommended human daily dose of 25 mg. A no-effect dose was not established.

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6 ADVERSE REACTIONS

Serious cardiac reactions, including myocardial infarction, have occurred following the use of Almotrex® 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 Almotrex® and 386 adult patients who received placebo. The most common adverse reactions during treatment with Almotrex® 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 Almotrex® and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with Almotrex® 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.

The most common adverse reactions (≥1% and greater than placebo) are:


To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Almotrex® Clinical Trials

Adults

Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with Almotrex®, and at an incidence greater than in patients treated with placebo, regardless of drug relationship.

System/Organ Class

Adverse Event

Almotrex® 6.25 mg

(n=527)

%

Almotrex® 12.5 mg

(n=1313)

%

Placebo

(n=386)

%

Digestive Disorders
Nausea 1 2 1
Dry mouth 1 1 0.5
Nervous System Disorders
Paresthesia 1 1 0.5

The incidence of adverse events in controlled clinical trials was not affected by gender, weight, age, presence of aura, or use of prophylactic medications or oral contraceptives. There were insufficient data to assess the effect of race on the incidence of adverse events.

Adolescents

Table 2 lists the adverse reactions reported by 1% or more of Almotrex®-treated adolescents age 12 to 17 years in 1 placebo-controlled, double-blind clinical trial.

System/Organ Class

Adverse Reaction

Almotrex® 6.25 mg

(n=180)

%

Almotrex® 12.5 mg

(n=182)

%

Placebo

(n=172)

%

Nervous System Disorders
Dizziness 4 3 2
Somnolence <1 5 2
Headache 1 2 1
Paresthesia <1 1 <1
Gastrointestinal Disorders
Nausea 1 3 0
Vomiting 2 0 <1

6.2 Other Adverse Reactions Observed in Almotrex® Clinical Trials

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. The reports include adverse reactions in 5 adult controlled studies and 1 adolescent controlled study. Variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used Almotrex® and reported a reaction divided by the total number of patients exposed to Almotrex®. All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are those occurring in 1/100 or more patients, infrequent adverse reactions are those occurring in fewer than 1/100 to 1/1000 patients, and rare adverse reactions are those occurring in fewer than 1/1000 patients.

Body: Frequent: Headache. Infrequent: Abdominal cramp or pain, Asthenia, Chills, Back pain, Chest pain, Neck pain, Fatigue, and Rigid neck. Rare: Fever and Photosensitivity reaction.

Cardiovascular: Infrequent: Vasodilation, Palpitations, and Tachycardia. Rare: Hypertension and Syncope.

Digestive: Infrequent: Diarrhea, Vomiting, Dyspepsia, Gastroenteritis, and Increased thirst. Rare: Colitis, Gastritis, Esophageal reflux, and Increased salivation.

Metabolic: Infrequent: Hyperglycemia and Increased serum creatine phosphokinase. Rare: Increased gamma glutamyl transpeptidase and Hypercholesteremia.

Musculo-Skeletal: Infrequent: Myalgia. Rare: Arthralgia, Arthritis, Myopathy, and Muscle weakness.

Nervous: Frequent: Dizziness and Somnolence. Infrequent: Tremor, Vertigo, Anxiety, Hypoesthesia, Restlessness, CNS stimulation, and Shakiness. Rare: Change in dreams, Impaired concentration, Abnormal coordination, Depressive symptoms, Euphoria, Hyperreflexia, Hypertonia, Nervousness, Neuropathy, Nightmares, Nystagmus, and Insomnia.

Respiratory: Infrequent: Pharyngitis, Rhinitis, Dyspnea, Laryngismus, Sinusitis, and Bronchitis. Rare: Hyperventilation, Laryngitis, Sneezing, and Epistaxis.

Skin: Infrequent: Diaphoresis, Pruritus, and Rash. Rare: Dermatitis and Erythema.

Special Senses: Infrequent: Ear pain and Tinnitus. Rare: Diplopia, Dry eyes, Eye pain, Otitis media, Parosmia, Scotoma, Conjunctivitis, Eye irritation, Hyperacusis, and Taste alteration.

Urogenital: Infrequent: Dysmenorrhea.

6.3 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Almotrex®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity reactions (including angioedema, anaphylactic reactions and anaphylactic shock)

Psychiatric Disorders: Confusional state, Restlessness

Nervous System Disorders: Hemiplegia, Hypoesthesia, Seizures

Eye Disorders: Blepharospasm, Visual impairment, Vision blurred

Ear and Labyrinth Disorders: Vertigo

Cardiac Disorders: Acute myocardial infarction, Coronary artery vasospasm, Angina pectoris, Tachycardia

Gastrointestinal Disorders: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Colitis, Hypoesthesia oral, Swollen tongue

Skin and Subcutaneous Tissue Disorders: Cold sweat, Erythema, Hyperhidrosis

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, Myalgia, Pain in extremity

Reproductive System and Breast Disorders: Breast pain

General Disorders: Malaise, Peripheral coldness.

7 DRUG INTERACTIONS

7.1 Ergot-Containing Drugs

These drugs have been reported to cause prolonged vasospastic reactions. Because, in theory, vasospastic effects may be additive, ergotamine-containing or ergot-type medications (like dihydroergotamine, ergotamine tartrate, or methysergide) and Almotrex® (almotriptan malate) should not be used within 24 hours of each other .

7.2 5-HT1 Agonists

Concomitant use of other 5-HT1 agonists (e.g., triptans) within 24 hours of treatment with Almotrex® is contraindicated .

7.3 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors

Cases of life-threatening serotonin syndrome have been reported during combined use of triptans and selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors (SNRIs) .

7.4 Ketoconazole and Other Potent CYP3A4 Inhibitors

Co-administration of almotriptan and oral ketoconazole, a potent CYP3A4 inhibitor, resulted in an approximately 60% increase in exposure of almotriptan. Increased exposures to almotriptan may be expected when almotriptan is used concomitantly with other potent CYP3A4 inhibitors .

In patients concomitantly using potent CYP3A4 inhibitors, the recommended starting dose of Almotrex® is 6.25 mg. The maximum daily dose should not exceed 12.5 mg within a 24-hour period. Concomitant use of Almotrex® and potent CYP3A4 inhibitors should be avoided in patients with renal or hepatic impairment .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, Almotrex® (almotriptan malate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

When almotriptan (125, 250, 500, or 1000 mg/kg/day) was administered orally to pregnant rats throughout the period of organogenesis, increased incidences of fetal skeletal variations (decreased ossification) were noted at a dose of 250 mg/kg/day or greater and an increase in embryolethality was seen at the highest dose. The no-effect dose for embryo-fetal developmental toxicity in rats (125 mg/kg/day) is approximately 100 times the maximum recommended human dose (MRHD) of 25 mg/day on a body surface area (mg/m2) basis. Similar studies in pregnant rabbits conducted with almotriptan (oral doses of 5, 20, or 60 mg/kg/day) demonstrated increases in embryolethality at the highest dose. The no-effect dose for embryo-fetal developmental toxicity in rabbits (20 mg/kg/day) is approximately 15 times the MRHD on a mg/m2 basis. When almotriptan (25, 100, or 400 mg/kg/day) was administered orally to rats throughout the periods of 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. The no-effect dose in this study (100 mg/kg/day) is 40 times the MRHD on a mg/m2 basis.

8.2 Labor and Delivery

The effect of Almotrex® on labor and delivery in humans is unknown.

8.3 Nursing Mothers

It is not known whether almotriptan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Almotrex® is administered to a nursing woman. Levels of almotriptan in rat milk were up to 7 times higher than in rat plasma.

8.4 Pediatric Use

Safety and efficacy of Almotrex® in pediatric patients under the age of 12 years have not been established. The pharmacokinetics, efficacy, and safety of Almotrex® have been evaluated in adolescent patients, age 12 to 17 years .

In a clinical study, Almotrex® 6.25 mg and 12.5 mg were found to be effective for the relief of migraine headache pain in adolescent patients age 12 to 17 years. Efficacy on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. The most common adverse reactions (incidence of ≥1%) associated with Almotrex® treatment were dizziness, somnolence, headache, paresthesia, nausea, and vomiting . The safety and tolerability profile of Almotrex® treatment in adolescents is similar to the profile observed in adults.

Postmarketing experience with other triptans include a limited number of reports that describe pediatric patients who have experienced clinically serious adverse events that are similar in nature to those reported rarely in adults.

8.5 Geriatric Use

Clinical studies of Almotrex® did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Clearance of almotriptan was lower in elderly volunteers than in younger individuals, but there were no observed differences in the safety and tolerability between the two populations . In general, dose selection for an elderly patient should be cautious, usually starting at the low dose, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The recommended dose of Almotrex® for elderly patients with normal renal function for their age is the same as that recommended for younger adults.

8.6 Hepatic Impairment

The recommended starting dose of Almotrex® in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period .

8.7 Renal Impairment

The recommended starting dose of Almotrex® in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period .

10 OVERDOSAGE

10.1 Signs and Symptoms

Patients and volunteers receiving single oral doses of 100 to 150 mg of almotriptan did not experience significant adverse events. Six additional normal volunteers received single oral doses of 200 mg without serious adverse events. During clinical trials with Almotrex®, one patient ingested 62.5 mg in a 5-hour period and another patient ingested 100 mg in a 38-hour period. Neither patient experienced adverse reactions.

Based on the pharmacology of triptans, hypertension or other more serious cardiovascular symptoms could occur after overdosage.

10.2 Recommended Treatment

There is no specific antidote to Almotrex®. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.

Clinical and electrocardiographic monitoring should be continued for at least 20 hours even if clinical symptoms are not observed.

It is unknown what effect hemodialysis or peritoneal dialysis has on plasma concentrations of almotriptan.

11 DESCRIPTION

Almotrex® (almotriptan malate) Tablets contain Almotrex, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Almotrex 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 C17H25N3O2S-C4H6O5, representing a molecular weight of 469.56. Almotriptan is a white to slightly yellow crystalline powder that is soluble in water. Almotrex® for oral administration contains Almotrex 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.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Almotriptan binds with high affinity to 5-HT1D, 5-HT1B, and 5-HT1F receptors. Almotriptan has weak affinity for 5-HT1A and 5-HT7 receptors, but has no significant affinity or pharmacological activity at 5-HT2, 5-HT3, 5-HT4, 5-HT6; alpha or beta adrenergic; adenosine ; angiotensin (AT1, AT2); dopamine (D1, D2); endothelin (ETA, ETB); or tachykinin (NK1, NK2, NK3) binding sites.

12.2 Pharmacodynamics

Current theories on the etiology of migraine headache suggest that symptoms are due to local cranial vasodilatation and/or to the release of vasoactive and pro-inflammatory peptides from sensory nerve endings in an activated trigeminal system. The therapeutic activity of almotriptan in migraine can most likely be attributed to agonist effects at 5-HT1B/1D receptors on the extracerebral, intracranial blood vessels that become dilated during a migraine attack and on nerve terminals in the trigeminal system. Activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathways.

12.3 Pharmacokinetics

Absorption

The absolute bioavailability of almotriptan is about 70%, with peak plasma levels occurring 1 to 3 hours after administration; food does not affect pharmacokinetics.

Distribution

Almotriptan is minimally protein bound (approximately 35%) and the mean apparent volume of distribution is approximately 180 to 200 liters.

Metabolism

Almotriptan is metabolized by two major and one minor pathways. Monoamine oxidase (MAO)-mediated oxidative deamination (approximately 27% of the dose), and cytochrome P450-mediated oxidation (approximately 12% of the dose) are the major routes of metabolism, while flavin monooxygenase is the minor route. MAO-A is responsible for the formation of the indoleacetic acid metabolite, whereas cytochrome P450 (3A4 and 2D6) catalyzes the hydroxylation of the pyrrolidine ring to an intermediate that is further oxidized by aldehyde dehydrogenase to the gamma-aminobutyric acid derivative. Both metabolites are inactive.

Excretion

Almotriptan has a mean half-life of 3 to 4 hours. Almotriptan is eliminated primarily by renal excretion (about 75% of the oral dose), with approximately 40% of an administered dose excreted unchanged in urine. Renal clearance exceeds the glomerular filtration rate by approximately 3-fold, indicating an active mechanism. Approximately 13% of the administered dose is excreted via feces, both unchanged and metabolized.

Drug-Drug Interactions

All drug interaction studies were performed in healthy volunteers using a single 12.5 mg dose of almotriptan and multiple doses of the other drug.

Monoamine Oxidase Inhibitors

Co-administration of almotriptan and moclobemide (150 mg twice daily for 8 days) resulted in a 27% decrease in almotriptan clearance and an increase in Cmax of approximately 6%. No dose adjustment is necessary.

Propranolol

Co-administration of almotriptan and propranolol (80 mg twice daily for 7 days) resulted in no significant changes in the pharmacokinetics of almotriptan.

Fluoxetine

Co-administration of almotriptan and fluoxetine (60 mg daily for 8 days), a potent inhibitor of CYP2D6, had no effect on almotriptan clearance, but maximal concentrations of almotriptan were increased 18%. This difference is not clinically significant.

Verapamil

Co-administration of almotriptan and verapamil (120 mg sustained-release tablets twice daily for 7 days), an inhibitor of CYP3A4, resulted in a 20% increase in the area under the plasma concentration-time curve, and in a 24% increase in maximal plasma concentrations of almotriptan. Neither of these changes is clinically significant. No dose adjustment is necessary.

Ketoconazole and other Potent CYP3A4 Inhibitors

Co-administration of almotriptan and ketoconazole, a potent CYP3A4 inhibitor, resulted in an approximately 60% increase in exposure of almotriptan. Increased exposures to almotriptan may be expected when almotriptan is used with other potent CYP3A4 inhibitors.

Special Populations

Geriatric

Renal and total clearance, and amount of drug excreted in the urine, were lower in elderly healthy volunteers (age 65 to 76 years) than in younger healthy volunteers (age 19 to 34 years), resulting in longer terminal half-life (3.7 hours vs. 3.2 hours) and a 25% higher area under the plasma concentration-time curve in the elderly subjects. The differences, however, do not appear to be clinically significant.

Pediatric

A pharmacokinetics study of almotriptan was conducted in adolescents (12 to 17 years) and adults (18 to 55 years) with or without a history of migraine. No differences were observed in the rate or extent of absorption of almotriptan in adolescents compared with adults.

Gender

No significant gender differences were observed in pharmacokinetic parameters.

Race

No significant differences were observed in pharmacokinetic parameters between Caucasian and African-American volunteers.

Hepatic Impairment

The pharmacokinetics of almotriptan have not been assessed in patients with hepatic impairment. Based on the known mechanisms of clearance of almotriptan, the maximum decrease expected in almotriptan clearance due to hepatic impairment would be 60% .

Renal Impairment

The clearance of almotriptan was approximately 65% lower in patients with severe renal impairment (Cl/F=19.8 L/hour; creatinine clearance between 10 and 30 mL/min) and approximately 40% lower in patients with moderate renal impairment (Cl/F=34.2 L/hour; creatinine clearance between 31 and 71 mL/min) than in healthy volunteers (Cl/F=57 L/hour). Maximal plasma concentrations of almotriptan increased by approximately 80% in these patients .

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Almotriptan was administered to mice and rats for up to 103–104 weeks at oral doses up to 250 mg/kg/day and 75 mg/kg/day, respectively. These doses were associated with plasma exposures (AUC) to parent drug that were approximately 40 and 80 times, in mice and rats respectively, the plasma AUC in humans at the maximum recommended human dose (MRHD) of 25 mg/day. Because of high mortality rates in both studies, which reached statistical significance in high-dose female mice, all female rats, all male mice, and high-dose female mice were terminated between weeks 96 and 98. There was no increase in tumors related to almotriptan administration.

Mutagenesis

Almotriptan was not mutagenic in two in vitro gene mutation assays, the Ames test, and the mouse lymphoma tk assay. Almotriptan was not clastogenic in an in vivo mouse micronucleus assay.

Impairment of Fertility

When male and female rats received almotriptan (25, 100, or 400 mg/kg/day) orally prior to and during mating and gestation, prolongation of the estrous cycle was observed at the mid-dose and greater, and fertility was impaired at the highest dose. Subsequent mating of treated with untreated animals indicated that the decrease in fertility was due to an effect on females. The no-effect dose for reproductive toxicity in rats (25 mg/kg/day) is approximately 10 times the MRHD on a mg/m2 basis.

14 CLINICAL STUDIES

14.1 Adults

The efficacy of Almotrex® 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 Almotrex® 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.

Placebo Almotrex®

6.25 mg

Almotrex®

12.5 mg

Study 1 33.8%

(n = 80)

55.4%p value 0.002 in comparison with placebo

(n = 166)

58.5%p value <0.001 in comparison with placebo

(n = 164)

Study 2 40.0%

(n = 95)

--- 57.1%p value 0.008 in comparison with placebo

(n =175)

Study 3 33.0%

(n = 176)

55.6%

(n = 360)

64.9%

(n = 370)


The estimated probability of achieving pain relief within 2 hours following initial treatment with Almotrex® 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 Almotrex® 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 Almotrex®.

The efficacy of Almotrex® 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.

Figure 1 Figure 2

14.2 Adolescents Age 12 to 17 Years

The efficacy of Almotrex® 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 Almotrex® 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.

Placebo Almotrex® 6.25 mg Almotrex® 12.5 mg
Study 1 55.3%

(n/N = 94/170)

71.8%p value 0.001 in comparison with placebo

(n/N = 127/177)

72.9%p value <0.001 in comparison with placebo

(n/N = 132/181)


The estimated probability of achieving pain relief within 2 hours following initial treatment with Almotrex® 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 Almotrex® 6.25 mg or 12.5 mg and those who received placebo.

Figure 3

16 HOW SUPPLIED/STORAGE AND HANDLING

Almotrex® (almotriptan malate) Tablets are available as follows:

6.25 mg: White, coated, circular, biconvex tablets with red code imprint "2080."

Unit Dose (aluminum blister pack)
6 tablets NDC 50458-211-01

12.5 mg: White, coated, circular, biconvex tablets with blue stylized imprint "A."

Unit Dose (aluminum blister pack)
12 tablets NDC 50458-210-01

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Drug Interactions

Advise patients to talk with their physician or pharmacist before taking any new medicines, including prescription and non-prescription drugs and supplements .

Hypersensitivity

Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking Almotrex® .

Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events

Inform patients that Almotrex® (almotriptan malate) may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, or slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Apprise the patient of the importance of this follow-up .

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of Almotrex® or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) .

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) .

Pregnancy

Advise patients to notify their physician if they become pregnant during treatment or intend to become pregnant .

Nursing Mothers

Advise patients to notify their physician if they are breastfeeding or plan to breastfeed .

Ability to Operate Machinery or Vehicles

Counsel patients that Almotrex® may cause dizziness, somnolence, visual disturbances, and other CNS symptoms that can interfere with driving or operating machinery. Accordingly, advise the patient not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience with Almotrex® to gauge whether it affects their mental or visual performance adversely.

Product of Spain

Almotrex® Tablets are manufactured by:

Janssen-Ortho, LLC

Gurabo, Puerto Rico 00778

Almotrex® Tablets are manufactured for:

Janssen Pharmaceuticals, Inc.

Titusville, NJ 08560

Licensed from: Almirall, S.A.

U.S. Patent No. 5,565,447

© Janssen Pharmaceuticals, Inc. 2009

7560705

This Patient Information has been approved by the U.S. Food and Drug Administration Revised : May 2017
PATIENT INFORMATION

Almotrex® (AX-ERT)

(almotriptan malate)

tablets

What is the most important information I should know about Almotrex?

Almotrex can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking Almotrex and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Almotrex is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
  • are past menopause
  • are a man over 40 years old

What is Almotrex?

  • Almotrex is a prescription medicine that belongs to a class of medicines called Triptans. Almotrex is used:
    • to treat acute migraine attacks in adults with a history of migraine with or without aura.
    • to treat acute migraine headache pain in children 12 to 17 years of age with a history of migraine with or without aura, and who have migraine attacks that last 4 hours or more when not treated.
  • It is not known if Almotrex is safe and effective in children 12 to 17 years of age with migraine related symptoms (nausea; light sensitivity; sound sensitivity).
  • Almotrex is not to be used to prevent migraine attacks.
  • Almotrex is not for the treatment of hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
  • It is not known if Almotrex is safe and effective for the treatment of cluster headaches.
  • It is not known if Almotrex is safe and effective in children under 12 years of age.

Do not take Almotrex if you:

  • have or have had heart problems
  • have or have had a stroke or transient ischemic attack (TIA)
  • have or have had blood vessel problems including ischemic bowel disease
  • have uncontrolled high blood pressure
  • have hemiplegic or basilar migraine. If you are not sure if you have these types of migraines, ask your health care provider.
  • have taken any of the following medicines in the last 24 hours:
    • ergotamines
    • dihydroergotamines
    • methysergide
    • sumatriptan
    • eletriptan
    • frovatriptan
    • naratriptan
    • rizatriptan
    • sumatriptan and naproxen
    • zolmitriptan
  • are allergic to Almotrex or any of the ingredients in Almotrex. See the end of this leaflet for a complete list of ingredients in Almotrex.

Ask your doctor if you are not sure if your medicine is listed above.


Before you take Almotrex, tell your doctor about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • are past menopause
  • are a man over 40 years old
  • are allergic to sulfa (sulfonamide)
  • are pregnant or plan to become pregnant. It is not known if Almotrex will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Almotrex passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Almotrex.

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 called:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)

Also tell your doctor if you take certain other types of medicines used to treat fungal infection (such as ketoconazole or itraconazole) or to treat HIV/AIDS (such as ritonavir).

Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.


How should I take Almotrex?

  • Take Almotrex exactly as your doctor tells you to take it.
  • 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 2 Almotrex tablets in a 24-hour period.
  • If you take too much Almotrex, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Almotrex?

Almotrex may cause dizziness, sleepiness, and problems seeing. Do not drive, operate machinery, or do other dangerous activities until you know how Almotrex affects you.


What are the possible side effects of Almotrex?

Almotrex may cause serious side effects, including:

  • See "What is the most important information I should know about Almotrex?"
  • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events)

    Symptoms of gastrointestinal and colonic ischemic events include:

    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Almotrex, especially if Almotrex is used with antidepressant medicines called SSRIs or SNRIs. Call your doctor if you have any of the following symptoms of serotonin syndrome:
    • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
    • fast heartbeat
    • changes in blood pressure
    • high body temperature
    • tight muscles
    • trouble walking
    • nausea, vomiting or diarrhea
  • medication overuse headaches. Some people who use too many Almotrex tablets, for 10 or more days every month, may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with Almotrex. Keep a headache diary by writing down how often you have a headache and when you take your medicine.
  • allergic reactions. Some people who are allergic to sulfa medicines may be allergic to Almotrex. Stop taking Almotrex and call your doctor or get emergency help right away if you get any of these symptoms of an allergic reaction:
    • a swollen face, lips, mouth, tongue or throat
    • difficulty swallowing or breathing
    • an itchy rash (hives)

The most common side effects of Almotrex in adults are:

  • nausea
  • dry mouth
  • tingling or burning feeling (paresthesia)

The most common side effects of Almotrex in adolescents are:

  • dizziness
  • sleepiness
  • headache
  • tingling or burning feeling (paresthesia)
  • nausea
  • vomiting

These are not all the possible side effects of Almotrex. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


How should I store Almotrex?

  • Store Almotrex at room temperature between 68°F to 77°F (20°C to 25°C).
  • Safely throw away medicine that is out of date or no longer needed.

Keep Almotrex and all medicines out of the reach of children.


General information about the safe and effective use of Almotrex.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Almotrex for a condition for which it was not prescribed. Do not give Almotrex to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Almotrex that is written for health professionals.


What are the ingredients in Almotrex?

Active ingredient: Almotrex

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.

Manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778

Almotrex® Tablets are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560

Licensed from: Almirall, S.A.

For more information, go to www. AXERT.com or call 1-800-526-7736.


PRINCIPAL DISPLAY PANEL - 6.25 mg Tablet Carton

NDC 50458-211-01

Almotrex ®

(almotriptan malate) Tablets

equivalent to

6.25 mg

almotriptan

6 tablets

Rx only

Janssen

PRINCIPAL DISPLAY PANEL - 6.25 mg Tablet Carton

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Carton

NDC 50458-210-01

Almotrex ®

(almotriptan malate) Tablets

equivalent to

12.5 mg

almotriptan

12 tablets

Rx only

Janssen

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Carton

Almotrex pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Almotrex available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Almotrex destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Almotrex Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Almotrex pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."AXERT (ALMOTRIPTAN MALATE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Almotrex?

Depending on the reaction of the Almotrex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Almotrex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Almotrex addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Almotrex, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Almotrex consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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