quent: 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 AXERT®. 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 AXERT® (almotriptan malate) should not be used within 24 hours of each other [see CONTRAINDICATIONS (4.5)].
7.2 5-HT1 Agonists (e.g., Triptans)
Concomitant use of other 5-HT1 agonists (e.g., triptans) within 24 hours of treatment with AXERT® is contraindicated [see CONTRAINDICATIONS (4.6)].
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 (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see WARNINGS AND PRECAUTIONS (5.5), CLINICAL PHARMACOLOGY (12.3)].
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 [see CLINICAL PHARMACOLOGY (12.3)].
In patients concomitantly using potent CYP3A4 inhibitors, the recommended starting dose of AXERT® is 6.25 mg. The maximum daily dose should not exceed 12.5 mg within a 24-hour period. Concomitant use of AXERT® and potent CYP3A4 inhibitors should be avoided in patients with renal or hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
In ani |
