Contraindications
4 CONTRAINDICATIONS Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ( 4.1 ) Cerebrovascular syndromes (e.g., history of stroke or TIA) ( 4.2 ) Peripheral vascular disease (including ischemic bowel disease) ( 4.3 ) Uncontrolled hypertension ( 4.4 ) Do not use almotriptan malate within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT 1 agonist, e.g., another triptan ( 4.5 , 4.6 ) Hemiplegic or basilar migraine ( 4.7 ) Known hypersensitivity to almotriptan malate ( 4.8 ) 4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease Do not use 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 [see Warnings and Precautions ( 5.1 )] . 4.2 Cerebrovascular Syndromes Do not use almotriptan malate tablets in patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks [see Warnings and Precautions ( 5.3 )] . 4.3 Peripheral Vascular Disease Do not use almotriptan malate tablets in patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see Warnings and Precautions ( 5.4 )] . 4.4 Uncontrolled Hypertension Because almotriptan malate may increase blood pressure, do not use almotriptan malate tablets in patients with uncontrolled hypertension [see Warnings and Precautions ( 5.7 )] . 4.5 Ergotamine-Containing and Ergot-Type Medications Do not use almotriptan malate tablets and ergotamine-containing or ergot-derived medications like dihydroergotamine, ergotamine tartrate, or methysergide within 24 hours of each other [see Drug Interactions ( 7.1 )]
Pregnancy & Breastfeeding
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, 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/m 2 ) 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/m 2 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/m 2 basis.