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MYLAN-ALMOTRIPTAN is a brand name for Almotriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General MYLAN-ALMOTRIPTAN (almotriptan malate) tablets should only be used where a clear diagnosis of migraine has been established. MYLAN-ALMOTRIPTAN should be administered with caution to patients with diseases that may alter the absorption, metabolism or excretion of drugs, such as those with mild to moderate hepatic impairment or with impaired renal function (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and DOSAGE AND ADMINISTRATION).
Treatment is contraindicated in patients with severe hepatic impairment (see CONTRAINDICATIONS).
Medication Overuse Headache:
Overuse of acute migraine treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients. 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. Hypersensitivity to Sulfonamides Caution should be exercised when prescribing almotriptan 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 evaluated. Ability to Operate Machinery and Vehicles MYLAN-ALMOTRIPTAN may cause dizziness, somnolence, visual disturbances, and other CNS symptoms that can interfere with driving or operating machinery.
Patients should be advised to avoid driving a car, operating complex machinery, or engage in hazardous activities until they are reasonably certain that MYLAN-ALMOTRIPTAN does not affect them adversely. Carcinogenesis and Mutagenesis The carcinogenic potential of almotriptan was evaluated by oral gavage for up to 103 weeks in mice at doses of up to 250 mg/kg/day, and in rats for up to 104 weeks at doses up to 75 mg/kg/day.
These doses were associated with plasma exposures (AUC) to parent drug that were approximately 40 and 78 times, in mice and rats respectively, the plasma AUC observed in humans receiving the MRDD of 25 mg. 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- Page 6 of 42 dose female mice were terminated between weeks 96 and 98.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Almotriptan in Canada.
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There was no increase in tumors related to almotriptan administration. Almotriptan was not mutagenic, with or without metabolic activation, when tested in two gene mutation assays, the Ames test and the in vitro thymidine locus mouse lymphoma assay.
Almotriptan was not determined to be clastogenic in two in vitro cytogenetics assays in human lymphocytes and an in vivo mouse micronucleus assay. Almotriptan produced an equivocal weakly positive response in in vitro cytogenetics assays in human lymphocytes.
Cardiovascular Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, MYLAN-ALMOTRIPTAN should not be given to patients with documented ischemic or vasospastic coronary artery disease (see CONTRAINDICATIONS).
It is strongly recommended that 5-HT1 agonists (including MYLAN-ALMOTRIPTAN) not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors such as: 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 examination 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 diseases or predisposition to coronary artery vasospasm is modest at best. If, during the cardiovascular evaluation, the patient’s medical history, electrocardiogram (ECG) or other evaluations reveal findings indicative of, or consistent with, coronary artery vasospasm, or myocardial ischemia, MYLAN-ALMOTRIPTAN should not be administered (see CONTRAINDICATIONS).
These evaluations, however, may not identify every patient who has cardiac disease, and in very rare cases, serious cardiac events, such as myocardial infarction or coronary ischemia have occurred in patients without evidence of underlying cardiovascular disease.
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 MYLAN-ALMOTRIPTAN takes place in a clinical setting, such as the physician’s office or a similarly staffed medical facility, unless the patient has previously received almotriptan.
Because cardiac ischemia can occur in the absence of any clinical symptoms, consideration should be given to obtaining an ECG during the interval immediately following the first use of MYLAN- ALMOTRIPTAN in a patient with risk factors.
However, an absence of drug-induced cardiovascular effects on the occasion of the initial dose does not preclude the possibility of such effects occurring with subsequent administrations. Page 7 of 42 If symptoms consistent with angina occur after the use of MYLAN-ALMOTRIPTAN, ECG evaluation should be carried out to look for ischemic changes.
It is recommended that patients who are intermittent long-term users of MYLAN- ALMOTRIPTAN and who have or acquire risk factors predictive of CAD as described above undergo periodic interval cardiovascular evaluation as they continue to use MYLAN- ALMOTRIPTAN.
The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease are inadvertently exposed to MYLAN-ALMOTRIPTAN. As […]