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SANDOZ 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.
Adverse Drug Reaction Overview Serious cardiac events, including some that have been fatal, have occurred following use of other 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD.
Events reported have included coronary artery vasospasms, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). Serious cardiac events, including myocardial infarction, coronary artery vasospasm and intermediate coronary syndrome, have occurred following the use of almotriptan tablets.
These events are extremely rare and have been reported mostly in patients with cardiovascular risk factors (see WARNINGS AND PRECAUTIONS and Post-Market Adverse Drug Reactions). Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. As with other 5-HT1 agonists, almotriptan has been associated with sensations of heaviness, pressure, tightness or pain which may be intense.
These may occur in any part of the body including the chest, throat, neck, jaw and upper limbs. Significant elevations in systemic blood pressure, including hypertensive crisis, have been reported on rare occasions in patients with and without a history of hypertension treated with other 5-HT1 agonists.
Almotriptan is contraindicated in patients with uncontrolled hypertension (see CONTRAINDICATIONS). 35 mmHg, respectively). The effect of almotriptan on blood pressure was also assessed in patients with hypertension controlled by medication.
26 mmHg, respectively. The slight increases in blood pressure in both volunteers and controlled hypertensive patients were not considered clinically significant (see also CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Adverse events were assessed in controlled clinical trials that included 1840 patients who received one or two doses of almotriptan and 386 patients who received placebo.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The most common adverse events during treatment with almotriptan were nausea, somnolence, Sandoz Almotriptan Page 13 of 37 headache, paresthesia, and dry mouth. In long-term, open-label studies where patients were allowed to treat multiple attacks for up to one year, 5% (63 out of 1347 patients) withdrew due to adverse experiences.
Tables 1 and 2 list the adverse events in clinical trials of adult patients and adolescents (12- 17 years of age), respectively, that occurred in at least 1% of the patients treated with almotriptan, and at an incidence greater than in patients treated with placebo, regardless of drug relationship.
These events reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behaviour, and the kinds of patients treated may differ.
5 mg (n=182) (%) Almotriptan 25 mg (n=186) (%) Nervous system disorders Dizziness 2 4 3 6 Somnolence 2 <1 5 3 Headache 2 1 2 1 Paresthesia <1 <1 1 1 Gastrointestinal disorders Nausea 0 1 3 2 Vomiting <1 2 0 2 Almotriptan is generally well tolerated.
Most adverse events were mild in intensity and were transient, and did not lead to long-lasting effects. 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. Sandoz Almotriptan Page 14 of 37 Less Common Clinical Trial Adverse Drug Reactions (<1%) The frequencies of less commonly reported adverse events are presented below.
However, the role of almotriptan in their causation cannot be reliably determined. , limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used almotriptan in controlled clinical trials and reported an event, divided by the total number of patients exposed to almotriptan in these studies.
All reported events are included, except the ones already listed in the previous table, and those unlikely to be drug related. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in at least 1/100 patients; infrequent adverse events are those […]