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ACCEL-RIZATRIPTAN ODT is a brand name for Rizatriptan, supplied as a tablet (orally disintegrating). 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.
Dosing Considerations ACCEL-RIZATRIPTAN ODT is recommended only for the acute treatment of migraine attacks. ACCEL-RIZATRIPTAN ODT should not be used prophylactically. Controlled trials have not established the effectiveness of a second dose if the initial dose is ineffective.
The safety of treating, on average, more than four headaches in a 30-day period has not been established. Recommended Dose and Dosage Adjustment ADULTS The recommended single adult dose is 5 mg. The maximum recommended single dose is 10 mg.
There is evidence that the 10 mg dose may provide a greater effect than the 5 mg dose (see ACTION AND CLINICAL PHARMACOLOGY, Clinical Studies). The choice of dose should therefore be made on an individual basis, weighing the possible benefit of the 10 mg dose with the potential risk for increased adverse events.
For ACCEL-RIZATRIPTAN ODT, administration with liquid is not necessary. The orally disintegrating tablet is packaged in a unit dose blister package. Patients should be instructed not to remove the tablet from the blister package until just prior to dosing.
The tablet should then be removed from the blister package with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva. Redosing Doses should be separated by at least 2 hours; no more than a total of 20 mg should be taken in any 24-hour period.
Patients receiving propranolol A single 5 mg dose of ACCEL-RIZATRIPTAN ODT should be used. In no instances should the total daily dose exceed 10 mg per day, given in two doses, separated by at least two hours (see DRUG INTERACTIONS).
73 m2), the AUC of rizatriptan was approximately 44% greater than in patients with normal renal function (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions). Consequently, if treatment is deemed advisable in these patients, the 5 mg ACCEL-RIZATRIPTAN ODT should be administered.
No more than a total of 10 mg should ACCEL-RIZATRIPTAN ODT 5 mg & 10 mg (rizatriptan benzoate) Page 21 of 39 be taken in any 24-hour period. Repeated dosing in renally impaired patients has not been evaluated. Hepatic Impairment ACCEL-RIZATRIPTAN ODT is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) due to the absence of safety data.
ACCEL-RIZATRIPTAN ODT is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes, valvular heart disease or cardiac arrhythmias (especially tachycardias). , atherosclerotic disease, congenital heart disease) should not receive ACCEL-RIZATRIPTAN ODT.
, stable angina of effort and vasospastic forms of angina such as the Prinzmetal’s variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks (TIAs).
Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, or Raynaud’s syndrome (see WARNINGS AND PRECAUTIONS). Because ACCEL-RIZATRIPTAN ODT may increase blood pressure, it is contraindicated in patients with uncontrolled or severe hypertension (see WARNINGS AND PRECAUTIONS).
ACCEL-RIZATRIPTAN ODT is contraindicated within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. ACCEL-RIZATRIPTAN ODT is contraindicated in patients with hemiplegic, ophthalmoplegic or basilar migraine.
Concurrent administration of MAO inhibitors or use of rizatriptan within 2 weeks of discontinuation of MAO inhibitor therapy is contraindicated (see DRUG INTERACTIONS). Because there are no data available, ACCEL-RIZATRIPTAN ODT is contraindicated in patients with severe hepatic impairment.
ACCEL-RIZATRIPTAN ODT is contraindicated in patients who are hypersensitive to rizatriptan or any component of the formulation. WARNINGS AND PRECAUTIONS General ACCEL-RIZATRIPTAN ODT should only be used where a clear diagnosis of migraine has been established.
For a given attack, if a patient has no response to the first dose of ACCEL-RIZATRIPTAN ODT, the diagnosis of migraine should be reconsidered before administration of a second dose. ACCEL-RIZATRIPTAN ODT 5 mg & 10 mg (rizatriptan benzoate) Page 5 of 39 Psychomotor Effect Dizziness, somnolence and asthenia/fatigue were experienced by some patients in clinical trials with rizatriptan benzoate (see ADVERSE REACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Plasma concentrations of rizatriptan were approximately 30% greater in patients with moderate hepatic insufficiency (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions). Consequently, if treatment is deemed advisable in the presence of moderate hepatic impairment, the 5 mg ACCEL-RIZATRIPTAN ODT should be administered.
No more than a total of 10 mg should be taken in any 24-hour period. Repeated dosing in hepatically impaired patients has not been evaluated. Patients with Hypertension ACCEL-RIZATRIPTAN ODT should not be used in patients with uncontrolled or severe hypertension.
In patients with mild to moderate controlled hypertension, patients should be treated cautiously at the lowest effective dose. OVERDOSAGE No overdoses of rizatriptan benzoate were reported during clinical trials in adults. Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2-hour interdose interval) was generally well tolerated in over 300 adult patients; dizziness and somnolence were the most common drug-related adverse effects.
In a clinical pharmacology study in which 12 adult subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours); a third degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms.
The second subject, a 25-year-old male, experienced transient dizziness, syncope, incontinence, and a 5-second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after overdosage. , gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with ACCEL-RIZATRIPTAN ODT.
The elimination half-life of rizatriptan is 2 to 3 hours (see ACTION AND CLINICAL PHARMACOLOGY). Clinical and For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. ACCEL-RIZATRIPTAN ODT 5 mg & 10 mg (rizatriptan benzoate) Page 22 of 39 electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
There is no specific antidote to rizatriptan. 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.
The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Rizatriptan benzoate is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors. It has weak affinity for other 5-HT1 receptor subtypes (5-HT1A, 5-HT1E, 5-HT1F) and the 5-HT7 receptor, but has no significant activity at 5-HT2, 5-HT3, alpha- and beta-adrenergic, dopaminergic, histaminergic, muscarinic or benzodiazepine receptors.
Current theories on the etiology of migraine headache suggest that symptoms are due to local cranial vasodilatation and/or to the release of […]
Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that ACCEL- RIZATRIPTAN ODT does not adversely affect them. Cardiovascular Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events Rizatriptan benzoate has been associated with transient chest and/or neck pain and tightness which may resemble angina pectoris.
Following the use of other 5-HT1 agonists, in rare cases these symptoms have been identified as being the likely result of coronary vasospasm or myocardial ischemia. Rare cases of serious coronary events or arrhythmia have occurred following use of other 5-HT1 agonists, and may therefore also occur with ACCEL-RIZATRIPTAN ODT.
Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, ACCEL-RIZATRIPTAN ODT should not be given to patients with documented ischemic or vasospastic coronary artery disease (see CONTRAINDICATIONS).
, 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 unknown. 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, ACCEL-RIZATRIPTAN ODT should not be administered (see CONTRAINDICATIONS).
For patients with risk factors predictive of CAD, who are considered to have a satisfactory cardiovascular evaluation, the first dose of ACCEL-RIZATRIPTAN ODT should be administered in the setting of a physician’s office or similar medically staffed and equipped facility.
Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following ACCEL-RIZATRIPTAN ODT, in these patients 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. Intermittent long-term users of ACCEL-RIZATRIPTAN ODT who have or acquire risk factors predictive of CAD, as described above, should receive periodic interval ACCEL-RIZATRIPTAN ODT 5 mg & 10 mg (rizatriptan benzoate) Page 6 of 39 cardiovascular evaluation as they continue to use ACCEL-RIZATRIPTAN ODT.
If symptoms consistent with angina occur after the use of ACCEL-RIZATRIPTAN ODT, ECG evaluation should be carried out to look for ischemic changes. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to ACCEL- RIZATRIPTAN ODT.
Discomfort in the chest, neck, throat and jaw (including pain, pressure, heaviness and tightness) has been reported after administration of rizatriptan. Because drugs in this class may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina […]