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PMS-RIZATRIPTAN RDT 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 ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations pms-RIZATRIPTAN RDT is recommended only for the acute treatment of migraine attacks. pms-RIZATRIPTAN RDT 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 pms-RIZATRIPTAN RDT Tablets 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.
Administration of pms-RIZATRIPTAN RDT with liquid is not necessary. pms-RIZATRIPTAN RDT should be 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 pms-RIZATRIPTAN RDT 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 pms- RIZATRIPTAN RDT should be administered. No more than a total of 10 mg should be taken in any 24-hour period. Repeated dosing in renally impaired patients has not been evaluated.
Hepatic Impairment pms-RIZATRIPTAN RDT is contraindicated in patients with severe hepatic impairment (Child- Pugh grade C) due to the absence of safety data. Plasma concentrations of rizatriptan were pms-RIZATRIPTAN RDT Product Monograph Page 19 of 35 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 pms- RIZATRIPTAN RDT 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rizatriptan in Canada.
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Patients with Hypertension pms-RIZATRIPTAN RDT 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 rizatriptan benzoate.
The elimination half-life of rizatriptan is 2 to 3 hours (see ACTION AND CLINICAL PHARMACOLOGY). Clinical and 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. For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. pms-RIZATRIPTAN RDT Product Monograph Page 20 of 35 ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Rizatriptan 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 vasoactive and pro-inflammatory peptides from sensory nerve endings in an activated trigeminal system.
The therapeutic activity of rizatriptan in migraine can most likely be attributed to agonist effects at 5-HT1B/1D receptors on the extracerebral, intracranial blood vessels that become dilated during […]