Overdose : מינון יתר

11       OVERDOSAGE
No overdoses of RIZALT were reported during clinical trials in adults.
Some adult patients who received 40 mg of RIZALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence.
In a clinical pharmacology study in which 12 adult subjects received RIZALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.
In addition, based on the pharmacology of RIZALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with RIZALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.


12       DESCRIPTION
RIZALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H- indole-3-ethanamine monobenzoate and its structural formula is:
Its empirical formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4.
Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
RIZALT Tablets are available for oral administration in a strength of 10 mg (corresponding to 14.53 mg of the benzoate salt). RIZALT RPD Wafers are available in the strength of 10 mg (corresponding to 14.53 mg of the benzoate salt). Each compressed tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, and ferric oxide (red).
Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint Naefco P.