Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
rizatriptan benzoate, Quantity: 7.265 mg (Equivalent: rizatriptan, Qty 5 mg)
Medis Pharma Pty Ltd
rizatriptan benzoate
Tablet, orally disintegrating
Excipient Ingredients: calcium silicate; aspartame; magnesium stearate; mannitol; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; Flavour
Oral
2, 3, 6
(S4) Prescription Only Medicine
RIZATRIPTAN ACT is indicated for the acute treatment of migraine attacks with or without aura.
Visual Identification: White, round, flat, bevel-edged tablet embossed with "IZ 5" on one side and plain on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-02-19
1 AUSTRALIAN PRODUCT INFORMATION – RIZATRIPTAN ACT (RIZATRIPTAN BENZOATE) 1 NAME OF THE MEDICINE Rizatriptan benzoate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 7.265 of rizatriptan benzoate (corresponding to 5 mg of rizatriptan, respectively). Ingredients with known effects: aspartame. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 5 mg orodispersible tablet - White, round, flat, bevel-edged tablet embossed with “IZ 5” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RIZATRIPTAN ACT is indicated for the acute treatment of migraine attacks with or without aura. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose is 10 mg. Clinical experience has shown that this dose provides the optimal clinical benefit. Onset of relief (i.e., reduction of headache pain to mild or none) can occur within 30 minutes after dosing. _Re-dosing: _Doses should be separated by at least 2 hours; no more than 30 mg should be taken in any 24-hour period. _for headache recurrence within 24 hours: _If headache returns after relief of the initial attack, further doses may be taken. The above dosing limits should be observed. _after non-response: _The effectiveness of a second dose for treatment of the same attack, when an initial dose is ineffective, has not been examined in controlled trials. – Clinical studies have shown that patients who do not respond to treatment of an attack are still likely to respond to treatment for subsequent attacks. _Patients receiving propranolol: _Plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions_). _The 10 mg dose is not appropriate for these patients. The physician should consider alternative therapies for these patients, for example, other 5- HT 1B/1D agonists that do not have this drug interaction. RIZATRIPTAN ACT is a rapidly dissolvi Read the complete document