Consumer medicine information

1. Why am I using RIZATRIPTAN ODT-WGR?

RIZATRIPTAN ODT-WGR contains the active ingredient rizatriptan benzoate. RIZATRIPTAN ODT-WGR is used to relieve the headache pain and other symptoms of migraine attacks.
For more information, see Section 1. Why am I using RIZATRIPTAN ODT-WGR? in the full CMI.

2. What should I know before I use RIZATRIPTAN ODT-WGR?

Do not use if you have ever had an allergic reaction to RIZATRIPTAN ODT-WGR or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use RIZATRIPTAN ODT-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with RIZATRIPTAN ODT-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use RIZATRIPTAN ODT-WGR?

• Take Rizatriptan ODT-WGR only when prescribed by your doctor

• The usual dose to treat a migraine is one 10 mg orally disintegrating tablet

• If the first RIZATRIPTAN ODT-WGR orally disintegrating tablet does help your migraine, but it comes back later, you may take another orally disintegrating tablet. Take the second orally disintegrating tablet at least 2 hours after the first.

5. What should I know while using RIZATRIPTAN ODT-WGR?

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). The most common side effects include dizziness, somnolence and weakness/fatigue. If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, tell your doctor immediately or go to accident and emergency at your nearest hospital.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Rizatriptan benzoate.

2 Qualitative and Quantitative Composition

Each orally disintegrating tablet contains 14.53 mg of rizatriptan benzoate (corresponding or 10 mg of rizatriptan, respectively).
Also contains aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Each orally disintegrating tablet contains 10 mg of rizatriptan - white, round, flat, bevel-edged tablet embossed with "IZ 10" on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

No overdoses of rizatriptan were reported during clinical trials.
Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2-hour inter-dose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drug-related adverse effects.
In a clinical pharmacology study in which 12 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. Gastrointestinal decontamination (e.g. gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with rizatriptan. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of haemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Rizatriptan, with and without metabolic activation, was neither genotoxic, mutagenic, nor clastogenic in all in vitro and in vivo genetic toxicity studies, including: microbial mutagenesis, in vitro chromosome aberration assays, in vitro V-79 mammalian cell mutagenesis assays, an in vitro alkaline elution/rat hepatocyte assay, and an in vivo chromosome aberration assay in mouse bone marrow.
Carcinogenicity. The carcinogenic potential of rizatriptan was evaluated in a 106 week study in rats and a 100 week study in mice at oral doses of up to 125 mg/kg/day. Exposure data were not obtained in those studies, but plasma AUC's of the parent drug were measured in other studies and indicate that exposures to the parent drug at the highest dose level would have been approximately 150 times (mice) and 240 times (rats) average AUC's measured in humans after three 10 mg doses, the maximum recommended daily dose. There was no evidence of an increase in tumour incidence related to rizatriptan in either species.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Rizatriptan benzoate is a white to off-white, crystalline solid. The molecular weight of the benzoate salt is 391.47; the molecular weight of the free base is 269.4. Rizatriptan benzoate is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
Chemical structure. N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate. Its empirical formula is C₁₅H₁₉N₅.C₇H₆O₂ and its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRIZBEN.gif CAS number. 145202-66-0.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/RZDTGRST.gif