ADR that result in revision of patient information
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| Canada: New dosage recommendations for Sublinox™ (zolpidem tartrate) to minimize risk of next-day impairment in both women and men |
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MEDA VALEANT PHARMA CANADA INC., in consultation with Health Canada, informed the public and healthcare professionals of important new dosing information which has been added to the Product Monograph for Sublinox™ (zolpidem tartrate).
Sublinox™ (zolpidem tartrate) is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings.
The following points summarize the updated Product Monograph information concerning recommended dose and dosage adjustment:
1. The recommended initial dose has been revised to 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening.
2. The total dose of Sublinox™ should not exceed 10 mg once daily immediately before bedtime. The lowest effective dose for the patient should be used.
3. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness.
The recommended initial doses for women and men are different because of lower rate of clearance and higher blood levels of zolpidem in women compared to men.
Healthcare professionals are also reminded that in geriatric patients (≥65 years of age) clearance rate of zolpidem is lower in both men and women when compared to young adults. The recommended dose of Sublinox™ in geriatric patients is 5 mg regardless of gender.
Additionally, healthcare professionals should advise patients (men and women) who use Sublinox™ about the risk of next-day impairment for activities that require complete mental alertness, including driving. In particular, the following points should be mentioned:
1. That this risk is increased if dosing instructions are not carefully followed.
2. Not to drive a car or engage in hazardous activities requiring complete alertness until they know how the drug affects them the next day.
3. Tell patients that if they took Sublinox™ as instructed and do not feel drowsy in the morning, they still have to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../37415a-eng.php
In Hong Kong, there are 16 registered pharmaceutical products containing zolpidem which include immediate-release 5mg or 10mg tablets and modified-release 6.25mg or 12.5mg tablets. All of the products are prescription-only medicines. Zolpidem is also controlled as psychotropic substance internationally including Hong Kong. Related news has been released by FDA and was posted on the Drug Office website on 11 January and 15 May 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 11 January 2013. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board in the meeting in February 2013 and was concluded that Drug Office will remain vigilant on any new safety update of zolpidem by other regulatory authorities for future consideration by the Registration Committee when necessary.
Ends/ Monday, January 06, 2014
Issued at HKT 14:30
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