Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Olbetam is indicated as alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments such as statin or fibrate treatment for:
Olbetam should be used after other measures have been taken such as dietary changes and other non-pharmacological treatment (e.g. exercise, weight reduction).
It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.
The daily dosage should be adjusted individually depending on plasma triglyceride and cholesterol levels.
The recommended dosage is one 250 mg capsule 2 or 3 times daily to be taken with or after meals. The lower dose is advised in type IV and the higher dose in type IIB hyperlipoproteinaemias.
Daily dosages of up to 1200 mg have been safely administered for long periods.
Improvement in the plasma lipid’s picture is usually seen within the first month of therapy.
In patients with slight renal impairment (creatinine clearance values >60 ml/min) no dose reduction is required. For patients with moderate to severe renal impairment (creatinine clearance values between 60 and 30 ml/min) the dose needs to be reduced accordingly to one 250 mg capsule 1 or 2 times daily to be taken with or after meals. Acipimox is eliminated entirely through the kidneys, therefore, accumulation can be expected and is related to the degree of renal impairment. It is advised that longer intervals are left between doses of the drug in patients with renal impairment.
To be given orally.
If toxic effects are observed, supportive care and symptomatic treatment should be administered.
4 years.
Store below 30°C in the original container to protect from moisture.
Packed in blisters of 10 capsules per strip, inside cartons. Each carton contains 90 capsules.
No special requirement.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
