Acipimox: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: December 13, 2024🚩 Report this page

Acipimox

Nicotinic Acid and Derivatives

GB MHRA

Drug class: Nicotinic Acid and Derivatives
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Acipimox is an active pharmaceutical ingredient in the Nicotinic Acid and Derivatives group (C10AD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	December 13, 2024

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised December 13, 2024[1]

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: • hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia); • hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIB hyperlipoproteinaemia).
g. exercise, weight reduction). It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.

How to take

Sources & citations

[1]MHRA (UK) · PL000571022 · revised December 13, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised December 13, 2024[1]

The following undesirable effects have been observed from the clinical and post- marketing experience and reported during treatment with acipimox with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Not Known (cannot be estimated from the available data).
MedDRA System Organ Class Frequency Undesirable Effects Eye Disorders Not Known Eye symptoms (dry or gritty eyes) Immune System Disorders Uncommon Anaphylactoid reaction* Nervous System Disorders Very Common Headache Very Common FlushingVascular Disorders Not Known Vasodilatation** Respiratory Thoracic and Mediastinal Disorders Uncommon Bronchospasm* Very Common Dyspepsia Common Abdominal pain upper Uncommon Nausea* Gastrointestinal Disorders Not Known Diarrhoea** Common UrticariaSkin and Subcutaneous Tissue Disorders Uncommon Angioedema*, Pruritus*, Rash*, Erythema* Musculoskeletal and Connective Tissue Disorders Uncommon Myositis*, Myalgia*, Arthralgia* Common AstheniaGeneral Disorders and Administration Site Conditions Uncommon Feeling hot*, Malaise* * AE frequency estimated from post-marketing safety database ** AE frequency cannot be estimated from the available data The drug may induce skin vasodilatation giving rise to a sensation of heat, flushing or itching, especially at the beginning of therapy and also rash and erythema.
These reactions usually disappear rapidly during the first day of treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised December 13, 2024[1]

Modification of hyperlipidaemia is recommended only for patients with hyperlipoproteinaemia of a degree and type considered appropriate for treatment. Low cholesterol and low-fat diets, together with cessation of alcohol consumption, exercise and weight loss, in case of obesity are preferable therapeutic approaches to be tried before starting treatment with acipimox.
Since long term administration of acipimox is recommended, all baseline values, including lipid profile, should be measured before treatment and periodic determinations of serum lipids should be obtained to confirm that the desired therapeutic effect has been achieved.
Acipimox is structurally related to nicotinic acid. e. a 3- hydroxy-3- methylglutaryl coenzyme A [HMG-CoA] reductase inhibitor). In one study, Chinese patients taking nicotinic acid plus laropiprant concomitantly with simvastatin were reported to have a higher incidence of myopathy and rhabdomyolysis compared to Caucasians.
Hepatic and renal functions should be monitored. The absorption of acipimox is not affected by the concomitant administration of colestyramine Evidence of clinical efficacy in the prevention of heart disease has not been established.
The possible beneficial and adverse, long-term consequences of some drugs used in the hyperlipidaemias are still the subject of scientific discussion.
Excipient Information:
Olbetam contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.