Nicotinic acid derivatives.

Acipimox

Acipimox INN 250.00 mg

Red-brown/dark pink hard gelatin capsules, size no. 1, containing a white to cream powder.

Olbetam is indicated for the treatment of lipid disorders characterised, according to Fredrickson, by elevated plasma levels of triglycerides (type IV hyperlipo-proteinaemia), or cholesterol (type IIA hyperlipoproteinaemia) and triglycerides and cholesterol (type IIB hyperlipoproteinaemia).

To be given orally.

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 types IIA and 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. 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.

Not applicable.

Acipimox is contra-indicated in patients who are hypersensitive to the active substance or to any of the excipients and those with peptic ulceration.

Acipimox should not be given to patients with severe renal impairment (creatinine clearance < 30 ml/min)

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.

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.

No interaction has been shown with other lipid lowering agents. However, the combination with statins or fibrates should be used with caution due to reports of an increased risk of musculoskeletal events with nicotinic acid (a structural analogue of acipimox) when used in combination with such lipid-lowering agents.

No interaction has been shown with digoxin and warfarin.

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).

* 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.

Pharmacia Limited

(POM)

23 November 2011