Antihypertensive Therapy – Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.
Information on acute overdose with ADVICOR in humans is limited. Until further experience is obtained, no specific treatment of overdose with ADVICOR can be recommended. The patient should be carefully observed and given supportive treatment.
The s.c. LD50 of niacin is 5 g/kg in rats.
The signs and symptoms of an acute overdose of niacin can be anticipated to be those of excessive pharmacologic effect: severe flushing, nausea/vomiting, diarrhea, dyspepsia, dizziness, syncope, hypotension, possibly cardiac arrhythmias and clinical laboratory abnormalities. Insufficient information is available on the potential for the dialyzability of niacin.
After oral administration of lovastatin to mice the median lethal dose observed was >15 g/m2.
Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdose have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 to 6 g. The dialyzability of lovastatin and its metabolites in man is not known at present.
ADVICOR is contraindicated in patients with a known hypersensitivity to niacin, lovastatin or any component of this medication, active liver disease or unexplained persistent elevations in serum transaminases (see WARNINGS), active peptic ulcer disease, or arterial bleeding.
Pregnancy and lactation – Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase, such as lovastatin, to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, ADVICOR is contraindicated in women who are pregnant and in lactating mothers. ADVICOR may cause fetal harm when administered to pregnant women. ADVICOR should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, ADVICOR should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS, Pregnancy).
DRUG ABUSE AND DEPENDENCE
Neither niacin nor lovastatin is a narcotic drug. ADVICOR has no known addiction potential in humans.
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2007 Abbott Laboratories, North Chicago, IL 60064, U.S.A.
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U.S. Patent Nos. 6,080,428; 6,129,930; 6,406,715 B1; 6,676,967;
6,746,691; 6,818,229; 7,011,848; and other patents pending.
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