ARTG Entry
Nicotinic
ARTG entry for Nicotinic (nicotinic acid), ARTG 27193 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Alphapharm
- Active ingredient: nicotinic acid
- Therapeutic area: Cardiology
What it is
Nicotinic is a tablet containing 250 mg of nicotinic acid as the active ingredient. Nicotinic acid is a water-soluble B complex vitamin which is able to reduce serum lipids.
Approved indications
— Treatment of hyperlipidaemia, hypertriglyceridaemia and Frederickson-Lees Levy hyperlipoproteinaemia type II, IIB, III, IV and V as adjunctive therapy in addition to diet and other measures. — Pellagra.
Dosing overview
For pellagra: 250 mg (one tablet) twice a day. For hypercholesterolaemia and hypertriglyceridaemia: 250 mg three times daily increased by 250 mg increments every fourth day until a final daily dose of 3 to 4.5 g is reached. Individual dosage is recommended because lipid reduction is dose related. Tablets should be taken orally after meals.
Key safety warnings
Nicotinic acid may exacerbate hepatic dysfunction and large doses may exacerbate peptic ulcer, overt diabetes mellitus, gout or hyperuricaemia. Patients taking antihypertensive drugs should consult a physician before taking Nicotinic, as antihypertensive drugs may have an additive vasodilating effect and produce postural hypotension. Frequent monitoring of liver function should be performed during therapy to ascertain that the drug has no adverse effects. As decreased glucose tolerance may occur, glucose tolerance tests should be performed regularly, and adjustment of diet and/or hypoglycaemic therapy may be necessary. Frequent monitoring of serum uric acid levels is advised as elevated uric acid levels may occur during long-term therapy.
Contraindications
Large doses of Nicotinic should not be used by persons with heart or gallbladder disease, arterial bleeding or glaucoma. Nicotinic is contraindicated in cases of recent myocardial infarction. Nicotinic is contraindicated in patients with severe idiosyncratic reactions to it or those who exhibit a sudden fall in peripheral vascular resistance. Nicotinic is contraindicated in pregnancy and lactation.
Regulatory history
Nicotinic Acid 250 mg was first listed on the Australian Register of Therapeutic Goods on 21 October 1991.