Adult Dosing

Niacin deficiency

Treatment

• Upto 500 mg PO in divided doses

Prophylaxis

• 10-20 mg/day PO

Hyperlipidemias

Immediate release TABS

• Initial: 100–500 mg/day PO; increase slowly up to 1–2 g/day PO tid. Max: 8 g/day PO

Extended release TABS

• Monotherapy:
• 500-2000 mg PO Daily
• Initial: 500 mg PO qhs; increase dose by not more than 500 mg in any 4 wks period
• Maintenance: 1000-2000 mg/day PO x1. Max: 2000 mg/day PO

• Combination therapy with lovastatin:
• Initial: lovastatin 20 mg/day PO. Max: 40 mg/day PO
• Max: niacin 2000 mg/day PO

• Combination therapy with simvastatin:
• Initial: simvastatin 20 mg/day PO. Max: 40 mg/day PO
• Max: niacin 2000 mg/day PO

Pediatric Dosing

Niacin deficiency prophylaxis

• Child birth-3yrs: 5-9 mg/day PO
• Child 4-6 yrs: 12 mg/day PO
• Child 7-10 yrs: 13 mg/day PO

Note:

• Safety and effectiveness of niacin therapy (Extended Release TABS) in pediatric patients (+<16 years) have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

Pellagra

• Treatment and prophylaxis of niacin deficiency

Niacin (generic)

• Adjunctive therapy in certain hyperlipidemias

Niaspan

• Indicated to treat elevated levels of total cholesterol (TC), LDL-C, TG, and apolipoprotein B levels, and to increase HDL-C in primary hyperlipidemia and mixed dyslipidemia
• Used in combination with lovastatin or simvastatin to treat primary hyperlipidemia and mixed dyslipidemia when treatment with monotherapy is inadequate
• To reduce the risk of recurrent nonfatal myocardial infarction in patients with history of myocardial infarction and hyperlipidemia
• Used concomitantly with bile acid binding resin to slow progression/promote regression of atherosclerotic disease in patients with history of coronary artery disease and hyperlipidemia, and to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia
• Adjunct therapy for treating severe hypertriglyceridemia in adult patients with risk of pancreatitis and who do not respond adequately to diet

• Hypersensitivity to any of the ingredients of the product
• Hepatic impairment
• Active peptic ulcer disease
• Severe Hypertension
• Arterial bleeding

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined, caution advised

Hepatic Dose Adjustment

• Significant or unexplained hepatic dysfunction: Contraindicated

• Events of severe hepatic toxicity, including fulminant hepatic necrosis have been reported in patients who have substituted sustained-release therapy for immediate-release therapy. Therefore periodically perform liver function tests during the therapy
• Concomitant use of lipid-altering doses (1 g/day) of niacin and HMG-CoA reductase inhibitors may cause rhabdomyolysis. Weigh the potential benefits and risks before instituting such therapy and carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness
• Prior to initiating therapy make an attempt to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems
• Cautiously administer therapy in patients with history of jaundice, hepatobiliary disease, or peptic ulcer. Liver function tests and blood glucose should be frequently performed
• Closely monitor and adjust dosage/diet accordingly as diabetic patients may experience a dose-related rise in glucose intolerance
• Caution advised in patients with unstable angina or in the acute phase of myocardial infarction
• Use with caution in patients predisposed to gout because elevated uric acid levels have occurred with the therapy

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• History of biliary disease
• History of PUD
• Alcohol abuse
• Diabetes mellitus
• Gout
• Unstable angina
• Acute MI
• Hypophosphatemia
• Surgery

Pregnancy Category:C

Breastfeeding: Safety unknown. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Dizziness, nervousness, panic, headache
• EENT: Blurred vision, loss of central vision, proptosis, toxic amblyopia, macular edema
• CV: Orthostatic hypotension, arrhythmias
• GI: GI upset, bloating, diarrhea, dry mouth, flatulence, heartburn, hunger pains, nausea, dyspepsia, vomiting, peptic ulceration
• HEPA: Hepatotoxicity, fulminant hepatic necrosis, jaundice, abnormal LFTs
• DERM: Flushing of the face and neck, pruritus, burning, dry skin, hyperpigmentation, sebaceous gland activity, rashes, stinging or tingling of skin
• METABOLIC: Glycosuria, hyperglycemia, hyperuricemia, decreased glucose tolerance, gout
• HYPERSENSITIVITY: Hypersensitivity reactions, anaphylaxis
• MUSC: Myalgia, progression of cataracts

• Water soluble vitamin; decreases lipoprotein and triglyceride synthesis by inhibiting the release of free fatty acids from adipose tissue and decreasing hepatic lipoprotein synthesis; required as coenzymes for lipid metabolism, glycogenolysis, and tissue respiration; in large doses causes peripheral vasodilatation
• Well absorbed following oral administration
• Metabolized by liver
• Excreted through kidney 88%
• half-life: 20-45 mins

US Trade Name(s)

• Niacor
• Niaspan

US Availability

niacin (generic)

• TABS: 500 mg
• ETABS: 1000 mg

Niacor

• TABS: 500 mg

Niaspan

• ETABS: 500, 750, 1000 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Antihyperlipidemic Agents

Other Antihyperlipidemic Agents

Cardiovascular

Antihyperlipidemic Agents

Other Antihyperlipidemic Agents

Pricing data from www.DrugStore.com in U.S.A.

• Niaspan 500 MG TBCR [Bottle] (ABBOTT)
  30 mg = $89.99
  90 mg = $246.97
• Niaspan 1000 MG TBCR [Bottle] (ABBOTT)
  30 mg = $161.98
  90 mg = $466.97
• Niacin 500 MG TABS [Bottle] (RUGBY)
  100 mg = $11.99
  200 mg = $16.96
• Niaspan 750 MG TBCR [Bottle] (ABBOTT)
  30 mg = $124.99
  90 mg = $347.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Niacor 500 MG Oral Tablet (UPSHER-SMITH LABORATORIES, INC.)
• Niaspan 1000 MG Extended Release Tablet (Abbott Laboratories)
• Niaspan 1000 MG Extended Release Tablet (Physicians Total Care, Inc.)
• Niaspan 500 MG Extended Release Tablet (Abbott Laboratories)
• Niaspan 500 MG Extended Release Tablet (Physicians Total Care, Inc.)
• Niaspan 750 MG Extended Release Tablet (Abbott Laboratories)
• Niaspan 750 MG Extended Release Tablet (Physicians Total Care, Inc.)