Treatment and prophylaxis of Niaspanor deficiency
Adult: For treatment of pellagra: 300-500 mg daily in divided doses. For management of Hartnup disease: 50-200 mg daily.
Child: For treatment of pellagra: 100-300 mg daily in divided doses.
Adult: Initially, 250 mg once daily in the evening. Increase dose every 4-7 days until desired LDL cholesterol and/or triglyceride level is achieved or dose of 1.5-2 g/day is reached. If hyperlipidaemia is not adequately controlled after 2 mth w/ this dose, it can be increased at 2- to 4-wk intervals to 1 g tid. Max: 6 g daily. As extended-release tab: Initially, 500 mg at night, gradually increased according to response to a maintenance of 1-2 g at bedtime.
Adult: 100-150 mg 3-5 times daily. As extended-release tab: 300-400 mg 12 hrly.
Mild to moderate inflammatory acne
Adult: As 4% gel: Apply to affected area bid.
Each tablet also contains the following excipients: Hypromellose, povidone, stearic acid and polyethylene glycol. Coloring Agents: FD & C yellow #6/sunset yellow FCF aluminum lake, synthetic red and yellow iron oxides and titanium dioxide.
Niaspanor contains Nicotinic Acid, which the therapeutic doses are antihyperlipidemic agent.
Niaspanor which is niacin or 3-pyridinecarboxylic acid is a white, crystalline powder and is soluble in water.
Initially 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy.
The recommended dose escalation schedule is shown in the following table: See Table 6.
Maintenance Dose: The daily dosage should not be increased by >500 mg in any 4-week period. Recommended Maintenance Dose: 1,000 mg (two 500-mg tablets or one 1,000-mg tablet) to 2,000 mg (two 1,000-mg tablets or four 500-mg tablets) once daily at bedtime. Doses >2,000 mg daily are not recommended. Women may respond at lower Niaspanor doses than men.
Single-dose bioavailability studies have demonstrated that 2 of the 500-mg and 1 of the 1000-mg tablet strengths are interchangeable.
If lipid response to nicotinic extended-release alone is insufficient or if higher doses are not well tolerated, some patients may benefit from combination therapy with a bile acid-binding resin or statin.
Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus and gastrointestinal distress are also greatly reduced by slowly increasing the dose of Niaspanor and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of Niaspanor extended-release ingestion.
Equivalent doses of Niaspanor extended-release should not be substituted for sustained-release (modified-release, timed-release) nicotinic preparations or immediate-release (crystalline) Niaspanor. Patients previously receiving other Niaspanor products started with the recommended Niaspanor titration schedule and the dose should subsequently be individualised based on the patient's response.
If Niaspan therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Concomitant Therapy with Lovastatin or Simvastatin: Patients already receiving a stable dose of lovastatin or simvastatin who require further triglyceride (TG)-lowering or high-density lipoprotein (HDL)-raising, may receive concomitant dosage titration with Niaspan per the recommended initial titration schedule. Combination therapy with Niaspan and lovastatin or Niaspan and simvastatin should not exceed doses of Niaspan 2,000 mg and lovastatin 40 mg or simvastatin daily.
Limitations of Use: No incremental benefit of Niaspan co-administered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin and lovastatin monotherapy, has been established.
Elderly: No dose adjustment is necessary.
Gender: Data from clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of Niaspan.
Administration: Niaspan tablets should be taken whole and should not be broken, crushed or chewed before swallowing.
Niaspan should be taken at bedtime, after a low-fat snack (eg, an apple, low fat yoghurt, slice of bread) and doses should be individualised according to the patient's response.
Concomitant alcohol or hot drinks may increase undesirable flushing and pruritus, and should be avoided around the time of Niaspan ingestion.
When Niaspan is administered concomitantly with anticoagulants, prothrombin time and platelet counts must be monitored closely.
Niaspanor may potentiate the blood pressure-lowering effect of ganglionic-blocking agents eg, transdermal nicotine or vasoactive drugs eg, nitrates, calcium-channel blockers or adrenergic-blocking agents.
Bile acid sequestrants bind to other orally administered medicinal products and should be taken separately.
An in vitro study results suggest that the bile acid-binding resins have high Niaspanor-binding capacity. Therefore, 4-6 hrs or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Niaspan.
Niaspanor may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines.
Niaspanor may also give false-positive reactions with cupric sulphate solution (Benedict's reagent) in urine glucose tests.
Combination of Niaspanor with HMG-CoA reductase inhibitors may increase the risk for myopathy and rhabdomyolysis. The prescribing information of the HMG-CoA reductase inhibitor should also be consulted.
Concomitant aspirin may decrease the metabolic clearance of Niaspanor. The clinical relevance of this finding is unclear.
Vitamins or other nutritional supplements containing large doses of Niaspanor or related compounds eg, nicotinamide may potentiate the adverse effects of Niaspan.
Flush: In the placebo-controlled clinical trials, flushing episodes (ie, feeling hot, erythema, pruritus and/or paresthesia) were the most common treatment-emergent adverse events for Niaspan (reported by 88% of patients). In these studies, <6% of Niaspan patients discontinued due to flushing.
In comparisons of immediate-release (IR) Niaspanor and Niaspan, although the number of patients who flushed was similar, fewer flushing episodes were reported by patients who received Niaspan. Following 4 weeks of maintenance therapy with Niaspan at daily doses of 1,500 mg, the frequency of flushing over the 4-week period averaged 1.88 events/patient.
Flushing reactions generally occur during early treatment and the dose titration phase. They are thought to be mediated by the release of prostaglandin D2 and tolerance to flushing usually develops over the course of several weeks.
Spontaneous reports suggest that in rare cases, flushing may be more severe and accompanied by symptoms of dizziness, tachycardia, palpitations, dyspnoea, sweating, burning sensation, skin burning sensation, chills and/or oedema, which in rare cases may lead to syncope. Medical treatment should be administered as necessary.
Hypersensitivity Reactions: Hypersensitivity reactions have been reported very rarely. These may be characterized by symptoms eg, generalized exanthema, flush, urticaria, vesiculobullous rash, angioedema, laryngospasm, dyspnoea, hypotension and circulatory collapse. Medical treatment should be administered as necessary.
The following adverse reactions have been observed in clinical studies or in routine patient management, in patients receiving the recommended daily maintenance doses (1,000, 1,500 and 2,000 mg) of Niaspan. They are presented by system organ class and frequency grouping (very common ≥1/10; common ≥1/100, <1/10; uncommon ≥1/1,000, <1/100; rare ≥1/10,000, <1/1,000; very rare <1/10,000, including isolated reports).
In general, the incidence of adverse reactions was higher in women compared to men.
Post-Marketing Experience: The following adverse reactions have been reported in post-marketing experience with Niaspan. Adverse reactions are presented by system organ class.
Infections and Infestations: Infection.
Metabolism and Nutrition Disorders: Diabetes mellitus.
Blood and Lymphatic System Disorders: Haemorrhage.
Nervous System Disorders: Burning sensation, skin burning sensation.
Eye Disorders: Blurred vision.
Hepatobiliary Disorders: Hepatitis.
Skin and Subcutaneous Tissue Disorders: Skin discoloration.
Contraindications for Vitamin B3 (Niaspanor)
Niaspanor is contraindicated in patients with a known hypersensitivity to any component of this medication; significant or unexplained hepatic dysfunction; active peptic ulcer disease; or arterial bleeding.
Nicotinic Acid in South Korea.
List of Niaspanor substitutes (brand and generic names)
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|Unit description / dosage (Manufacturer)||Price, USD|
|Niaspan 1000mg (Bulgaria, Israel)|
|Niaspan 375mg (Bulgaria)|
|Niaspan 500mg (Bulgaria, Israel)|
|Niaspan 750mg (Bulgaria, Israel)|
|Niaspan CF (Chile)|
|Niaspan CR (Argentina)|
|Niaspan Extended-Release (Singapore)|
|Niaspan Extended-Release 500 mg x 28's (Abbott)|
|Niaspan Extended-Release 750 mg x 28's (Abbott)|
|Niaspan Extended-Release 1000 mg x 28's (Abbott)|
|Niaspan ER XR tab 500 mg 30's (Abbott)|
|Niatroy SR 500 mg Tablet (Troikaa Pharmaceuticals Ltd.)||$ 0.06|
|Nicocin 375mg ER-TAB / 10 (Ethics Health-Care Pvt. Ltd.)||$ 0.32|
|375 mg x 10's (Ethics Health-Care Pvt. Ltd.)||$ 0.32|
|Nicocin 200 mg Tablet (Ethics Health-Care Pvt. Ltd.)||$ 0.07|
|NICOCIN ER tab 375 mg x 10's (Ethics Health-Care Pvt. Ltd.)||$ 0.32|
|Nicocin ER 375 mg Tablet (Ordain Health Care (P) Ltd.)||$ 0.03|
|Nicortinic Acid (Japan)|
|Nicotabs 50 mg x 1, 000's (Thaipharmed)||$ 15.15|
|Nicotinato de Metilo Pharma Arte (Paraguay)|
|Nicotinic Acid 100mg Tab|
|NICOTINIC ACID 25MG TAB|
|Nicotinic Acid Alphapharm (Australia)|
|Nicotinic Acid Beacons (Singapore)|
|Nicotinic Acid Beacons 50 mg x 1's|
|Nicotinic Acid Darnitsa (Georgia)|
|Nicotinic Acid Greater Pharma (Thailand)|
|Nicotinic Acid Greater Pharma 50 mg x 1000's|
|Nikotino rūgšties 1% Bakteriniai preparatai (Lithuania)|
|Nikotino rūgšties 1% Endokrininiai preparatai (Lithuania)|
|Nyclin 10% (Japan)|
|Rhea Nicotinic Acid (Philippines)|
|Rhea Nicotinic Acid 50 mg x 100's||$ 1.14|
|Rhea Nicotinic Acid 100 mg x 100's||$ 1.77|
|Rubriment (Chile, Germany)|
|Rui Zhi (China)|
|Shu Cheng (China)|
|Unguent cu Nicotinat de Metil (Romania)|
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Information checked by Dr. Sachin Kumar, MD Pharmacology