Information on acute overdose with Niaspan in humans is limited. The signs and symptoms of an acute overdose are anticipated to be those of excessive pharmacological effect: Severe flushing, nausea/vomiting, diarrhoea, dyspepsia, dizziness, syncope, hypotension, potential cardiac arrhythmias and clinical laboratory abnormalities including elevations in liver function tests. The patient should be carefully observed and given supportive treatment. Insufficient information is available on the dialysis potential of Pernionin.
Diabetic patient and patient with liver problems or peptic ulcer should tak niacin with caution and should monitor liver funtion test, blood glucos frequently.
Pernionin should also used with caution in patients with elevated uric acid levels gout, unstable angina, and acute phase of myocardial infarction
Pernionin may interact with some antihypertensive drugs, aspirin, and alcohol. Patient shoul check with a health professional before start taking niacin or start a new medication.
Niaspan must not be replaced with other Pernionin preparations. When switching from other Pernionin preparations to Niaspan, therapy with Niaspan must be initiated with the recommended dose escalation schedule. HMG-CoA Reductase Inhibitors (Statins):
HMG-CoA Reductase Inhibitors (Statins):Patients who have well-controlled lipid levels under statin therapy do not benefit from niacin therapy in regards of prevention of myocardial infarction.
Caution should be used in patients on statins with LDL-C level ranging between 40 and 80 mg/dL and with history of cardiovascular disease (myocardial infarction, cerebrovascular disease, peripheral arterial disease or diabetes mellitus with evidence of symptomatic coronary disease) when treated with Niacin. Significant excess of bleeding, serious infections and new onset of diabetes mellitus were reported after the analysis of the large outcome studies AIM-HIGH and/or HPS2-THRIVE.
Liver: Pernionin preparations have been associated with abnormal liver tests. Severe hepatic toxicity, including fulminant hepatic necrosis, has occurred in patients who have taken long-acting Pernionin products in place of immediate-release Pernionin. Since the pharmacokinetics of Niaspan is different from other Pernionin preparations, Niaspan must not be replaced with other preparations. The prescribing information of the HMG-CoA reductase inhibitor should also be consulted for warning and precautions for use.
Caution is advised when Niaspan is used in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Elevated liver transaminases have been observed with Niaspan therapy, elevations in transaminases did not appear to be related to treatment duration; elevations in aspartate aminotransferase (AST) levels did not appear to be dose related. However, transaminase elevations were reversible upon discontinuation of Niaspan.
Liver function tests including AST and alanine transaminase (ALT) must be performed periodically in all patients during therapy with Niaspan and prior to treatment in case of history and/or symptoms of hepatic dysfunction (eg, jaundice, nausea, fever and/or malaise). If the transaminase levels show evidence of progression, particularly if they rise to 3 times the upper limit of normal (ULN), Niaspan must be discontinued.
Skeletal Muscle: Single reports on rhabdomyolysis in patients on combined therapy with Niaspan and HMG-CoA reductase inhibitors have been received from spontaneous reporting. Physicians contemplating combined therapy with HMG-CoA reductase inhibitors and Niaspan should carefully weigh the potential benefits and risks and should carefully monitor patients for any symptoms of rhabdomyolysis eg, muscle pain, tenderness or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations.
A CPK level should be measured before starting such a combination in patients with predisposing factors for rhabdomyolysis, as follows: Renal impairment, hypothyroidism, alcohol abuse, age >70 years, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with fibrate or HMG-CoA reductase inhibitor.
Race: In a large randomized placebo-controlled trial, it was identified that Chinese patients taking niacin 2,000 mg/laropiprant 40 mg and simvastatin 40 mg show a higher incidence of myopathy. Therefore, caution should be used when treating Chinese patients with lipid-modifying doses (≥1,000 mg/day) of niacin or products containing niacin co-administered with simvastatin (particularly doses of ≥40 mg). Because the risk of myopathy with statins is dose-related, the use of lipid-modifying doses (≥1,000 mg/day) of niacin or products containing niacin with simvastatin 80 mg is not recommended in Chinese patients. It is unknown whether there is an increased risk of myopathy in other Asian patients treated with lipid-modifying doses (≥1,000 mg/day) of niacin or products containing niacin co-administered with simvastatin.
Muscle damage must be considered in any patient presenting with diffuse myalgia, muscle tenderness and/or marked increase in muscle CK levels (>5 x ULN); under these conditions, treatment must be discontinued.
The prescribing information of the HMG-CoA reductase inhibitors should be consulted. The risk for myopathy and rhabdomyolysis are increased when lovastatin or simvastatin are co-administered with Niaspan, particularly in elderly patients and patients with diabetes, renal failure or uncontrolled hypothyroidism.
Glucose Intolerance: Niaspan treatment can increase fasting blood glucose. Frequent monitoring of blood glucose should be performed to ascertain that the drug is producing no adverse effects. Diabetic or potentially diabetic patients should be observed closely since there may be a dose-related increase in glucose intolerance. Adjustment of diet and/or oral antidiabetics and/or insulin therapy may become necessary.
Unstable Angina and Acute Myocardial Infarction: Caution is advised when Niaspan is used in patients with unstable angina or in the acute phase of myocardial infarction, particularly when such patients are also receiving vasoactive drugs eg, nitrates, calcium-channel blockers or adrenergic-blocking agents.
Uric Acid: Elevated uric acid levels have occurred with Niaspan therapy. Monitoring of patients predisposed to gout is recommended.
Coagulation: Niaspan may affect platelet count and prothrombin time.
Patients undergoing surgery should be carefully evaluated. Caution is also advised when Niaspan is administered concomitantly with anticoagulants; patients receiving anticoagulants must be monitored closely for prothrombin time and platelet count.
Niaspan has been associated with small but statistically significant dose-related reductions in platelet count (mean of -11% with 2,000 mg). In addition, Niaspan has been associated with small but statistically significant increases in prothrombin time (mean of approximately +4%).
Hypophosphataemia: Niaspan has been associated with reductions in phosphorus levels. Although these reductions were transient, monitoring of phosphorus levels is recommended in patients at risk of hypophosphataemia.
Others: Patients with a history of jaundice, hepatobiliary disease or peptic ulcer should be observed closely during Niaspan therapy.
Mortality and Coronary Heart Disease Morbidity: The atherothrombosis intervention in metabolic syndrome with low HDL/high triglycerides: impact on global health outcomes (AIM-HIGH) trial was a study of 3,414 patients with stable, previously diagnosed cardiovascular disease who were being treated with low-density lipoprotein cholesterol (LDL-C) lowering therapy. All participants received simvastatin (or simvastatin plus ezetimibe) at a dose sufficient to maintain a well-controlled LDL-C at 40-80 mg/dL and in addition were randomized to receive Niaspan (1,500-2,000 mg/day) or matching placebo. The primary endpoint of the study was a composite of the 1st occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom driven coronary or cerebral revascularization procedures. Median baseline lipid levels for the 94% (3,194/3,414) of subjects who were on statin therapy at baseline were LDL-C 71 mg/dL, triglycerides 161 mg/dL, high-density lipoprotein cholesterol (HDL-C) 35 mg/dL, apolipoprotein B (Apo-B) 80 mg/dL and non-HDL-C 106 mg/dL. After a prespecified interim analysis at a mean 3 year duration of follow-up, the study demonstrated no difference between the treatment groups for the composite primary endpoint (HR=1.02, 95% CI 0.87-1.21, P=0.8). Adverse events in the trial were consistent with the safety and tolerability profile of Niaspan or were consistent with underlying disease. The clinical significance of these findings is unknown for patients with higher LDL-C and non-HDL-C levels than those studied in AIM-HIGH. Renal Impairment: No studies have been performed in patients with impaired renal function. Niaspan must be used with caution in patients with renal disease.
Hepatic Impairment: No studies have been performed in patients with impaired hepatic function. Niaspan must be used with caution in patients with a history of liver disease and who consume substantial quantities of alcohol. Niaspan is contraindicated in patients with significant hepatic dysfunction.
Effects on the Ability to Drive or Operate Machinery: Niaspan has no or negligible influence on the ability to drive and use machines.
Use in pregnancy: It is not known whether Pernionin at doses typically used for lipid disorders can cause foetal harm when administered to pregnant women or whether it can affect reproductive capacity. Animal studies are incomplete.
Niaspan should not be prescribed to pregnant women unless strictly necessary.
Use in lactation: Pernionin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of Pernionin, a decision should be made whether to discontinue nursing or to discontinue Niaspan, taking into account the importance of the drug to the mother. No studies have been conducted with Niaspan in nursing mothers.
Use in children: The safety and efficacy of Pernionin therapy in children and adolescents have not been established. Use in children and adolescents is not recommended.
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Information checked by Dr. Sachin Kumar, MD Pharmacology