Ridel ER

• Primary hyperlipidemia:
  Treatment of elevated low-density lipoprotein cholesterol (LDL-C), triglycerides, and low high-density lipoprotein cholesterol (HDL-C) to reduce cardiovascular risk.
• Mixed dyslipidemia:
  Management of combined elevations in LDL-C and triglycerides with low HDL-C.
• Prevention of cardiovascular events:
  Used as an adjunct to diet and lifestyle modifications to reduce risk of myocardial infarction and stroke in high-risk patients.
• Niacin deficiency (Pellagra):
  Prevention and treatment of pellagra characterized by dermatitis, diarrhea, and dementia.
• Off-label/Clinically accepted uses:
  Adjunct therapy in metabolic syndrome and diabetic dyslipidemia with careful monitoring.

• Route: Oral.
• Adults:
• Immediate-release formulations: Start with 100–250 mg three times daily, titrate gradually to 1.5–3 grams daily in divided doses.
• Extended-release formulations: Start at 500 mg once daily at bedtime; may be increased up to 2 grams daily.
• Pediatrics: Safety and efficacy not established for lipid disorders; used only for niacin deficiency under medical supervision.
• Elderly: Initiate at lower doses with gradual titration due to increased sensitivity.
• Renal/Hepatic impairment: Use cautiously with dose adjustment and monitoring, particularly in hepatic dysfunction due to hepatotoxicity risk.
• Administration advice:
  Take with food to reduce flushing. Extended-release tablets should not be crushed or chewed. Avoid alcohol near dosing time to minimize flushing and hepatotoxicity risk.

Nicotinic acid reduces lipid levels by inhibiting hepatic synthesis of very-low-density lipoprotein (VLDL) through inhibition of diacylglycerol acyltransferase-2 and decreasing free fatty acid mobilization from adipose tissue via inhibition of hormone-sensitive lipase. These actions lead to reduced triglyceride production, decreased LDL cholesterol, and increased HDL cholesterol. Additionally, niacin induces vasodilation via prostaglandin release, accounting for common flushing side effects.

• Absorption: Rapid and complete from the gastrointestinal tract, though bioavailability varies by formulation.
• Distribution: Widely distributed in body tissues.
• Metabolism: Primarily hepatic conjugation to nicotinuric acid and nicotinamide metabolites.
• Active metabolites: Nicotinamide, which lacks lipid-lowering effects.
• Elimination: Mainly renal excretion of metabolites.
• Half-life: Immediate-release ~20–45 minutes; extended-release formulations provide prolonged plasma levels.

• Pregnancy: FDA Category C. Use only if clearly needed; animal studies show no direct fetal harm but adequate human data lacking.
• Lactation: Excreted in breast milk; caution advised, weighing benefits against risks.

• Lipid-lowering agent
• Nicotinic acid derivative (Vitamin B3)

• Hypersensitivity to nicotinic acid or excipients.
• Active liver disease or severe hepatic dysfunction.
• Active peptic ulcer disease.
• Severe hypotension.
• Arterial hemorrhage.
• Persistent unexplained hyperglycemia.

• Monitor liver function tests due to risk of hepatotoxicity.
• Use with caution in diabetic patients; may impair glucose tolerance.
• Risk of exacerbating gout or hyperuricemia.
• Flushing is common but can be mitigated with aspirin pre-treatment.
• Gradual dose escalation recommended to minimize adverse effects.
• Avoid abrupt discontinuation to prevent rebound effects.

• Common:
• Flushing and warmth sensation (dose-dependent, often transient)
• Pruritus
• Gastrointestinal upset (nausea, abdominal pain)
• Serious/Rare:
• Hepatotoxicity (particularly with sustained-release formulations)
• Hyperglycemia
• Gout flare-ups
• Rhabdomyolysis (especially when combined with statins)
• Hypotension

• Statins: Increased risk of myopathy and rhabdomyolysis.
• Alcohol: Increases risk of flushing and liver toxicity.
• Antihypertensive drugs: May cause additive hypotensive effects.
• Bile acid sequestrants: May reduce absorption; separate administration recommended.
• Other lipid-lowering agents: Monitor for enhanced adverse effects.

• Current lipid management guidelines prioritize statins; niacin is reserved for specific cases where statins are insufficient or contraindicated.
• Enhanced warnings regarding hepatotoxicity, especially with extended-release forms, have been issued.
• Ongoing research supports cautious use with vigilant monitoring for adverse effects.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture, heat, and light.
• Keep tablets in tightly sealed containers.
• Keep out of reach of children.