Normolip-300mg

Manufactured By Sun Pharma-cns Division

Class: Antihyperlipidemic Action Decreases blood levels of triglycerides and VLDL by decreasing their production. Also decreases cholesterol and increases HDL. Indications Treatment of hypertriglyceridemia in adult patients with type IV or V hyperlipidemia that presents risk of pancreatitis and does not respond to diet; reduction of coronary heart disease risk in type IIb patients who have low HDL levels (in addition to elevated LDL and triglycerides) and have not responded to other measures. Contraindications Hepatic or severe renal dysfunction, including primary biliary cirrhosis; preexisting gallbladder disease. Route/Dosage ADULTS: PO 600 mg bid 30 min before morning and evening meals. Interactions Lovastatin: Increases risk of rhabdomyolysis. Oral anticoagulants (eg, warfarin): Anticoagulant effect may be increased. Lab Test Interferences None well documented. Adverse Reactions CV: Atrial fibrillation. CNS: Fatigue; vertigo; headache. DERM: Eczema; rash. EENT: Blurred vision. GI: Dyspepsia; abdominal pain; diarrhea; nausea; vomiting; constipation; acute appendicitis. GU: Impotence. HEMA: Anemia; leukopenia; bone marrow hypoplasia; eosinophilia. HEPA: Elevated liver function test results; cholestatic jaundice. META: Mild hyperglycemia. OTHER: Muscle pain or weakness; myositis; rhabdomyolysis; taste perversions. Precautions Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established. Cholelithiasis: Drug may increase cholesterol excretion into the bile, leading to cholelithiasis. PATIENT CARE CONSIDERATIONS Administration/Storage Administer 30 min before breakfast and supper. Store at room temperature in a tightly closed container. Assessment/Interventions Obtain patient history, including drug history and any known allergies. Note preexisting kidney, liver, or gallbladder disease, or diabetes. Assess dietary intake of fats. Perform periodic blood counts during first 12 mo of administration. Obtain periodic determinations of serum lipids. Monitor liver studies. Assess for side effects, particularly abdominal pain, nausea, and vomiting. Patient/Family Education Inform patient of need to restrict dietary intake of fats; teach patient dietary restrictions to follow. Emphasize importance of the following increased cardiac risk factors: smoking, alcohol consumption, lack of exercise. Instruct patient to report the followin symptoms to health care provider: abdominal pain, persistent nausea and vomiting, bleeding, and irregular heartbeat. Advise patient that drug may cause dizziness or blurred vision and to use caution while driving or performing other tasks requiring mental alertness.