Ezetimibe

Ezetimibe tablets are indicated: • In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). • In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. • In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. …

• The recommended dose of ezetimibe tablets is 10 mg orally once daily, administered with or without food. • If as dose is missed, take the missed dose as soon as possible
• Do not double the next dose. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablets. • Administer ezetimibe tablets at least 2 hours before or 4 hours after administration of a bile acid sequestrant [see Drug Interactions ]. • 10 mg orally once daily, with or without food • Administer ezetimibe tablets either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablets

Ezetimibe tablets USP, 10 mg are white to off-white, capsule shaped, flat faced bevel edged tablets debossed with ‘I’ on one side and ‘83’ on the other side. • Tablets: 10 mg ( 3 )

• The safety and effectiveness of ezetimibe in combination with a statin as an adjunct to diet to reduce LDL-C have been established
• In pediatric patients 10 years of age and older with HeFH
• Use of ezetimibe for this indication is based on a double-blind, placebo-controlled clinical trial in 248
• Pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with HeFH [see Clinical Studies ]
• In this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females. …

Of the 2,396 patients who received ezetimibe in clinical trials, 669 (28%) were 65 years of age and older, and 111 (5%) were 75 years of age and older. Of the 11,308 patients who received ezetimibe in combination with a statin in clinical trials, 3587 (32%) were 65 years of age and older, and 924 (8%) were 75 years of age and older [see Clinical Studies (14) ] . …

• Advise the patient to read the FDA-Approved Patient Labeling (Patient Information)
• Inform patients that ezetimibe tablets may cause liver enzyme elevations [see Warnings and Precautions ]
• Muscle Pain Advise patients that ezetimibe tablets may cause myopathy and rhabdomyolysis
• Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider
• Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions , and Drug Interactions ]. …

• Ezetimibe tablets are contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets
• Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see Adverse Reactions ]
• When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ezetimibe tablets are contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated. …

Table 3 includes a list of drugs with clinically important drug interactions when administered concomitantly with ezetimibe and instructions for preventing or managing them. Table 3: Clinically Important Drug Interactions with Ezetimibe Cyclosporine Clinical Impact: Concomitant use of ezetimibe and cyclosporine increases ezetimibe and cyclosporine concentrations. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency [see Clinical Pharmacology (12.3) ] . Intervention: Monitor cyclosporine concentrations in patients receiving ezetimibe and cyclosporine. …

• Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies : Refer to the Prescribing Information of these products for a description of their risks including, but not limited to, the warnings and precautions. ( 5.1 ) • Liver Enzyme Abnormalities and Monitoring : Increases in serum transaminases have been reported with use of ezetimibe. Perform liver enzyme testing as clinically indicated and consider withdrawal of ezetimibe if increases in ALT or AST ≥3 X ULN persist. ( 5.2 ) • Skeletal Muscle Effects (e.g., Myopathy and Rhabdomyolysis) : Ezetimibe may cause myopathy and rhabdomyolysis. …

The following serious adverse reactions are discussed in greater detail in other sections of the label: • Liver enzyme abnormalities [see Warnings and Precautions (5.2) ] • Rhabdomyolysis and myopathy [see Warnings and Precautions (5.3) ] • Common adverse reactions in clinical trials: o Ezetimibe administered alone (incidence ≥2% and greater than placebo): upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. …

8.1 Pregnancy Risk Summary There are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human …

In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.