Ezeta 10

Indications

• Primary Hypercholesterolemia: Ezeta is prescribed alongside a statin for managing primary (heterozygous familial and non-familial) hypercholesterolemia in patients who don’t achieve adequate control with statin therapy alone. Ezeta can also be used as a standalone treatment for those who cannot tolerate statins or where statin use is not appropriate.
• Prevention of Cardiovascular Events: Ezeta is recommended to lower the risk of cardiovascular events in individuals with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when used in conjunction with ongoing statin therapy or when starting treatment with a statin.
• Homozygous Familial Hypercholesterolemia (HoFH): When used with a statin, Ezeta serves as an adjunct to diet in patients with HoFH. It may also be used alongside other treatments like LDL apheresis.
• Homozygous Sitosterolemia (Phytosterolemia): Ezeta is used as an adjunct to diet for managing homozygous familial sitosterolemia.

Pharmacology

Ezeta contains Ezetimibe, which works by inhibiting cholesterol absorption in the small intestine through the Niemann-Pick C1-Like1 (NPC1L1) transporter. This leads to reduced cholesterol delivery to the liver, lowering hepatic cholesterol levels and increasing blood cholesterol clearance.

Dosage & Administration

Recommended Dose: 10 mg once daily, with or without food.

Interactions

Fibrates: May lead to increased cholesterol excretion and gallbladder issues; co-administration with Ezeta is not recommended until further studies are conducted.

Contraindications

• Hypersensitivity: Contraindicated in those with known allergies to Ezetimibe or its components.
• Liver Disease: Not to be used with HMG-CoA reductase inhibitors in patients with active liver disease or unexplained persistent transaminase elevations.

Side Effects

Ezeta is generally well tolerated, with adverse events similar in frequency to placebo. Discontinuation rates due to side effects are comparable to those seen with placebo.

Pregnancy & Lactation

• Pregnancy: Ezetimibe should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.
• Lactation: No sufficient data is available on the excretion of Ezetimibe in human milk.

Precautions & Warnings

• Dyslipidemia: Ensure secondary causes of dyslipidemia are addressed before starting treatment.
• Renal & Hepatic Impairment: Use with caution.
• Pregnancy & Lactation: Follow guidelines for these conditions.

Use in Special Populations

• Pediatric Use:
  • Ages 10 to 17: No dose adjustment needed, though clinical experience is limited. Refer to dosing guidelines for statins if used concurrently.
  • Under 10 years: Not recommended due to insufficient safety and efficacy data.

Overdose Effects

No significant toxicity reported for doses up to 50 mg/day. In case of overdose, provide symptomatic and supportive care.

Therapeutic Class

Ezetimibe

Storage Conditions

Store in a cool, dry place away from light and moisture. Keep out of reach of children.