Zetriol: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Ezetimibe.

Description

Each caplet contains: Ezetimibe 10 mg.
Excipients/Inactive Ingredients: Povidone, Sodium lauryl sulfate, Lactose monohydrate, Croscarmellose sodium, Microcrystalline cellulose, Magnesium stearate.

Indications/Uses

Primary Hypercholesterolemia. Homozygous Familial Hypercholesterolemia (HoFH).

Dosage/Direction for Use

10 mg once daily, used alone, or in combination with a statin or fenofibrate.

Contraindications

The combination of Zetriol with HMG-CoA reductase inhibitors is contraindicated in patients with active liver disease or persistent, unexplained elevations in serum transaminases.

Special Precautions

If Zetriol is to be administered with statins or fenofibrate, which are contraindicated during pregnancy and lactation, refer to the product information for those medications.

Adverse Reactions

Significant: Hepatic effects, including increased serum aspartate aminotransferase/alanine aminotransferase levels and acute liver injury (e.g. hepatocellular hepatitis, cholestatic hepatitis); muscle-related effects (e.g. myalgia, myopathy, rhabdomyolysis [very rarely]).
Gastrointestinal disorders: Abdominal pain, flatulence, diarrhoea, nausea, dyspepsia, dry mouth.
General disorders and administration site conditions: Fatigue.
Immune system disorders: Anaphylaxis, angioedema.
Investigations: Increased blood creatine phosphokinase (CPK).
Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasm, pain in extremity.
Nervous system disorders: Headache, dizziness, paraesthesia.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, sinusitis.
Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus.

View ADR Reporting Link

Drug Interactions

Decreased absorption with bile acid sequestrants (e.g. colestyramine); administer ezetimibe at least 2 hours before or 4 hours after the bile acid sequestrant. Increased plasma concentration with ciclosporin and gemfibrozil. Increased risk of cholelithiasis and gallbladder disease with fenofibrate. May result in increased international normalized ratio with oral anticoagulants (e.g. warfarin, fluindione).

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.

Regulatory Classification

Presentation/Packing

Form

Zetriol caplet 10 mg

Packing/Price

3 × 10's

Zetriol

ezetimibe

Manufacturer:

Interbat