Medication info
Drop Top Tablet 10/10 mg

Drop Top Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets (10 tablets x 3)/Alu-Alu
Approval status
Active

MFDS item code 201708317 · Approved 2017.12.12 · Insurance code 642905920

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, dosing ranges from 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg daily. For patients who require greater reduction in LDL cholesterol, the dose can be adjusted. After initiation or adjustment of dosage, lipid levels should be checked with an interval of at least 4 weeks before modifying the dose.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, mixed) and dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to dietary therapy to lower total cholesterol, LDL cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is particularly administered to patients at risk of atherosclerotic vascular disease due to hypercholesterolemia and should be used in conjunction with appropriate dietary measures for effectiveness. If dyslipidemia is due to secondary factors such as diabetes or hypothyroidism, it is important to address these underlying causes first. Additionally, lipid levels should be regularly monitored, and management should follow clinical guidelines for patients with acute coronary events. This medication helps to control lipid levels and improve cardiovascular disease risk in conjunction with dietary therapy.

How to take

Adult dose

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, dosing ranges from 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg daily. For patients who require greater reduction in LDL cholesterol, the dose can be adjusted. After initiation or adjustment of dosage, lipid levels should be checked with an interval of at least 4 weeks before modifying the dose.

Precautions

This medication may cause serious muscle problems, so if symptoms such as muscle pain or weakness occur, contact a doctor immediately. Extreme caution is required in cases of severe infection, hypotension, major surgery or trauma, hypothyroidism, or kidney issues. Individuals allergic to this medication, those with liver disease, or muscle disorders should not take it. Furthermore, pregnant or breastfeeding women should not use this medication, and women of childbearing age must take effective contraceptive measures. Since this medication may affect liver function, regular liver function tests are necessary, and treatment should be discontinued if abnormalities occur. Patients with poor kidney function also require caution while taking this medication and should have blood tests to check for muscle damage. Drug interactions may occur when taking with other medications, so it is essential to inform healthcare professionals about any other drugs being taken. Neurogenic symptoms like dizziness or headaches may appear, so care is needed when driving or operating machinery. Safety and efficacy in children have not been established, and it is not recommended for pediatric use. If skin rashes or severe allergic reactions occur while taking this medication, discontinue use immediately and consult a physician. There is no specific antidote for overdose; therefore, symptomatic treatment is required, and tests to assess liver function and muscle status are necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, Cold sweat, Chest tightness, Difficulty breathing, Severe swelling (edema), Severe allergic reaction, High fever with severe rash, Blisters, Skin peeling, Pain in oral/ocular mucosa, Severe skin reactions, Shortness of breath or difficulty breathing, Asthma attacks, Respiratory abnormalities accompanied by cough and fever, Breathing problems, Yellowing of the skin or eyes (jaundice), Profound lethargy, Liver abnormalities (jaundice), Sudden and severe

Mild side effects

  • Increased ALT
  • Increased AST
  • Gastroesophageal reflux
  • Dizziness
  • Pruritus
  • Increased CPK
  • Sensory loss
  • Back pain
  • Headache
  • Constipation
Show 28 more
  • Nausea
  • Abdominal pain
  • Diarrhea
  • Loss of appetite
  • Itching
  • Abnormal liver function tests
  • Weakness
  • Joint pain
  • Fatigue
  • Numbness
  • Paresthesia
  • Syncope
  • Generalized pain
  • Muscle cramps
  • Gout
  • Erectile dysfunction
  • Cough
  • Phlegm
  • Nasal discharge
  • Hives
  • Rash
  • Sweating
  • Headache
  • Fatigue
  • Abdominal pain
  • Diarrhea
  • Pharyngitis
  • Sinusitis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets (10 tablets x 3)/Alu-Alu

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.