Medication info
Drop Top Tablet 10/20 Milligrams

Drop Top Tablet 10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletRosuvastatin Calcium›20.8mg / 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 201708316 · Approved 2017.12.12 · Insurance code 642905930

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, mixed) and dyslipidemia
Who takes it
Adults
Adult dose
The medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg daily is recommended, and the dosage can be adjusted for patients requiring more reduction in LDL cholesterol. After initiation of treatment or dose adjustment, lipid levels should be checked at least 4 weeks apart before adjusting the dosage.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement of cholesterol and lipid levels 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
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia.
View approved original text

This medication is used to improve cholesterol and lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Specifically, it reduces total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels while increasing HDL cholesterol. It is also an adjunctive treatment used alongside diet to reduce the risk of atherosclerotic vascular disease due to hypercholesterolemia. This medication is administered when dietary modifications and other non-drug therapies are ineffective to minimize side effects, and it is important to first identify and treat other causes of dyslipidemia. Treatment effects are monitored through lipid tests (total cholesterol, LDL, HDL, triglycerides), especially in patients with acute coronary events, where tests are performed upon admission or within 24 hours. This medication helps effectively manage the patient's dyslipidemia and lower the risk of cardiovascular disease.

How to take

Adult dose

The medication is administered once daily, regardless of meals. For primary hypercholesterolemia, the dosage range is from 10/5 mg to 10/20 mg per day. A starting dose of 10/5 mg daily is recommended, and the dosage can be adjusted for patients requiring more reduction in LDL cholesterol. After initiation of treatment or dose adjustment, lipid levels should be checked at least 4 weeks apart before adjusting the dosage.

Precautions

This medication has been reported to cause a rare side effect known as rhabdomyolysis, which can lead to severe muscle damage. This can cause acute kidney injury, so if symptoms of severe muscle pain or myopathy occur, treatment should be stopped immediately and a doctor should be consulted. Patients with severe infections, hypotension, post-major surgery, trauma, severe metabolic disorders or electrolyte imbalances, or uncontrolled seizures may require temporary discontinuation of this medication. This medication should not be administered to certain patients. For example, if there is an allergy to any component of this drug, active liver disease or persistent unexplained elevation of liver enzymes, patients with muscle diseases, patients taking cyclosporine, those with severe renal impairment, pregnant or potentially pregnant women, and nursing mothers, etc. In addition, caution is required as high-dose administration is prohibited in patients at high risk of myopathy. Patients with a history of alcoholism or liver disease, severe hepatic impairment, renal impairment, or hypothyroidism should receive this medication with caution, and frequent blood tests should be conducted if there is a high risk of myopathy. During the course of treatment, side effects such as abnormal liver function, muscle pain, dizziness, and gastrointestinal disturbances may occur, and rare cases of severe skin reactions, liver failure, or severe muscle weakness have been reported. This medication can interact with other drugs, so it is important to inform a doctor if taking anticoagulants, fibrates, certain antibiotics, antifungals, immunosuppressants, etc. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should employ appropriate contraception while taking it. It should be administered with caution to children or the elderly, especially as older individuals are at a higher risk of myopathy. In cases of overdose, specific antidotes are not available, so treatment according to symptoms and supportive therapy is necessary, along with regular liver and muscle-related blood tests. This medication should be kept out of reach of children and should not be transferred to other containers. If symptoms such as muscle pain, muscle weakness, fatigue, and muscle pain with fever occur during treatment, consult a doctor immediately, and it is safe to have regular liver function and muscle enzyme tests.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Increased ALT
  • increased AST
  • gastroesophageal reflux disease
  • dizziness
  • pruritus
  • increased CPK
  • sensory deficit
  • back pain
  • headache
  • drowsiness
Show 18 more
  • neurodegenerative disorders
  • orthostatic dizziness
  • migraine
  • diabetes
  • glucose tolerance abnormality
  • depression
  • bronchitis
  • rhinitis
  • cystitis
  • dermatophyte infection of nails
  • soft tissue infection
  • fatty liver
  • liver dysfunction
  • liver toxicity
  • acute hepatitis
  • toxic hepatitis
  • increased gamma-glutamyl transferase
  • blood cholesterol increase.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication and prevents deterioration.

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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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.