Medication info
Basta Tablet 10/10 (Ezetimibe, Simvastatin)

Basta Tablet 10/10 (Ezetimibe, Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
White to pale yellow, bilaterally convex rectangular tablet
Packaging
30 tablets (10 tablets/PTP packaging x 3)
Approval status
Active

MFDS item code 201601733 · Approved 2016.03.31 · Insurance code 658603350

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed dyslipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening without regard to meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg daily, with the generally recommended starting dose being 10/20 mg daily. Patients who have less need for LDL-cholesterol reduction may start with 10/10 mg daily. After starting treatment or adjusting the dosage, lipid levels should be checked after intervals of at least 4 weeks.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
View approved original text

This drug is used as an adjunct to diet for lowering elevated total cholesterol and LDL-cholesterol, apoB protein, and triglycerides in patients with primary hypercholesterolemia and mixed dyslipidemia, while raising HDL-cholesterol levels. Additionally, it is administered as an adjunct when other lipid-lowering treatments are not effective in patients with homozygous familial hypercholesterolemia. This medication should be used together with an appropriate diet that includes restrictions on saturated fats and cholesterol, and applied when non-pharmacological measures are insufficiently effective. Prior to treatment, secondary causes such as diabetes, hypothyroidism, and chronic renal failure should be identified and treated if necessary. During treatment, regular lipid tests for total cholesterol, LDL, HDL, and triglycerides are essential, especially for acute coronary event patients, where testing should be done at the time of admission or within 24 hours. In summary, this drug is used to effectively control blood lipid levels associated with hypercholesterolemia to reduce cardiovascular risk.

How to take

Adult dose

This medication is taken once daily in the evening without regard to meals. The dosage range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg daily, with the generally recommended starting dose being 10/20 mg daily. Patients who have less need for LDL-cholesterol reduction may start with 10/10 mg daily. After starting treatment or adjusting the dosage, lipid levels should be checked after intervals of at least 4 weeks.

Precautions

This drug may cause muscle-related side effects such as myopathy or rhabdomyolysis, so if muscle pain or weakness occurs, the patient must promptly inform their physician. The risk may increase when taking high doses or certain medications together. Patients with allergies to the components of this drug or those with liver diseases should not take it. Pregnant or breastfeeding women should not take this drug, and women planning to become pregnant should consult their physician. Furthermore, this drug should not be taken with strong CYP3A4 inhibitors such as certain antifungals, antibiotics, and antivirals. Special caution is also needed when co-administering with specific immunosuppressants or anticoagulants. Patients with liver function abnormalities or elevated liver enzymes should receive regular testing and immediately inform their physician of any unusual symptoms. Elderly patients or those with reduced renal function also require special management when taking this drug. It is advisable to avoid grapefruit juice while taking this drug, and to inform healthcare providers of this medication when starting other prescriptions. There is no specific antidote in case of overdose, and symptomatic treatment will be administered accordingly. This drug has not been adequately proven safe and effective in children, hence caution is advised when administering to pediatric patients.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, jaundice (yellowing of skin or eyes), extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe body swelling with elevated blood pressure, anaphylaxis,

Mild side effects

  • Muscle pain
  • headache
  • diarrhea
  • abdominal pain
  • nausea
  • constipation
  • dyspepsia
  • pruritus
  • rash
  • weakness
Show 27 more
  • dizziness
  • paresthesia
  • insomnia
  • depression
  • upper respiratory infection
  • sore throat
  • hematuria
  • nocturia
  • weight loss
  • fatigue
  • limb pain
  • joint pain
  • back pain
  • fever
  • chills
  • flushing
  • malaise
  • cholelithiasis
  • cholecystitis
  • alopecia
  • thrombocytopenia
  • post-cholecystectomy hospitalization
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • ocular muscle paralysis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to store it at a cool room temperature, between 1 and 30 degrees Celsius, to maintain the drug's effectiveness.

Appearance and packaging

Appearance

White to pale yellow, bilaterally convex rectangular tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.