Medication info
Duophito Tablet 10/20 mg

Duophito Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
White to off-white, biconvex, oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PVC×3]
Approval status
Active

MFDS item code 202101419 · Approved 2021.02.18

Summary

Main use
Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primarily, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the initial dose is recommended to be 10/10 mg or 10/20 mg once daily. For patients requiring a larger reduction in LDL-cholesterol (over 55%), 10/40 mg once daily is recommended. After initiation of treatment or dosage adjustment, blood lipid levels should be checked at intervals of more than two weeks to adjust the dosage.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Improvement of lipid levels through reduction of cholesterol and increase of HDL in hypercholesterolemia (primarily, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • dyslipidemia
  • homozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL-cholesterol
View approved original text

This medication is used to lower elevated total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL-cholesterol levels, and to increase the good cholesterol HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It may also be used as an adjunctive treatment in patients with homozygous familial hypercholesterolemia when other treatments such as LDL apheresis are insufficient. This medication should be used in conjunction with a proper diet, and is recommended only when non-pharmacological measures are ineffective. It is important to identify and treat secondary causes such as diabetes and hypothyroidism before treatment, and treatment plans should be based on regular blood lipid tests. Caution should be exercised in patients with multiple risk factors for cardiovascular disease.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. For primary hypercholesterolemia, the initial dose is recommended to be 10/10 mg or 10/20 mg once daily. For patients requiring a larger reduction in LDL-cholesterol (over 55%), 10/40 mg once daily is recommended. After initiation of treatment or dosage adjustment, blood lipid levels should be checked at intervals of more than two weeks to adjust the dosage.

Precautions

This medication may rarely cause muscle damage, resulting in severe muscle pain or weakness, which can pose a risk to kidney function. In particular, the medication should be temporarily discontinued or halted in patients with acute infections, hypotension, major surgery or trauma, severe metabolic or electrolyte abnormalities, or poorly controlled seizures. It should not be administered to patients with known allergies to its components, severe liver dysfunction, persistent unexplained liver enzyme elevations, muscle diseases, pregnant or potentially pregnant women, breastfeeding women, patients taking certain antiviral medications, or patients with genetic issues such as lactose intolerance. Caution is advised when prescribing this medication to patients with a history of alcohol addiction or liver disease, renal impairment, hypothyroidism, family history of muscle disease, or previous experiences of muscle toxicity with similar drugs, as well as in the elderly over 70 years of age, and those taking medications that may increase the blood concentration of this drug. This medication may cause side effects such as muscle pain, abdominal pain, increased liver enzymes, and rarely serious muscle damage or liver dysfunction, as well as skin reactions. Patients should report any symptoms such as muscle pain, muscle weakness, fatigue, or fever immediately to their healthcare provider for assessment. Regular liver function and muscle enzyme tests should be conducted while on this medication, and any abnormal findings should prompt consideration of dose adjustments or discontinuation. Furthermore, alcohol consumption should be avoided during treatment, and special care should be taken for those with a history of liver disease. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use suitable contraception while on this medication. This medication may interact with other drugs, so patients should inform their healthcare provider of any other medications they are taking, especially certain antibiotics, antivirals, antifungals, and immunosuppressants. In case of overdose, there is no specific antidote, and treatment should be symptomatic while monitoring liver function and muscle enzyme levels. Safety in children or adolescents has not been established, so this medication is not recommended for them. Elderly patients should be cautious due to the risk of myopathy; however, no separate dose adjustment is necessary. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and urination.

Mild side effects

  • Muscle pain
  • abdominal pain
  • increased liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
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  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • fatigue
  • vasomotor swelling
  • chest pain
  • facial swelling
  • fever
  • headache
  • vomiting
  • dry mouth
  • discomfort in the epigastrium
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux disease
  • tongue disorders
  • sleep disturbances
  • nightmares
  • perceptual disturbances
  • sensory loss
  • taste disorders
  • and dysgeusia.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, preferably in a cool place below 30 degrees Celsius. Proper storage maintains the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White to off-white, biconvex, oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PVC×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

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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.