Medication info
Newpex Duo Tablets 5mg/10mg

Newpex Duo Tablets 5mg/10mg

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White oval film-coated tablet
Packaging
For Domestic Use: 30 tablets/bottle For Export: 30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201403872 · Approved 2014.08.20 · Insurance code 644308810

Summary

Main use
Reduces the risk of hypertension and coronary artery disease, improves dyslipidemia
Who takes it
Adults
Adult dose
Amlodipine (as esamlodipine) is usually administered orally once daily at a dose of 5(2.5) mg, which may be increased to a maximum of 10(5) mg daily depending on the patient's response. Dosage may be adjusted according to symptoms. The recommended initial dose of atorvastatin is 10 mg once daily; for patients requiring greater reductions in LDL cholesterol levels, treatment can start with 20 mg or 40 mg once daily. This medication is administered once daily.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Reduces the risk of hypertension and coronary artery disease, improves dyslipidemia

  • Hypertension
  • fixed obstruction of coronary arteries
  • vascular spasm
  • vascular constriction
  • myocardial ischemia
  • angina
  • multiple risk factors for coronary artery disease
  • retinopathy
  • albuminuria
  • type 2 diabetes
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
View approved original text

This medication is used for patients who require treatment with both amlodipine and atorvastatin. Amlodipine is effective for treating hypertension and ischemia due to fixed obstruction of coronary arteries or vascular spasms, and it reduces the risk of hospitalization due to angina and the risk of coronary revascularization. Atorvastatin reduces the risk of several cardiovascular diseases, including myocardial infarction, stroke, and angina, and it helps treat hypercholesterolemia and dyslipidemia. In particular, it contributes to lowering the incidence of cardiovascular events in patients with various risk factors. The combined use of these two medications effectively improves cardiovascular health.

How to take

Adult dose

Amlodipine (as esamlodipine) is usually administered orally once daily at a dose of 5(2.5) mg, which may be increased to a maximum of 10(5) mg daily depending on the patient's response. Dosage may be adjusted according to symptoms. The recommended initial dose of atorvastatin is 10 mg once daily; for patients requiring greater reductions in LDL cholesterol levels, treatment can start with 20 mg or 40 mg once daily. This medication is administered once daily.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to this medication or similar drugs, severely impaired liver function, active liver diseases, pregnant women or women who may become pregnant, breastfeeding women, patients with muscular diseases, patients with severe aortic stenosis, patients in shock, patients within one month after a myocardial infarction, patients with unstable angina, and patients taking specific antiviral agents should not be administered this medication. Moreover, patients with severely impaired renal function, elderly individuals, patients with a history of alcohol abuse or liver diseases, patients at high risk for muscle damage, patients with acute heart failure, patients in hypertensive crisis, patients with mild to moderate liver dysfunction, and patients with severe myasthenia gravis should use this medication cautiously. This medication is primarily composed of two ingredients and is generally well tolerated, but some patients may experience symptoms such as flushing due to vasodilation, fatigue, edema, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Additionally, rare side effects such as myalgia, muscle cramps, hepatic dysfunction, allergic reactions, skin rashes, hair loss, insomnia, and coughing have been reported. One of the components of this medication is metabolized in the liver, so patients with impaired liver function require regular liver function tests, and the medication should be discontinued if any liver dysfunction is detected. Moreover, if muscle-related abnormal symptoms appear, the physician should be notified immediately, and if severe muscle pain or muscle weakness occurs, the medication should be stopped. This medication may interact with other drugs, particularly certain antibiotics, antifungals, immunosuppressants, some antivirals, and grapefruit juice, requiring caution when used concurrently. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraception while taking this medication. The safety in pediatric and elderly populations has not been sufficiently confirmed, so caution is needed in these groups. In case of overdose, symptoms such as decreased blood pressure and cardiac dysfunction may appear, necessitating immediate medical attention. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • toxic epidermal necrolysis
  • severe edema
  • chest tightness
  • dyspnea
  • jaundice
  • hepatitis
  • profound lethargy
  • severe allergic reactions
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  • severe skin adverse reactions
  • respiratory issues
  • liver abnormalities
  • acute and severe liver damage
  • fulminant hepatitis
  • acute heart failure
  • severe edema or urination abnormalities
  • sudden and very severe headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • severe neurological symptoms
  • bleeding

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain and loss
  • hypotension
  • vasculitis
  • increased muscle tone
  • sensory loss/parethesia
  • peripheral neuropathy
  • syncope
  • altered taste
  • tremors
  • extrapyramidal symptoms
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • gum overgrowth
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best kept in a cool place between 15 and 30 degrees Celsius. This way, the effectiveness of the medication can be well maintained.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

For Domestic Use: 30 tablets/bottle For Export: 30 tablets (10 tablets/PTP 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

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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.