Medication info
Newstatin TS Tablet 80/10/20 Milligrams

Newstatin TS Tablet 80/10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Oval-shaped, bilayer tablet consisting of a white layer and a light blue layer
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201802235 · Approved 2018.05.30 · Insurance code 647804690

Summary

Main use
(Hypertension, Hypercholesterolemia) Effect on controlling blood pressure and improving cholesterol, reducing cardiovascular disease risk
Who takes it
Adults
Adult dose
The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). For the Telmisartan/Amlodipine combination, doses of 40/5 milligrams, 80/5 milligrams, 40/10 milligrams, and 80/10 milligrams may be administered depending on blood pressure control status, and dose adjustments may be necessary based on renal impairment, liver impairment, or elderly patients. Rosuvastatin initial dosing should be evaluated based on the patient's clinical circumstances.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

(Hypertension, Hypercholesterolemia) Effect on controlling blood pressure and improving cholesterol, reducing cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used for patients with essential hypertension where blood pressure is not adequately controlled with a combination of Telmisartan and Amlodipine, while Rosuvastatin must be coadministered. Rosuvastatin helps treat lipid disorders in patients with primary and familial hypercholesterolemia, or mixed dyslipidemia who cannot control their lipids through diet and exercise. Additionally, Rosuvastatin is effective in slowing the progression of atherosclerosis and reducing the risk of cardiovascular diseases. Particularly in middle-aged patients with high-sensitivity C-reactive protein levels and additional cardiovascular risk factors, it contributes to risk reduction related to stroke, myocardial infarction, and arterial revascularization. Therefore, this medication is used to effectively manage cardiovascular health by assisting in both blood pressure control and lipid improvement.

How to take

Adult dose

The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). For the Telmisartan/Amlodipine combination, doses of 40/5 milligrams, 80/5 milligrams, 40/10 milligrams, and 80/10 milligrams may be administered depending on blood pressure control status, and dose adjustments may be necessary based on renal impairment, liver impairment, or elderly patients. Rosuvastatin initial dosing should be evaluated based on the patient's clinical circumstances.

Precautions

This medication may cause serious harm to the fetus and newborns in pregnant women, so it must be discontinued immediately if pregnancy is confirmed. Patients with allergies to this drug's active ingredients or similar drugs, hereditary angioedema patients, those with severe liver impairment or bile obstruction, and severe renal impairment patients should not take this drug. Additionally, patients with diabetes or moderate to severe renal dysfunction, those with certain muscle diseases or a history of muscle toxicity should not use this medication. Elderly patients, those with hypotension, slightly impaired liver function, and patients with hyperkalemia should take this medication with more caution and are advised to undergo regular liver function and muscle-related examinations. This medication can cause muscle pain, muscle weakness, and rarely severe muscle damage and renal issues, so patients should see a doctor immediately if symptoms such as muscle pain or cramps appear. This medication can interact with other drugs, so if the patient is taking other medications, they must inform their doctor or pharmacist. Pregnant and nursing women should not take this drug and should use appropriate methods of contraception if necessary. It is not recommended for children under 18 years old as safety and efficacy have not been adequately established. In the event of an overdose, symptoms such as hypotension, dizziness, and worsening renal function may occur, so medical attention should be sought immediately. This medication should be kept out of reach of children and care should be taken not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and very severe headaches, lightning headaches, seizures, confusion of consciousness, visual disturbances, paralysis,

Mild side effects

  • Dyspepsia
  • frequent bowel movements
  • diabetes
  • dizziness
  • dry vesicular sound
  • urticaria
  • unstable angina
  • onychomycosis
  • lumbar spinal stenosis
  • ear fluid
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  • vertigo
  • chronic gastritis
  • hiatal hernia
  • various gastrointestinal disorders
  • painful urination
  • rhinitis
  • oral-pharyngeal discomfort
  • pulmonary disease
  • unspecified gastrointestinal disease
  • benign gastric tumors
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • atherosclerosis
  • frequent urination
  • tinnitus
  • hearing loss
  • bad breath

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

Storage

This medication is sensitive to light and should be stored in a tightly closed container that blocks light. Additionally, it should be kept at room temperature between 1 to 30 degrees Celsius to maintain its effect.

Appearance and packaging

Appearance

Oval-shaped, bilayer tablet consisting of a white layer and a light blue layer

Package unit

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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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.