Medication info
Newstatin T.S. Tablet 80/5/10 Milligrams

Newstatin T.S. Tablet 80/5/10 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium›10.4mg / 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 201802237 · Approved 2018.05.30 · Insurance code 647804700

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (including atherosclerosis)
Who takes it
Adults
Adult dose
This medication is taken once daily as one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosing for the telmisartan/amlodipine combination and rosuvastatin should be individualized for each patient. For the telmisartan/amlodipine combination, if blood pressure is uncontrolled, the following dosing may be considered: - 40/5 milligrams: For patients with blood pressure not properly controlled on amlodipine 5 milligrams or telmisartan 40 milligrams.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (including atherosclerosis)

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

This medication is used only in patients with essential hypertension whose blood pressure is not adequately controlled with either telmisartan or amlodipine alone and in cases where rosuvastatin needs to be administered simultaneously. The telmisartan/amlodipine combination effectively controls and stabilizes blood pressure. Rosuvastatin calcium improves lipid disorders such as hypercholesterolemia and is used as an adjunct to diet when not controlled by diet and exercise. This medication also helps slow the progression of atherosclerosis and reduce the risk of stroke, myocardial infarction, and revascularization in patients at risk for cardiovascular disease by controlling both blood pressure and cholesterol simultaneously, thus effectively improving cardiovascular health.

How to take

Adult dose

This medication is taken once daily as one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosing for the telmisartan/amlodipine combination and rosuvastatin should be individualized for each patient. For the telmisartan/amlodipine combination, if blood pressure is uncontrolled, the following dosing may be considered: - 40/5 milligrams: For patients with blood pressure not properly controlled on amlodipine 5 milligrams or telmisartan 40 milligrams.

Precautions

This medication should not be used during pregnancy as it may cause serious harm to the fetus and newborn. If pregnancy is confirmed, discontinuation should occur immediately. Do not take this medication if you are allergic to any of its ingredients or have certain genetic diseases, severe liver or kidney diseases. Particularly, patients with a history of angioedema, severe aortic stenosis, myopathy, and severe renal impairment should not take this medication. Patients with hypertension, decreased liver function, elderly patients, and those with hyperkalemia should use this medication cautiously and monitor liver function tests and muscle-related tests periodically. If symptoms such as muscle pain or weakness appear, consult a doctor immediately and discontinue if necessary. This medication may interact with various other drugs, so inform your healthcare provider of any other medications you are taking. Women of childbearing potential should use appropriate contraception and it is recommended not to use this medication while breastfeeding. Safety and efficacy have not been well established for children under 18 years of age; therefore, it is not recommended. For elderly patients, especially those over 75 years old, it is advisable to start with a lower dose and gradually increase. In cases of overdose, symptoms such as low blood pressure, dizziness, and cardiac abnormalities may occur, so visit a medical institution immediately. Keep this medication out of the reach of children and do not transfer it to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe edema, unstable angina, angioedema (accompanied by fatal outcomes), asthma, difficulty breathing, liver dysfunction (jaundice), severe skin reactions (Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms), acute renal failure, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, thrombocytopenia, increased serum creatinine, congestive heart failure, hepatocellular carcinoma, cerebral infarction

Mild side effects

  • Dyspepsia
  • frequent bowel movement
  • diabetes
  • dizziness
  • dry bullous dermatitis
  • hives
  • peripheral edema
  • low back pain
  • dizziness
  • headache
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  • upper abdominal discomfort
  • orthostatic dizziness
  • rhinitis
  • oral discomfort
  • pulmonary disease
  • unspecified gastroenteritis
  • benign gastric neoplasm
  • hemorrhoids
  • musculoskeletal pain
  • osteoporosis
  • sensory loss
  • movement disorders
  • tinnitus
  • hearing loss
  • halitosis
  • fatty liver
  • erectile dysfunction
  • nausea
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • liver function test abnormalities

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

Storage

This medication is sensitive to light, so it should be stored in an opaque container that does not allow light to enter. Additionally, it is important to store the medication at room temperature, between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

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.