Medication info
Newstatin TS Tablet 40/5/10 milligrams

Newstatin TS Tablet 40/5/10 milligrams

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
An oval biconvex 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 201802236 · Approved 2018.05.30 · Insurance code 647804710

Summary

Main use
Treatment for improvement of hypertension and hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This medication is taken once daily, with 1 tablet swallowed with water at any time regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The dosage of the Telmisartan/Amlodipine combination can be given as 40/5 mg, 80/5 mg, 40/10 mg, or 80/10 mg depending on blood pressure control status. Dosage adjustments may be necessary for those with renal impairment, liver impairment, and in the elderly. Rosuvastatin should be started at a low dose.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Treatment for improvement of hypertension and hypercholesterolemia and reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • 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 administered to patients with essential hypertension for whom blood pressure is not sufficiently controlled by monotherapy with Telmisartan and Amlodipine, and is used when Rosuvastatin needs to be taken concurrently. The Telmisartan/Amlodipine combination effectively controls blood pressure and helps stabilize blood pressure levels. Rosuvastatin serves as an adjunct to the dietary management of hypercholesterolemia and hyperlipidemia, lowering levels of cholesterol and LDL cholesterol in the blood, thus delaying the progression of atherosclerosis. Additionally, it is effective in reducing the risk of stroke or myocardial infarction, and the risk of recurrence after revascularization in patients at high risk for cardiovascular diseases. Therefore, this medication is used to manage both hypertension and dyslipidemia, improving cardiovascular health.

How to take

Adult dose

This medication is taken once daily, with 1 tablet swallowed with water at any time regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The dosage of the Telmisartan/Amlodipine combination can be given as 40/5 mg, 80/5 mg, 40/10 mg, or 80/10 mg depending on blood pressure control status. Dosage adjustments may be necessary for those with renal impairment, liver impairment, and in the elderly. Rosuvastatin should be started at a low dose.

Precautions

This medication should not be used during pregnancy. If pregnancy is confirmed, discontinue use immediately, and women of childbearing potential should use appropriate contraception. This medication should not be administered to patients who are allergic to the active ingredients or other components, patients with severe liver or kidney impairment, or those with a history of specific muscle disorders. Patients with very low blood pressure, elderly individuals, patients with hyperkalemia, and those with weakened liver function should use this medication with caution, and it is important to periodically check liver and kidney function before and during treatment. If symptoms such as muscle pain, weakness, or cramps occur, consult a physician immediately, and if necessary, blood tests should be performed to check for muscle damage. This medication may interact with other drugs, so patients should inform healthcare providers about any medications they are currently taking, especially with certain antibiotics, immunosuppressants, and fibrate medications that require caution when combined. Breastfeeding mothers are advised against taking this medication, and if necessary, should discontinue breastfeeding during treatment. Overdosage may lead to low blood pressure, dizziness, cardiac issues, etc.; immediate medical attention is required. Safety and effectiveness in children have not been established, so administration is not recommended. During treatment, there may be dizziness or drowsiness when driving or operating hazardous machinery, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities combined with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Dyspepsia
  • frequent bowel movements
  • diabetes
  • dizziness
  • dry cough
  • hives
  • unstable angina
  • onychomycosis
  • lumbar spinal canal stenosis
  • otorrhea
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  • vertigo
  • peripheral edema
  • gastrointestinal disorders
  • chronic gastritis
  • hiatal hernia
  • various gastrointestinal disorders
  • dysuria
  • rhinitis
  • discomfort in the oropharynx
  • pulmonary diseases
  • unspecified gastrointestinal disease
  • benign gastric neoplasm
  • hemorrhoids
  • skeletal pain
  • osteoporosis
  • sensory impairment
  • movement disorders
  • atherosclerosis
  • frequent urination
  • ear symptoms

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 container that protects it from light. It is also advisable to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

An oval biconvex 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.