Medication info

Twin Beta-Al Tablets 80/5/10 mg (Telmisartan, Amlodipine, Rosuvastatin)

Prescription medicationApproval withdrawn
Ingredient · strength
Telmisartan›Strength being verifiedAmlodipine Besylate›Strength being verifiedRosuvastatin Calcium›Strength being verified
Manufacturer / importer
대웅바이오(주)
Appearance
Bright pink oval film-coated tablets
Packaging
30 tablets (10 tablets x 3)/PTP
Approval status
Approval withdrawn

MFDS item code 201803890 · Approved 2018.10.02

This product's status changed to Approval withdrawn on 2023.04.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)
Who uses it
Adults
Adult dosage
This medication should be taken once daily, 1 tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The dosage of the telmisartan/amlodipine combination should be adjusted according to blood pressure control, and adjustments may be needed for patients with renal impairment, liver impairment, or the elderly. Rosuvastatin should start at a dose of 5 mg once daily, and if necessary, the dose may be increased to 10 mg or a maximum of 20 mg.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (risk reduction of atherosclerosis)

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

This medication is used for patients with essential hypertension who cannot adequately control their blood pressure with telmisartan and amlodipine combination therapy, as well as those who need to be administered rosuvastatin simultaneously. The telmisartan/amlodipine combination helps to manage hypertension that is insufficiently controlled by monotherapy. Rosuvastatin is used as an adjunct in patients with hypercholesterolemia and mixed dyslipidemia that are not improved by diet and exercise, and it is also effective in certain patients with familial hypercholesterolemia. Additionally, it is helpful in treating patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia, and lowers total cholesterol and LDL cholesterol to delay the progression of atherosclerosis. In middle-aged patients at high risk for cardiovascular disease, a reduction in the risk of stroke, myocardial infarction, and arterial revascularization can be expected. Therefore, this medication is used to improve cardiovascular health through the management of blood pressure and blood lipids.

Dosage and Administration

Adult dosage

This medication should be taken once daily, 1 tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The dosage of the telmisartan/amlodipine combination should be adjusted according to blood pressure control, and adjustments may be needed for patients with renal impairment, liver impairment, or the elderly. Rosuvastatin should start at a dose of 5 mg once daily, and if necessary, the dose may be increased to 10 mg or a maximum of 20 mg.

Precautions

This medication can cause serious harm to the fetus and newborn during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. It should not be administered to patients with hypersensitivity to any component of the medication, certain hereditary angioedema conditions, severe liver impairment or kidney impairment, or severe aortic stenosis. Caution is necessary when prescribing to elderly patients, those with low blood pressure, those with compromised liver function, or those at risk for hyperkalemia, and regular monitoring may be needed. If symptoms such as muscle pain or weakness occur, it is important to consult a healthcare professional immediately and regularly check muscle-related test values. This medication may affect liver and kidney function; therefore, regular liver and kidney function tests should be conducted. As this medication can interact with other drugs, it is essential to inform your healthcare provider of any other medications you are currently taking. Women who could become pregnant should use appropriate contraception, and it is safe not to take this medication while breastfeeding. It is not recommended for children or adolescents under the age of 18. In case of overdose, symptoms such as low blood pressure, dizziness, and heart rhythm abnormalities may occur, requiring immediate medical attention. 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

  • Hives
  • severe swelling (edema)
  • angioedema (may be fatal)
  • chest tightness
  • difficulty breathing
  • angioedema
  • angioedema (may be fatal)
  • angioedema
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  • angioedema
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Mild side effects

  • Headache
  • dizziness
  • orthostatic hypotension
  • back pain
  • dyspepsia
  • rectal bleeding
  • atopic dermatitis
  • peripheral edema
  • fatigue
  • malaise
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  • muscle pain
  • muscle cramps
  • angioedema
  • itching
  • rash
  • erythema
  • dermatitis
  • thrombocytopenia
  • leukopenia
  • nausea
  • abdominal pain
  • diarrhea
  • constipation
  • drowsiness
  • insomnia
  • anxiety
  • depression
  • neuromuscular excitability
  • increased blood pressure
  • worsened blood pressure
  • dizziness
  • palpitations
  • chest pain
  • anemia
  • thrombocytopenia
  • urinary tract infection
  • cough

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 protected from light. Additionally, it is important to store it at a cool room temperature, specifically between 1 degree and 30 degrees Celsius to maintain the drug's effectiveness.

Appearance and packaging

Appearance

Bright pink oval film-coated tablets

Package unit

30 tablets (10 tablets x 3)/PTP

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.