Medication info

Twinbeta Tablets 40/5/10 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Prescription medicationApproval withdrawn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
Pink oval film-coated tablets
Packaging
30 tablets (10 tablets x 3)/PTP
Approval status
Approval withdrawn

MFDS item code 201803888 · 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This product's status changed to Approval withdrawn on 2023.04.25.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 (to reduce the risk 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 around the same time each day (e.g., in the morning). The Telmisartan/Amlodipine combination is administered at the doses of 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg, depending on blood pressure control. Rosuvastatin is started at a dose of 5 mg once daily and can be increased to 10 mg if necessary.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Treatment of essential hypertension and hypercholesterolemia (to reduce the risk of atherosclerosis)

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

This drug is used for patients who need to take both Telmisartan/Amlodipine combination and Rosuvastatin simultaneously. The Telmisartan/Amlodipine combination helps effectively lower blood pressure in patients with essential hypertension, where blood pressure control is difficult with monotherapy. Rosuvastatin Calcium helps control cholesterol levels in patients with hypercholesterolemia and dyslipidemia, slowing the progression of atherosclerosis and reducing the risk of cardiovascular disease. It is particularly used to reduce the risk of stroke, myocardial infarction, and recurrence after vascular interventions in high-risk patients with elevated high-sensitivity C-reactive protein levels. The co-administration of these two drugs is effective in improving cardiovascular health by managing both blood pressure and cholesterol levels simultaneously. Therefore, this drug is used to prevent and improve cardiovascular diseases through blood pressure and lipid management.

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 around the same time each day (e.g., in the morning). The Telmisartan/Amlodipine combination is administered at the doses of 40/5 mg, 80/5 mg, 40/10 mg, and 80/10 mg, depending on blood pressure control. Rosuvastatin is started at a dose of 5 mg once daily and can be increased to 10 mg if necessary.

Precautions

This drug can cause serious harm to the fetus and newborn during pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Patients who are allergic to this drug's components or similar drugs, those with a history of angioedema, severely impaired liver or kidney function, or certain heart diseases should not take this medication. Elderly patients, patients with impaired liver function, significantly low blood pressure, and high serum potassium levels should use this drug with more caution, and regular blood tests and condition monitoring are necessary. This drug may cause muscle-related side effects, such as myalgia, muscle weakness, and rhabdomyolysis, so if muscle pain or weakness occurs during treatment, consult a doctor immediately. The Telmisartan component may affect kidney function, so patients with impaired kidney function need regular blood tests and monitoring. The Amlodipine component has blood pressure-lowering effects; thus, caution is needed in patients with excessively low blood pressure or poor cardiac function. The Rosuvastatin component can affect liver function, so regular liver enzyme tests should be done before and during treatment, and treatment should be discontinued if liver function abnormalities are found. This drug may interact with other medications; therefore, if other medications are being taken, patients must inform their doctor or pharmacist, especially when taking blood pressure medications, diuretics, anticoagulants, or immunosuppressants. Breastfeeding is not recommended while taking this drug; if it is necessary to take it, breastfeeding should be discontinued. Overdose may lead to hypotension, dizziness, and muscle abnormalities, so it is important to follow the dosage exactly and visit a healthcare facility immediately if abnormal symptoms occur. The safety and effectiveness of this drug in children have not been established, so it is recommended not to administer it to them. During treatment, drowsiness or dizziness may occur, so caution is advised when driving or operating dangerous machinery.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, angioedema, anaphylaxis, severe allergic reactions, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthmatic attacks, respiratory issues accompanied by cough + fever, respiratory problems, yellowing of the skin or eyes (jaundice), severe lethargy, liver

Mild side effects

  • Headache
  • dizziness
  • weakness
  • cough
  • nausea
  • fatigue
  • malaise
  • lower limb swelling
  • angioedema
  • itching
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  • rash
  • leg pain
  • lethargy
  • palpitations
  • pain
  • fatigue
  • back pain
  • dyspepsia
  • diarrhea
  • constipation
  • abdominal pain
  • flatulence
  • urinary tract infection
  • myalgia
  • muscle cramps
  • arthralgia
  • arthritis
  • insomnia
  • drowsiness
  • nausea
  • vasculitis
  • thrombocytopenia
  • visual disturbances
  • conjunctivitis
  • diplopia
  • eye pain
  • tinnitus
  • ear pain
  • frequent urination

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

Storage

This drug is sensitive to light, so it should be stored in a container that blocks light. Additionally, it is important to store it at a temperature between 1 degree and 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

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.