Medication info
Telmisartan/Amlodipine Double Tablet 80/5 mg (Telmisartan, Amlodipine Besylate)

Telmisartan/Amlodipine Double Tablet 80/5 mg (Telmisartan, Amlodipine Besylate)

Prescription medication경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
White and light blue, double convex oval-shaped tablet
Packaging
30 tablets (10 tablets/PTP X 3), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201606799 · Approved 2016.11.29 · Insurance code 698003360

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily and should be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). Dosage adjustments for 40/5 mg, 80/5 mg, and 40/10 mg should be made based on the patient's blood pressure control status. For patients with kidney impairment, dosage adjustments are not needed for mild to moderate impairment, but for severe impairment, treatment should be initiated at a lower dose.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its administration is not recommended.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Used in patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with telmisartan or amlodipine.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily and should be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). Dosage adjustments for 40/5 mg, 80/5 mg, and 40/10 mg should be made based on the patient's blood pressure control status. For patients with kidney impairment, dosage adjustments are not needed for mild to moderate impairment, but for severe impairment, treatment should be initiated at a lower dose.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its administration is not recommended.

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can cause serious harm to the fetus. If pregnancy is planned or confirmed, this medication should be discontinued as soon as possible. This medication is contraindicated in patients with certain diseases or conditions, such as liver impairment, severe hypotension, heart failure, certain heart diseases, biliary obstruction, and severely impaired kidney function. Additionally, patients who have allergies to this medication or its components, women of childbearing potential, and nursing mothers should not take this medication. While taking this medication, regular blood tests and physician monitoring are necessary due to possible side effects such as hypotension, changes in kidney function, and hyperkalemia. Special caution should be exercised in patients with compromised kidney function, heart failure patients, and the elderly. This medication may interact with other antihypertensive agents or specific medications, so if you are taking other medications, you must inform your healthcare provider. Dizziness or drowsiness may occur while driving or operating machinery, so caution is advised. This medication contains sorbitol, so patients with certain genetic conditions such as fructose intolerance should not use it. In case of overdose, severe hypotension or cardiac issues may occur, so strict adherence to the prescribed dose is essential and immediate medical attention should be sought in case of adverse symptoms. Safety and efficacy in children or adolescents under 18 years of age have not been sufficiently established, so use is not recommended. This medication should be stored out of the reach of children, should not be transferred to other containers, and should be taken immediately after opening the packaging.

Side effects and when to seek care immediately

Serious side effects

  • Sepsis
  • thrombocytopenia
  • anaphylactic reactions
  • hyperkalemia
  • hypoglycemia
  • hyperglycemia
  • confusion
  • extrapyramidal syndrome
  • myocardial infarction
  • ventricular tachycardia
Show 17 more
  • arrhythmia
  • atrial fibrillation
  • vasculitis
  • respiratory distress
  • hepatitis
  • jaundice
  • angioedema (with fatal outcomes)
  • toxic skin rash
  • urticaria
  • exfoliative dermatitis
  • Stevens-Johnson syndrome
  • photosensitivity reactions
  • interstitial lung disease
  • kidney function disorder
  • increased blood creatinine
  • liver function abnormalities
  • intestinal vascular edema

Mild side effects

Dizziness, peripheral edema, fainting, drowsiness, headache, migraine, sensory disturbances, taste disturbances, tremor, visual impairment, vertigo, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, gastrointestinal adverse reactions (changes in bowel habits, abdominal pain, dyspepsia, nausea, vomiting, dry mouth, etc.), liver function abnormalities, itching, rash, hair loss, angioedema, eczema, erythema, arthralgia, muscle cramps, myalgia, back pain,

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. To maintain the medication's effectiveness, it is important to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White and light blue, double convex oval-shaped tablet

Package unit

30 tablets (10 tablets/PTP X 3), 30 tablets/bottle, 100 tablets/bottle

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.