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

Tezalbai Tablet 80/5 mg (Telmisartan, Amlodipine)

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
White oval tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201606391 · Approved 2016.10.31 · Insurance code 670607550

Summary

Main use
Improvement in blood pressure control of essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (for example, in the morning). The dose of individual components should be adjusted based on the patient's condition, and for patients with kidney impairment, lower doses should be started and gradually increased in cases of severe impairment. Patients with liver impairment should not exceed a daily dose of 40 milligrams, and elderly patients should start with lower doses.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, so administration of this medication is not recommended.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Improvement in blood pressure control of essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension for whom blood pressure control is difficult with amlodipine or telmisartan monotherapy. It effectively lowers blood pressure and helps prevent cardiovascular complications.

How to take

Adult dose

The recommended dose is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (for example, in the morning). The dose of individual components should be adjusted based on the patient's condition, and for patients with kidney impairment, lower doses should be started and gradually increased in cases of severe impairment. Patients with liver impairment should not exceed a daily dose of 40 milligrams, and elderly patients should start with lower doses.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should not be taken by pregnant women or women who may become pregnant. This medication should not be administered to patients with certain conditions such as severe liver dysfunction, left ventricular outflow obstruction, severe hypotension, cardiogenic shock, and unstable heart failure after acute myocardial infarction. Additionally, caution is needed when used in combination with certain drugs in patients with diabetes or moderate to severe renal impairment. This medication may be affected by liver function, thus dose adjustment is necessary for patients with impaired liver function, and caution is needed for patients with gastrointestinal diseases. Patients with kidney disease or renovascular hypertension may be at risk of deteriorating kidney function, hence regular monitoring is required. Elderly patients may respond more sensitively, so the dose should be adjusted slowly. During the use of this medication, side effects such as dizziness, lowered blood pressure, and peripheral edema may occur, hence caution is advised when driving or operating machinery. Potassium levels in the blood may increase, so potassium levels should be monitored regularly, and caution is needed when taking potassium supplements or medications containing potassium. This medication may interact with other drugs, so especially in combination with digoxin, lithium, nonsteroidal anti-inflammatory drugs, grapefruit juice, consultation with a physician or pharmacist is required. Breastfeeding women are advised not to take this medication and it is not recommended for children as safety has not been established. In case of overdose, symptoms such as hypotension, heart rate changes, and renal failure may occur, so immediate contact with a medical institution is required for appropriate treatment. This medication should be stored away from direct sunlight and out of reach of children, and it is advisable to take it immediately after opening.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling (edema), chest tightness, difficulty breathing, severe allergic reaction, severe skin adverse reactions, angioedema (accompanied by life-threatening outcomes), toxic skin rash, drug rash, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity reactions, intestinal vascular edema, liver dysfunction, liver damage, hepatitis, jaundice, increased liver enzymes (with cholestasis), myocardial infarction, ventricular tachycardia, arrhythmia, atrial fibrillation, vasculitis

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • depression
  • insomnia
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  • mood changes
  • confusion
  • drowsiness
  • migraine
  • headache
  • sensory disturbance
  • fainting
  • taste disturbance
  • tremors
  • visual impairment
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • itching
  • sweating
  • rash
  • hair loss
  • purpura

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 blocks light. Additionally, it is important to store it at a temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White oval tablet

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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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.