Medication info
Telodipine Tablets 80/5 mg

Telodipine Tablets 80/5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.935mg / 1 tabletTelmisartan›80mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
White or off-white rectangular tablet
Packaging
30 tablets (10 tablets/blister x 3), 30 tablets/bottle
Approval status
Active

MFDS item code 201605749 · Approved 2016.09.30 · Insurance code 670104070

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage is one tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with kidney impairment: Mild and moderate kidney impairment do not require dose adjustments; however, for severe kidney impairment, treatment should be initiated at a lower dose and gradually increased. For patients with liver impairment: The dosage of Telmisartan for mild to moderate liver impairment cannot exceed 40 mg per day.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established, thus administration of this drug is not recommended.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Essential hypertension is a condition characterized by persistently high blood pressure that places a strain on the cardiovascular system. In cases where blood pressure cannot be adequately controlled with just Telmisartan or Amlodipine monotherapy, additional treatment may be necessary. This medication helps to effectively control blood pressure in such situations to reduce the risk of cardiovascular complications. Therefore, it is used for blood pressure management in patients with essential hypertension.

How to take

Adult dose

The recommended dosage is one tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with kidney impairment: Mild and moderate kidney impairment do not require dose adjustments; however, for severe kidney impairment, treatment should be initiated at a lower dose and gradually increased. For patients with liver impairment: The dosage of Telmisartan for mild to moderate liver impairment cannot exceed 40 mg per day.

Child dose

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

Precautions

This medication should not be used during pregnancy, particularly in the second and third trimesters, as it can pose serious risks to the fetus. This drug should not be administered to patients with allergies to its components, pregnant or breastfeeding women, or patients with severe liver or heart problems. Patients with impaired liver function or cholestatic disease should use this medication cautiously, and dosage adjustments may be necessary. Patients with very low blood pressure, severe heart failure, or unstable conditions following acute myocardial infarction should also avoid using this medication. Side effects such as dizziness and edema may commonly occur, and severe side effects may also rarely occur. If any unusual symptoms appear, consult a doctor immediately. Due to the blood pressure-lowering effect, hypotension may occur, so special caution is required for patients who are particularly deficient in fluids or salt. While taking this medication, potassium levels in the blood may increase, so patients at risk of hyperkalemia should undergo regular blood tests. Patients with impaired kidney function should also frequently monitor kidney status and electrolyte levels through blood tests. This medication may interact with other antihypertensive agents or certain drugs, so it is essential to inform the doctor of all medications being taken. In particular, combining this medication with grapefruit juice may excessively increase the blood pressure-lowering effect, so it is advisable to avoid it. This medication is not recommended for breastfeeding women, and if one is breastfeeding, it should be avoided. The safety and efficacy of this medication in children and adolescents under 18 years have not been sufficiently established, so it is advisable not to use it in this population. When administrating to the elderly, it is important to initiate treatment cautiously and adjust the dosage slowly while carefully observing for possible side effects. In the case of overdose, symptoms such as hypotension, dizziness, and acute renal failure may occur, so immediate medical attention should be sought for appropriate treatment. This medication should be stored out of the reach of children and kept sealed to protect from moisture.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory disturbances with cough and fever, yellowing of the skin or eyes (jaundice), severe fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, decreased urine output

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory tract infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
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  • insomnia
  • anxiety
  • confusion
  • drowsiness
  • headache
  • sensory disturbances
  • fainting
  • peripheral neuropathy
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • eczema
  • rash
  • itching
  • hair loss
  • angioedema

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 special container that does not allow light to enter. Additionally, it is important to maintain a room temperature of between 1 and 30 degrees Celsius while storing the medication to retain its effectiveness.

Appearance and packaging

Appearance

White or off-white rectangular tablet

Package unit

30 tablets (10 tablets/blister x 3), 30 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.