Medication info

Telmisartan and Amlodipine Besylate Tablet 80/5mg

Prescription medication경구Expired
Ingredient · strength
Telmisartan Powder 23.9%›334.72mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
It is a white and light gray, double convex, oval-shaped tablet.
Packaging
30 tablets/PTP [30 tablets (10 tablets/Alu-Alu × 3)]
Approval status
Expired

MFDS item code 201906173 · Approved 2019.08.29

This product's status changed to Expired on 2024.08.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is one tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). For patients with renal impairment: no dosage adjustment is necessary in cases of mild and moderate renal impairment; however, for patients with severe renal impairment, treatment should start at a lower dose and be gradually increased. For patients with liver impairment: mild or moderate liver impairment patients should not exceed a daily dose of 40 mg of telmisartan.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Patients have difficulty controlling their blood pressure with either amlodipine or telmisartan monotherapy. This medication effectively lowers blood pressure to manage essential hypertension. It is used as a combination therapy when sufficient blood pressure control cannot be achieved with a single drug therapy, thereby helping to reduce cardiovascular risk and improve health. It is used in the treatment of essential hypertension.

How to take

Adult dose

The recommended dosage for adults is one tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). For patients with renal impairment: no dosage adjustment is necessary in cases of mild and moderate renal impairment; however, for patients with severe renal impairment, treatment should start at a lower dose and be gradually increased. For patients with liver impairment: mild or moderate liver impairment patients should not exceed a daily dose of 40 mg of telmisartan.

Child dose

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

Precautions

This medication can cause serious harm to the fetus, especially during the second and third trimesters of pregnancy; therefore, it should not be used by women who are pregnant or may become pregnant. Do not use in patients who are allergic to the active ingredient or similar components, those with severe liver impairment or hypotension, patients with serious heart problems, or diabetic patients with severely impaired kidney function. Patients with problems in the liver, heart, or kidneys or specific heart valve diseases should exercise special caution when using this medication, and dosage adjustment may be necessary. Common side effects such as dizziness or swelling may occur while taking this medication, and in severe cases, fainting or heart issues may arise, so consult your healthcare provider immediately if symptoms develop. Avoid using this medication during pregnancy, and if pregnancy is confirmed, discontinue immediately and switch to another safe therapy. Hypotension may occur if blood pressure is too low or if there is a shortage of fluids and salts in the body; caution is needed, and appropriate treatment is required if symptoms arise. There is a risk of elevated potassium levels in the blood; therefore, regular blood tests to monitor potassium levels should be conducted if taking potassium-rich medications or supplements. Patients with weak kidney function should periodically check kidney function and electrolyte status while taking this medication. This medication may interact with other antihypertensive agents or multiple medications, so inform your healthcare provider of any other drugs you are taking. Breastfeeding women are advised not to take this medication, and they should consult with a healthcare provider if they do. It is recommended not to use this medication in children due to insufficient evidence of its safety and efficacy. Elderly patients may be more sensitive to the medication, so starting with a lower dose and gradually increasing it is advisable. Overdose may result in hypotension, dizziness, cardiac arrhythmias, etc., so immediate medical attention is required.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • difficulty breathing
  • severe allergic reactions
  • angioedema (potentially fatal outcomes)
  • urticaria
  • Stevens-Johnson syndrome
  • skin peeling
  • severe skin reactions
  • interstitial lung disease
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  • hepatitis
  • jaundice
  • increased liver enzymes
  • severe edema or urination issues
  • myocardial infarction
  • ventricular tachycardia
  • arrhythmia
  • atrial fibrillation
  • syncope
  • severe neurological symptoms
  • cerebral infarction
  • congestive heart failure

Mild side effects

  • Dizziness
  • peripheral edema
  • upper respiratory infection
  • urinary tract infection
  • anemia
  • hyperkalemia
  • hypoglycemia
  • hyponatremia
  • hyperglycemia
  • depression
Show 28 more
  • insomnia
  • mood changes
  • anxiety
  • confusion
  • drowsiness
  • migraine
  • headache
  • paresthesia
  • visual impairment
  • dizziness
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • dry mouth
  • liver dysfunction
  • itching
  • sweating
  • rash
  • hair loss

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 a dark container that does not allow light in. Additionally, it is important to store it at a temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

It is a white and light gray, double convex, oval-shaped tablet.

Package unit

30 tablets/PTP [30 tablets (10 tablets/Alu-Alu × 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.