Medication info
Tops Tablets 80/5 mg

Tops Tablets 80/5 mg

Prescription medication경구
Ingredient · strength
Telmisartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
This medicine is a white and light blue, double-sided, convex oval tablet.
Packaging
30 tablets/box [10 tablets/Alu-Alu)x3], 30 tablets/bottle
Approval status
Active

MFDS item code 201605613 · Approved 2016.09.22 · Insurance code 642905760

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with renal impairment: - Patients with mild to moderate renal impairment do not require dosage adjustment; however, those with severe renal impairment should start treatment at a low dosage and increase it gradually. For patients with liver impairment: - The dosage of telmisartan for patients with mild or moderate hepatic impairment should not exceed 40 mg per day.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under 18 years, and its use is not recommended.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not well controlled with monotherapy of telmisartan or amlodipine. In other words, this medicine helps to effectively lower and manage blood pressure when monotherapy is insufficient to achieve adequate blood pressure control. This reduces the risk of cardiovascular complications and improves patients' health.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, to be taken with water irrespective of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with renal impairment: - Patients with mild to moderate renal impairment do not require dosage adjustment; however, those with severe renal impairment should start treatment at a low dosage and increase it gradually. For patients with liver impairment: - The dosage of telmisartan for patients with mild or moderate hepatic impairment should not exceed 40 mg per day.

Child dose

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

Precautions

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can pose a serious risk to the fetus. If pregnancy is confirmed, treatment with this medication should be discontinued as soon as possible. This medication is contraindicated for individuals allergic to certain components, pregnant women or those who may become pregnant, lactating women, and those with severe liver or heart problems. Additionally, it should not be given to patients with severe hypotension or in shock, or those who are unstable after an acute myocardial infarction. Caution is advised in administering this medication to some patients, such as those with impaired liver function, valvular heart disease, reduced kidney function, or elderly individuals. Side effects such as dizziness or swelling may occur frequently during treatment, so caution is necessary. While serious side effects are rare, any unusual symptoms should prompt immediate consultation with healthcare professionals. Because this medication lowers blood pressure, if symptoms of hypotension occur, the patient should be laid down, and intravenous fluids may be administered if necessary. This drug can also increase potassium levels, so periodic monitoring of serum potassium levels is required. Potential interactions may occur with other medications, therefore any concurrent medications should be disclosed to a doctor or pharmacist. This medication is not recommended for children as its safety and efficacy have not been sufficiently established. For elderly patients, dose adjustments and careful monitoring are required. In case of overdose, symptoms such as hypotension, dizziness, and heart rate changes may occur, requiring immediate medical attention. This medication should be kept out of reach of children and stored in a dry place, avoiding transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, hypersensitivity, anaphylactic reaction, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, angioedema (may lead to fatal outcomes), Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema with hypertension, interstitial lung disease, hepatitis, jaundice, elevated liver enzymes (with cholestasis), myocardial infarction, ventricular tachycardia, arrhythmia, atrial fibrillation, vascular complications

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
  • taste disturbances
  • tremors
  • extrapyramidal symptoms
  • muscle rigidity
  • visual disturbances
  • vertigo
  • tinnitus
  • palpitations
  • bradycardia
  • tachycardia
  • flushing
  • hypotension
  • orthostatic hypotension
  • cough
  • abdominal pain
  • dyspepsia
  • nausea
  • vomiting
  • oral dryness

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

Storage

This medication is sensitive to light and must be stored in a special container that prevents light exposure. Additionally, the medication should be stored at room temperature between 1 and 30 degrees Celsius to maintain effectiveness.

Appearance and packaging

Appearance

This medicine is a white and light blue, double-sided, convex oval tablet.

Package unit

30 tablets/box [10 tablets/Alu-Alu)x3], 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.