Medication info

TDS Sartan Tablet 10/160 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)티디에스팜
Appearance
Bright yellow rectangular film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201901336 · Approved 2019.03.05

This product's status changed to Expired on 2024.03.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control in essential hypertension with the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, taken with water, regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). The individual components (amlodipine or valsartan) should be adjusted in dosage, and if blood pressure is not controlled with monotherapy, the following doses will be administered. ㆍ5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of either amlodipine 5 mg or valsartan 80 mg.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age, and its use is not recommended.

Ingredients

Manufacturer
(주)티디에스팜

Efficacy & effects

Improvement in blood pressure control in essential hypertension with the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or valsartan.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, taken with water, regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). The individual components (amlodipine or valsartan) should be adjusted in dosage, and if blood pressure is not controlled with monotherapy, the following doses will be administered. ㆍ5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of either amlodipine 5 mg or valsartan 80 mg.

Child dose

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

Precautions

This drug can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. This drug should not be used in patients with a hypersensitivity to its components, pregnant or breastfeeding women, patients with severe kidney or liver dysfunction, or patients with certain heart diseases. Patients with sodium or fluid depletion may experience hypotension; therefore, their condition should be carefully evaluated before administration, and appropriate treatment should be received if hypotension occurs. Patients with high potassium levels should take this drug and potassium supplements with caution, and their serum potassium levels should be regularly tested. Patients with vascular issues in the kidneys or those who have received a kidney transplant should be closely monitored for changes in kidney function when using this drug, and it should be discontinued immediately if vascular edema occurs. Patients with heart failure or those recovering from myocardial infarction must undergo kidney function tests when taking this medication, as there is a risk of heart failure worsening. This drug may cause side effects such as dizziness, headache, edema, hypotension, cough, skin rash, etc.; if any unusual symptoms occur, consult healthcare professionals. Caution is advised when driving or operating machinery as dizziness or fatigue may occur. This drug may interact with other antihypertensive medications, potassium-sparing diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), certain antibiotics, etc., so all current medications must be disclosed. Pregnant women or those planning to become pregnant should not take this drug, and breastfeeding women should avoid taking this medication as well. This drug is not recommended for children under the age of 18 as its safety and efficacy have not been adequately established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough accompanied by fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination abnormalities.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • light-headedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • local swelling
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness
  • facial flushing
  • nasal congestion.

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

Bright yellow rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu X 2), 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.