Medication info

Dualthera Tablet 30/2.5 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Fimasartan Potassium Trihydrate›33.005mg / 1 tabletS-Amlodipine Besylate 2.5 Hydrate›3.74mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
White, rounded square film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202300134 · Approved 2023.01.06

This product's status changed to Approval withdrawn on 2024.02.20. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose for adults is one tablet once daily, taken with water without regard to meals. Daily administration at the same time (e.g., in the morning) is encouraged. If blood pressure is not controlled, the following dosing adjustments are recommended: • 30/2.5 mg: Administer to patients whose blood pressure is not adequately controlled with Pimasartan 30 mg monotherapy. • 60/2.5 mg: Administer to patients whose blood pressure is not adequately controlled with Pimasartan 60 mg monotherapy.
Child dose
The safety and efficacy in pediatric and adolescent patients under 18 years of age have not been established.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Pimasartan potassium is a medication used for patients with essential hypertension and serves as an additional treatment option when monotherapy inadequately controls blood pressure. This medication effectively lowers blood pressure, helping to reduce cardiovascular risk. Therefore, it is used to improve blood pressure control in patients for whom blood pressure management is challenging.

How to take

Adult dose

The recommended dose for adults is one tablet once daily, taken with water without regard to meals. Daily administration at the same time (e.g., in the morning) is encouraged. If blood pressure is not controlled, the following dosing adjustments are recommended: • 30/2.5 mg: Administer to patients whose blood pressure is not adequately controlled with Pimasartan 30 mg monotherapy. • 60/2.5 mg: Administer to patients whose blood pressure is not adequately controlled with Pimasartan 60 mg monotherapy.

Child dose

The safety and efficacy in pediatric and adolescent patients under 18 years of age have not been established.

Precautions

This medication can cause serious harm or death to the fetus and newborn if taken during pregnancy, especially during the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used in patients with allergies to its active ingredients or similar drugs, those who are pregnant or breastfeeding, patients on dialysis, those with moderate to severe liver impairment, patients with bile duct obstruction, diabetic patients with certain kidney disorders, and certain genetically predisposed lactose intolerant patients. Patients with reduced blood volume or sodium, impaired renal function, renal artery stenosis, aortic stenosis, severe hypotension, and elderly patients should use this medication cautiously, and symptoms of hypotension may appear during the initial treatment or dosage increase; therefore, their condition should be closely monitored. This medication may cause side effects such as dizziness, headaches, edema, urination disturbances, insomnia, and flushing; it can rarely lead to serious kidney disease, blood pressure drop, or allergic reactions, so any unusual symptoms should be discussed with a healthcare professional immediately. For patients with hypotension or electrolyte imbalance, it is essential to correct these conditions before starting this medication, and blood pressure and electrolyte levels should be regularly monitored during treatment. Furthermore, this medication may interact with specific drugs, so patients taking other medications must inform their healthcare provider, particularly if using potassium-sparing diuretics, lithium, or non-steroidal anti-inflammatory drugs, as caution is needed. Serious effects on the fetus may occur during pregnancy, so those planning to become pregnant or who are pregnant should consult their healthcare provider; breastfeeding women are advised to stop breastfeeding or the medication due to the possibility of drug transfer through breast milk. The safety and efficacy of this medication in patients under 18 years of age have not been established. Elderly patients require no dosage adjustment, but caution is advised as sensitive reactions may occur. Patients with severely compromised liver function should not use this medication, and overdose may result in severe symptoms such as hypotension and arrhythmia, requiring immediate emergency care. Finally, this medication should be kept out of reach of children and stored in its original packaging to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), profound fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Dizziness, orthostatic dizziness, headaches, facial edema, peripheral edema, urination disturbances, insomnia, flushing, dyspepsia, vomiting, nausea, upper abdominal pain, weakness, foreign body sensation, elevated liver enzyme levels (ALT, AST), decreased platelet count, increased serum creatine phosphokinase levels, cough, muscle cramps, musculoskeletal rigidity, itching, local urticaria, erectile dysfunction, syncope, sedation, migraine, muscle weakness, headaches, drowsiness, vasculitis,

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 container that does not allow light to enter. Additionally, it is essential to maintain a temperature between 1°C and 30°C when storing the medication. This helps preserve the effectiveness of the drug over time.

Appearance and packaging

Appearance

White, rounded square film-coated tablet

Package unit

30 tablets/bottle, 300 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.