Medication info

Dizaltan Tablets 5/50 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White oblong film-coated tablets
Packaging
Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201502697 · Approved 2015.04.30

This product's status changed to Approval withdrawn on 2024.03.19. 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 and stage 2 hypertension
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 recommended to take it at the same time every day (e.g., morning). Typically, this medication 5/50 mg is administered once daily, and if blood pressure is still insufficiently controlled after 2 weeks of administration, the dose can be increased to 1 tablet of 10/50 mg once daily.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established, thus the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension and stage 2 hypertension

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used in patients with essential hypertension who find it difficult to control blood pressure with Amlodipine or Losartan alone. It can also be used as a first-line treatment in patients with stage 2 hypertension who require combination therapy to achieve target blood pressure. In other words, this drug effectively works to control hypertension, helping to manage blood pressure stably.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., morning). Typically, this medication 5/50 mg is administered once daily, and if blood pressure is still insufficiently controlled after 2 weeks of administration, the dose can be increased to 1 tablet of 10/50 mg once daily.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, particularly in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. When taken by pregnant women, it can reduce fetal kidney function, leading to decreased amniotic fluid, which may cause fetal growth retardation or malformations. Patients with volume depletion need adequate treatment prior to using this medication, as there is a risk of excessively low blood pressure. Do not administer this drug to patients with allergies to the main components or similar components, severe liver impairment, pregnant women, or patients with specific heart conditions. Use cautiously in patients with high blood potassium levels or poor kidney function, and in patients requiring strict sodium restriction. This medication can cause side effects such as dizziness, headaches, swelling, dyspepsia, coughing, etc., so consult healthcare professionals if abnormal symptoms persist. Especially, when taken with other antihypertensive agents as a treatment for hypertension, there may be an increased blood pressure-lowering effect, requiring caution. It is safer not to take this medication during pregnancy or breastfeeding, and nursing women should also avoid taking it. The use of this medication is not recommended for children under 18 or the elderly over 75. In cases of overdose, blood pressure may drop rapidly, and abnormal heartbeats may occur, so seek immediate medical attention if suspected. Store this medication out of reach of children, and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (angioedema), chest discomfort, difficulty breathing, angioedema (which may cause airway obstruction due to laryngeal/glottic edema, swelling of the face/lips/pharynx/tongue), cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, breathing problems

Mild side effects

  • Dizziness
  • headaches
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • dependent edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • conjunctival congestion
  • frequent urination
  • drowsiness
  • cerebral infarction
  • malaise
  • weight gain/loss
  • vasculitis
  • tension
  • sensory impairment/sensory abnormalities
  • peripheral neuropathy
  • syncope
  • taste disorders
  • tremors
  • erectile dysfunction
  • gynecomastia

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air and moisture, and it is best to keep it at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a prolonged period.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

Bottle - 30 tablets/bottle, 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

No questions yet.

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.