Medication info

Dizaltan Tablet 5/100 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
Light pink rectangular film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201502698 · 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This product's status changed to Approval withdrawn on 2024.03.19.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 target blood pressure control of essential hypertension and 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., in the morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after 2 weeks, the dose may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy for pediatric patients under the age of 18 have not been established; therefore, the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement in target blood pressure control of essential hypertension and hypertension

  • Essential hypertension
  • Stage 2 hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension who have difficulty controlling blood pressure with monotherapy of amlodipine or losartan. It is also utilized as initial therapy in patients with stage 2 hypertension who require combination therapy to reach target blood pressure. This medication helps manage hypertension and is useful in reducing the risk of cardiovascular diseases. Therefore, this medication is used to improve blood pressure control.

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., in the morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after 2 weeks, the dose may be increased to 10/50 mg once daily.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters; therefore, it should be stopped immediately upon confirmation of pregnancy. Decreased amniotic fluid may occur due to fetal kidney dysfunction, which increases the risk of fetal growth retardation or malformations. Risks to the fetus should be adequately recognized even when taking this medication during early pregnancy, and if unavoidable, it should be administered under strict supervision by a specialist. Patients with reduced intravascular blood volume, such as those taking diuretics, may have a risk of hypotension, and their condition should be stabilized before administering this medication. This medication should not be given to patients with allergies to the active ingredients or similar components, pregnant or breastfeeding women, patients with severe liver dysfunction, severe aortic stenosis, and those in a state of shock. Due to the blood pressure-lowering effect, dizziness or drowsiness may occur, so caution should be taken when driving or operating hazardous machines. During treatment with this medication, regular monitoring of blood pressure, renal function, and potassium levels is required to check for abnormalities. Caution is needed when taking this medication with other antihypertensives, potassium-sparing diuretics, or potassium supplements, as potassium levels may increase. This medication is not recommended for children under 18 years of age as safety and efficacy have not been established. In elderly patients, especially those 75 years of age or older, initial dose adjustment is necessary, and consultation with a specialist is advised as the dosage may not be suitable. In case of overdose, severe hypotension and cardiac arrhythmias may occur, and immediate medical attention should be sought for appropriate treatment. This medication should be kept out of reach of children, and transferring it to another container could lead to quality degradation or accidents.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reaction, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, breathing problems, yellowing of skin or eyes (jaundice), extreme malaise, liver abnormalities (jaundice), sudden and

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • generalized pruritus
  • generalized urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival congestion
  • frequent urination
  • drowsiness
  • fatigue
  • malaise
  • fever
  • palpitations
  • vertigo
  • conjunctival congestion
  • cough
  • dry cough
  • hair loss.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Light pink rectangular film-coated tablet

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

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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.