Medication info
Newcozartan Tablets 10/50 mg (Amlodipine, Losartan Potassium)

Newcozartan Tablets 10/50 mg (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pale pink rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201903730 · Approved 2019.06.04

Summary

Main use
Improvement of blood pressure control in essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time every day (e.g. in the morning). Typically, 5/50 mg is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks, the dosage can be increased to 10/50 mg once daily.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under 18 years old, therefore its use is not recommended.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with amlodipine or losartan. It is also applied as an initial therapy for patients with stage 2 hypertension who require combination therapy to reach their target blood pressure. In other words, this drug is used to effectively improve hypertension through proper blood pressure management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time every day (e.g. in the morning). Typically, 5/50 mg is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks, the dosage can be increased to 10/50 mg once daily.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the 2nd and 3rd trimesters, so it should be discontinued immediately upon confirmation of pregnancy. It may lower blood pressure rapidly, so patients with low blood volume or those on diuretics should manage their condition well before starting this medication. Patients who are allergic to the active ingredients, have severe liver dysfunction, are pregnant or breastfeeding, have severe aortic stenosis, or are in shock should not be administered this medication. Patients with high potassium levels or poor kidney function, as well as those requiring strict sodium restriction, should use this medication with caution. Side effects such as dizziness, headaches, indigestion, edema, or skin rashes may occur during use; if symptoms persist, consult a physician. Due to the blood pressure-lowering effect of this medication, caution is necessary when driving or operating dangerous machinery. Patients with impaired liver or kidney function may require dose adjustment and should undergo regular examinations. Drug interactions may occur if taken with other antihypertensives or potassium supplements, so it is essential to inform healthcare providers about all medications being taken. Pregnant or breastfeeding women should refrain from using this medication, and its use is not recommended for children or elderly individuals aged 75 or older. In case of overdose, severe hypotension or cardiac problems may arise, so the dosage should be strictly adhered to, and immediate medical attention should be sought if abnormal symptoms occur. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthmatic attack, respiratory distress accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme overall lethargy, liver dysfunction (jaundice), sudden and severe headaches, thunderclap headache

Mild side effects

  • Dizziness
  • headaches
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • abdominal discomfort
  • indigestion
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  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • conjunctival injection
  • increased urination
  • fatigue
  • hypotension
  • sinus block
  • atrioventricular block
  • abdominal discomfort
  • epigastric pain
  • diarrhea
  • loose stools
  • skin erythema
  • papular rash
  • heaviness in the head
  • warmth
  • impaired glucose tolerance
  • weakness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effect for a longer period.

Appearance and packaging

Appearance

Pale pink rectangular film-coated tablet

Package unit

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.