Medication info
New Cozal Tablet 5/100 mg (Amlodipine, Losartan Potassium)

New Cozal Tablet 5/100 mg (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pale pink rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201903731 · Approved 2019.06.04

Summary

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

Ingredients

Manufacturer
(주)다산제약

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 whose blood pressure is not sufficiently controlled with either amlodipine or losartan monotherapy. Additionally, it is prescribed as an initial treatment for stage 2 hypertension patients who require combination therapy to achieve target blood pressure. This helps effectively control blood pressure, assisting in the treatment of hypertension.

How to take

Adult dose

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

Child dose

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

Precautions

This medication may cause serious harm to the fetus when used during pregnancy, especially in the second and third trimesters; therefore, if pregnancy is confirmed, it should be discontinued immediately. Women who could become pregnant should consult a physician before taking this medication. Patients with excessively low blood pressure or insufficient blood volume should stabilize their condition before taking this medication, and it is advisable to avoid administering it to such patients. It should not be used in patients with severe liver dysfunction, severe aortic stenosis, or in a state of shock. It should be used cautiously in patients with elevated potassium levels in the blood or severely impaired kidney function, and regular blood tests are required. Symptoms such as dizziness or headaches may occur, so caution is advised during hazardous activities such as working at heights or driving. The effectiveness of this medication may be enhanced when used in conjunction with other antihypertensives, so it should be taken strictly according to a physician's instructions. Taking grapefruit juice with this medication may intensify its effects, so it is better to avoid taking them together. Pregnant or breastfeeding women should not take this medication, especially since it may be transmitted through breast milk. Safety and efficacy have not been established for children and adolescents under 18 years of age, so its use is not recommended. In elderly patients, particularly those over 75 years old, initial dose adjustments are necessary, and consultation with a physician is advised before taking this medication. An overdose of this medication may cause a rapid drop in blood pressure, so if an overdose is suspected, medical attention should be sought immediately. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 26 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • increased urination
  • fatigue
  • vasculitis
  • muscle tension
  • sensory loss
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbances
  • tremor
  • erectile dysfunction
  • gynecomastia
  • bowel movement

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 and protected from direct sunlight at room temperature between 1°C and 30°C.

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.