Medication info

Lozaska Tablet 5/100 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Losartan Potassium›100mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국바이오켐제약(주)
Appearance
White oblong film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, for export - 30 tablets/PTP [(10 tablets/PTP*3)]
Approval status
Approval withdrawn

MFDS item code 201504976 · Approved 2015.07.21

This product's status changed to Approval withdrawn on 2025.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control in 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 advised to take it at the same time every day (e.g., in the morning). Normally, 5/50 mg of this medication is administered once daily, and if blood pressure is still not adequately controlled after 2 weeks, the dose may 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, and administration is not recommended.

Ingredients

Manufacturer
한국바이오켐제약(주)

Efficacy & effects

Improvement in blood pressure control in 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 have difficulty controlling blood pressure with monotherapy using amlodipine or losartan. Additionally, it is utilized as an initial therapy in patients with stage 2 hypertension who require combination therapy to reach target blood pressure. Therefore, this drug is effectively used for hypertension management and 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 advised to take it at the same time every day (e.g., in the morning). Normally, 5/50 mg of this medication is administered once daily, and if blood pressure is still not adequately controlled after 2 weeks, the dose may 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, and administration is not recommended.

Precautions

This medication can cause serious harm or death to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Taking this medication during pregnancy can increase the risk of impaired fetal kidney function, oligohydramnios, growth retardation, and other congenital anomalies. Patients with low blood volume or those on diuretics should stabilize their condition before taking this medication, as hypotension may occur. Individuals with hypersensitivity to any of the ingredients in this medication, pregnant women, breastfeeding mothers, patients with severe liver dysfunction, severe aortic stenosis, and those in a state of shock should not take this medication. Patients with low blood volume or impaired kidney function, those requiring strict salt restriction, and patients with hyperkalemia should be monitored closely when taking this medication. This medication may occasionally cause side effects like dizziness, headache, indigestion, skin rash, palpitations along with neurological abnormalities such as dizziness or headache. If symptoms like sudden severe hypotension, loss of consciousness, or difficulty breathing arise, discontinue use immediately and consult a healthcare professional. The effect may be enhanced if this medication is taken with other antihypertensives, so it should be taken as directed by a healthcare professional. Avoid taking with grapefruit juice as it may increase drug concentration. Absolutely avoid use during pregnancy and be cautious during breastfeeding as this medication can be excreted in breast milk. Use is not recommended for children under 18 years of age as its safety and efficacy have not been established. For elderly patients, especially those over 75 years of age, initial dosage adjustment is required, so consultation with a healthcare professional is advised. In case of overdose, severe hypotension and cardiac arrhythmias may occur, requiring immediate emergency treatment and it is not removed through dialysis. Store this medication out of reach of children, and it is safer not to transfer it to another container.

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 high fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • cerebral infarction
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
Show 25 more
  • abdominal discomfort
  • indigestion
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • difficulty breathing
  • cough
  • vertigo
  • conjunctival injection
  • frequent urination
  • muscle cramps
  • back pain
  • limb pain
  • congestion
  • upper respiratory tract infection
  • sinusitis
  • diarrhea
  • sinus disorder
  • nausea

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperature in the range of 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, for export - 30 tablets/PTP [(10 tablets/PTP*3)]

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.