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

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

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

MFDS item code 202001926 · Approved 2020.03.19 · Insurance code 649104810

Summary

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

Ingredients

Manufacturer
한국휴텍스제약(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 for patients with essential hypertension whose blood pressure is not adequately controlled with either amlodipine or losartan monotherapy. It may also be used as an initial treatment for patients with stage 2 hypertension who require combination therapy to reach their target blood pressure. Therefore, this medication is effectively utilized to manage hypertension and help stabilize blood pressure.

How to take

Adult dose

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

Child dose

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

Precautions

This drug may cause serious harm to the fetus if taken during pregnancy, particularly in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Care must be taken as serious adverse effects such as decreased kidney function in the fetus, hypotension, and decreased cranial formation may occur if pregnant women take this medication. Patients with decreased blood volume, for example, those taking diuretics, may experience hypotension when this drug is first administered; hence their condition should be closely monitored. Patients who are allergic to any components of this drug, those with severe liver impairment, severe aortic stenosis, or those in shock should not take this medication. Due to the blood pressure-lowering effects, dizziness or drowsiness may occur, so it is advisable to avoid hazardous activities such as working at heights or operating heavy machinery. This medication may affect liver and kidney function, so patients with liver or kidney disease should take it with caution after consulting their physician. During the course of this medication, potassium levels may increase, thus potassium-sparing diuretics or potassium supplements should be taken with frequent monitoring of blood potassium levels. It is not recommended for children and adolescents under 18 years of age due to the lack of established safety and efficacy. Elderly patients, especially those over 75 years old, may require dose adjustments, hence should take it under their doctor's direction. Overdosing on this medication may lead to severe hypotension and cardiac issues, so strict adherence to dosing is necessary. Taking this medication with grapefruit juice may enhance its blood pressure-lowering effects; therefore, concurrent intake is not advisable. If taken with other antihypertensive medications, the effect may be heightened, so it is essential to consult with a healthcare provider or pharmacist. Women who are pregnant, may become pregnant, or breastfeeding should avoid using this drug, and it should be discontinued immediately upon confirmation of pregnancy.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rash accompanied by high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, shortness of breath or breathing difficulties, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • fatigue
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • hollow swelling
  • abdominal discomfort
Show 26 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • eye congestion
  • frequent urination
  • drowsiness
  • cerebral infarction
  • angioedema
  • increased sweating
  • purpura
  • skin discoloration
  • hair loss
  • pruritus
  • rash
  • vasculitis
  • muscle tension
  • sensory loss
  • sensory abnormalities
  • peripheral neuropathy
  • fainting

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. Furthermore, it should be stored at room temperature between 1 to 30 degrees Celsius, avoiding overly hot or cold places.

Appearance and packaging

Appearance

Pink oval 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.