Medication info
Losartan/Amlodipine Tablet 5/100 mg

Losartan/Amlodipine Tablet 5/100 mg

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›100mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White oval film-coated tablets
Packaging
Domestic Use - 30 tablets/bottle, Export Use - 30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 201504975 · Approved 2015.07.21 · Insurance code 644308970

Summary

Main use
Effect of blood pressure control to achieve target blood pressure in essential hypertension and treatment of hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is one 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 of this medication is administered once daily, and if blood pressure is not adequately controlled after two weeks of treatment, the dose may be increased to 10/50 mg once daily.
Child dose
Safety and effectiveness have not been established for pediatric patients under 18 years of age, hence its use is not recommended.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Effect of blood pressure control to achieve target blood pressure in essential hypertension and treatment of hypertension

  • Essential hypertension
  • Stage 2 hypertension
View approved original text

This medication helps control blood pressure in patients with hypertension. It is especially used for patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or losartan. It is also indicated for patients with stage 2 hypertension who need combination therapy to reach the treatment target blood pressure as an initial therapy. This drug helps to effectively manage blood pressure and prevent cardiovascular complications. It is used for the treatment of hypertension.

How to take

Adult dose

The recommended dose for this medication is one 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 of this medication is administered once daily, and if blood pressure is not adequately controlled after two weeks of treatment, the dose may be increased to 10/50 mg once daily.

Child dose

Safety and effectiveness have not been established for pediatric patients under 18 years of age, hence its use is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Patients starting this medication who have a reduced blood volume may experience hypotension symptoms, so their condition should be carefully assessed before taking the medication. This drug should not be used in individuals with allergic reactions to the active ingredients or similar medications, pregnant or potentially pregnant women, nursing women, patients with severely impaired liver function, patients with certain heart conditions, and those in a state of shock. Caution is advised when prescribing to patients with reduced blood volume, those on a strict salt-restricted diet, patients with severe renal impairment, and patients with hyperkalemia, requiring regular monitoring. Taking this medication may lead to neurological symptoms such as dizziness or headache, and occasionally side effects like drowsiness, palpitations, digestive disorders, and skin rash may occur, so caution is advised. Particularly during hypertension treatment, this medication may cause excessively low blood pressure, so it is advisable to avoid dangerous activities such as working at heights or driving. When taken with other antihypertensive agents, the effect can be potentiated, so it should only be combined after consulting a physician. Taking this drug with grapefruit juice may increase the drug concentration, so co-administration should be avoided. During pregnancy, this drug could affect fetal renal function; therefore, it should not be taken by women planning to become pregnant or who are currently pregnant, and it is also safe to avoid while breastfeeding. Safety and effectiveness have not been established for patients under 18 years of age, hence its use is not recommended in this population. In elderly individuals, particularly those over 75 years of age, initial dose adjustment is necessary, as appropriate dose adjustments may be challenging with this medication. In case of overdose, severe hypotension and impaired cardiac function may occur, necessitating immediate medical attention for proper treatment. This medication should be kept out of reach of children and should not be transferred to other containers to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • dependent edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • shortness of breath
  • cough
  • conjunctival injection
  • increased urination
  • drowsiness
  • brain infarction
  • congestion
  • upper respiratory infections
  • sinusitis
  • diarrhea
  • sinus disorders
  • pharyngitis
  • myalgia
  • insomnia
  • fatigue
  • swelling
  • abdominal pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture exposure, and kept at a cool room temperature between 1 and 30 degrees Celsius. Such storage conditions help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

Domestic Use - 30 tablets/bottle, Export Use - 30 tablets/box [(10 tablets/PTP x 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.