Medication info

Amlodipine Rosuvastatin 5/50 mg Tablets

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
White, rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201903027 · Approved 2019.05.10

This product's status changed to Expired on 2024.05.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Blood pressure control effect for essential hypertension and achieving target blood pressure
Who takes it
Adults · Children
Adult dose
The recommended dosage is 1 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). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after two weeks, the dosage may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy for pediatric patients under 18 years of age have not been established, and administration of this medication is not recommended.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Blood pressure control effect for essential hypertension and achieving target blood pressure

  • Essential hypertension
  • Stage 2 hypertension
View approved original text

This medication is used in patients with essential hypertension who find it difficult to control their blood pressure with Amlodipine or Losartan monotherapy. It is also used as initial treatment for patients with Stage 2 hypertension who require combination therapy to reach their target blood pressure. Therefore, this medication is effectively used for hypertension treatment.

How to take

Adult dose

The recommended dosage is 1 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). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after two weeks, the dosage may be increased to 10/50 mg once daily.

Child dose

Safety and efficacy for pediatric patients under 18 years of age have not been established, and administration of this medication 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 trimester, so it should be discontinued immediately upon confirmation of pregnancy. Additionally, hypotension may occur when initially administered to patients with reduced effective blood volume, thus such conditions should be treated before use. It should not be used in patients with hypersensitivity to this medication, severe liver impairment, severe aortic stenosis, or in a state of shock. Due to the blood pressure-lowering effect, dizziness may occur; thus caution is required when driving or operating hazardous machinery. This medication should be administered carefully in elderly patients or those with impaired kidney function, as there is a risk of hyperkalemia, hence potassium level monitoring is necessary. Care should be taken with combined use of other antihypertensives as the effect may be enhanced. Pregnant and breastfeeding women are advised not to take this medication, particularly during pregnancy, as it poses serious risks to the fetus and newborn. Safety in children has not been established, and therefore it is not recommended. In case of overdose, severe hypotension and cardiac dysfunction may occur; immediate medical attention is required if symptoms arise. This medication should be stored out of reach of children and not transferred to other containers.

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, peeling skin, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination issues.

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
  • hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • shortness of breath
  • cough
  • conjunctival injection
  • frequent urination
  • drowsiness
  • cerebral infarction
  • vasculitis
  • hypotension
  • blood pressure lowering
  • sinoatrial block
  • atrioventricular block
  • abdominal discomfort
  • left-sided chest pain
  • diarrhea
  • loose stools
  • skin rash.

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 closed container. The storage temperature should be maintained between 1°C and 30°C at room temperature. Proper storage will help maintain its effectiveness for a prolonged period.

Appearance and packaging

Appearance

White, rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 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.