Medication info

PlusFour 5/160mg

Prescription medicationTablet경구Expired
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)라이트팜텍
Appearance
Dark yellow oblong film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP x 2], 30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201906444 · Approved 2019.09.16

This product's status changed to Expired on 2024.09.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosage adjustments are as follows: 5/80mg: to be administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5mg or valsartan 80mg. 5/160mg: to be administered to patients whose blood pressure is not adequately controlled by amlodipine 5mg or valsartan 160mg. 10/160mg: to be administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 10mg or valsartan 160mg or by 5/160mg. For patients taking valsartan and amlodipine in combination, switching to this medication (combination product with the same active ingredient dosages) may be convenient. In cases of renal impairment: No dosage adjustment is needed for mild to moderate renal impairment (creatinine clearance > 10 mL/min), but this medication is contraindicated in severe renal impairment (creatinine clearance < 10 mL/min) and dialysis patients. In moderate renal impairment, monitoring of potassium levels and creatinine is recommended. In liver impairment: The daily dosage of valsartan should not exceed 80mg for patients with mild to moderate liver impairment. This medication is contraindicated in patients with severe liver impairment, cholestasis, or bile duct obstruction. For elderly patients over 65 years: exercise caution when increasing the dosage. In children: Use of this medication is not recommended as safety and efficacy in pediatric patients under 18 years of age have not been established.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and therefore, use of this medication is not recommended.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

There may be cases where blood pressure is not sufficiently controlled with either amlodipine or valsartan as monotherapy due to essential hypertension. In such cases, both medications can be used together for more effective blood pressure management. Proper regulation of blood pressure helps reduce cardiovascular risks and improve overall health. Therefore, a combination therapy of amlodipine and valsartan is used in the treatment of essential hypertension.

How to take

Adult dose

The recommended dosage of this medication is one tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosage adjustments are as follows: 5/80mg: to be administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5mg or valsartan 80mg. 5/160mg: to be administered to patients whose blood pressure is not adequately controlled by amlodipine 5mg or valsartan 160mg. 10/160mg: to be administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 10mg or valsartan 160mg or by 5/160mg. For patients taking valsartan and amlodipine in combination, switching to this medication (combination product with the same active ingredient dosages) may be convenient. In cases of renal impairment: No dosage adjustment is needed for mild to moderate renal impairment (creatinine clearance > 10 mL/min), but this medication is contraindicated in severe renal impairment (creatinine clearance < 10 mL/min) and dialysis patients. In moderate renal impairment, monitoring of potassium levels and creatinine is recommended. In liver impairment: The daily dosage of valsartan should not exceed 80mg for patients with mild to moderate liver impairment. This medication is contraindicated in patients with severe liver impairment, cholestasis, or bile duct obstruction. For elderly patients over 65 years: exercise caution when increasing the dosage. In children: Use of this medication is not recommended as safety and efficacy in pediatric patients under 18 years of age have not been established.

Child dose

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

Precautions

This medication should not be taken during the second and third trimesters of pregnancy as it can cause serious harm to the fetus or newborn. Women who are pregnant, planning to become pregnant, or breastfeeding should not take this medication. Additionally, individuals allergic to any of the components of this medication or patients with severe kidney or liver disease should avoid using it. Patients with severe aortic stenosis or in a state of shock may be at risk if they take this medication, so it should be avoided. Patients with low sodium or fluid levels may experience low blood pressure, hence their condition should be checked before taking the medication under medical supervision. Patients with high potassium levels or those taking other medications that increase potassium should monitor potassium levels frequently. Patients with vascular issues in the kidneys may experience worsening kidney function, so caution is needed. Patients with heart failure or those recovering from myocardial infarction should monitor changes in kidney function carefully while taking this medication. Dizziness or fatigue may occur when driving or operating machinery, so caution is needed. There may be interactions when taken with other blood pressure medications, so it is important to inform the healthcare provider of other medications being taken. Pregnant women or those planning to become pregnant should not take this medication and should immediately discontinue it if pregnancy is confirmed while on this medication. It is also recommended for breastfeeding women to avoid taking this medication. Use in children under 18 years of age is not recommended.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances,

Mild side effects

  • Pharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory disturbances
  • lightheadedness
  • tinnitus
Show 27 more
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pain in the throat and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • ankle edema
  • facial edema

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its efficacy safely.

Appearance and packaging

Appearance

Dark yellow oblong film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2], 30 tablets/bottle, 100 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

No questions yet.

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.