Medication info

Dual Force 5/160 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
(주)제뉴파마
Appearance
Dark yellow rectangular film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201900891 · Approved 2019.02.12

This product's status changed to Approval withdrawn on 2023.09.11. 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
Who uses it
Adults · Children
Adult dosage
The recommended dosage of this medication is one tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). For patients with mild to moderate renal impairment, no dosage adjustment is necessary; however, it should not be administered to patients with severe renal impairment or those on dialysis. For hepatic impairment, the daily dose of valsartan should not exceed 80 mg.
Children's dosage
Safety and efficacy have not been established in pediatric patients under 18 years of age; therefore, this medication is not recommended for use.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy using amlodipine or valsartan.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is one tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). For patients with mild to moderate renal impairment, no dosage adjustment is necessary; however, it should not be administered to patients with severe renal impairment or those on dialysis. For hepatic impairment, the daily dose of valsartan should not exceed 80 mg.

Children's dosage

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

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. Patients with hypersensitivity to this medication, pregnant or breastfeeding women, patients with severe renal or liver impairment, and those with certain vascular or heart diseases should not take it. Patients with fluid or sodium deficiency may experience hypotension, so their condition should be closely monitored before and during administration, paying careful attention to blood pressure changes. Patients with high potassium levels should be cautious when taking this medication alongside other potassium-raising medications and should frequently monitor their serum potassium levels. Patients with kidney issues or kidney transplant recipients may experience worsening renal function when taking this medication; therefore, it should be administered cautiously. If symptoms of angioedema occur, administration must be discontinued immediately and should not be resumed. Patients with heart failure or post-myocardial infarction should periodically assess their renal function while taking this medication, and caution is needed for heart failure patients as pulmonary edema may occur. Dizziness and fatigue may occur while driving or operating machinery; thus, caution is advised. When combined with other antihypertensive medications, there is an increased risk of hypotension, renal function decline, and hyperkalemia, so regular monitoring of blood pressure, renal function, and electrolyte status is necessary. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women should also avoid its use. Safety and efficacy have not been adequately established in pediatric patients; therefore, use in this population is not recommended. Overdosage may result in dizziness, severe hypotension, and reflex tachycardia, necessitating immediate medical attention. During the course of treatment, liver function or renal function abnormalities may arise, making regular check-ups necessary. Adherence to the above precautions is essential; any unusual symptoms should prompt an immediate consultation with a physician or pharmacist.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthmatic attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), excessive lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Rhinitis
  • influenza
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
Show 27 more
  • palpitations
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • polydipsia
  • erectile dysfunction
  • edema
  • pedal edema
  • facial edema
  • peripheral edema
  • fatigue

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius. This ensures prolonged efficacy and safe use of the medication.

Appearance and packaging

Appearance

Dark yellow rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.

Related searches

Search tags

Suggested searches

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.