Medication info

Dualpor Injection 10/160 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
(주)제뉴파마
Appearance
Bright 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Approval withdrawn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 201900889 · 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This product's status changed to Approval withdrawn on 2023.09.11.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 dose is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients with renal impairment, dosage adjustment is not necessary in mild to moderate cases, but it should not be administered to patients with severe impairment. For patients with liver impairment, the daily dose of valsartan should not exceed 80 mg in mild to moderate cases, and it should not be administered to severe cases.
Children's dosage
The safety and efficacy of this medication have not been established in pediatric patients under 18 years, therefore its use is not recommended.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who do not achieve adequate blood pressure control with monotherapy using amlodipine or valsartan. It helps to stabilize blood pressure, thereby reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

The recommended dose is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients with renal impairment, dosage adjustment is not necessary in mild to moderate cases, but it should not be administered to patients with severe impairment. For patients with liver impairment, the daily dose of valsartan should not exceed 80 mg in mild to moderate cases, and it should not be administered to severe cases.

Children's dosage

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

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimester of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the active ingredients or similar compounds, women who are pregnant or breastfeeding, and individuals with severe kidney or liver dysfunction should not take this medication. Those who are low in sodium or body fluids may experience hypotension, so their condition should be thoroughly checked before taking the medication, and blood pressure and condition should be closely monitored during treatment. Patients with high potassium levels should exercise particular caution when taking this medication with other drugs that can elevate potassium levels, and they should regularly monitor their serum potassium concentration. Patients with renal artery stenosis or those who have recently undergone kidney transplantation may experience worsening renal function while taking this medication. This medication can cause a serious allergic reaction resulting in angioedema, which leads to swelling of the face, lips, or tongue; if such symptoms appear, the medication should be stopped immediately and medical attention sought. Patients with heart failure or post-myocardial infarction should carefully monitor their kidney function and blood pressure while taking this medication, as cardiac-related symptoms such as pulmonary edema may worsen. Possible side effects include dizziness, drowsiness, headache, orthostatic hypotension, cough, dyspepsia, skin rash, edema, and other unusual symptoms. If any abnormal symptoms appear, consult a physician. Caution is advised when driving or operating machinery, as dizziness or fatigue may occur. This medication may interact with other antihypertensives, diuretics, potassium supplements, and some anti-inflammatory drugs; inform healthcare professionals if you are taking any other medications. Women who are pregnant or planning to conceive should not take this medication, and breastfeeding women are also advised to avoid it. This medication is not recommended for children under 18 as its safety and efficacy have not been fully established. Elderly patients can take the same dosage as adults but should follow the advice of healthcare professionals based on their condition. In cases of overdose, serious symptoms such as hypotension may occur, so it’s critical to adhere to the prescribed dose, and if an overdose is suspected, seek immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory disturbances
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • hyperhidrosis
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • angioedema
  • facial edema
  • peripheral edema
  • fatigue
  • flushing
  • asthenia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve the drug's efficacy.

Appearance and packaging

Appearance

Bright 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

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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.