Medication info

Dual Poching 5/80 mg

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201900890 · 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This product's status changed to Approval withdrawn on 2023.09.11.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 with the combination of amlodipine and valsartan
Who uses it
Adults · Children
Adult dosage
The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Available in dosages of 5/80 mg, 5/160 mg, and 10/160 mg, and the appropriate dose should be chosen based on blood pressure control status. For patients with renal impairment, dosage adjustment is required for mild to moderate cases (creatinine clearance 10 mL/min or more).
Children's dosage
Safety and efficacy have not been established for pediatric patients under 18 years of age, and the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement in blood pressure control in essential hypertension with the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure with either amlodipine or valsartan monotherapy. It effectively lowers blood pressure and helps reduce the risk of cardiovascular complications. It can improve health through safe and consistent blood pressure management.

Dosage and Administration

Adult dosage

The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Available in dosages of 5/80 mg, 5/160 mg, and 10/160 mg, and the appropriate dose should be chosen based on blood pressure control status. For patients with renal impairment, dosage adjustment is required for mild to moderate cases (creatinine clearance 10 mL/min or more).

Children's dosage

Safety and efficacy have not been established for pediatric patients under 18 years of age, and the administration of this medication is not recommended.

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 upon confirmation of pregnancy. Patients with hypersensitivity to this medication, pregnant or breastfeeding women, and patients with severe renal or hepatic impairment should not take this medication. Patients with sodium or fluid depletion may experience hypotension, so their condition should be carefully assessed before administration, and appropriate measures should be taken if symptoms of hypotension occur during treatment. Patients with high potassium levels or those taking medications that may increase potassium should have their potassium levels monitored frequently. Patients with renal artery stenosis or those who have recently undergone kidney transplantation should use this medication with caution as it may affect kidney function. If symptoms of angioedema occur, this medication should be stopped immediately and should not be re-administered. Patients who have heart failure or have had a myocardial infarction should be closely monitored for changes in kidney function, as some heart failure patients may experience worsening edema. This medication may cause dizziness or fatigue while driving or operating machinery, so caution is advised. When used in conjunction with other antihypertensive medications or potassium supplements, diuretics, NSAIDs, etc., there is a risk of side effects due to interactions, so medical advice should be followed. Pregnant women or those planning to become pregnant should not use this medication, and breastfeeding women are also advised against taking it. The safety and efficacy of this medication have not been sufficiently established in pediatric patients under 18 years of age, therefore its use is not recommended. In cases of overdose, severe hypotension or heart-related side effects may occur, so immediate medical attention should be sought. Regular monitoring of blood pressure, kidney function, and electrolyte levels during treatment is essential for detecting any abnormalities.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, mucosal pain in mouth/eyes, dyspnea or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination changes.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
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  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • perspiration
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • increased urination
  • erectile dysfunction
  • edema
  • local swelling
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • nasal congestion.

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 best stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Dark yellow round film-coated tablets

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.

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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.