Medication info
Newzen 5/80 Milligrams (Amlodipine Besilate, Valsartan)

Newzen 5/80 Milligrams (Amlodipine Besilate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Dark yellow oval film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X2)
Approval status
Active

MFDS item code 201403570 · Approved 2014.07.31 · Insurance code 646203590

Summary

Main use
Improvement in blood pressure control for essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose 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). Administer 5/80 milligrams for patients whose blood pressure is not adequately controlled by monotherapy with 5 milligrams of amlodipine or 80 milligrams of valsartan. Administer 5/160 milligrams for patients whose blood pressure is not adequately controlled with monotherapy of 5 milligrams of amlodipine or 160 milligrams of valsartan.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age, so its use is not recommended.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

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

  • Essential hypertension
View approved original text

This medication is used to help manage blood pressure effectively in patients with essential hypertension who do not achieve adequate blood pressure control with single-agent therapy with amlodipine or valsartan.

How to take

Adult dose

The recommended dose 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). Administer 5/80 milligrams for patients whose blood pressure is not adequately controlled by monotherapy with 5 milligrams of amlodipine or 80 milligrams of valsartan. Administer 5/160 milligrams for patients whose blood pressure is not adequately controlled with monotherapy of 5 milligrams of amlodipine or 160 milligrams of valsartan.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Patients with an allergy to any component of this medication, pregnant or breastfeeding women, and patients with severe renal or hepatic impairment should not take this medication. Patients with low sodium or fluid levels in their body should stabilize their condition before taking this medication and should be carefully monitored for any symptoms of hypotension during treatment. Patients with elevated potassium levels should have regular blood tests if taking this medication along with potassium supplements, as potassium levels may increase further. Patients with renal vascular issues or kidney transplant recipients need careful monitoring as there is a risk of renal function deterioration when taking this medication. If symptoms of angioedema such as swelling of the face, lips, or tongue occur during treatment, discontinue use immediately and consult a healthcare professional. Patients with heart failure or post-myocardial infarction have an increased risk of side effects like pulmonary edema when taking this medication, so it should be used with caution. Be cautious while driving or operating machinery, as dizziness or fatigue may occur. This medication may interact with other antihypertensives, diuretics, potassium-sparing agents, and certain anti-inflammatory medications (NSAIDs), so you must inform your healthcare provider about all medications you are currently taking. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women should also avoid using it. The safety and efficacy of this medication have not been sufficiently established in children under 18 years of age, so its use is not recommended. In case of overdose, symptoms such as hypotension, dizziness, and arrhythmia may occur, so it is vital to adhere to the prescribed dosage and report any unusual symptoms to medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in the mouth/eyes mucosa, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, hepatic abnormalities (jaundice), sudden and

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory disturbances
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
Show 29 more
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • angioedema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • diplopia

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store this medication at room temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu X2)

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.