Medication info
Newcoposizone 5/160 mg

Newcoposizone 5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)새한제약
Appearance
Dark yellow rectangular film-coated tablets
Packaging
For domestic use - 30 tablets/bottle
Approval status
Active

MFDS item code 202000769 · Approved 2020.02.10 · Insurance code 651300940

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medicine 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). Dosages available are 5/80 mg, 5/160 mg, and 10/160 mg, and if blood pressure is not adequately controlled, a switch to this medication may be considered after monotherapy with individual components. In patients with renal impairment, mild and moderate (creatinine clearance greater than 10 mL/min) do not require dose adjustment, but patients with severe renal impairment (creatinine clearance less than 10 mL/min) and dialysis patients should not be prescribed this medication.
Child dose
The safety and efficacy for pediatric patients under 18 years have not been established, so the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)새한제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medicine can be effectively used to manage blood pressure for patients with essential hypertension who do not achieve sufficient blood pressure control with monotherapy of amlodipine or valsartan.

How to take

Adult dose

The recommended dose of this medicine 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). Dosages available are 5/80 mg, 5/160 mg, and 10/160 mg, and if blood pressure is not adequately controlled, a switch to this medication may be considered after monotherapy with individual components. In patients with renal impairment, mild and moderate (creatinine clearance greater than 10 mL/min) do not require dose adjustment, but patients with severe renal impairment (creatinine clearance less than 10 mL/min) and dialysis patients should not be prescribed this medication.

Child dose

The safety and efficacy for pediatric patients under 18 years have not been established, so 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 trimester of pregnancy, so it's important to stop taking it immediately if pregnancy is confirmed. Patients with allergies to any components of this medicine, pregnant or nursing women, patients with severe kidney or liver disease, and those with certain heart conditions should not take this medicine. Patients with low sodium or fluid levels in their body may be at risk for low blood pressure, so it's crucial to check their condition carefully before taking this medication and to monitor blood pressure closely while taking it. Patients with high potassium levels or those using medications that can increase potassium should have their blood potassium levels frequently tested. Patients with impaired kidney function or kidney transplant recipients should use this medication cautiously as it may worsen kidney function. If symptoms of angioedema, such as swelling of the face, lips, or tongue occur while taking this medicine, it should be stopped immediately and medical advice should be sought. Patients with heart failure or myocardial infarction should monitor kidney function and blood pressure closely while taking this medicine, and those with acute myocardial infarction should observe symptoms carefully during the initial period of taking this medication. Patients with reduced liver function should have their dosage limited, and any signs of liver dysfunction should be reported to healthcare providers. Dizziness or fatigue may occur while taking this medicine, so caution is needed when driving or operating machinery. When taking other medications, there may be changes in effectiveness or increased risk of side effects due to interactions, so patients must inform their healthcare providers of all medications they are taking. Women who are pregnant or planning to become pregnant should not use this medicine, and nursing mothers are also advised to avoid it as much as possible. The safety and efficacy of this medicine have not been sufficiently established for children under 18 years of age; therefore, its use is not recommended. The elderly can take similar doses as general adults, but should follow the guidance of healthcare providers based on their condition. In case of overdose, severe low blood pressure or heart problems may occur, so immediate medical attention should be sought for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, yellowing of skin or eyes, extreme lethargy, sudden and very severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output

Mild side effects

  • Rhinitis
  • influenza
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
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  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and larynx pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • rash
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • diabetes insipidus
  • erectile dysfunction
  • edema
  • local edema
  • facial swelling

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

Storage

This medicine may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, to maintain the efficacy of the drug, it should be stored at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Dark yellow rectangular film-coated tablets

Package unit

For domestic use - 30 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.