Medication info

Amvasartan Tablets 5/160 mg

Prescription medicationExpired
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
(주)한국팜비오
Appearance
Dark yellow, rectangular film-coated tablets
Packaging
14 tablets/PTP x 2
Approval status
Expired

MFDS item code 201308730 · Approved 2013.08.08

This product's status changed to Expired on 2023.08.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who uses it
Adults · Children
Adult dosage
The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). For patients with mild to moderate renal impairment (creatinine clearance above 10 mL/min), dose adjustment is not necessary, but severe renal impairment patients and patients on dialysis should not receive it. For patients with liver impairment, valsartan daily dose should not exceed 80 mg.
Children's dosage
The safety and efficacy in pediatric patients under 18 years of age have not been established, so the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)한국팜비오

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension whose blood pressure control is insufficient with monotherapy of amlodipine or valsartan. It effectively lowers blood pressure, reducing the risk of cardiovascular diseases and improving health.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). For patients with mild to moderate renal impairment (creatinine clearance above 10 mL/min), dose adjustment is not necessary, but severe renal impairment patients and patients on dialysis should not receive it. For patients with liver impairment, valsartan daily dose should not exceed 80 mg.

Children's dosage

The safety and efficacy in pediatric patients under 18 years of age 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 trimesters of pregnancy, so if pregnancy is confirmed, it should be discontinued immediately. Patients with allergies to components contained in this medication or similar medications, pregnant or breastfeeding women, patients with severe kidney or liver disorders, and patients with certain heart diseases should not take this medication. Patients with body sodium or fluid depletion, hyperkalemia, renal artery stenosis, recently transplanted kidney patients, patients with a history of angioedema, and those who have had heart failure or myocardial infarction should exercise caution while taking this medication and require strict monitoring and testing from healthcare professionals. Various side effects, such as headaches, dizziness, edema, hypotension, skin rash, dyspepsia, and fatigue, may occur while taking this medication, and rarely, serious allergic reactions, blood disorders, or liver function abnormalities may arise, so if any unusual symptoms occur, medical consultation should be sought immediately. Dizziness or fatigue may occur while driving or operating machinery, so caution is advised, and concurrent use with other specific medications may alter effects or increase the risk of side effects, so consultation with a physician or pharmacist is essential. This medication is not recommended for pregnant or breastfeeding women, and its safety and efficacy in children under 18 years of age has not been sufficiently established, hence its use is not recommended. In case of overdose, severe hypotension or cardiac arrhythmias may occur, so strict adherence to dosages is necessary, and medical attention should be sought immediately in case of overdose.

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, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, consciousness confusion, vision changes, paralysis, urination issues

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • light-headedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
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  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • angioneurotic edema
  • facial edema
  • peripheral edema
  • fatigue
  • flushing
  • weakness

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture infiltration and should be kept at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Dark yellow, rectangular film-coated tablets

Package unit

14 tablets/PTP x 2

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.