Medication info

Amvasartan Tablet 5/80 mg

Prescription medicationExpired
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
(주)한국팜비오
Appearance
Dark yellow round film-coated tablet
Packaging
14 tablets/PTPX2
Approval status
Expired

MFDS item code 201308729 · 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 of blood pressure control in essential hypertension
Who uses it
Adults · Children
Adult dosage
The recommended dose for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). 5/80 mg: To be given to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. 5/160 mg: To be given to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg monotherapy.
Children's dosage
The safety and efficacy of this medication in pediatric patients under 18 years have not been established, so it is not recommended for this age group.

Ingredients

Manufacturer
(주)한국팜비오

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This is for patients with essential hypertension. This medication is used when blood pressure is not sufficiently controlled with either amlodipine or valsartan alone. The combination of the two medications can lower blood pressure more effectively. Stabilizing blood pressure helps reduce the risk of cardiovascular diseases. This medication is used to improve blood pressure control to maintain a healthy lifestyle.

Dosage and Administration

Adult dosage

The recommended dose for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). 5/80 mg: To be given to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. 5/160 mg: To be given to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg monotherapy.

Children's dosage

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

Precautions

This medication can cause serious harm to the fetus and neonate if taken during the second and third trimesters of pregnancy, so it must be discontinued immediately if pregnancy is confirmed. This medication should not be taken by anyone who is allergic to any of its ingredients or similar medications, pregnant or breastfeeding women, and patients with severe kidney or liver disease. Patients with low sodium or fluid levels in their body should stabilize their condition before taking this medication and carefully monitor blood pressure and condition during treatment. Patients with high potassium levels or those taking medications that can raise potassium levels should have their potassium concentrations checked frequently. Patients with renal vascular issues or those who have recently undergone a kidney transplant require special caution as kidney function may worsen with this medication. This medication can cause angioedema, which results in swelling of the face, lips, tongue, etc., and if such symptoms appear, it should be discontinued immediately. Patients after heart failure or myocardial infarction should closely monitor kidney function and blood pressure when taking this medication, and those with severe heart failure require special attention. Patients with acute myocardial infarction or specific heart conditions such as aortic stenosis should take caution when using this medication. The risk of hypotension, hyperkalemia, and kidney function decline may increase when this medication is used with other antihypertensives or certain medications, so it should be discussed with a healthcare professional. Dizziness or fatigue may occur when driving or operating machinery, so caution is needed. Generally, normal doses are recommended for older adults, but those with weak kidney or liver function should take their condition into account. Overdosage may lead to severe hypotension or heart issues; immediate medical attention is required in such cases. The safety and efficacy of this medication in children under 18 years of age have not been sufficiently established, so it is not recommended for this age group. Pregnant women, women planning to become pregnant, or breastfeeding women are advised not to use this medication and should consult a healthcare professional before use.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, angioedema, severe skin adverse reactions, Stevens-Johnson syndrome, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), hepatitis, jaundice, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness,

Mild side effects

  • Pharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • postural dizziness
  • paresthesia
  • vertigo
  • tinnitus
Show 27 more
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • sore throat and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • fatigue
  • increased urination
  • polyuria
  • erectile dysfunction
  • edema
  • angioedema
  • facial swelling

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 closed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

14 tablets/PTPX2

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.