Medication info
Amvaltan Tablet 10/160 Milligrams

Amvaltan Tablet 10/160 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.87mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Bright yellow oblong film-coated tablets
Packaging
28 tablets/box [(14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 201401996 · Approved 2014.04.24 · Insurance code 650303150

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., morning). If blood pressure is not adequately controlled, dosages of 5/80 milligrams, 5/160 milligrams, or 10/160 milligrams of amlodipine and valsartan alone may be administered based on individual treatment regimens. Patients with renal impairment of mild to moderate degree do not require dosage adjustment.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established, and thus the administration of this drug is not recommended.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure control is insufficient with either amlodipine or valsartan alone. The two components work together to effectively lower blood pressure and help prevent complications caused by hypertension. Therefore, it is used for the treatment of patients who require appropriate blood pressure management.

How to take

Adult dose

The recommended dosage of this medication is one tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., morning). If blood pressure is not adequately controlled, dosages of 5/80 milligrams, 5/160 milligrams, or 10/160 milligrams of amlodipine and valsartan alone may be administered based on individual treatment regimens. Patients with renal impairment of mild to moderate degree do not require dosage adjustment.

Child dose

The safety and efficacy in pediatric patients under 18 years of age have not been established, and thus the administration of this drug is not recommended.

Precautions

This medication should not be taken during the 2nd and 3rd trimesters of pregnancy as it poses serious risks of harm or death to the fetus and newborns; it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the main components of this drug or similar substances, pregnant or breastfeeding women, and patients with severe kidney or liver dysfunction should not take this medication. Patients with low sodium or fluid levels in the body may experience hypotension, so their condition should be carefully checked before taking the drug, and blood pressure should be closely monitored during use. Patients with high potassium levels or those taking medications that may increase potassium levels should have their potassium levels tested frequently. Patients with kidney vascular issues or those who have received kidney transplants may experience impacts on kidney function when taking this drug, so careful monitoring is necessary. This drug can cause a serious side effect called angioedema; if symptoms such as swelling of the face, lips, or tongue occur, the drug should be stopped immediately. Patients with heart failure or those who have had a myocardial infarction may face risks of worsening kidney function or hypotension when taking this medication, so regular kidney function tests are needed. Patients with acute myocardial infarction or heart ailments such as aortic stenosis should be cautious when using this medication. Taking this drug in conjunction with other antihypertensives may increase the risk of hypotension, hyperkalemia, and kidney function deterioration, thus regular blood pressure and blood tests as per doctor's instructions are necessary. Caution should be taken when driving or operating machinery as dizziness or fatigue may occur. In cases of overdose, severe hypotension or shock may develop, requiring immediate emergency intervention. The usual dosage for the elderly is recommended as the same as that for adults, but if there are issues with liver or kidney function, this should be discussed with a doctor. Women who are pregnant or planning to become pregnant should not use this medication, and breastfeeding women should also avoid it if possible. The safety and efficacy in children have not been sufficiently established, so its use is not recommended.

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 high fever, blisters, skin peeling, pain in oral/eye mucosa, dyspnea or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensation disorders
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
Show 28 more
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • anasarca
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness

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

Storage

This medicine should be stored in a tightly sealed container to prevent air and moisture from entering. The storage temperature is recommended to be maintained between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow oblong film-coated tablets

Package unit

28 tablets/box [(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

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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.