Medication info
Amvaltan Tablet 5/80 mg

Amvaltan Tablet 5/80 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Bright yellow round film-coated tablet
Packaging
28 tablets/box [(14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 201308553 · Approved 2013.07.31 · Insurance code 650303030

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for adults is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time daily (e.g., in the morning). 5/80 mg: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5 mg or valsartan 80 mg monotherapy. 5/160 mg: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5 mg or valsartan 160 mg monotherapy.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine alone or valsartan alone. It helps to effectively lower blood pressure and reduce the risk of cardiovascular diseases.

How to take

Adult dose

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

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. Individuals with allergies to any of the active ingredients or similar components, pregnant or potentially pregnant women, nursing mothers, and patients with severe renal or hepatic dysfunction should not take this medication. Patients with insufficient sodium or fluid levels in the body should correct their condition before taking this medication, and if symptoms of hypotension occur during treatment, they should be laid down immediately and receive fluid therapy if necessary. Patients with high potassium levels should frequently monitor their potassium levels when using this medication alongside potassium-containing drugs or supplements. Patients with renal vascular issues or those who have recently undergone kidney transplantation should take this medication with caution and discontinue it immediately if symptoms of angioedema occur. Patients with heart failure or myocardial infarction should periodically check their renal function and blood pressure while taking this medication, as some heart failure patients may have an increased risk of pulmonary edema. This medication may cause dizziness or fatigue when driving or operating machinery, so caution is advised. In cases of overdose, severe hypotension or shock may occur, so if the dosage is exceeded, medical personnel should be notified immediately for appropriate treatment. This medication may interact with other antihypertensive drugs, diuretics, potassium-sparing agents, non-steroidal anti-inflammatory drugs, etc., so it is essential to inform the doctor or pharmacist about all other medications being taken. For the elderly, a dose similar to that of the general adult population is recommended, but care should be taken by considering their renal or liver function status. The safety and efficacy of this medication have not been established for pediatric patients under 18 years of age and therefore is not recommended for use in this population. If any abnormal symptoms or side effects occur during treatment, immediate consultation with medical personnel is necessary, especially if symptoms such as angioedema, severe dizziness, or difficulty breathing occur, as prompt action is required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory disturbances accompanied by cough and fever, jaundice (yellowing of the skin or eyes), generalized malaise, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination difficulties.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • localized edema
  • facial swelling
  • peripheral edema
  • tiredness
  • flushing
  • weakness
  • facial flushing
  • nasal congestion.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for an extended period.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

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.