Medication info
Exrofine Tablet 5/160 mg

Exrofine Tablet 5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
Bright yellow egg-shaped film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2)
Approval status
Active

MFDS item code 201607206 · Approved 2016.12.21 · Insurance code 628800860

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 daily, taken with water regardless of meal times. It is recommended to take it at the same time every day (e.g., in the morning). The dosing may be adjusted based on blood pressure control according to the available strengths of 5/80 mg, 5/160 mg, and 10/160 mg. Patients with renal impairment should not be administered the drug if they have severe renal impairment or are on dialysis, and for liver impaired patients, the daily dose of valsartan should not exceed 80 mg.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, so the use of this drug is not recommended.

Ingredients

Manufacturer
(주)휴비스트제약

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 is not adequately controlled by single-agent treatment with amlodipine or valsartan. It effectively lowers blood pressure, reduces cardiovascular risk, and improves overall health. This treatment is suitable for individuals who have difficulty controlling their blood pressure and helps in continuous management. It is used for safely and effectively treating hypertension.

How to take

Adult dose

The recommended dosage of this medication is one tablet once daily, taken with water regardless of meal times. It is recommended to take it at the same time every day (e.g., in the morning). The dosing may be adjusted based on blood pressure control according to the available strengths of 5/80 mg, 5/160 mg, and 10/160 mg. Patients with renal impairment should not be administered the drug if they have severe renal impairment or are on dialysis, and for liver impaired patients, the daily dose of valsartan should not exceed 80 mg.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established, so the use of this drug is not recommended.

Precautions

This drug can cause serious harm to the fetus or newborn when taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the active ingredients or similar medications, pregnant or breastfeeding women, patients with severe kidney or liver disease, and patients with certain heart conditions should not take this medication. In patients with insufficient sodium or body fluids, hypotension may occur, so the state should be well-confirmed before taking it, and blood pressure and symptoms should be closely monitored during use. Patients with high potassium levels in the blood may have an increased risk of side effects when taking this medication with potassium-raising drugs, so regular blood tests are necessary. Patients with kidney vascular issues or those who have recently undergone kidney transplants, patients with a history of vascular edema, and patients after heart failure or myocardial infarction need special caution when taking this medication, and renal function and symptoms should be closely monitored as per the physician's instructions. During treatment with this medication, dizziness and fatigue may occur, so caution should be exercised when driving or operating machinery. Drug interactions can occur when taken with other antihypertensive or specific drugs, so all medications being taken should be fully disclosed and discussed with the physician or pharmacist. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women are also advised to avoid it. The safety and efficacy of this medication have not been sufficiently established in children under 18 years of age, so it is not recommended. In the event of an overdose, blood pressure may drop too low, so it is essential to adhere to the prescribed dose, and immediate consultation with healthcare professionals is required if any abnormal symptoms occur. Regular checks on blood pressure, renal function, and electrolyte levels during this medication course are important to identify any abnormalities.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/conjunctival mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, disorientation, visual abnormalities, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
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  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • fatigue
  • increased frequency of urination
  • polyuria
  • impotence
  • edema
  • ankle edema
  • facial swelling

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

Storage

This medication may be sensitive to air or moisture, so it should be kept in a tightly sealed container. It is important to maintain the storage temperature between 1 to 30 degrees Celsius in a cool and dry place. Proper storage will ensure the medication's effectiveness.

Appearance and packaging

Appearance

Bright yellow egg-shaped film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.