Medication info
Exivitan Tablet 5/80 mg

Exivitan Tablet 5/80 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
케이엠에스제약(주)
Appearance
Dark yellow round film-coated tablet
Packaging
14 tablets/Alu-Alu [28 tablets (14 tablets/Alu-Alu x 2)]
Approval status
Active

MFDS item code 201403319 · Approved 2014.07.23 · Insurance code 654701520

Summary

Main use
Improves blood pressure control in essential hypertension with the combination of amlodipine and valsartan.
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 advisable to take it at the same time each day (e.g., in the morning). In patients with mild to moderate renal impairment, dose adjustment is not necessary, but in severe renal impairment and dialysis patients, this medication should not be administered. In patients with mild to moderate hepatic impairment, the daily dosage of valsartan should not exceed 80 mg.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, the use of this medication is not recommended.

Ingredients

Manufacturer
케이엠에스제약(주)

Efficacy & effects

Improves blood pressure control in essential hypertension with the combination of amlodipine and valsartan.

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension who do not achieve adequate blood pressure control with monotherapy of either amlodipine or valsartan.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). In patients with mild to moderate renal impairment, dose adjustment is not necessary, but in severe renal impairment and dialysis patients, this medication should not be administered. In patients with mild to moderate hepatic impairment, the daily dosage of valsartan should not exceed 80 mg.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, the use 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 it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used by individuals with allergies to the active ingredients or similar substances, women who are pregnant or may become pregnant, nursing mothers, individuals with severe renal or hepatic impairment, or those with specific heart conditions. Patients with low body sodium or fluid may experience hypotension, so it's important to assess their condition before administering and monitor blood pressure closely during treatment. Patients with high potassium levels or who are taking medications that increase potassium levels should have their potassium levels monitored frequently. Patients with renal vascular issues or those who have received a kidney transplant should use this medication cautiously due to the risk of worsening renal function. Angioedema may occur, so if swelling of the face or neck or difficulty breathing arises, discontinue use immediately and consult a healthcare professional. Patients with heart failure or post-myocardial infarction should have their renal function regularly checked during treatment with this medication and should be aware of the possibility of worsening heart failure or pulmonary edema. This medication may cause dizziness or fatigue while driving or operating machinery, so caution is required. There may be interactions with other medications, so it is important to inform the physician or pharmacist of any other medications currently being taken. Women who are pregnant or planning to become pregnant should not take this medication, and it is not recommended for nursing mothers. Safety and efficacy in children under 18 years of age have not been fully established, so use is not recommended. Elderly patients can be given the same dosage as general adults, but caution may be necessary depending on the individual condition. In case of overdose, severe hypotension or heart problems may occur, so immediate medical attention should be sought.

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, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine changes.

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
Show 27 more
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • oropharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • pruritus
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • peripheral 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 must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. This will help to safely preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

14 tablets/Alu-Alu [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.