Medication info
Exkressesba Tablets 5/160/5 mg

Exkressesba Tablets 5/160/5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pale yellow-pink oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202106228 · Approved 2021.08.27 · Insurance code 649105380

Summary

Main use
(Hypertension, Dyslipidemia) Improvement and Reduction of Cardiovascular Disease Risk
Who takes it
Adults
Adult dose
Take 1 tablet once a day with water. It is recommended to take it at the same time every day (e.g., before breakfast). For the amlodipine/valsartan combination product, if blood pressure is not adequately controlled with monotherapy, it can be administered as follows: - 5/80 mg: administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 80 mg valsartan monotherapy. - 5/160 mg: administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 160 mg valsartan monotherapy.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Hypertension, Dyslipidemia) Improvement and Reduction of Cardiovascular Disease Risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is for patients who require treatment with a combination of amlodipine and valsartan for essential hypertension that cannot be adequately controlled, as well as those who need to treat hypercholesterolemia and dyslipidemia with rosuvastatin. Amlodipine/valsartan is effective for blood pressure control, and rosuvastatin lowers blood cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis, and reducing the risk of cardiovascular diseases, strokes, myocardial infarction, and revascularization procedures. In other words, this medication is used to aid in blood pressure management and the prevention of cardiovascular diseases in patients with both hypertension and dyslipidemia.

How to take

Adult dose

Take 1 tablet once a day with water. It is recommended to take it at the same time every day (e.g., before breakfast). For the amlodipine/valsartan combination product, if blood pressure is not adequately controlled with monotherapy, it can be administered as follows: - 5/80 mg: administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 80 mg valsartan monotherapy. - 5/160 mg: administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 160 mg valsartan monotherapy.

Precautions

This medication should not be used during pregnancy, particularly in the second and third trimesters, as it can cause serious harm to the fetus; it must be discontinued immediately upon confirmation of pregnancy. Do not use this medication in women who are allergic to any component or who have severe liver dysfunction, severe renal impairment, or are pregnant or breastfeeding. Patients with a deficiency of sodium or fluid in the body, patients with hyperkalemia, and those with vascular issues in the kidneys should use this medication with particular caution, requiring careful monitoring by a physician. In patients with heart conditions such as heart failure or post-myocardial infarction, as well as patients with aortic stenosis, this medication should also be used cautiously due to the risk of side effects such as hypotension and vascular edema. If unusual symptoms like muscle pain, muscle weakness, or sudden muscle pain occur during the course of this medication, consult a doctor immediately, and it is advisable to regularly undergo liver function tests and blood tests. Caution is needed when driving or operating machinery as dizziness or fatigue may occur, particularly when starting this medication or changing dosages. Interactions may occur with other medications, so inform your physician or pharmacist about all medications currently being taken, particularly if taking potassium-sparing diuretics, potassium supplements, certain antibiotics, immunosuppressants, or fibrate medications. Women who are pregnant or breastfeeding should not take this medication and should use appropriate contraceptive methods if they are planning to become pregnant. The use of this medication is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established. In elderly patients, bodily responses may be more sensitive, so it is advisable to start at a lower dosage and gradually adjust. In cases of overdose, serious hypotension, shock, and decreased heart function may occur, necessitating immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe edema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, decreased urine output

Mild side effects

  • Peripheral edema
  • heat sensation
  • increased ALT
  • increased AST
  • increased serum creatinine
  • flank pain
  • sore throat
  • dizziness
  • sensory reduction
  • rhinitis
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  • rash
  • nasopharyngitis
  • influenza
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • sensory abnormalities
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • erythema
  • sweating
  • itching

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

Storage

Store this medication in a tightly closed container to protect it from exposure to air and moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius (room temperature).

Appearance and packaging

Appearance

Pale yellow-pink oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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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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.