Medication info
Orosartan Tablet 10/160 mg

Orosartan Tablet 10/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Orotate›13.82mg / 1 tablet
Manufacturer / importer
동아에스티(주)
Appearance
Bright yellow oval film-coated tablets
Packaging
30 tablets/PTP, 300 tablets/bottle
Approval status
Active

MFDS item code 201308524 · Approved 2013.07.30 · Insurance code 642506970

Summary

Main use
Improves blood pressure control in essential hypertension by combining amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is one tablet once a day, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). When blood pressure is not adequately controlled with monotherapy with amlodipine or valsartan, the following dosing is suggested: - 5/80 mg: administered to patients whose blood pressure is not controlled with either amlodipine 5 mg or valsartan 80 mg monotherapy.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration of this medication is not recommended.

Ingredients

Manufacturer
동아에스티(주)

Efficacy & effects

Improves blood pressure control in essential hypertension by combining amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with amlodipine or valsartan. It effectively lowers blood pressure and helps reduce the risk of cardiovascular diseases. This treatment is suitable for patients who have difficulty managing their blood pressure and contributes to maintaining health by improving blood pressure control.

How to take

Adult dose

The recommended dose of this medication is one tablet once a day, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). When blood pressure is not adequately controlled with monotherapy with amlodipine or valsartan, the following dosing is suggested: - 5/80 mg: administered to patients whose blood pressure is not controlled with either amlodipine 5 mg or valsartan 80 mg monotherapy.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration 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 in people with an allergy to the active ingredients or dihydropyridine derivatives, women who are pregnant or breastfeeding, or patients with severe renal or liver dysfunction. Patients with a deficiency of sodium or body fluids may experience hypotension, so it is important to verify the condition before taking this medication and to take appropriate action immediately if symptoms of hypotension occur during treatment. Patients with high potassium levels should be cautious when taking this medication along with potassium supplements or other drugs that can increase potassium, and they should regularly monitor blood potassium levels. Patients with vascular problems in the kidneys or kidney transplant patients should be cautious when taking this medication as it may worsen kidney function. If symptoms of angioedema occur, treatment should be discontinued immediately and should not be resumed. Patients with heart failure or myocardial infarction should closely monitor kidney function and blood pressure changes when taking this medication. This medication has not been proven safe and effective for children, and is not recommended for this population. Older adults may take the same dosage as the general adult population, but should consult a physician if any unusual symptoms occur during treatment. Caution should be exercised when driving or operating machinery as dizziness or fatigue may occur. In cases of overdose, severe hypotension or arrhythmias may occur, so it is important to avoid exceeding the recommended dosage. This medication may interact with other antihypertensives, diuretics, potassium supplements, certain anti-inflammatory drugs, and lithium preparations; therefore, it is essential to inform the physician or pharmacist about any concurrent medications. Women planning to become pregnant should consult with healthcare professionals before taking this medication and should avoid it during pregnancy. Women who are breastfeeding should avoid this medication, and should consult healthcare professionals if unavoidable.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied by respiratory abnormalities, jaundice (yellowing of the skin or eyes), extreme fatigue, liver abnormalities (jaundice), sudden and severe headache, lightning-like pain

Mild side effects

  • Pharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • abnormal sensations
  • 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
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advised to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablets

Package unit

30 tablets/PTP, 300 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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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.