Medication info
Orosartan 5/160mg Tablets

Orosartan 5/160mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Orotate›6.91mg / 1 tablet
Manufacturer / importer
동아에스티(주)
Appearance
Dark yellow oval film-coated tablets
Packaging
30 tablets/PTP, 300 tablets/bottle
Approval status
Active

MFDS item code 201308526 · Approved 2013.07.30 · Insurance code 642506980

Summary

Main use
Improved blood pressure control in essential hypertension through combination therapy of amlodipine or valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients whose blood pressure is not adequately controlled with monotherapy at doses of 5/80mg, 5/160mg, or 10/160mg. In patients with mild to moderate renal impairment, dose adjustment is not necessary, but in severe cases, further evaluation is required.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Ingredients

Manufacturer
동아에스티(주)

Efficacy & effects

Improved blood pressure control in essential hypertension through combination therapy of amlodipine or valsartan

  • Essential hypertension
View approved original text

This drug is used to control blood pressure in patients with essential hypertension who are not adequately controlled with either amlodipine or valsartan alone.

How to take

Adult dose

The recommended dose for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). For patients whose blood pressure is not adequately controlled with monotherapy at doses of 5/80mg, 5/160mg, or 10/160mg. In patients with mild to moderate renal impairment, dose adjustment is not necessary, but in severe cases, further evaluation is required.

Child dose

The safety and efficacy in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn if used during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with an allergy to any of the major ingredients of this medication, in pregnant or breastfeeding women, or in patients with severe kidney or liver disorders. Patients with low sodium or fluid levels in the body should manage their condition before taking this medication, and should monitor blood pressure and their condition carefully while taking it. Patients with hyperkalemia should have their potassium levels frequently checked when taking this medication together with potassium supplements, as potassium levels can become dangerously high. Patients with renal vascular issues or those who have had a kidney transplant should also monitor kidney function closely when taking this medication. This medication may cause an allergic reaction known as angioedema, so if there are symptoms of swelling in the face, lips, or tongue, they should stop taking it immediately. Patients after heart failure or myocardial infarction should frequently check kidney function and blood pressure when taking this medication and be alert to the possibility of side effects, such as pulmonary edema. This medication can interact with other blood pressure medications, diuretics, potassium-sparing agents, and non-steroidal anti-inflammatory drugs (NSAIDs), so it is essential to inform healthcare providers of any other medications being taken. Caution is needed as dizziness or fatigue may occur when driving or operating machinery. In cases of overdose, severe hypotension or reflex tachycardia may occur, requiring immediate medical intervention. It can be safely used in the elderly at standard dosing, but caution is advised based on their physical condition. Safety and efficacy in pediatric patients have not been sufficiently established, and its use is not recommended. It is important to regularly monitor blood pressure, kidney function, and potassium levels during treatment with this medication to ensure there are no abnormalities.

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 high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Rhinitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • postural dizziness
  • paresthesia
  • vertigo
  • tinnitus
Show 27 more
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low 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 should be stored in a tightly sealed container to protect it from air and moisture, and should be kept at a temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy.

Appearance and packaging

Appearance

Dark 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.