Medication info

Widprazole 5/160 mg

Prescription medicationExpired
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
Dark yellow oval film-coated tablets
Packaging
28 tablets (14 tablets/Alu-Alu X 2)
Approval status
Expired

MFDS item code 201802019 · Approved 2018.05.11

This product's status changed to Expired on 2023.05.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control in essential hypertension through the combination of amlodipine and valsartan
Who uses it
Adults · Children
Adult dosage
The recommended dose of this medication is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosing should be adjusted according to blood pressure control status for the 5/80 mg, 5/160 mg, and 10/160 mg formulations. For patients with renal impairment (mild to moderate) or hepatic impairment (mild to moderate), dose adjustment and monitoring are recommended; severe cases should not use
Children's dosage
The safety and efficacy of this medication in pediatric patients under the age of 18 have not been established, and its use is not recommended.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension through the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication can be used together in patients with essential hypertension for whom blood pressure control is insufficient with monotherapy with either amlodipine or valsartan, allowing for more effective management of blood pressure. This drug helps to dilate blood vessels and lower blood pressure, reducing the risk of cardiovascular diseases. By maintaining stable blood pressure control, it contributes to the prevention of complications and overall health improvement. Therefore, this medication is used to improve blood pressure control in these situations.

Dosage and Administration

Adult dosage

The recommended dose of this medication is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Dosing should be adjusted according to blood pressure control status for the 5/80 mg, 5/160 mg, and 10/160 mg formulations. For patients with renal impairment (mild to moderate) or hepatic impairment (mild to moderate), dose adjustment and monitoring are recommended; severe cases should not use

Children's dosage

The safety and efficacy of this medication in pediatric patients under the age of 18 have not been established, and its use 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. Patients allergic to this medication, those who are pregnant or breastfeeding, patients with severe kidney or liver disease, or certain heart conditions should not take this medication. Patients who are deficient in body sodium or fluids should correct their condition before taking this medication, and during treatment, they should carefully monitor changes in blood pressure. Patients with high potassium levels or those taking medications that can raise potassium levels should frequently check their potassium levels. Patients with renal vascular issues should take this medication cautiously as there is a risk of worsening kidney function, following a doctor's guidance. There is a lack of safety information regarding recent kidney transplant patients, requiring caution in their use. If swelling of the face, lips, tongue, or similar occurs while taking this medication, it should be discontinued immediately and a visit to the hospital is necessary. Patients with heart failure or those post-myocardial infarction should regularly check kidney function and blood pressure while taking this medication, as there is a risk of worsening heart failure. In patients with acute myocardial infarction, symptoms of angina or myocardial infarction may worsen upon starting this medication or increasing the dose. Patients with aortic stenosis, mitral stenosis, or obstructive hypertrophic cardiomyopathy should take this medication with special care. This medication should not be used in combination with other renin-angiotensin-aldosterone system drugs as it increases the risk of hypotension, hyperkalemia, and worsening kidney function. Care should be taken when driving or operating machinery as dizziness or fatigue may occur. In case of overdose, severe hypotension or cardiovascular abnormalities may occur; thus, medical attention should be sought immediately if symptoms arise. Regular monitoring of blood pressure, kidney function, and electrolyte levels is important during treatment to detect abnormalities early.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, airway obstruction and/or swelling of the face, lips, and tongue, vasculitis, syncope, severe allergic reactions, Stevens-Johnson syndrome, jaundice, hepatitis, acute renal failure, renal impairment and renal injury, markedly decreased urine output, severe generalized edema with accompanying hypertension, severe dermatological reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, myocardial infarction, myocardial infarction, heart failure.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory abnormalities
  • light-headedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • hyperhidrosis
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • pedal edema
  • facial edema
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • anxiety

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and should be kept at room temperature between 1 to 30 degrees Celsius for safety. Proper storage will help maintain the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablets

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.