Medication info

Valsartan Hydrochlorothiazide Plus Tablet 160/12.5 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Valsartan›Strength being verifiedHydrochlorothiazide›Strength being verified
Manufacturer / importer
한림제약(주)
Appearance
Opaque red oval film-coated tablet
Packaging
98 tablets (14 tablets/PTP packed x 7), 30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201105613 · Approved 2011.08.25

This product's status changed to Approval withdrawn on 2023.07.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who uses it
Adults
Adult dosage
Take 1 tablet of Valsartan 80 mg/Hydrochlorothiazide 12.5 mg once daily with a small amount of water, regardless of meals. Valsartan 160 mg/Hydrochlorothiazide 12.5 mg applies when prescribed for blood pressure lowering. Dose adjustment is not necessary for patients with mild to moderate renal impairment. Patients with mild to moderate hepatic impairment should not use more than 80 mg of Valsartan per day.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy. In other words, it helps with additional blood pressure control when blood pressure does not reduce sufficiently with existing treatments. This aids in more effective blood pressure management.

Dosage and Administration

Adult dosage

Take 1 tablet of Valsartan 80 mg/Hydrochlorothiazide 12.5 mg once daily with a small amount of water, regardless of meals. Valsartan 160 mg/Hydrochlorothiazide 12.5 mg applies when prescribed for blood pressure lowering. Dose adjustment is not necessary for patients with mild to moderate renal impairment. Patients with mild to moderate hepatic impairment should not use more than 80 mg of Valsartan per day.

Precautions

This medication can cause serious harm to the fetus during pregnancy, particularly in the second and third trimesters, so it should be stopped immediately upon confirmation of pregnancy. This medication or its ingredients should not be used if there is an allergy to it or sulfonamide medications, or if pregnant. Patients with severe liver or kidney dysfunction, certain liver diseases, and specific electrolyte imbalances should not take this medication. Elderly patients, heart failure patients, diabetic patients, and patients with kidney impairment should use this medication cautiously, and regular blood tests and kidney function tests are required. This medication can cause a variety of side effects, including hypotension, dizziness, electrolyte imbalance, skin rash, angioedema, liver dysfunction, kidney failure, and blood abnormalities, so any abnormal symptoms should be discussed with a doctor immediately. Particularly, dizziness or drowsiness may occur, so caution is needed when driving or operating machinery. Do not take potassium supplements or potassium-containing foods without consulting a doctor, and electrolyte levels should be monitored regularly. There are many interactions with other medications, so if you are currently taking other medications, it is essential to inform your doctor or pharmacist. This medication can react sensitively to sunlight, increasing the risk of skin cancer, thus it is advisable to avoid sun exposure and take protective measures. It is preferable not to use this medication for children, pregnant women, or nursing mothers as its safety has not been established. In case of overdose, symptoms of hypotension, electrolyte abnormalities, or worsening kidney function may occur, necessitating immediate medical attention. This medication should be stored in a tightly closed container, protected from moisture and direct sunlight, and kept out of reach of children, preferably in its original container.

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, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Headache
  • dizziness
  • rhinitis
  • fatigue
  • back pain
  • cough
  • upper respiratory infection
  • diarrhea
  • joint pain
  • abdominal pain
Show 26 more
  • epigastric pain
  • blurred vision
  • visual disturbances
  • anxiety
  • arthritis
  • bronchitis
  • acute bronchitis
  • chest pain
  • orthostatic dizziness
  • dry mouth
  • indigestion
  • erectile dysfunction
  • enteritis
  • hyperhidrosis
  • sensory impairment
  • insomnia
  • hypokalemia
  • hypotension
  • influenza
  • muscle cramps
  • myalgia
  • nausea
  • nasal congestion
  • nasal bleeding
  • throat pain
  • otitis media

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to keep it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Opaque red oval film-coated tablet

Package unit

98 tablets (14 tablets/PTP packed x 7), 30 tablets/bottle, 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.