Medication info
Covalset Tablets 80/12.5 mg

Covalset Tablets 80/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201904738 · Approved 2019.07.16 · Insurance code 057600090

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults
Adult dose
The recommended adult dosage is 80 mg of valsartan and 12.5 mg of hydrochlorothiazide, taken once daily as one tablet with a small amount of water, irrespective of meals. The dosage of valsartan 160 mg and hydrochlorothiazide 12.5 mg applies when prescribed for blood pressure reduction. In patients with mild to moderate renal impairment, dose adjustment is not necessary. For patients with liver impairment who do not have cholestasis,

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for additional blood pressure control in patients with essential hypertension who do not achieve sufficient control with monotherapy.

How to take

Adult dose

The recommended adult dosage is 80 mg of valsartan and 12.5 mg of hydrochlorothiazide, taken once daily as one tablet with a small amount of water, irrespective of meals. The dosage of valsartan 160 mg and hydrochlorothiazide 12.5 mg applies when prescribed for blood pressure reduction. In patients with mild to moderate renal impairment, dose adjustment is not necessary. For patients with liver impairment who do not have cholestasis,

Precautions

This medication may cause serious harm to the fetus if taken during pregnancy, particularly in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the ingredients of this medication or sulfonamide drugs should not use it. It should not be administered to patients with severely impaired liver or kidney function, certain liver diseases, or very poor kidney function. Patients with a history of angioedema or those who have previously experienced angioedema after taking ACE inhibitors or angiotensin II receptor antagonists should also avoid this medication. Patients with electrolyte imbalances, fluid depletion, renal or hepatic dysfunction, acute angle-closure glaucoma, cerebrovascular disease, elderly patients, and those with heart failure should use this medication cautiously. In particular, this medication can cause or worsen electrolyte abnormalities such as hypokalemia, hyponatremia, hypercalcemia, and hyperuricemia, so regular blood tests are necessary. Dizziness or drowsiness may occur during the use of this medication, so caution is advised when driving or operating machinery. Potassium supplements or potassium-containing foods should not be taken without consulting a physician, and care should be taken, especially in cases of dehydration, excessive sweating, diarrhea, or vomiting, as blood pressure may drop excessively. Additionally, this medication may interact with other blood pressure medications, diuretics, lithium preparations, NSAIDs, etc., so it is essential to discuss any other medications being taken with a physician or pharmacist. The hydrochlorothiazide component may increase sensitivity to sunlight, raising the risk of skin cancer, so limiting sun exposure and taking protective measures is important. The safety and efficacy of this medication in pediatric patients have not been established, and it can be used in elderly patients without special dose adjustment but with caution. In case of overdose, symptoms such as hypotension, arrhythmia, and electrolyte disturbances may arise, necessitating immediate medical attention and appropriate treatment. Store this medication out of reach of children, keep it away from moisture, and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, symptoms of anaphylaxis, angioedema, hepatitis, renal failure, hyperkalemia, hyponatremia, shock, syncope, loss of consciousness, agranulocytosis, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia, necrotizing vasculitis, toxic epidermal necrolysis (Stevens-Johnson syndrome), interstitial pneumonia, pulmonary edema, exacerbation of systemic lupus erythematosus, hypoglycemia, rhabdomyolysis, angioedema,

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • fatigue
  • back pain
  • cough
  • upper respiratory infection
  • diarrhea
  • joint pain
  • abdominal pain
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  • epigastric pain
  • blurred vision
  • visual abnormalities
  • anxiety
  • arthritis
  • bronchitis
  • acute bronchitis
  • chest pain
  • orthostatic dizziness
  • dry mouth
  • dyspepsia
  • erectile dysfunction
  • gastroenteritis
  • sweating
  • sensory disturbance
  • insomnia
  • hypokalemia
  • hypotension
  • influenza
  • muscle cramps
  • muscle strain
  • nausea
  • nasal congestion
  • nasal bleeding
  • throat pain
  • otitis media

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature below 30 degrees Celsius. This will help preserve the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

Pink oval film-coated tablet

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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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.