Medication info
Humetec Tablets 20 mg (Olmesartan Medoxomil)

Humetec Tablets 20 mg (Olmesartan Medoxomil)

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201100896 · Approved 2011.02.24 · Insurance code 649101960

Summary

Main use
Improvement of essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended initial dose for adults is 10 mg once daily, regardless of meals. If blood pressure is not adequately controlled at this dose, it may be increased to 20 mg once daily, with a maximum of 40 mg per day. Blood pressure-lowering effects typically appear within 2 weeks of treatment initiation, with maximum effects occurring around 8 weeks. If blood pressure remains uncontrolled, it may be combined with a thiazide diuretic. For better adherence, it is recommended to take the medication at the same time each day (e.g., in the morning). In patients who may have reduced effective blood volume (e.g., those taking diuretics, especially with kidney impairment), observe carefully and consider starting treatment at a lower dose. <Elderly> No dose adjustment is necessary for patients aged 65 and older. Overall, no significant differences have been observed between elderly and younger patients regarding efficacy and safety, though heightened sensitivity may not be ruled out in some elderly individuals. <Renal impairment patients> For patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min), the maximum dosage is 20 mg once daily. <Liver impairment patients> Mild liver impairment does not require dose adjustment. For moderate liver impairment, the recommended initial dose is 10 mg once daily, with a maximum increase to 20 mg per day. There is no experience with severe liver impairment, and the use of this medication is not recommended. <Children> Safety and efficacy in children have not been established.
Child dose
The safety and efficacy in children have not been established.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of essential hypertension

  • Essential hypertension
View approved original text

Essential hypertension is high blood pressure that occurs without a specific cause; this medication lowers blood pressure, protecting heart and vascular health while helping to prevent complications. Regular intake contributes to stable blood pressure control. Therefore, it is used for the treatment of essential hypertension.

How to take

Adult dose

The recommended initial dose for adults is 10 mg once daily, regardless of meals. If blood pressure is not adequately controlled at this dose, it may be increased to 20 mg once daily, with a maximum of 40 mg per day. Blood pressure-lowering effects typically appear within 2 weeks of treatment initiation, with maximum effects occurring around 8 weeks. If blood pressure remains uncontrolled, it may be combined with a thiazide diuretic. For better adherence, it is recommended to take the medication at the same time each day (e.g., in the morning). In patients who may have reduced effective blood volume (e.g., those taking diuretics, especially with kidney impairment), observe carefully and consider starting treatment at a lower dose. <Elderly> No dose adjustment is necessary for patients aged 65 and older. Overall, no significant differences have been observed between elderly and younger patients regarding efficacy and safety, though heightened sensitivity may not be ruled out in some elderly individuals. <Renal impairment patients> For patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min), the maximum dosage is 20 mg once daily. <Liver impairment patients> Mild liver impairment does not require dose adjustment. For moderate liver impairment, the recommended initial dose is 10 mg once daily, with a maximum increase to 20 mg per day. There is no experience with severe liver impairment, and the use of this medication is not recommended. <Children> Safety and efficacy in children have not been established.

Child dose

The safety and efficacy in children have not been established.

Precautions

This medication can cause serious harm or even death to the fetus or newborn if taken during the second or third trimester of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Do not take this medication if you are allergic to any of the ingredients, pregnant or breastfeeding, undergoing renal dialysis, have severe liver disorders, have bile duct obstruction, or have genetic issues such as lactose intolerance. Be cautious if you have low blood volume or salt levels before taking this medication, as low blood pressure may occur; immediate appropriate actions must be taken if low blood pressure develops. Patients with impaired kidney function or those who have received a kidney transplant should regularly check potassium levels and kidney function indicators. Severe renal impairment is not advised for use of this medication. Patients with specific heart diseases or those at risk of hyperkalemia should regularly monitor serum potassium levels while on this medication. This medication may cause dizziness; caution is required when operating hazardous machinery or driving. If gastrointestinal symptoms such as chronic diarrhea or weight loss occur while taking this medication, consult a physician immediately. If symptoms of intestinal vascular edema appear, discontinue use and seek appropriate treatment. Caution is advised when taken with potassium-sparing diuretics or potassium supplements as it may dangerously elevate blood potassium levels, as well as with lithium or non-steroidal anti-inflammatory drugs. Taking this medication during pregnancy may lead to serious adverse effects in the fetus, such as low blood pressure, renal function impairment, and skull development issues; thus, it should be discontinued immediately upon confirmation of pregnancy. Breastfeeding may allow this medication to pass into breast milk, potentially causing adverse reactions in infants; therefore, it is recommended to either discontinue breastfeeding or stop taking the medication. The safety and efficacy of this medication in children have not been sufficiently established, so it should be administered cautiously to children. In elderly patients, the concentration of this medication may increase in the body, requiring caution during use. Overdosage may result in symptoms such as low blood pressure and palpitations, and appropriate treatment should be received if necessary. It has been reported that the risk of carcinogenicity or genotoxicity is low even with long-term administration of this medication; however, any adverse reactions should be reported to a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, intestinal vascular edema, rhabdomyolysis, hyperkalemia, acute renal failure, elevated serum creatinine, abnormal liver function tests (increased transaminases or total bilirubin), autoimmune hepatitis, asthma

Mild side effects

  • Dizziness
  • headache
  • palpitations
  • back pain
  • bronchitis
  • increased creatine phosphokinase
  • diarrhea
  • hematuria
  • hyperglycemia
  • hypertriglyceridemia
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  • influenza-like symptoms
  • pharyngitis
  • rhinitis
  • sinusitis
  • abdominal pain
  • dyspepsia
  • gastritis
  • nausea
  • rash
  • hypercholesterolemia
  • hyperlipidemia
  • hyperuricemia
  • arthralgia
  • arthritis
  • myalgia
  • hair loss
  • itching
  • cough
  • epistaxis
  • upper respiratory infection
  • increased blood pressure
  • facial swelling
  • peripheral 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 advisable to maintain a storage temperature between 1 degree to 25 degrees Celsius. Proper storage facilitates the maintenance of the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

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

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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.