Medication info
Sevitension Tablets 5/40 mg

Sevitension Tablets 5/40 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pale yellow round film-coated tablets
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201500327 · Approved 2015.01.21 · Insurance code 678600330

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication should be taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosage is as follows: - 5/20 mg: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Administer to patients whose blood pressure is not adequately controlled on olmesartan medoxomil 20 mg monotherapy.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Amlodipine or Olmesartan Medoxomil are medications used to treat essential hypertension. These medications are helpful in effectively lowering blood pressure when monotherapy does not sufficiently control blood pressure. If blood pressure is not properly managed, the risk of serious complications such as heart disease or stroke increases, making the use of these medications important for reducing risks and improving health. Amlodipine primarily lowers blood pressure by dilating blood vessels, while Olmesartan Medoxomil inhibits the action of angiotensin II, which causes an increase in blood pressure. These two medications are used effectively to control hypertension, either alone or in combination. Therefore, these medications improve blood pressure control in the treatment of essential hypertension.

How to take

Adult dose

This medication should be taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosage is as follows: - 5/20 mg: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: Administer to patients whose blood pressure is not adequately controlled on olmesartan medoxomil 20 mg monotherapy.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during pregnancy in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used in patients with known allergy to any of its components, severe liver impairment, aortic stenosis, biliary obstruction, those undergoing renal dialysis, in patients in shock, or certain diabetic patients. Patients with hypotension due to deficiency in fluid or sodium may experience hypotensive symptoms upon initial administration; thus, they should be carefully monitored and treated as needed if hypotension occurs. Due to the presence of components that dilate blood vessels, it should be administered with caution to patients with acute hypotension or cardiovascular diseases. Caution is required in patients with heart failure and renal function should be closely monitored in patients with impaired kidney function. The metabolism and elimination of this medication may be delayed in patients with impaired liver function, so dosage adjustments may be necessary. While taking this medication, adverse reactions such as dizziness, headache, hypotension, edema, dyspepsia, skin rash, etc. may occur, and if symptoms are severe, consultation with a doctor is advised. This medication may interact with other antihypertensive drugs, diuretics, potassium-sparing agents, etc., so if other medications are being taken, this must be disclosed. Women who are pregnant or planning to become pregnant should consult a doctor to explore safe alternative treatments, and caution is advised for breastfeeding women as this medication may affect the baby. This medication is not recommended for children under 18 years as safety and efficacy have not been established. Elderly patients should start with a low dose considering possible declines in liver, kidney, or heart function and accompanying diseases. In cases of overdose, severe hypotension and tachycardia may occur, requiring immediate medical treatment. This medication should be stored in a tightly sealed container, protected from moisture and heat, and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), serious allergic reactions, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice).

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • sensory disturbances
  • decreased libido
  • vascular dilation
  • palpitations
  • hypotension
  • orthostatic hypotension
  • cough
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  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • skin rash
  • muscle tension
  • limb pain
  • low back pain
  • increased urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • dependent edema
  • fatigue
  • asthenia
  • facial swelling
  • decreased blood potassium levels
  • increased blood creatinine levels
  • increased blood uric acid levels
  • increased gamma-glutamyl transferase.

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is recommended to keep it at room temperature, between 1 and 30 degrees Celsius, avoiding excessive heat or cold.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTP 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.