Medication info
Selprobell Plus Tablet 300/12.5 mg

Selprobell Plus Tablet 300/12.5 mg

Prescription medicationTablet
Ingredient · strength
Irbesartan›300mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink, biconvex, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707499 · Approved 2017.10.18 · Insurance code 693902720

Summary

Main use
Improvement in blood pressure control and treatment goal achievement in essential hypertension
Who uses it
Adults · Children
Adult dosage
This medication is administered once daily regardless of meals. 1. For patients whose blood pressure is not adequately controlled with monotherapy - Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg: 1 tablet once daily - Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg: 1 tablet once daily - Irbesartan 300 mg/Hydrochlorothiazide 25 mg: 1 tablet once daily. Doses exceeding Irbesartan 300 mg/Hydrochlorothiazide 25 mg are not recommended. If necessary, this medication may be administered in combination with other antihypertensives. 2. For initial therapy in patients with moderate to severe hypertension (stage 2), individualization should take into account baseline blood pressure, target treatment blood pressure, and the expected degree of increased achievement of treatment goals compared to monotherapy. Typically, therapy starts with Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily, and if blood pressure control is needed, it may be increased to a maximum of Irbesartan 300 mg/Hydrochlorothiazide 25 mg after 1 to 2 weeks. It is not recommended to initiate this medication in patients with intravascular volume depletion. In patients with renal impairment, due to the hydrochlorothiazide component, this medication is not recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). Loop diuretics are preferred for these patient groups. For patients with creatinine clearance ≥ 30 mL/min, dosage adjustment is not necessary. In patients with fluid volume depletion, sodium and/or fluids should be appropriately balanced before administration of this medication. In patients with hepatic impairment, this medication is not used in severe liver disease. Thiazide medications should be used with caution in patients with liver disease. For patients with mild to moderate liver impairment, dosage adjustment is not necessary. Elderly patients do not require dosage adjustment. In children, the safety and efficacy of this medication have not been established in those under 18 years of age.
Children's dosage
The safety and efficacy of this medication in children and adolescents under 18 years of age have not been established.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement in blood pressure control and treatment goal achievement in essential hypertension

  • Essential hypertension
  • moderate hypertension
  • severe hypertension
View approved original text

This medication is used to control blood pressure in patients with essential hypertension. It is effective in cases where blood pressure is not adequately controlled by monotherapy, and it may be used as initial treatment in moderate to severe hypertensive patients (stage 2) in conjunction with combination therapy to reach target blood pressure. Therefore, it is used to improve blood pressure control and management in essential hypertension.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. 1. For patients whose blood pressure is not adequately controlled with monotherapy - Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg: 1 tablet once daily - Irbesartan 300 mg/Hydrochlorothiazide 12.5 mg: 1 tablet once daily - Irbesartan 300 mg/Hydrochlorothiazide 25 mg: 1 tablet once daily. Doses exceeding Irbesartan 300 mg/Hydrochlorothiazide 25 mg are not recommended. If necessary, this medication may be administered in combination with other antihypertensives. 2. For initial therapy in patients with moderate to severe hypertension (stage 2), individualization should take into account baseline blood pressure, target treatment blood pressure, and the expected degree of increased achievement of treatment goals compared to monotherapy. Typically, therapy starts with Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg once daily, and if blood pressure control is needed, it may be increased to a maximum of Irbesartan 300 mg/Hydrochlorothiazide 25 mg after 1 to 2 weeks. It is not recommended to initiate this medication in patients with intravascular volume depletion. In patients with renal impairment, due to the hydrochlorothiazide component, this medication is not recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). Loop diuretics are preferred for these patient groups. For patients with creatinine clearance ≥ 30 mL/min, dosage adjustment is not necessary. In patients with fluid volume depletion, sodium and/or fluids should be appropriately balanced before administration of this medication. In patients with hepatic impairment, this medication is not used in severe liver disease. Thiazide medications should be used with caution in patients with liver disease. For patients with mild to moderate liver impairment, dosage adjustment is not necessary. Elderly patients do not require dosage adjustment. In children, the safety and efficacy of this medication have not been established in those under 18 years of age.

Children's dosage

The safety and efficacy of this medication in children and adolescents under 18 years of age have not been established.

Precautions

This medication can cause serious harm to the fetus during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Additionally, patients who are allergic to this medication or its ingredients, or those with severely impaired kidney function, or anuria should not take this medication. Patients with hypotension, renal or hepatic dysfunction, or heart valve diseases should use this medication with caution. Since hydrochlorothiazide may increase the risk of skin cancer, exposure to sunlight should be minimized and skin conditions should be monitored periodically. Side effects such as dizziness, fatigue, nausea, and vomiting may occur; kidney function and electrolyte levels should be monitored through blood tests. This medication has a low likelihood of affecting driving or operating machinery, but caution is advised due to the possibility of dizziness. It is especially important to manage salt intake and hydration status to prevent blood pressure from dropping too low, and patients with impaired kidney function should be examined regularly for serum potassium and creatinine levels. Diabetic patients may be affected in blood sugar control, so dosage adjustment may be necessary after consultation with a physician. Since there is a possibility of interactions with other medications, patients taking other drugs should inform their doctor or pharmacist. The safety and efficacy of this medication in children and adolescents have not been established, so use is not recommended. Elderly patients may be more sensitive to medications, requiring caution during administration. In case of suspected overdose, symptoms of hypotension, electrolyte imbalances, or dehydration may occur, and medical consultation should be sought immediately. This medication should be kept out of the reach of children, and stored sealed 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, peeling skin, pain in mucous membranes of mouth/eyes, breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • fatigue
  • nausea/vomiting
  • abnormal urination
  • elevated BUN
  • increased creatine kinase
  • elevated creatinine
  • headache
  • orthostatic dizziness
  • fainting
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  • hypotension
  • tachycardia
  • edema
  • flushing
  • cough
  • diarrhea
  • dyspepsia
  • altered taste
  • hepatitis
  • abnormal liver function
  • sexual dysfunction
  • changes in libido
  • limb edema
  • joint pain
  • myalgia
  • tinnitus
  • decreased serum potassium and sodium
  • hyperkalemia
  • fatigue
  • decreased serum potassium
  • hyperuricemia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to maintain its effectiveness for a long time.

Appearance and packaging

Appearance

Pink, biconvex, rectangular 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.