Medication info
Seltepozigen 5/160 mg

Seltepozigen 5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Dark yellow oblong film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu x 2)
Approval status
Active

MFDS item code 201401227 · Approved 2014.03.17 · Insurance code 693901250

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage is one tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time every day (for example, in the morning). 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of 5 mg amlodipine or 80 mg valsartan. 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of 5 mg amlodipine or 160 mg valsartan.
Child dose
The safety and efficacy of this medication for patients under 18 years of age have not been established; therefore, its use is not recommended.

Ingredients

Manufacturer
(주)셀트리온제약

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 either amlodipine or valsartan alone. This means that when satisfactory blood pressure control is difficult with single-drug therapy, this medicine can help effectively manage blood pressure.

How to take

Adult dose

The recommended dosage is one tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time every day (for example, in the morning). 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of 5 mg amlodipine or 80 mg valsartan. 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of 5 mg amlodipine or 160 mg valsartan.

Child dose

The safety and efficacy of this medication for patients under 18 years of age have not been established; therefore, its use is not recommended.

Precautions

This medication should be discontinued immediately if pregnancy is confirmed, as it can cause serious harm or death to the fetus and newborn if taken during the second or third trimester of pregnancy. Patients with allergic reactions to the active ingredients or similar substances, pregnant women, those with severe kidney dysfunction, severe liver dysfunction, and specific kidney disease should not take this medication. Patients with low sodium or body fluid should manage their condition before taking this medication and should carefully monitor blood pressure and status during use. Those with high potassium levels or taking potassium supplements, potassium-sparing diuretics, etc., should frequently check potassium levels while on this medication. Patients with renal artery stenosis or those who have received a kidney transplant should closely monitor kidney function while on this medication. If symptoms of angioedema occur, the medication should be stopped immediately and should not be resumed, and careful evaluation before use is required for patients with severe heart failure or recent myocardial infarction. Patients with acute myocardial infarction should be cautious as symptoms of angina or myocardial infarction may worsen with this medication. Patients with aortic stenosis, mitral stenosis, or obstructive hypertrophic cardiomyopathy require special caution when using this medication. This medication can increase the risk of hypotension, hyperkalemia, and worsening renal function when used with other angiotensin receptor blockers, ACE inhibitors, or aliskiren, so it is advisable to avoid such combinations or closely monitor blood pressure and renal function. Dizziness and fatigue may occur during treatment, so caution is advised when driving or operating machinery. This medication can cause various adverse reactions, with common symptoms including headache, swelling, fatigue, and dizziness. Severe allergic reactions, liver dysfunction, and cardiac arrhythmias may occur, so if any unusual symptoms arise, consult a healthcare professional immediately. This medication may interact with other drugs, so it is essential to inform healthcare professionals of any ongoing treatments, particularly if taking potassium supplements, diuretics, NSAIDs, simvastatin, or CYP3A4 inhibitors or inducers. Breastfeeding women are advised to avoid taking this medication, and its use is not recommended for pediatric patients under 18 years of age due to insufficient evidence of safety and efficacy. Overdose can lead to hypotension, dizziness, and cardiac rhythm disturbances; hence, caution should be exercised to avoid exceeding the recommended dose, and immediate medical attention is required in case of overdose.

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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulty accompanied by cough and fever, yellowing of skin or eyes (jaundice), generalized malaise, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • postural dizziness
  • paresthesia
  • vertigo
  • tinnitus
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  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • malaise
  • frequency of urination
  • polyuria
  • erectile dysfunction
  • swelling
  • peripheral edema
  • facial swelling

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

Storage

This medication should be stored in a tightly closed container as it may be sensitive to air or moisture. It is recommended to maintain a storage temperature between 1 degree to 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

Dark yellow oblong film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.