Medication info
Expoten Tablet 10/160 Milligrams

Expoten Tablet 10/160 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
Bright yellow oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201309085 · Approved 2013.08.30 · Insurance code 653804880

Summary

Main use
Improvement in blood pressure control for essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose for adults is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take the medication at the same time each day (e.g., in the morning). Before administration, it is recommended to adjust the dosage using the individual components (amlodipine or valsartan). If blood pressure is not controlled, conversion to this medication can be considered based on individual dosing. - 5/80 milligrams: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5mg or valsartan 80mg monotherapy. - 5/160 milligrams: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5mg or valsartan 160mg monotherapy. - 10/160 milligrams: Administered to patients whose blood pressure is not adequately controlled by amlodipine 10mg or valsartan 160mg monotherapy, or 5/160 milligrams. Patients taking valsartan and amlodipine in combination may switch to this medication for convenience (with a fixed combination containing the same doses of the individual active ingredients). Patients with renal impairment: No dose adjustment is needed for mild to moderate renal impairment (creatinine clearance above 10 mL/min), but patients with severe renal impairment (creatinine clearance below 10 mL/min) and those on dialysis should not be treated with this medication. For patients with moderate renal impairment, monitoring of potassium levels and creatinine is recommended. Patients with liver impairment: For patients with mild to moderate liver impairment, the daily dose of valsartan should not exceed 80mg. This medication should not be administered to patients with severe liver impairment, cholestatic liver cirrhosis, or obstructive jaundice. Elderly patients (65 years and older): Caution is needed when increasing the dosage. Pediatrics: The safety and efficacy of this medication in children under 18 years of age have not been established, so its use is not recommended.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension through the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medicine is used to effectively lower blood pressure in patients with essential hypertension when blood pressure is not adequately controlled by monotherapy with amlodipine or valsartan.

How to take

Adult dose

The recommended dose for adults is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take the medication at the same time each day (e.g., in the morning). Before administration, it is recommended to adjust the dosage using the individual components (amlodipine or valsartan). If blood pressure is not controlled, conversion to this medication can be considered based on individual dosing. - 5/80 milligrams: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5mg or valsartan 80mg monotherapy. - 5/160 milligrams: Administered to patients whose blood pressure is not adequately controlled by amlodipine 5mg or valsartan 160mg monotherapy. - 10/160 milligrams: Administered to patients whose blood pressure is not adequately controlled by amlodipine 10mg or valsartan 160mg monotherapy, or 5/160 milligrams. Patients taking valsartan and amlodipine in combination may switch to this medication for convenience (with a fixed combination containing the same doses of the individual active ingredients). Patients with renal impairment: No dose adjustment is needed for mild to moderate renal impairment (creatinine clearance above 10 mL/min), but patients with severe renal impairment (creatinine clearance below 10 mL/min) and those on dialysis should not be treated with this medication. For patients with moderate renal impairment, monitoring of potassium levels and creatinine is recommended. Patients with liver impairment: For patients with mild to moderate liver impairment, the daily dose of valsartan should not exceed 80mg. This medication should not be administered to patients with severe liver impairment, cholestatic liver cirrhosis, or obstructive jaundice. Elderly patients (65 years and older): Caution is needed when increasing the dosage. Pediatrics: The safety and efficacy of this medication in children under 18 years of age have not been established, so its use is not recommended.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters, and must be discontinued immediately upon confirmation of pregnancy. Patients with allergies to any of the components of this medication, pregnant or breastfeeding women, patients with severe renal or liver dysfunction, and those with specific cardiac conditions should not take this medication. Patients with a deficiency of sodium or fluids in the body may be at risk for hypotension, so the condition should be thoroughly checked before taking this medication, and blood pressure and condition should be closely monitored during treatment. Patients with high potassium levels should be cautious when using medications or supplements that can increase potassium levels alongside this drug, and should have their blood potassium levels checked frequently. Patients with kidney issues or those who have had a kidney transplant should use this medication cautiously as its safety has not been fully established. If symptoms of angioedema such as swelling of the face, lips, tongue, etc., occur during treatment, discontinue use immediately and do not take it again. Patients with heart failure or myocardial infarction should carefully monitor renal function and blood pressure changes while using this medication, as pulmonary edema may worsen in some heart failure patients. This medication can be administered to the elderly at similar dosages as in adults, but caution is advised when driving or operating machinery as dizziness or fatigue may occur. Additionally, this medication may interact with other antihypertensives, diuretics, potassium-sparing agents, non-steroidal anti-inflammatory drugs (NSAIDs), lithium preparations, etc., so concurrent use should be managed carefully under a doctor's supervision, monitoring blood pressure, renal function, and electrolyte levels. In case of overdose, severe hypotension or heart-related issues may occur; prompt medical attention should be sought. Safety and effectiveness have not been established in children under 18 years of age, so its use is not recommended. If any unusual symptoms or discomfort occur during use, consult a doctor or pharmacist immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain of oral/eye mucosa, dyspnea or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, jaundice (skin or eye yellowing), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, numbness, urine volume

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
Show 27 more
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • lower back pain
  • arthritis
  • muscle cramps
  • weakness
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema
  • fatigue
  • flushing
  • asthenia

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. The storage temperature should be kept between 1 degree and 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablets

Package unit

30 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.