Medication info
Candesartan Amlodipine Tablets 16/5 mg

Candesartan Amlodipine Tablets 16/5 mg

Prescription medicationTablet경구
Ingredient · strength
Candesartan Cilexetil›16mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Yellow, biconvex, round film-coated tablet
Packaging
300 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 201603933 · Approved 2016.06.24 · Insurance code 648507610

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is preferable to take it at the same time each day (e.g., in the morning). For patients with kidney impairment, the initial dose of candesartan cilexetil is recommended as 4 mg once daily; therefore, it is not advisable to administer this medication during initial treatment. For patients with liver impairment, the initial dose of candesartan cilexetil is recommended as 2 mg once daily for mild and moderate liver impairment; therefore, it is also not advisable to initiate this medication at that time.
Child dose
Safety and efficacy in individuals under 18 years of age have not been established, hence use of this medication is not recommended.

Ingredients

Manufacturer
신풍제약(주)

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 candesartan cilexetil or amlodipine monotherapy.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is preferable to take it at the same time each day (e.g., in the morning). For patients with kidney impairment, the initial dose of candesartan cilexetil is recommended as 4 mg once daily; therefore, it is not advisable to administer this medication during initial treatment. For patients with liver impairment, the initial dose of candesartan cilexetil is recommended as 2 mg once daily for mild and moderate liver impairment; therefore, it is also not advisable to initiate this medication at that time.

Child dose

Safety and efficacy in individuals under 18 years of age have not been established, hence use of this medication is not recommended.

Precautions

This medication can cause serious harm or death to the fetus or newborn if taken during pregnancy, particularly in the second and third trimesters. It should be discontinued immediately if pregnancy is confirmed. It is safer for women who are pregnant or may become pregnant, as well as nursing mothers, not to use this medication. Use is contraindicated in certain patients, including those with severely impaired liver or kidney function, specific hereditary angioedema, and severe liver disease. Elderly patients, those with hyperkalemia, and patients with slightly impaired liver function should be monitored closely when using this medication. Since this medication lowers blood pressure, special caution is required for hypotensive patients or those with reduced intravascular blood volume. While taking this medication, side effects such as dizziness, headache, fatigue, chest discomfort, edema, and dyspepsia may occur, and any unusual symptoms should be discussed with a healthcare professional. Regular blood tests are recommended as abnormalities in liver function, hyperkalemia, and decreased renal function may appear. The risk of side effects may increase when this medication is combined with other antihypertensives, certain diuretics, or potassium-sparing diuretics, so professional guidance is advised when combining medications. Grapefruit juice can increase the blood concentration of this medication, so it is advisable to avoid this combination. Caution is advised as dizziness or drowsiness may occur when driving or operating machinery. Overdose may result in severe hypotension, dizziness, and tachycardia, requiring immediate medical attention. Safety and efficacy in children and adolescents have not been established, therefore, this medication is not recommended for use in these populations. Store this medication in a place inaccessible to children and avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Dizziness
  • headache
  • discomfort in the head
  • hyposmia
  • sensory disturbances
  • elevated triglycerides
  • palpitations
  • chest discomfort
  • fatigue
  • myalgia
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  • arthralgia
  • bursitis
  • limb pain
  • low back pain
  • itching
  • rash
  • eosinophilia
  • hearing impairment
  • dry eyes
  • cystitis
  • acute sinusitis
  • pharyngitis
  • ocular contusions
  • ligament sprains
  • lacerations
  • dyslipidemia
  • hypertriglyceridemia
  • cough
  • nausea
  • abdominal pain
  • diarrhea
  • vomiting
  • increased blood pressure
  • gastrointestinal discomfort

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

Storage

Store this medication in a sealed container to protect it from air and moisture, and keep it at a temperature between 1 to 30 degrees Celsius. This will help maintain the medication’s effectiveness and prevent degradation.

Appearance and packaging

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

300 tablets/bottle, 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

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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.