Medication info
Candesartan HCTZ and Amlodipine Tablets 16/10 mg

Candesartan HCTZ and Amlodipine Tablets 16/10 mg

Prescription medicationTablet경구
Ingredient · strength
Candesartan Cilexetil›16mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
White, round, biconvex film-coated tablets
Packaging
300 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 201603932 · Approved 2016.06.24 · Insurance code 648507600

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). In cases where blood pressure is not adequately controlled, appropriate dosages of 8/5 mg, 16/5 mg, or 16/10 mg may be administered based on the dosage of Candesartan Cilexetil and Amlodipine monotherapies. For patients with renal impairment, the initial dose of Candesartan Cilexetil 4 mg once daily is recommended, so it is not advisable to administer this medication in initial treatment.
Child dose
The safety and efficacy in adolescents and children under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension who have difficulty controlling blood pressure with monotherapy of either Candesartan Cilexetil or Amlodipine. It helps effectively lower blood pressure and reduce the risk of cardiovascular disease. The medication assists in maintaining a healthy life through adequate blood pressure control.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). In cases where blood pressure is not adequately controlled, appropriate dosages of 8/5 mg, 16/5 mg, or 16/10 mg may be administered based on the dosage of Candesartan Cilexetil and Amlodipine monotherapies. For patients with renal impairment, the initial dose of Candesartan Cilexetil 4 mg once daily is recommended, so it is not advisable to administer this medication in initial treatment.

Child dose

The safety and efficacy in adolescents and children under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Precautions

This medication can cause serious harm or even death to the fetus and neonate if administered to pregnant women, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with a history of allergies to this medication, specific liver disorders, kidney disorders, or angioedema, and in pregnant or breastfeeding women. Special caution is required for elderly patients or those with specific health conditions such as hyperkalemia, liver disorders, or hypotension when using this medication. During the use of this medication, side effects such as dizziness, headaches, gastrointestinal disorders, edema, and skin rashes may occur; if symptoms are severe or persistent, consult a doctor. Patients with impaired kidney function or heart failure should regularly monitor blood pressure and kidney function, as well as blood potassium levels while on this medication, and must inform their doctor if taking other medications that may increase the risk. This medication may interact with other antihypertensive agents, potassium-sparing diuretics, and NSAIDs, so if you are taking other medications, inform your healthcare professional. Pregnant or breastfeeding women should avoid using this medication and should discontinue breastfeeding if necessary. The safety and efficacy of this medication have not been established in children or adolescents under 18 years of age; therefore, its use is not recommended. In cases of overdose, symptoms such as severe hypotension, dizziness, and tachycardia may appear, so seek medical attention immediately if suspected. Store this medication out of reach of children and in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, breathing difficulties, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory difficulties accompanied by coughing and fever, yellowing of the skin or eyes, overall extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output,

Mild side effects

  • Hemorrhoids
  • gastritis
  • upper abdominal pain
  • colorectal polyps
  • pancreatitis
  • chronic gastritis
  • gastroesophageal reflux disease
  • irritable bowel syndrome
  • reflux
  • constipation
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  • nausea
  • abdominal discomfort
  • dizziness
  • headaches
  • head discomfort
  • anosmia
  • sensory abnormalities
  • liver function test abnormalities
  • elevated ALT
  • elevated AST
  • increased triglyceride levels
  • palpitations
  • chest discomfort
  • fatigue
  • peripheral edema
  • facial swelling
  • chest pain
  • muscle pain
  • joint pain
  • mucosal cystitis
  • limb pain
  • lower back pain

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture and keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, round, biconvex film-coated tablets

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.