Medication info

COTENSHUN Tablet 5/50 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Amlodipine Besylate›Strength being verifiedLosartan Potassium›Strength being verified
Manufacturer / importer
제이더블유신약(주)
Appearance
White, rectangular film-coated tablets
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201502707 · Approved 2015.04.30

This product's status changed to Approval withdrawn on 2023.06.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension and stage 2 hypertension
Who uses it
Adults · Children
Adult dosage
The recommended dosage of this drug is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g. in the morning). Typically, this drug, 5/50 mg, is administered once daily, and if blood pressure is not adequately controlled after 2 weeks of administration, the dosage may be increased to 10/50 mg once daily.
Children's dosage
The safety and efficacy of this drug have not been established for pediatric patients under 18 years of age, therefore its use is not recommended.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension and stage 2 hypertension

  • Essential hypertension
  • hypertension
View approved original text

This medication is used in patients with essential hypertension where blood pressure is not adequately controlled by monotherapy with amlodipine or losartan. It is also effective when initially administering combination therapy to reach the target blood pressure in patients with stage 2 hypertension. These medications help maintain heart and vascular health and reduce the risk of complications by effectively lowering blood pressure. Therefore, this drug is utilized as an essential treatment option for hypertension management.

Dosage and Administration

Adult dosage

The recommended dosage of this drug is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g. in the morning). Typically, this drug, 5/50 mg, is administered once daily, and if blood pressure is not adequately controlled after 2 weeks of administration, the dosage may be increased to 10/50 mg once daily.

Children's dosage

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

Precautions

This drug can cause serious harm to the fetus during pregnancy, especially in the second and third trimesters; therefore, if pregnancy is confirmed, discontinuation should occur immediately. Taking this drug during pregnancy may lead to several complications such as decreased kidney function in the fetus, hypotension, impaired skull formation, and oligohydramnios. It can also result in fetal growth retardation or malformations, so it should never be taken during pregnancy. Patients with reduced effective blood volume, such as those taking diuretics, should stabilize their condition before taking this drug as hypotension may occur when administering it. This drug should not be administered to patients with allergies to its ingredients, severe liver dysfunction, aortic stenosis, or in shock. Patients with significantly reduced kidney function or hyperkalemia should use this drug with caution. Side effects such as dizziness, headache, drowsiness, dyspepsia, pruritus, palpitations, orthostatic hypotension, and dyspnea may occur, and any unusual symptoms should be discussed with a doctor. In particular, if blood pressure drops too low or symptoms such as loss of consciousness or dyspnea occur, discontinue use immediately and seek medical treatment. This drug has a blood pressure-lowering effect, so caution is needed when performing hazardous activities such as working at heights or driving. Additionally, it may affect liver and kidney functions, so patients with liver or kidney diseases should undergo regular check-ups. If taken with other antihypertensives, the effects may be amplified; therefore, consult a doctor before taking it. Taking this drug with grapefruit juice may excessively increase its effects, so it is advisable to avoid it. Women who are pregnant or breastfeeding should not take this drug, and if planning to become pregnant or if there is a possibility of pregnancy, they must inform their doctor. Its safety and efficacy have not been established for children and teenagers under 18 years old, so it is not recommended. Older adults, particularly those over 75 years of age, require careful dosage adjustment. In case of overdose, blood pressure may drop sharply, so it is important to adhere strictly to the dosage, and if unusual symptoms occur, consult medical personnel immediately. This drug should be stored out of reach of children and should not be transferred to another container.

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 fever, blisters, skin sloughing, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual abnormalities, paralysis,

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
Show 25 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • pruritus
  • urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • vertigo
  • conjunctival injection
  • increased urination
  • drowsiness
  • muscle cramps
  • back pain
  • leg pain
  • congestion
  • upper respiratory infection
  • sinusitis
  • diarrhea
  • pharyngitis
  • myalgia

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve its effectiveness.

Appearance and packaging

Appearance

White, rectangular 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

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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.