Medication info

Cotonition 10/50 mg

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201502709 · 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This product's status changed to Approval withdrawn on 2023.06.02.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 in blood pressure control for essential hypertension and stage 2 hypertension
Who uses it
Adults · Children
Adult dosage
The recommended dosage is one tablet once daily, taken with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after 2 weeks of treatment, the dose may be increased to 10/50 mg once daily.
Children's dosage
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established; thus, its use is not recommended.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used in patients with essential hypertension who do not achieve sufficient blood pressure control with either amlodipine or losartan monotherapy. It is also used as an initial treatment in stage 2 hypertension patients who require combination therapy to reach target blood pressure. This medication effectively aids in blood pressure control and contributes to reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

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

Children's dosage

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, particularly in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. Pregnant women taking this medication should be cautious due to risks such as impaired fetal kidney function, oligohydramnios, and the potential for congenital abnormalities. Patients with reduced effective blood volume, such as those on diuretics, should stabilize their condition before taking this medication, and it may be better not to administer this medication. Patients with hypersensitivity to this medication or severe hepatic impairment, severe aortic stenosis, or in a state of shock should avoid taking it. Due to the blood pressure-lowering effect, dizziness or drowsiness may occur, so avoid driving or operating hazardous machinery. This medication should be administered cautiously to elderly patients or those with significantly impaired kidney function, as there is a risk of elevated potassium levels when combined with potassium-sparing agents. Regular monitoring of blood pressure, kidney function, and electrolyte levels during treatment is important. In case of overdose, severe hypotension and tachycardia may occur, requiring immediate medical attention. It is safest for children, pregnant women, and nursing mothers not to take this medication. Taking this medication with grapefruit juice may increase blood concentration; therefore, it is advisable to avoid this combination. While on this medication, consult healthcare professionals if taking other antihypertensives, as this may excessively enhance blood pressure-lowering effects.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, angioedema (swelling of larynx/glottis leading to airway obstruction, swelling of face/lips/pharynx/tongue), vasculitis (Henoch-Schönlein purpura), anaphylactic reaction, severe rash with high fever, blistering, peeling skin, oral/ocular mucosal pain, acute hepatitis, fulminant hepatitis, yellowing of the skin (jaundice), etc.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • discomfort in the chest
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • reflux esophagitis
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • vertigo
  • eye congestion
  • frequent urination
  • drowsiness
  • malaise
  • weight gain/loss
  • hypotension
  • tension headache
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • fainting

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store it at room temperature between 1 to 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

Pale pink, oblong film-coated tablet

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.