Medication info

Cosalex 5/50 mg Tablet

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201904760 · Approved 2019.07.16

This product's status changed to Approval withdrawn on 2024.03.29. 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 takes it
Adults · Children
Adult dose
The recommended dosage for adults is 1 tablet once daily, taken with water irrespective of meals. It is advised to take at the same time each day (e.g., morning) if possible. Typically, the 5/50 mg dosage is administered once daily, and if blood pressure is not adequately controlled after two weeks, the dosage may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years; therefore, the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

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

  • Essential hypertension
  • hypertension
View approved original text

This medication is used in patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or losartan. It is also suitable for initial treatment in patients with stage 2 hypertension who require combination therapy to achieve target blood pressure. This drug helps manage hypertension effectively and aids in the prevention of complications.

How to take

Adult dose

The recommended dosage for adults is 1 tablet once daily, taken with water irrespective of meals. It is advised to take at the same time each day (e.g., morning) if possible. Typically, the 5/50 mg dosage is administered once daily, and if blood pressure is not adequately controlled after two weeks, the dosage may be increased to 10/50 mg once daily.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years; therefore, the administration of this medication 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. When initially administered to patients with low blood volume, hypotensive symptoms may occur; hence therapy should be initiated after correcting this condition. This medication should not be used in individuals with allergies to any of its components, women who are pregnant or breastfeeding, patients with severe liver dysfunction or aortic stenosis, and those in a state of shock. It should be administered with caution in patients with reduced blood volume, strict salt restriction, moderate to severe renal impairment, and also in patients with hyperkalemia. Potential side effects may include dizziness, headaches, drowsiness, edema, palpitations, orthostatic hypotension, dyspnea, and skin rashes. Caution is advised while driving or operating machinery as this medication may cause dizziness. Blood pressure may slowly decrease even after discontinuing this medication, so dose adjustment and monitoring are necessary when used alongside other antihypertensives. Patients with impaired liver or kidney function should consult their doctor before taking this medication, and caution is required in cases of elevated potassium levels. Taking this medication in combination with other antihypertensives may enhance its blood pressure-lowering effect; thus, it should be taken per medical advice. This medication may pose risks to the fetus during pregnancy; hence consultation with a physician is essential in the case of planned or confirmed pregnancy, and it is advisable not to take it while breastfeeding. It is not recommended for children under 18 years as its safety and efficacy have not been established. Overdosing may lead to severe hypotension and cardiac issues; therefore, it is crucial to adhere to the prescribed dosage and report any unusual symptoms to healthcare professionals immediately. This medication should be kept 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 high fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, dysuria

Mild side effects

  • Dizziness
  • headaches
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • abdominal discomfort
  • indigestion
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  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • frequent urination
  • drowsiness
  • cerebral infarction
  • hypotension
  • sinoatrial block
  • atrioventricular block
  • abdominal malaise
  • diarrhea
  • loose stools
  • skin flushing
  • maculopapular rash
  • heaviness in the head

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture exposure, and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its efficacy.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.