Medication info

Cosalex Tablet 10/50 Milligrams

Prescription medication경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201904761 · 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This product's status changed to Approval withdrawn on 2024.03.29.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 of blood pressure control in essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this drug is one tablet once daily, taken with water without regard to meals. It is recommended to take it at the same time daily (e.g., in the morning). Typically, 5/50 milligrams of this drug is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks, it can be increased to 10/50 milligrams once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration of this drug is not recommended.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement of blood pressure control in 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 adequate blood pressure control with monotherapy of amlodipine or losartan. Additionally, it is used as initial therapy in patients with stage 2 hypertension who require combination therapy to reach the target blood pressure. It helps in effectively controlling hypertension and stabilizing blood pressure.

How to take

Adult dose

The recommended dosage of this drug is one tablet once daily, taken with water without regard to meals. It is recommended to take it at the same time daily (e.g., in the morning). Typically, 5/50 milligrams of this drug is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks, it can be increased to 10/50 milligrams once daily.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration of this drug is not recommended.

Precautions

This drug can cause serious harm to the fetus if taken during pregnancy, especially during the second and third trimesters, and must be discontinued immediately upon confirmation of pregnancy. Pregnant women taking this drug may experience serious problems such as decreased fetal kidney function, hypotension, and cranial formation anomalies. Patients with reduced effective blood volume, for example, those on diuretics, may experience hypotension upon initial administration of this drug, so caution is required. This drug should not be administered to patients who are allergic to the active ingredients or similar components, pregnant or potentially pregnant women, patients with severe liver dysfunction, significant aortic stenosis, or those in a state of shock. Patients with reduced effective blood volume or those on stringent salt restrictions, moderate to severe renal dysfunction, or hyperkalemia should be administered this drug cautiously. This medication can cause various side effects such as dizziness, headache, drowsiness, edema, dyspepsia, and skin rash, and if any unusual symptoms occur, medical consultation should be sought immediately. Due to its blood pressure-lowering effects, dizziness or orthostatic hypotension may occur, so caution should be taken with high-risk activities such as working at heights or driving. Patients with impaired liver or kidney function may require dose adjustments, and due to the risk of hyperkalemia, potassium levels should be monitored regularly when used in combination with potassium supplements or potassium-sparing diuretics. This medication may have an enhanced effect when used together with other antihypertensive agents, so it should be taken cautiously under medical supervision. It is advisable for pregnant or breastfeeding women not to take this drug, and its safety for children has not been established, so it is not recommended. In case of overdose, severe hypotension or cardiac issues may occur, so prescribed doses should be adhered to, and immediate medical attention should be sought in case of unusual symptoms. This medication should be kept out of the reach of children, and transferring it to other containers may lead to quality deterioration or accidents, so caution is required.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), generalized lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • increased urination
  • drowsiness
  • cerebral infarction
  • vasculitis
  • hypertonia
  • sensory loss/abnormal sensation
  • peripheral neuropathy
  • syncope
  • taste alteration
  • tremor
  • erectile dysfunction
  • gynecomastia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Pink rectangular 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.