Medication info

Kosalex Tablet 5/100 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pale pink rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201904704 · Approved 2019.07.12

This product's status changed to Approval withdrawn on 2024.03.29.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
Improves control of target blood pressure in essential hypertension and hypertension treatment
Who takes it
Adults · Children
Adult dose
The recommended dosage of this drug is one tablet once daily, taken with water, regardless of meals. It is recommended to take it at the same time every day (e.g., morning). Typically, 5/50 mg of this drug is administered once daily, and if blood pressure is still not adequately controlled after two weeks of treatment, it may be increased to 10/50 mg once daily.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established, and the use of this medication is not recommended.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improves control of target blood pressure in essential hypertension and hypertension treatment

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medicine is used for patients with essential hypertension whose blood pressure is not well controlled by amlodipine or losartan alone. It is also effective when initiating treatment with a combination drug for patients with stage 2 hypertension who are difficult to reach their target blood pressure. It effectively controls hypertension and helps prevent cardiovascular complications. It is used to safely lower and manage blood pressure.

How to take

Adult dose

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

Child dose

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

Precautions

This drug can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it must be discontinued immediately upon confirmation of pregnancy. Taking this medication by a pregnant woman can lead to serious side effects in the newborn such as hypotension, renal function impairment, and craniofacial deformities. Hypotension may occur when initially administered to patients with reduced intravascular blood volume, so caution is required, and the patient's condition should be stabilized before administration. It is contraindicated in patients allergic to any components of this drug, in pregnant or nursing women, patients with severe liver dysfunction, severe aortic stenosis, and patients in shock. It should be used cautiously in patients with reduced blood volume, strict sodium restriction, moderate to severe renal impairment, and hyperkalemia. Dizziness, headaches, drowsiness, and other symptoms may occur while taking this drug, so it is advised to avoid dangerous tasks such as working at heights or operating vehicles. The blood pressure-lowering effect may be enhanced when taken with other antihypertensive agents, so it should be taken carefully as directed by a physician. Taking grapefruit juice with this drug may increase the drug concentration, so co-administration is not recommended. It is prohibited for pregnant women, and nursing mothers should also avoid this medication. The safety and efficacy in children and adolescents under 18 years have not been established, so its use is not recommended. Overdose may lead to severe hypotension and decreased heart function, requiring immediate medical attention. This product should be kept out of the reach of children, and transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, painful mucosa of the mouth/eyes, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attack, respiratory irregularities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and very severe headache, lightning headache, seizure

Mild side effects

  • Dizziness
  • headaches
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • dependent edema
  • abdominal discomfort
Show 25 more
  • indigestion
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • shortness of breath
  • cough
  • conjunctival injection
  • frequent urination
  • drowsiness
  • cerebral infarction
  • vasculitis
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • tension
  • sensory loss/sensation abnormalities
  • peripheral neuropathy
  • syncope

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 or moisture from entering. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale 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.