Medication info
Crestive Tablet 10/5mg

Crestive Tablet 10/5mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
White to almost white round film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201601213 · Approved 2016.02.29 · Insurance code 649103480

Summary

Main use
Improving cholesterol and lipid levels through the treatment of hypercholesterolemia (primary and mixed type)
Who takes it
Adults
Adult dose
This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5mg to 10/20mg once daily, with the initial dose being 10/5mg per day. For patients requiring more significant reductions in LDL-cholesterol, the dosage can be adjusted. After initiation of therapy or dosage adjustment, check blood lipid levels at intervals of more than 4 weeks and adjust the dosage as needed.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improving cholesterol and lipid levels through the treatment of hypercholesterolemia (primary and mixed type)

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication helps reduce total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in the blood of patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol to reduce the risk of cardiovascular disease. It is used in conjunction with dietary therapy and is administered as an adjunct when dietary therapy alone is insufficient. It is important to identify and treat secondary causes of hyperlipidemia before medication administration, and lipid levels are monitored regularly. This is effective in reducing the risk of atherosclerotic vascular disease and improving health. Therefore, this medication is used in the treatment of dyslipidemia.

How to take

Adult dose

This medication is taken once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/5mg to 10/20mg once daily, with the initial dose being 10/5mg per day. For patients requiring more significant reductions in LDL-cholesterol, the dosage can be adjusted. After initiation of therapy or dosage adjustment, check blood lipid levels at intervals of more than 4 weeks and adjust the dosage as needed.

Precautions

This medication can rarely cause rhabdomyolysis, which may lead to serious kidney dysfunction due to muscle tissue damage, so patients showing severe myopathy symptoms or at high risk for rhabdomyolysis should temporarily discontinue or stop this medication. This medication should not be used in patients with certain diseases or conditions. For example, it should not be given to patients with allergies to any of the components of this medication, those with severely impaired liver function, patients with muscle diseases, those taking specific immunosuppressants, those with severe kidney dysfunction, pregnant women, or women who may become pregnant, and nursing mothers. Patients at high risk for muscle diseases or rhabdomyolysis, alcoholics, those with a history of liver disease or moderate to severe liver dysfunction, elderly patients, or those taking particular medications should use this medication with caution, and regular monitoring may be required as directed by a physician. While taking this medication, if symptoms such as muscle pain, muscle cramps, muscle weakness, fatigue, or fever occur, the patient should immediately inform a doctor and undergo an examination, and discontinuation of the medication may be necessary in cases of severe muscle damage. As this medication can affect liver function, liver function tests should be performed before and during treatment, and if liver enzyme levels significantly exceed the normal range, the use of the medication should be discontinued or the dosage adjusted. Pregnant or nursing women should not use this medication as it may harm the fetus or newborn, and women of childbearing age should use appropriate contraception. This medication is not recommended for children as safety and efficacy have not been sufficiently established. Elderly patients should use this medication with caution as the risk of myopathy may increase. There may be interactions with other medications, so patients, especially those taking specific antibiotics, antifungals, immunosuppressants, anticoagulants, fibrate class drugs, etc., should consult with their doctor or pharmacist. In case of overdose, there is no specific antidote; therefore, treatment should be symptomatic and appropriate supportive care should be administered, monitoring liver function and muscle enzyme levels.

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 in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory tract infection
  • myalgia
  • itching
  • rash
  • urticaria
  • pruritus
Show 28 more
  • weakness
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • anorexia
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • cough
  • sputum
  • runny nose
  • palpitations
  • flushing
  • pharyngitis
  • sinusitis
  • bronchitis
  • rhinitis
  • cystitis
  • dermatophyte infection of nails
  • soft tissue infection

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

Storage

This medication is sensitive to air and moisture and should be stored in a tightly sealed container. It is essential to maintain room temperature between 1 degree and 30 degrees Celsius. Proper storage helps to preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White to almost white round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.