Medication info
Newshubatin Tablet 5 Milligrams (Rosuvastatin Calcium)

Newshubatin Tablet 5 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201802673 · Approved 2018.06.27 · Insurance code 053600770

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer once daily 5 milligrams at any time of day, regardless of meals. The maintenance dose is once daily 10 milligrams, which can be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The maximum dose is 20 milligrams per day.
Children's dosage
Pediatric patients aged 10 to 17 years are administered once daily from 5 milligrams to 20 milligrams. The dose is adjusted per individual therapy goals at intervals of 4 weeks or more. For children under 10 years, safety and efficacy have not been established.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medicine is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia who are inadequately controlled by diet and exercise. It is also applied as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It is effective in lowering total cholesterol and LDL cholesterol levels in hypercholesterolemic patients, thereby slowing the progression of atherosclerosis. In certain pediatric patients aged 10 to 17 years with familial hypercholesterolemia, it is also used as an adjunct to dietary therapy to reduce cholesterol levels. It is helpful for patients with primary dysbetalipoproteinemia and is used in older patients with a high risk of cardiovascular disease to reduce the risks of stroke, myocardial infarction, and arterial revascularization. Overall, this medicine is used for various dyslipidemias and the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

Administer once daily 5 milligrams at any time of day, regardless of meals. The maintenance dose is once daily 10 milligrams, which can be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. The maximum dose is 20 milligrams per day.

Children's dosage

Pediatric patients aged 10 to 17 years are administered once daily from 5 milligrams to 20 milligrams. The dose is adjusted per individual therapy goals at intervals of 4 weeks or more. For children under 10 years, safety and efficacy have not been established.

Precautions

This medication should not be used in certain patients. Patients with hypersensitivity to this medicine, severe hepatic impairment, muscle disorders, severely impaired kidney function, or women who are pregnant or breastfeeding should not take it. Additionally, this medicine contains lactose; therefore, patients with lactose intolerance or related genetic disorders should avoid its use. It is important to periodically monitor liver function and muscle status while taking this medicine. Patients with a high alcohol intake or a history of liver disease, hypothyroidism patients, and patients with impaired kidney function should use caution. If symptoms of myalgia or muscle weakness occur, the doctor should be informed immediately, and if necessary, the use of this medicine may be discontinued. This medicine may increase blood glucose levels in some patients; hence, individuals at risk for diabetes should manage blood glucose levels rigorously. Attention should be paid to drug interactions, as the concentration of this medicine may increase when taken with certain other medications, raising the risk of muscle damage. Women with potential for pregnancy should use appropriate contraception and should not take this medicine during pregnancy. There is no specific antidote for overdose; treatment should be symptom-based, and hepatic and muscle enzyme levels should be monitored. This medication is known not to significantly affect driving or machine operation, but caution is advised due to the possibility of dizziness. Severe skin reactions or serious side effects may occur, and if any unusual symptoms arise, medical personnel should be consulted immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, chest tightness, difficulty breathing, dyspnea, severe muscle weakness, ophthalmoplegia, immune-mediated necrotizing myopathy, rhabdomyolysis, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • fatigue
  • diarrhea
  • chest discomfort
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  • loss of appetite
  • abdominal distension
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • increased serum creatinine
  • increased ALT
  • increased AST
  • increased CK
  • arthralgia
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 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.