Medication info
Newbust Tablets 20 mg (Atorvastatin Strontium Hydrate)

Newbust Tablets 20 mg (Atorvastatin Strontium Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Atorvastatin Strontium Pentahydrate›23.19mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200811251 · Approved 2008.11.28 · Insurance code 643504580

Summary

Main use
Improves hyperlipidemia in children and adults; prevention of cardiovascular diseases (myocardial infarction, stroke, etc.)
Who takes it
Adults · Children
Adult dose
Before and during treatment with atorvastatin, patients should follow a standard cholesterol-lowering diet. The medicine may be taken at any time of day, with or without food. 1. Hyperlipidemia The recommended starting dose is 10 mg of atorvastatin once daily. For patients who require greater reductions in LDL cholesterol, treatment may be started at 20 mg or 40 mg once daily (40 mg only when an LDL cholesterol reduction of more than 45 % is required). This medicine is administered in a dose range of 10 ~ 80 mg once daily. The initial and maintenance doses of this medicine should be individualized according to the patient's characteristics, taking into account treatment goals and response. Lipid levels should be analyzed 2 ~ 4 weeks after starting treatment and/or titrating the dose, and the dose should be adjusted accordingly. Because the goal of treatment is to lower LDL cholesterol, it is recommended that LDL cholesterol be used when initiating treatment and evaluating the response. However, if LDL cholesterol levels are unavailable, total cholesterol levels should be used to monitor the treatment response. Patients with homozygous familial hypercholesterolemia The dose of this medicine is 10 ~ 80 mg once daily. Administer this medicine in combination with other lipid-lowering treatments (e.g., LDL apheresis), or when such treatments are unavailable. ○ Patients with renal impairment: Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect; therefore, no dose adjustment is necessary. ○ Older adults: Efficacy and safety in patients aged 70 years and older are similar to those in the general adult population.
Child dose
10 ~ 17 years: The recommended starting dose is 10 mg of this medicine once daily, and the recommended maximum dose is 20 mg daily (there are no clinical data on doses of this medicine higher than 20 mg in pediatric patients). The dose should be adjusted as appropriate according to the recommended treatment goal for each patient. Adjust the dose at intervals of 4 weeks or longer.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Improves hyperlipidemia in children and adults; prevention of cardiovascular diseases (myocardial infarction, stroke, etc.)

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • dysbetalipoproteinemia
  • elevated serum triglycerides
  • familial hypercholesterolemia
View approved original text

This medication is mainly used to reduce the risk of cardiovascular diseases. It lowers the risk of myocardial infarction, stroke, vascular surgery, and angina in adults with various risk factors for coronary heart disease and type 2 diabetes patients. It is also effective in reducing the risks of nonfatal myocardial infarction, fatal and nonfatal strokes, hospitalizations due to congestive heart failure, and angina in patients with existing coronary heart disease. It is highly effective in treating hyperlipidemia, lowering total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia and dyslipidemia who are not adequately controlled by diet, while increasing HDL cholesterol. In particular, it is used as an adjunct to diet in pediatric patients with familial hypercholesterolemia to improve lipid levels. Thus, this medication plays an important role in reducing the risk of cardiovascular diseases and improving dyslipidemia.

How to take

Adult dose

Before and during treatment with atorvastatin, patients should follow a standard cholesterol-lowering diet. The medicine may be taken at any time of day, with or without food. 1. Hyperlipidemia The recommended starting dose is 10 mg of atorvastatin once daily. For patients who require greater reductions in LDL cholesterol, treatment may be started at 20 mg or 40 mg once daily (40 mg only when an LDL cholesterol reduction of more than 45 % is required). This medicine is administered in a dose range of 10 ~ 80 mg once daily. The initial and maintenance doses of this medicine should be individualized according to the patient's characteristics, taking into account treatment goals and response. Lipid levels should be analyzed 2 ~ 4 weeks after starting treatment and/or titrating the dose, and the dose should be adjusted accordingly. Because the goal of treatment is to lower LDL cholesterol, it is recommended that LDL cholesterol be used when initiating treatment and evaluating the response. However, if LDL cholesterol levels are unavailable, total cholesterol levels should be used to monitor the treatment response. Patients with homozygous familial hypercholesterolemia The dose of this medicine is 10 ~ 80 mg once daily. Administer this medicine in combination with other lipid-lowering treatments (e.g., LDL apheresis), or when such treatments are unavailable. ○ Patients with renal impairment: Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect; therefore, no dose adjustment is necessary. ○ Older adults: Efficacy and safety in patients aged 70 years and older are similar to those in the general adult population.

Child dose

10 ~ 17 years: The recommended starting dose is 10 mg of this medicine once daily, and the recommended maximum dose is 20 mg daily (there are no clinical data on doses of this medicine higher than 20 mg in pediatric patients). The dose should be adjusted as appropriate according to the recommended treatment goal for each patient. Adjust the dose at intervals of 4 weeks or longer.

Precautions

This medication may cause musculoskeletal symptoms; therefore, if there are symptoms such as muscle pain, weakness, or cramps, you should consult your doctor immediately. Particularly, if muscle enzyme levels rise significantly or if muscle disease is suspected, the use of this medication should be discontinued. Patients with liver function issues or significantly elevated liver enzyme levels should not take this medication. Pregnant women or women who may become pregnant, and breastfeeding women should not use this medication. It should not be given to children under 10 years of age. Patients with alcohol dependence or a history of liver disease should use this medication with caution and undergo regular liver function tests. Elderly patients or those with compromised kidney function should be carefully monitored for the risk of muscle abnormalities. This medication may increase the risk of side effects when taken with certain other medications; you must inform your doctor or pharmacist if you are taking other medications. Reproductive-aged women in need of contraception should use appropriate contraceptive methods during the use of this medication, and must discontinue use immediately if pregnancy is confirmed. If symptoms such as nausea, vomiting, malaise, muscle pain, or fever occur during use, notify healthcare personnel immediately. This medication should be kept out of reach of children and should be stored in its original container.

Side effects

  • Weakness
  • lethargy
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • complications due to rupture
  • myopathy
  • myositis
  • rhabdomyolysis
  • tendinopathy
  • muscle rupture
  • lupus-like syndrome
  • thrombocytopenia
  • vasculitis
  • allergic reaction
  • anaphylaxis
  • hepatitis
  • cholestasis
  • hepatic failure
  • blurred vision
  • visual impairment
  • tinnitus
  • hearing loss
  • urticaria
  • skin rash
  • itching
  • hair loss
  • angioedema
  • angioneurotic edema
  • polycyclic erythema
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • gynecomastia
  • abnormal liver function tests
  • elevated serum CK
  • positive urinary leukocyte
  • leukopenia
  • anemia
  • decreased testosterone
  • elevated cholinesterase
  • increased TSH
  • increased ACTH
  • decreased aldosterone
  • increased potassium
  • elevated BUN
  • cerebral infarction
  • palpitations
  • tachycardia
  • vomiting
  • abdominal anomaly
  • cholestasis
  • cholestatic jaundice
  • abnormal liver function test values
  • gastritis
  • enteritis
  • dry mouth
  • rectal bleeding
  • esophagitis
  • belching
  • glossitis
  • oral ulcer
  • stomatitis
  • gallbladder pain
  • cheilitis
  • gastric and duodenal ulcer
  • dysphagia
  • melena
  • gingival bleeding
  • postprandial urgency
  • bronchitis
  • rhinitis
  • pneumonia
  • dyspnea
  • asthma
  • sensory disturbances
  • vertigo
  • photophobic reactions
  • drowsiness
  • forgetfulness
  • abnormal dreams
  • decreased libido
  • emotional instability
  • motor coordination disorder
  • torticollis
  • facial paralysis
  • hyperkinesia
  • depression
  • hypertonia
  • myositis
  • muscle diseases
  • arthritis
  • bursa inflammation
  • synovitis
  • myasthenia gravis
  • tendon shortening
  • elevated serum myoglobin
  • contact dermatitis
  • dry skin
  • sweating
  • acne
  • eczema
  • seborrhea
  • skin ulcer
  • erectile dysfunction
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis
  • fibrocystic breast condition
  • vaginal bleeding
  • albuminuria
  • breast enlargement
  • cervical discharge
  • nephritis
  • urinary incontinence
  • urinary retention
  • urgent urination
  • abnormal ejaculation
  • uterine bleeding
  • colored urine
  • hypothermia
  • elevated non-protein nitrogen
  • hyperlipidemia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is good to maintain a storage temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy and safety of the medication over time.

Appearance and packaging

Appearance

White oval 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.

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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.