Medication info
New Bust Tablet 10 mg (Atorvastatin Strontium Hydrate)

New Bust Tablet 10 mg (Atorvastatin Strontium Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Atorvastatin Strontium Pentahydrate›11.595mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200811250 · Approved 2008.11.28 · Insurance code 643504570

Summary

Main use
Improves hyperlipidemia; 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. 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
Pediatric patients with heterozygous familial hypercholesterolemia (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; prevention of cardiovascular diseases (myocardial infarction, stroke, etc.)

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • abetalipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
View approved original text

This medication is primarily used to reduce the risk of cardiovascular diseases. It helps lower the risk of myocardial infarction, stroke, vascular surgeries, and angina in adult patients with multiple risk factors such as hypertension, smoking, high cholesterol, and diabetes. It also reduces the risk of hospitalization due to non-fatal or fatal myocardial infarction and stroke, and congestive heart failure, thus improving cardiovascular health. Additionally, it is used to treat dyslipidemia by lowering LDL cholesterol and triglyceride levels in patients with primary hypercholesterolemia or mixed dyslipidemia, while increasing HDL cholesterol levels. It is particularly applicable to pediatric patients with a family history or when diet control is insufficient, effectively managing total cholesterol and LDL cholesterol levels. Therefore, this medication is used for reducing the risk of cardiovascular diseases and improving hyperlipidemia.

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. 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

Pediatric patients with heterozygous familial hypercholesterolemia (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 muscle problems, so if symptoms of muscle pain or weakness occur, discontinue use immediately and consult a physician. Do not use in patients with allergies to this medication, liver disease, muscle disease, women who are pregnant or may become pregnant, or nursing mothers, and in children under 10 years old. Patients with a history of liver disease or alcohol addiction should use this medication with special caution, and patients at high risk of muscle damage should undergo regular muscle-related tests. During use of this medication, regular liver function tests and muscle enzyme tests should be performed, and if abnormalities are found, treatment should be discontinued immediately. This medication can interact with other medications; therefore, consult a physician particularly if taking certain antibiotics, antifungals, HIV drugs, some cardiac medications, or grapefruit juice. Women of childbearing age should use appropriate contraception while taking this medication, and it must not be taken during pregnancy. This medication is also contraindicated for nursing mothers, and breastfeeding should be discontinued during use. Elderly patients or those with reduced kidney function are at higher risk of muscle damage, so they should be more cautious during use and report any symptoms immediately to medical personnel. In case of overdose, there is no specific antidote and treatment should be symptomatic, closely monitoring liver function and muscle condition. Keep out of reach of children, and store in the original container to prevent misuse or quality degradation.

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
  • sensory disturbance
  • sensory loss
  • taste disturbance
  • memory loss
  • 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
  • tendon disorders
  • muscle rupture
  • lupus-like syndrome
  • thrombocytopenia
  • vasculitis
  • allergic reactions
  • anaphylaxis
  • hepatitis
  • cholestasis
  • liver failure
  • blurred vision
  • visual impairment
  • tinnitus
  • hearing loss
  • urticaria
  • skin rash
  • itching
  • hair loss
  • angioedema
  • neurogenic edema
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • gynecomastia
  • abnormal liver function tests
  • increased serum CK
  • positive urinary leukocytes
  • vomiting
  • abdominal abnormalities
  • hepatitis
  • pancreatitis
  • cholestasis
  • cholestatic jaundice
  • abnormal liver function test results
  • gastroenteritis
  • enteritis
  • dry mouth
  • rectal bleeding
  • esophagitis
  • belching
  • glossitis
  • oral ulcers
  • stomatitis
  • gallbladder pain
  • cheilitis
  • gastric and duodenal ulcers
  • dysphagia
  • black tarry stools
  • gingival bleeding
  • postprandial urgency
  • bronchitis
  • rhinitis
  • pneumonia
  • respiratory distress
  • asthma
  • sensory abnormalities
  • dizziness
  • photosensitivity reactions
  • drowsiness
  • forgetfulness
  • abnormal dreams
  • decreased libido
  • emotional instability
  • ataxia
  • torticollis
  • facial paralysis
  • hyperkinesia
  • depression
  • tension
  • myositis
  • muscle disorders
  • arthritis
  • bursitis
  • synovitis
  • myasthenia gravis
  • tendon contractions
  • increased serum myoglobin
  • contact dermatitis
  • dry skin
  • sweating
  • acne
  • eczema
  • seborrhea
  • skin ulcers
  • erectile dysfunction
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis
  • fibrocystic breast disease
  • vaginal bleeding
  • albuminuria
  • breast enlargement
  • cervical discharge
  • nephritis
  • urinary incontinence
  • urinary retention
  • urgency
  • abnormal ejaculation
  • uterine bleeding
  • pigmented urine
  • lethargy
  • vascular neurogenic edema
  • chest pain
  • angina
  • facial swelling
  • fever
  • neck stiffness
  • generalized edema
  • amblyopia
  • dry eyes
  • refractive errors
  • ocular bleeding
  • hearing loss
  • glaucoma
  • acanthosis nigricans
  • taste loss
  • dysgeusia
  • leukopenia
  • anemia
  • reduced testosterone
  • increased cholinesterase
  • elevated TSH
  • elevated ACTH
  • decreased aldosterone
  • increased potassium
  • increased BUN
  • cerebral infarction
  • palpitations
  • tachycardia

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. Additionally, it is advisable to store the medication at room temperature, meaning between 1 degree and 30 degrees, avoiding extreme heat or cold. Proper storage will help maintain the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

White oval film-coated tablet

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.