Medication info

New Bust Tablet 80 mg (Atorvastatin Strontium Ousuhua)

Prescription medicationTabletOral
Ingredient · strength
Atorvastatin Strontium Pentahydrate›92.76mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200811253 · Approved 2008.11.28 · Insurance code 643504600

Summary

Main use
Treatment of hyperlipidemia; prevention of cardiovascular diseases (myocardial infarction, stroke, etc.)
Who takes it
Adults
Adult dose
Patients receiving atorvastatin before and during treatment should follow a standard cholesterol-lowering diet. This medication may be taken at any time of day, with or without food. Hyperlipidemia The recommended initial dose is 10 mg of atorvastatin once daily. However, patients who require greater reductions in LDL cholesterol may start with 20 mg or 40 mg once daily (only when a reduction in LDL cholesterol of 45 % or greater is required). This medication is administered once daily at a dose of 10 ~ 80 mg. The initial and maintenance doses of this medication should be individualized according to the patient’s characteristics, taking into account treatment goals and response. Lipid levels should be analyzed within 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 reduce LDL cholesterol, it is recommended that LDL cholesterol be used when initiating treatment and evaluating treatment response. However, if LDL cholesterol levels are unavailable, total cholesterol levels should be used to monitor treatment response. Patients with homozygous familial hypercholesterolemia This medication is administered at a dose of 10 ~ 80 mg once daily, in combination with other lipid-lowering therapies (e.g., LDL apheresis) or when such lipid-lowering therapies are not available. ○ Patients with renal impairment : Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect; therefore, dose adjustment is not necessary. ○ Elderly patients : The efficacy and safety in patients aged 70 years or older are similar to those in the general adult patient population.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of hyperlipidemia; prevention of cardiovascular diseases (myocardial infarction, stroke, etc.)

  • Multiple risk factors of coronary artery disease
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
View approved original text

This medication helps reduce various risks related to cardiovascular diseases. In particular, it can lower the risk of myocardial infarction and stroke in adults with multiple risk factors such as smoking, hypertension, family history, and in patients with type 2 diabetes. Additionally, for patients with coronary artery disease, it effectively reduces the risk of myocardial infarction, stroke, the need for vascular surgery, hospitalizations due to congestive heart failure, and angina. In the treatment of hyperlipidemia, it lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and dyslipidemia, increases good cholesterol, HDL-cholesterol, and is also used as an adjunct in patients who do not respond to dietary therapy. It is thus used to effectively improve risk factors for cardiovascular diseases and dyslipidemia.

How to take

Adult dose

Patients receiving atorvastatin before and during treatment should follow a standard cholesterol-lowering diet. This medication may be taken at any time of day, with or without food. Hyperlipidemia The recommended initial dose is 10 mg of atorvastatin once daily. However, patients who require greater reductions in LDL cholesterol may start with 20 mg or 40 mg once daily (only when a reduction in LDL cholesterol of 45 % or greater is required). This medication is administered once daily at a dose of 10 ~ 80 mg. The initial and maintenance doses of this medication should be individualized according to the patient’s characteristics, taking into account treatment goals and response. Lipid levels should be analyzed within 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 reduce LDL cholesterol, it is recommended that LDL cholesterol be used when initiating treatment and evaluating treatment response. However, if LDL cholesterol levels are unavailable, total cholesterol levels should be used to monitor treatment response. Patients with homozygous familial hypercholesterolemia This medication is administered at a dose of 10 ~ 80 mg once daily, in combination with other lipid-lowering therapies (e.g., LDL apheresis) or when such lipid-lowering therapies are not available. ○ Patients with renal impairment : Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect; therefore, dose adjustment is not necessary. ○ Elderly patients : The efficacy and safety in patients aged 70 years or older are similar to those in the general adult patient population.

Precautions

This medication may cause muscular symptoms; therefore, if there is significant muscle pain or weakness, or if creatine kinase levels markedly increase, discontinue use immediately and consult a doctor. It should not be used if there is an allergy to this medication, severe liver dysfunction, or muscle disorders. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Elderly patients or those with impaired renal function should be closely monitored while taking this medication due to an increased risk of muscle-related side effects. This medication can affect liver function, so liver function tests should be performed regularly before and during treatment, and if symptoms of hepatitis (nausea, vomiting, fatigue, etc.) occur, a doctor should be notified immediately. This medication may increase blood concentration when taken with certain other drugs, leading to a higher risk of side effects, so if other medications are being taken, it is essential to inform the doctor or pharmacist. During the use of this medication, vigorous exercise or activities that strain the muscles should be avoided, and if muscle pain or weakness symptoms occur, the doctor should be notified immediately. Children, especially those under 10 years old, should not take this medication, and long-term safety has not been adequately studied in adolescents under 18. Women taking this medication should use appropriate contraceptive methods, and if pregnancy is confirmed, usage should be discontinued. During treatment, excessive consumption of grapefruit juice should be avoided, and caution is necessary when combining with certain antibiotics, antifungal agents, and antivirals. There is no specific antidote in case of overdose, so immediate medical attention should be sought for symptomatic treatment. This medication should be kept out of reach of children and stored in its original container to prevent quality degradation.

Side effects

  • Lethargy
  • apathy
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • 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 from rupture
  • myopathy
  • myositis
  • rhabdomyolysis
  • tendon disorders
  • muscle rupture
  • lupus-like syndrome
  • thrombocytopenia
  • vasculitis
  • allergic reaction
  • anaphylaxis
  • hepatitis
  • cholestasis
  • liver failure
  • blurred vision
  • visual impairment
  • tinnitus
  • hearing loss
  • urticaria
  • skin rash
  • itching
  • hair loss
  • angioedema
  • vasomotor swelling
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • gynecomastia
  • abnormal liver function tests
  • elevated serum CK
  • positive urinary leukocytes
  • leukopenia
  • anemia
  • decreased testosterone
  • elevated cholinesterase
  • increased TSH
  • increased ACTH
  • decreased aldosterone
  • elevated potassium
  • increased BUN
  • cerebral infarction
  • palpitations
  • tachycardia
  • vomiting
  • abdominal abnormalities
  • cholestasis
  • cholestatic jaundice
  • abnormal liver function test results
  • gastroenteritis
  • enteritis
  • dry mouth
  • rectal bleeding
  • esophagitis
  • glossitis
  • oral ulcers
  • stomatitis
  • gallbladder pain
  • cheilitis
  • gastric and duodenal ulcers
  • dysphagia
  • black stools
  • gingival bleeding
  • urgency
  • bronchitis
  • rhinitis
  • pneumonia
  • shortness of breath
  • asthma
  • sensory disturbance
  • vertigo
  • phototoxic reaction
  • drowsiness
  • forgetfulness
  • abnormal dreams
  • decreased libido
  • anxiety disorders
  • ataxia
  • torticollis
  • facial paralysis
  • hyperkinesia
  • depression
  • hypertonia
  • arthritis
  • mucous cystitis
  • synovitis
  • myasthenia gravis
  • tendon contracture
  • elevated serum myoglobin
  • contact dermatitis
  • dry skin
  • sweating
  • acne
  • eczema
  • seborrhea
  • skin ulceration
  • erectile dysfunction
  • urinary tract infection
  • frequent urination
  • cystitis
  • hematuria
  • dysuria
  • kidney stones
  • nocturia
  • epididymitis
  • fibrocystic breasts
  • vaginal bleeding
  • albuminuria
  • breast enlargement
  • cervical discharge
  • nephritis
  • urinary incontinence
  • urinary retention
  • urgency
  • abnormal ejaculation
  • uterine bleeding
  • discolored urine
  • increased appetite
  • vasogenic edema
  • chest pain
  • angina
  • facial edema
  • fever
  • neck stiffness
  • generalized edema
  • amblyopia
  • dry eye
  • refractive error
  • ocular hemorrhage
  • hearing loss
  • glaucoma
  • dysgeusia
  • taste loss
  • ageusia
  • sleep disorders
  • interstitial lung disease
  • sexual dysfunction
  • cognitive impairment
  • severe myasthenia gravis
  • oculomotor myasthenia
  • increased AST

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 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.