Medication info
Bivocone Atorvastatin Tablet 10mg (Atorvastatin Calcium Trihydrate)

Bivocone Atorvastatin Tablet 10mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201603587 · Approved 2016.06.20 · Insurance code 658203160

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily; if greater LDL-cholesterol reduction is needed, it may be started at 20 mg or 40 mg once daily. This medication can be administered within a range of 10 to 80 mg once daily. Initial and maintenance doses should be individualized based on treatment goals and patient response; lipid levels should be analyzed within 2 to 4 weeks after treatment initiation.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 – 17), the recommended initial dose is 10 mg daily, and the maximum recommended dose is 20 mg daily. Dosage is adjusted appropriately based on treatment goals.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia

  • Myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • hyperlipidemia
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication helps reduce the risk of myocardial infarction, stroke, and angina in adult patients with various risk factors related to cardiovascular diseases, as well as in patients with type 2 diabetes. It also lowers the risk of hospitalization due to congestion heart failure or requires vascular surgery. It is used to lower total cholesterol, LDL-cholesterol, Apo-B protein, and triglyceride levels, while increasing HDL-cholesterol levels in patients with hyperlipidemia. Especially, it acts effectively in patients with primary and mixed dyslipidemia, as well as in patients with elevated serum triglycerides, in conjunction with diet. It is also suitable as an adjunct treatment for pediatric patients aged 10 to 17 years who meet specific criteria for familial hypercholesterolemia. This drug is used to improve cardiovascular health and treat hyperlipidemia.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily; if greater LDL-cholesterol reduction is needed, it may be started at 20 mg or 40 mg once daily. This medication can be administered within a range of 10 to 80 mg once daily. Initial and maintenance doses should be individualized based on treatment goals and patient response; lipid levels should be analyzed within 2 to 4 weeks after treatment initiation.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 – 17), the recommended initial dose is 10 mg daily, and the maximum recommended dose is 20 mg daily. Dosage is adjusted appropriately based on treatment goals.

Precautions

This medication may cause problems with muscles; therefore, if symptoms of muscle pain or weakness appear, usage should be discontinued immediately and consult a doctor. If there is an allergic reaction to this drug, severe liver dysfunction, a history of muscle disease, pregnant or breastfeeding women, children under 10 years, or patients taking certain other medications, this drug should not be used. Patients with a history of liver disease or alcoholism should use this medication with caution, and those at high risk for muscle-related side effects should verify their muscle status through blood tests before treatment. While this medication is generally well tolerated, side effects such as skin rash, digestive disorders, headache, muscle pain, and liver function abnormalities may occasionally occur, so any unusual symptoms should be reported to a doctor. In particular, regular liver function tests should be performed during the use of this medication, and if symptoms like nausea, fatigue, or jaundice appear, medical personnel should be notified immediately. This medication may interact with other drugs; hence, current medications should be disclosed to a doctor or pharmacist, as caution is needed when used alongside certain antibiotics, antifungals, HIV medications, some antihypertensives, or oral contraceptives. Women who are pregnant or may become pregnant must ensure appropriate contraception while taking this medication, and should discontinue use immediately upon confirmation of pregnancy. Breastfeeding women should not take this medication, and special attention should be given to children and the elderly as they are at a higher risk for side effects. There are no specific antidotes for overdose; treatment is based on symptoms, with monitoring of liver function and muscle status required. This medication should be kept out of reach of children, and should be stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, chills, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities associated with cough and fever, jaundice (yellowing of skin or eyes), severe malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems.

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal or laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • amnesia
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is recommended to store at room temperature between 1 and 30 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained, and it can be used safely.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.