Medication info
Lipitor Tablet 10 mg (Atorvastatin Calcium Hydrate)

Lipitor Tablet 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603247 · Approved 2016.06.07 · Insurance code 623004040

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
As an atorvastatin initial dose, 10 mg once daily is recommended, with the option to start 20 mg or 40 mg once daily for patients requiring a more significant decrease in LDL cholesterol levels. The dosage range is within 10 to 80 mg once daily, and adjustments should be made based on treatment goals and responses, with lipid levels analyzed within 2 to 4 weeks after starting or adjusting the dose. For patients with homozygous familial hypercholesterolemia
Children's dosage
The recommended initial dosage for pediatric patients (10 to 17 years old) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum recommended dosage of 20 mg per day. Dosage should be adjusted appropriately based on therapeutic goals.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke and improvement of hypercholesterolemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It is particularly effective in reducing the risk of myocardial infarction, stroke, revascularization procedures, congestive heart failure, and angina in adults who have risk factors for coronary heart disease, patients with type 2 diabetes, and those with clinical evidence of heart disease. Additionally, it effectively lowers total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia and dyslipidemia, while increasing HDL cholesterol to improve serum lipid levels. This medication is also used to treat familial hypercholesterolemia in children of specific age groups, as well as patients with hypercholesterolemia that is not managed by diet alone. In this way, this medication plays a crucial role in maintaining heart and vascular health and in reducing the risk of related diseases.

Dosage and Administration

Adult dosage

As an atorvastatin initial dose, 10 mg once daily is recommended, with the option to start 20 mg or 40 mg once daily for patients requiring a more significant decrease in LDL cholesterol levels. The dosage range is within 10 to 80 mg once daily, and adjustments should be made based on treatment goals and responses, with lipid levels analyzed within 2 to 4 weeks after starting or adjusting the dose. For patients with homozygous familial hypercholesterolemia

Children's dosage

The recommended initial dosage for pediatric patients (10 to 17 years old) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum recommended dosage of 20 mg per day. Dosage should be adjusted appropriately based on therapeutic goals.

Precautions

This medication may cause muscular symptoms. Therefore, if you experience severe muscle pain or weakness or a significant increase in creatine kinase levels, you must immediately stop taking it and consult a doctor. In cases of severe infections, hypotension, major surgery or trauma, or metabolic disorders, it may be necessary to temporarily discontinue use. Patients with known allergies to this medication or its constituents, individuals with severe liver disease, those with muscular disorders, women who are pregnant or breastfeeding, children under 10 years of age, and patients taking certain hepatitis treatment medications should not use this product. Patients with a history of alcoholism or liver disease, impaired renal function, hypothyroidism, or those with a family history of muscular disorders, as well as patients over 70 years old should use this medication cautiously. While taking this medication, various side effects such as liver function abnormalities, muscle pain, indigestion, headaches, fatigue, and allergic reactions may occur; thus, any severe symptoms should be reported to a doctor. Regular liver function tests should be conducted, and treatment should be immediately suspended if any abnormal symptoms occur. This medication may interact with multiple drugs; therefore, patients taking other medications must inform their healthcare professional. Caution is needed when taking this medication with specific antibiotics, antifungals, antiviral agents, certain antihypertensives, oral contraceptives, and grapefruit juice. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraceptive methods while on this treatment. Children, elderly individuals, and those with reduced kidney function require special attention during treatment, and dosage adjustments may be necessary. There is no specific detoxification method for overdose; symptomatic treatment should be continued, and liver function and muscle status should be closely monitored. Store this medication out of reach of children and securely in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin shedding, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory issues, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, altered consciousness, visual disturbances, paralysis, urination issues

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
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory disturbances
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint issues

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness.

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.

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.