Medication info
Atorogen Tablets 10 mg (Atorvastatin Calcium Hydrate)

Atorogen Tablets 10 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201602875 · Approved 2016.05.23 · Insurance code 073001440

Summary

Main use
Reduction of risk for myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dosage is 10 mg once daily. For patients needing greater reductions in LDL cholesterol, treatment may begin with 20 mg or 40 mg once daily. The dosage range is from 10 to 80 mg once daily. The dosage may be individualized based on treatment goals and patient characteristics, and lipid levels should be assessed within 2 to 4 weeks after initiation or dosage adjustment. The goal of treatment is to lower LDL cholesterol, thus monitoring LDL cholesterol during treatment initiation and response evaluation is recommended. If LDL cholesterol levels cannot be utilized, total cholesterol levels can be used for monitoring treatment response. The dosage for patients with homozygous familial hypercholesterolemia is 10 to 80 mg once daily, either used alone or in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) if such treatments are not possible.
Children's dosage
The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum dosage of 20 mg once daily. The dosage should be adjusted according to treatment goals with intervals of at least 4 weeks.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • revascularization
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. Particularly, it lowers the risk of myocardial infarction and stroke in adult patients who have risk factors for coronary heart disease or type 2 diabetes. Furthermore, in adult patients who already have coronary heart disease, it lowers the risks of non-fatal myocardial infarction, stroke, the need for revascularization, congestive heart failure hospitalization, and angina. This medication is also used to treat hyperlipidemia, effectively lowering total cholesterol, LDL cholesterol, and triglyceride levels, while increasing HDL cholesterol. It is especially used as an adjunct therapy for patients with dyslipidemia who do not respond to dietary therapy. It helps reduce cholesterol levels in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. Overall, it is used to improve cardiovascular health and treat hyperlipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dosage is 10 mg once daily. For patients needing greater reductions in LDL cholesterol, treatment may begin with 20 mg or 40 mg once daily. The dosage range is from 10 to 80 mg once daily. The dosage may be individualized based on treatment goals and patient characteristics, and lipid levels should be assessed within 2 to 4 weeks after initiation or dosage adjustment. The goal of treatment is to lower LDL cholesterol, thus monitoring LDL cholesterol during treatment initiation and response evaluation is recommended. If LDL cholesterol levels cannot be utilized, total cholesterol levels can be used for monitoring treatment response. The dosage for patients with homozygous familial hypercholesterolemia is 10 to 80 mg once daily, either used alone or in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) if such treatments are not possible.

Children's dosage

The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum dosage of 20 mg once daily. The dosage should be adjusted according to treatment goals with intervals of at least 4 weeks.

Precautions

This medication may present symptoms affecting the muscles. If there is severe muscle pain or weakness, or if creatine kinase levels become significantly elevated, discontinue use immediately and consult a physician. This medication should not be used in patients with certain diseases or conditions, such as those with severely impaired liver function, muscle disorders, women who are pregnant or breastfeeding, children under 10 years old, or patients taking certain medications. Patients with liver or kidney problems or alcohol dependence need to exercise caution when using this medication and should have regular liver function tests before and during treatment. This medication can cause rare but serious side effects, such as interstitial lung disease or severe myasthenia gravis, so report breathing difficulties or muscle weakness symptoms to medical personnel immediately. This medication can interact with several other drugs; thus, it is essential to inform your physician or pharmacist about any other medications you are taking, especially when combined with specific antibiotics, antifungals, antivirals, blood pressure medications, antidiabetics, and oral contraceptives. Women who are pregnant or may become pregnant must use appropriate contraceptive methods while taking this medication and discontinue it immediately if pregnancy is confirmed. If symptoms such as muscle pain, fatigue, or fever occur during treatment, report them to your physician promptly for evaluation, especially if muscle-related symptoms are severe, as treatment may need to be discontinued. Children and elderly patients require special attention when using this medication, particularly because elderly patients face a higher risk of myopathy, making monitoring critical. In cases of overdose, there is no specific antidote, and treatment should focus on symptom management while monitoring liver function and muscle enzyme levels. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or quality deterioration.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, dyspnea or difficulty in breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
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  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorder
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

White round 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.