Medication info

Atorvin 10mg (Atorvastatin Calcium Trihydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›Strength being verified
Manufacturer / importer
한국노바티스(주)
Appearance
White or off-white, round, biconvex film-coated tablet engraved with HLA10 on one side
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 200800081 · Notified 2008.01.03

This product's status changed to Approval withdrawn on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia, treatment of familial hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; if a greater reduction in LDL-cholesterol is needed, treatment may begin with 20 mg or 40 mg once daily. The dosage range is 10-80 mg once daily, and should be individualized according to treatment goals and patient characteristics, adjusting the dose every 2 to 4 weeks as necessary. In patients with homozygous familial hypercholesterolemia, the dosing regimen is 10-80 mg once daily.
Children's dosage
The recommended initial dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum recommended dose of 20 mg per day. Dose adjustments should be made with an interval of at least 4 weeks.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia, treatment of familial hypercholesterolemia

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
View approved original text

This drug helps reduce the risk of cardiovascular diseases. It is particularly effective in reducing the risk of myocardial infarction, stroke, revascularization, and angina in adults with multiple risk factors or patients with type 2 diabetes. It also lowers the risk of myocardial infarction, stroke, and hospitalization due to congestive heart failure in patients with existing heart disease. In patients with hyperlipidemia, it is used as an adjunct to dietary therapy to improve cholesterol and triglyceride levels. It is also beneficial in lowering LDL-cholesterol levels in patients with familial heterozygous hypercholesterolemia. Overall, it is used to improve cardiovascular health and reduce the risks of associated diseases.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; if a greater reduction in LDL-cholesterol is needed, treatment may begin with 20 mg or 40 mg once daily. The dosage range is 10-80 mg once daily, and should be individualized according to treatment goals and patient characteristics, adjusting the dose every 2 to 4 weeks as necessary. In patients with homozygous familial hypercholesterolemia, the dosing regimen is 10-80 mg once daily.

Children's dosage

The recommended initial dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum recommended dose of 20 mg per day. Dose adjustments should be made with an interval of at least 4 weeks.

Precautions

This drug requires attention to muscle-related side effects. If you experience muscle pain or weakness, or markedly elevated levels of creatine kinase in the muscle, you should stop taking the medication immediately and consult your doctor. Particularly, if severe myopathy or rhabdomyolysis is suspected, caution is necessary for patients with risk factors as it may worsen kidney problems. This drug should not be administered to certain patients. For example, individuals allergic to this drug or its ingredients, those with active liver disease, pregnant or nursing women, and children under 10 years of age should not take this medication. Patients with genetic issues like galactose intolerance should also avoid it. Patients with liver or kidney function issues, alcohol addiction, hypothyroidism, or elderly patients should use it cautiously after consulting a doctor. Regular liver function tests are necessary due to the risk of liver dysfunction, hepatitis, or liver failure, and any abnormal symptoms should be reported to a doctor immediately. Additionally, if symptoms such as muscle pain, weakness, or fever appear during treatment, you should inform your doctor promptly, and blood tests may be necessary to check for muscle damage. This drug is contraindicated during pregnancy, and women of childbearing age should practice appropriate contraception while taking it. Nursing mothers should also avoid this medication. This drug may interact with other medications, so caution is needed, especially when used with certain antibiotics, antifungals, HIV treatments, and some antihypertensives. Consumption of grapefruit juice should also be avoided as it may increase the drug's blood concentration. There is no specific antidote for overdose, and treatment should be symptomatic while monitoring liver function and markers for muscle damage. This drug should be stored out of reach of children and kept in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema, and angioneurotic edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin reactions, asthma attacks, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden severe headache, lightning headache, seizures

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory abnormalities
  • decreased sensation
  • taste distortion
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1°C and 30°C.

Appearance and packaging

Appearance

White or off-white, round, biconvex film-coated tablet engraved with HLA10 on one side

Package unit

30 tablets (10 tablets/PTP x 3)

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.