Medication info

Sandoz Atorvastatin Tablets 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
White or off-white, round, biconvex film-coated tablets imprinted with HLA10 on one side
Packaging
30 tablets/PTP (10 tablets/PTP x3)
Approval status
Approval withdrawn

MFDS item code 200800082 · 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This product's status changed to Approval withdrawn on 2023.06.29.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 risk for myocardial infarction and stroke and improvement of high cholesterol
Who uses it
Adults · Children
Adult dosage
For treating hyperlipidemia, the recommended initial dose is 10 mg once daily; however, in cases where a greater reduction in LDL cholesterol is required, it may be initiated at 20 mg or 40 mg once daily.\nThe dosing range is 10 to 80 mg once daily.\nLipid levels should be analyzed and the dosage adjusted within 2 to 4 weeks after starting treatment.\nWhen treating patients with homozygous familial hypercholesterolemia, the dosing range is also 10 to 80 mg once daily.
Children's dosage
For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily.\nDosage may be adjusted appropriately at intervals of 4 weeks or more.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Reduction of risk for myocardial infarction and stroke and improvement of high cholesterol

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

This medication is used to reduce the risk of cardiovascular diseases. It is particularly helpful in decreasing the risk of myocardial infarction and stroke in adults with risk factors such as hypertension, smoking, family history, and in patients with type 2 diabetes. Additionally, it reduces the risks of myocardial infarction, stroke, vascular interventions, heart failure hospitalizations, and angina in patients with evidence of coronary artery disease. In patients with hyperlipidemia, it lowers total cholesterol, LDL cholesterol, Apo B protein, and triglyceride levels, while raising HDL cholesterol, serving as an adjunct to dietary therapy. It is also effective in pediatric patients with heterozygous familial hypercholesterolemia. Therefore, it is used for improving cardiovascular diseases and hyperlipidemia.

Dosage and Administration

Adult dosage

For treating hyperlipidemia, the recommended initial dose is 10 mg once daily; however, in cases where a greater reduction in LDL cholesterol is required, it may be initiated at 20 mg or 40 mg once daily.\nThe dosing range is 10 to 80 mg once daily.\nLipid levels should be analyzed and the dosage adjusted within 2 to 4 weeks after starting treatment.\nWhen treating patients with homozygous familial hypercholesterolemia, the dosing range is also 10 to 80 mg once daily.

Children's dosage

For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily.\nDosage may be adjusted appropriately at intervals of 4 weeks or more.

Precautions

This medication may cause muscle symptoms; if muscle pain or weakness occurs, especially if severe, treatment should be immediately discontinued and a doctor consulted. This medication may affect liver function; thus, it should not be administered in cases of liver disease or abnormally high liver enzyme levels, and regular liver function tests should be conducted during treatment. Women who are pregnant or may become pregnant should not take this medication and should use appropriate birth control methods during treatment. Nursing mothers should also not take this medication, and it should not be administered to children under the age of 10. The risk of side effects may increase when taken with certain medications; thus, it is important to inform a doctor or pharmacist if taking other medications. Caution is particularly needed when combined with drugs that affect the liver, certain antibiotics, antifungals, HIV treatments, and some hyperlipidemia treatments. During treatment, excessive alcohol consumption should be avoided, and those with a history of liver disease should be more carefully monitored. Elderly patients or those with reduced kidney function are at higher risk for myopathy or rhabdomyolysis; therefore, symptoms should be carefully monitored. If skin rash, hives, itching, or severe allergic reactions develop during treatment, the medication should be immediately discontinued, and a doctor consulted. In case of overdose, as there is no specific antidote, one should immediately go to the hospital for appropriate treatment, and monitor liver function as well as muscle condition. Store this medication out of reach of children, and keep it in its original container; transferring to another container may increase the risk of misuse or deterioration of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with associated fever and respiratory distress, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • loss of appetite
  • constipation
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory disturbances
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint swelling

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 sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius. This will help to maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

White or off-white, round, biconvex film-coated tablets imprinted with HLA10 on one side

Package unit

30 tablets/PTP (10 tablets/PTP x3)

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.