Medication info

Tobastin Tablets 80 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›86.8mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201604108 · Approved 2016.06.30

Summary

Main use
Reduces the risk of myocardial infarction and stroke and improves hyperlipidemia
Who uses it
Adults
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg once daily, and in cases requiring greater reductions in LDL cholesterol levels, it may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2 to 4 weeks after starting treatment.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Reduces the risk of myocardial infarction and stroke and improves hyperlipidemia

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

This medication effectively helps patients with various risk factors for cardiovascular disease to lower the risks of myocardial infarction and stroke. It particularly reduces the risk of cardiovascular events in adult patients with multiple risk factors for coronary heart disease or those with diabetes. It also decreases the risk of myocardial infarction, stroke, and hospitalization due to revascularization procedures, angina, and congestive heart failure, thereby improving patients' cardiovascular health. In the treatment of hyperlipidemia, it lowers levels of total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides while increasing HDL cholesterol levels, which is the good cholesterol. This lipid regulation plays a crucial role in preventing cardiovascular diseases, even when dietary management is challenging. In summary, this medication is used to reduce the risk of cardiovascular diseases and treat hyperlipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg once daily, and in cases requiring greater reductions in LDL cholesterol levels, it may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2 to 4 weeks after starting treatment.

Precautions

This medication may cause muscle issues, so if muscle pain, weakness, or severe fatigue occurs, you should inform your doctor immediately. It may affect liver function, so it should not be taken if there is liver disease or elevated liver enzymes, and regular liver function tests should be conducted during treatment. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and women of childbearing potential must use appropriate contraception while taking this medication. Children, especially those under 10 years old, should not take this medication unless absolutely necessary. This medication can increase the risk of side effects when taken with certain drugs, so inform your doctor or pharmacist if you are taking any other medications. Elderly patients or those with decreased kidney function are at higher risk for muscle-related issues, so caution is advised and patients should follow their doctor's instructions. During treatment, if symptoms such as muscle pain, weakness, fever, or malaise occur, inform the healthcare provider immediately, and blood tests may be needed to check for muscle damage. This medication should be avoided with grapefruit juice, as it may increase blood concentration. If any symptoms of liver disease, unusual skin rashes, hives, or itching occur during use, discontinue the medication immediately and consult your doctor. This medication 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 (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, severe dermatological reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, breathing difficulties, yellowing of skin or eyes (jaundice), extreme lethargy, liver issues (jaundice), sudden/

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinitis
  • high blood sugar
  • low blood sugar
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • paresthesia
  • taste disturbances
  • 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 must be stored in a tightly closed container to prevent exposure to air or moisture. It should be kept away from excessively hot or cold places, ideally at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White round film-coated tablets

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.