Medication info
Tobastine Tablet (Atorvastatin Calcium Trihydrate)

Tobastine Tablet (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200706537 · Notified 2007.06.07 · Insurance code 693900570

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia and treatment of dyslipidemia
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily. If further reductions of LDL cholesterol are needed, it may be initiated at 20 mg or 40 mg once daily. The administered dose should be adjusted within the range of 10-80 mg once daily based on the patient's treatment goals and response, with lipid levels analyzed 2-4 weeks after starting treatment to adjust the dosage accordingly.
Child dose
The recommended starting dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be adjusted based on the patient's treatment goals, with adjustments made every 4 weeks.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

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

  • Multiple risk factors for coronary artery disease
  • myocardial infarction
  • stroke
  • vascular interventions and chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
  • angina
  • hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. Specifically, it decreases the risk of myocardial infarction and stroke in adult patients with multiple risk factors for coronary artery disease and in patients with type 2 diabetes, and it also lowers the risk of vascular interventions and angina. Additionally, it is effective in reducing the risk of non-fatal myocardial infarction, fatal and non-fatal stroke, vascular interventions, hospitalizations due to congestive heart failure, and angina in patients who already have coronary artery disease. It is also used for the treatment of hyperlipidemia, lowering total cholesterol and LDL cholesterol levels, while raising HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It assists in reducing total cholesterol and LDL cholesterol levels as a dietary supplement for pediatric patients with heterozygous familial hypercholesterolemia. Therefore, it is used to improve the risk of cardiovascular diseases and hyperlipidemia.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily. If further reductions of LDL cholesterol are needed, it may be initiated at 20 mg or 40 mg once daily. The administered dose should be adjusted within the range of 10-80 mg once daily based on the patient's treatment goals and response, with lipid levels analyzed 2-4 weeks after starting treatment to adjust the dosage accordingly.

Child dose

The recommended starting dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be adjusted based on the patient's treatment goals, with adjustments made every 4 weeks.

Precautions

This drug may cause muscle-related symptoms; if severe muscle pain or weakness occurs, you must stop taking it immediately and consult your doctor. This drug should not be administered to patients with poor liver function or liver disease, and regular liver function tests should be conducted. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication, and women of childbearing age should practice appropriate contraception while receiving treatment. This drug may interact with certain medications, so if you are taking other drugs, it is essential to inform your doctor or pharmacist, especially when combined with medications affecting liver metabolism. This medication is not used for children, especially for those under 10 years old. Elderly patients are at increased risk for muscle-related side effects when taking this medication, thus observing them closely is necessary. In case of overdose, there is no specific antidote, so treatment should follow symptomatically while closely monitoring liver function and muscle condition. When storing this medication, keep it out of reach of children and store it in the original container. If symptoms such as muscle pain, fever, or weakness occur during treatment, immediately inform healthcare personnel and undergo examination. If a rash or blisters develop on the skin, or if a severe allergic reaction occurs, discontinue use immediately and seek medical attention.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), generalized lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, 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
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmare
  • headache
  • dizziness
  • sensory abnormalities
  • decreased sensation
  • taste alterations
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint swelling
  • back 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 must be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 to 30 degrees Celsius to ensure the medication's effectiveness and safety are maintained over time.

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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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.