Medication info
Actova Tablets (Atorvastatin Calcium Hydrate)

Actova Tablets (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)킴스제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201209000 · Approved 2012.11.30 · Insurance code 059600060

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily, and if greater LDL-cholesterol reduction is required, it can be started at 20 mg or 40 mg once daily. Generally, it is administered within the range of 10-80 mg once daily. Lipid levels should be analyzed within 2-4 weeks after starting treatment to adjust the dosage, and this should be individualized based on treatment goals and responses. For patients with homozygous familial hypercholesterolemia, the dosing range is 10-80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or if such therapies are not possible.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. Dosage adjustments should be made at intervals of at least 4 weeks based on the treatment goals.

Ingredients

Manufacturer
(주)킴스제약

Efficacy & effects

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

  • 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 medication helps reduce the risk of cardiovascular diseases. It particularly decreases the risk of heart-related issues such as myocardial infarction, stroke, vascular surgery, and angina, and is effective for high-risk patients and those with type 2 diabetes. Additionally, it is used to lower total cholesterol, LDL-cholesterol, apolipoprotein B, and triglyceride levels while increasing HDL-cholesterol levels in hyperlipidemia patients. In pediatric patients with specific family histories and risk factors, it helps manage cholesterol and apolipoprotein B levels. Thus, this medication is used for various heart diseases and hyperlipidemia treatment.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily, and if greater LDL-cholesterol reduction is required, it can be started at 20 mg or 40 mg once daily. Generally, it is administered within the range of 10-80 mg once daily. Lipid levels should be analyzed within 2-4 weeks after starting treatment to adjust the dosage, and this should be individualized based on treatment goals and responses. For patients with homozygous familial hypercholesterolemia, the dosing range is 10-80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or if such therapies are not possible.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. Dosage adjustments should be made at intervals of at least 4 weeks based on the treatment goals.

Precautions

This medication may cause muscle-related symptoms; therefore, if there is severe muscle pain or weakness, or a significant increase in creatine kinase levels, discontinue use immediately and consult a physician. This medication should not be used by patients with certain conditions, such as liver disease or severe muscle disorders, pregnant women or those who may become pregnant, children under the age of 10, or patients taking specific medications. Particular caution is needed for patients with a history of alcoholism, liver function issues, elderly patients, and those with decreased kidney function. Regular testing may be required for these patients. While this medication is generally safe, various side effects can occur, including digestive disturbances, headaches, muscle pain, and liver function abnormalities, so any unusual symptoms should be reported to a healthcare provider. Regular liver function tests and muscle-related tests should be conducted during the period of taking this medication, and especially if muscle pain or weakness arises, immediate testing is necessary. This medication may interact with other drugs; thus, if you are taking other medications, you must inform your doctor or pharmacist, particularly if combined with certain antibiotics, antifungals, antivirals, and some lipid-lowering agents. Pregnant or nursing women should not take this medication, and women of childbearing age should use appropriate contraception while taking it. The long-term safety of this medication in children and adolescents has not been sufficiently established; therefore, it should be used cautiously in individuals under 18 years of age. In case of overdose, there is no specific antidote available, and you should visit a medical institution immediately for treatment based on symptoms and monitor liver function and muscle status. This medication should be kept out of reach of children and stored in its original container to avoid quality deterioration and misuse.

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 rashes with fever, blisters, skin peeling, oral/eye mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, liver dysfunction (jaundice), sudden and

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
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory impairment
  • 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 medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.