Medication info
Atroad 10 mg Tablets (Atorvastatin Calcium Hydrate)

Atroad 10 mg Tablets (Atorvastatin Calcium Hydrate)

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

MFDS item code 201309332 · Approved 2013.09.13 · Insurance code 625200130

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of high cholesterol
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater LDL cholesterol reduction is needed, treatment may start at 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily, and it should be adjusted individually based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks post-initiation to adjust the dose as necessary.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosage adjustments should be made with intervals of at least 4 weeks between adjustments, based on the patient's response.

Ingredients

Manufacturer
(주)화이트생명과학

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, and improvement of high cholesterol

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

This medication helps reduce the risk of cardiovascular diseases. It decreases the risk of complications related to heart diseases such as myocardial infarction, stroke, vascular surgery, and angina in adult patients with multiple risk factors for major heart diseases or with type 2 diabetes. It also helps reduce the risk of non-fatal myocardial infarction, fatal and non-fatal strokes, the need for vascular surgery, heart failure hospitalization, and angina in patients who already have heart diseases. Furthermore, it is effective in lowering total cholesterol, LDL cholesterol, apo-B protein, and triglycerides levels, and increasing HDL cholesterol levels in patients with hyperlipidemia. This medication is also used to improve high cholesterol issues in children and adolescents with a family history or risk factors for heart disease. Overall, it is used to enhance cardiovascular health and improve dyslipidemia.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater LDL cholesterol reduction is needed, treatment may start at 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily, and it should be adjusted individually based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks post-initiation to adjust the dose as necessary.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosage adjustments should be made with intervals of at least 4 weeks between adjustments, based on the patient's response.

Precautions

This medication may carry a risk of muscle problems, so it should be discontinued immediately if severe muscle pain or weakness occurs, or if there is a significant increase in creatine kinase levels. In particular situations such as severe infections, hypotension, major surgery, or trauma, treatment may need to be paused. This medication should not be used by individuals with certain allergic reactions, severely impaired liver function, muscle disorders, pregnant or breastfeeding women, children under 10 years of age, or those taking certain antiviral agents. Patients with liver or kidney diseases, the elderly, or those with hypothyroidism - who are at a higher risk of muscle problems - should use this medication cautiously, and it is important to periodically check the muscle condition and blood tests before and during treatment. Generally, this medication has few side effects, but various symptoms such as fatigue, indigestion, headache, muscle pain, liver function abnormalities, and allergic reactions may occur, so consult a doctor if any unusual symptoms arise. Also, since this medication is metabolized in the liver, patients with liver diseases should undergo liver function tests before starting and regularly during treatment. Women who could become pregnant must use effective contraception while taking this medication, and if pregnancy is confirmed, use must be stopped immediately. This medication can interact with various drugs, so if other medications are being taken, it is essential to inform a doctor or pharmacist, especially when used in combination with certain antibiotics, antifungals, antivirals, immunosuppressants, grapefruit juice, etc. In case of overdose, there is no specific antidote, so treatment will be according to symptoms, monitoring liver function and muscle enzyme levels. This medication should be kept out of reach of children and stored in its original container, and ongoing collection of safety and side effects data from clinical trials and post-marketing surveys necessitates regular consultations with healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe allergic reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, respiratory issues, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory disturbances
  • numbness
  • taste disturbances
  • 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 medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness for a longer duration.

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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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.