Medication info
New Phito Tablet 10mg (Atorvastatin Calcium Hydrate)

New Phito Tablet 10mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201902690 · Approved 2019.04.26 · Insurance code 690300910

Summary

Main use
Treatment to reduce the risk of myocardial infarction and stroke and improve hyperlipidemia.
Who uses it
Adults · Children
Adult dosage
Hyperlipidemia: The recommended initial dosage is 10 mg of atorvastatin once daily, but for patients requiring greater reductions in LDL cholesterol levels, it can be started at 20 mg or 40 mg once daily (only for those requiring more than a 45% reduction in LDL cholesterol.) This medication is administered in a dose range of 10 to 80 mg once daily. The initial dose and maintenance dose should be individualized based on treatment goals and response.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10–17), the recommended initial dosage is 10 mg once daily, and the maximum recommended dosage is 20 mg once daily. The dosage should be adjusted based on the recommended treatment goals for individual patients.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

Treatment to reduce the risk of myocardial infarction and stroke and improve hyperlipidemia.

  • Coronary artery heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • increased serum triglyceride
View approved original text

This medication helps reduce the risk of myocardial infarction and stroke in adults with various risk factors for cardiovascular disease and in patients with type 2 diabetes. It is also effective in reducing the occurrence of complications related to revascularization procedures, angina pectoris, and congestive heart failure. In hyperlipidemia patients, it helps lower total cholesterol, LDL cholesterol, and triglyceride levels while raising HDL cholesterol, and is beneficial even when dietary changes are ineffective. It is especially used as an adjunct to dietary therapy in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17, lowering total cholesterol and LDL cholesterol levels. Thus, it is effective in improving various cardiovascular diseases and abnormal lipid states.

Dosage and Administration

Adult dosage

Hyperlipidemia: The recommended initial dosage is 10 mg of atorvastatin once daily, but for patients requiring greater reductions in LDL cholesterol levels, it can be started at 20 mg or 40 mg once daily (only for those requiring more than a 45% reduction in LDL cholesterol.) This medication is administered in a dose range of 10 to 80 mg once daily. The initial dose and maintenance dose should be individualized based on treatment goals and response.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10–17), the recommended initial dosage is 10 mg once daily, and the maximum recommended dosage is 20 mg once daily. The dosage should be adjusted based on the recommended treatment goals for individual patients.

Precautions

This medication may cause unusual symptoms in the muscles, so if there is severe muscle pain or weakness, or if creatine kinase levels significantly increase, discontinue the medication immediately and consult with a physician. This medication should not be used by individuals with certain diseases, such as severe liver dysfunction, muscle disorders, women who are pregnant or nursing, children under 10 years of age, and patients with certain genetic metabolic disorders. Patients with liver or kidney problems, heavy alcohol consumers, and the elderly should use this medication with more caution, and regular examinations to monitor liver and muscle status are necessary. During the use of this medication, symptoms such as liver dysfunction, muscle pain, skin rash, and allergic reactions may occur, so it is crucial to inform the healthcare provider immediately if such symptoms arise. This medication can interact with several other drugs, so if you are taking any medications, you must inform your doctor or pharmacist, especially when taking certain antibiotics, antifungals, HIV treatments, some blood pressure medications, and oral contraceptives. Pregnant or potentially pregnant women must use proper contraception during the use of this medication and should discontinue it immediately if pregnancy is confirmed. Nursing mothers should not take this medication, and should choose alternative treatments or stop breastfeeding. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, and liver function and muscle status should be monitored regularly. This medication should be kept out of the reach of children, and must be stored in its original container to prevent misuse or quality degradation.

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 fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, paralysis, urination issues.

Mild side effects

  • Weakness
  • lethargy
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • oropharyngeal pain
  • epistaxis
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • amnesia
  • 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 should be stored in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius. Avoid storing it in too hot or too cold places.

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.