Ranexa Extended-Release Tablet 375mg (Ranolazine)

Adult dose

1. Adults The recommended initial dose of this medicine is 375 milligrams twice daily. After 2 - 4 weeks, increase the dose to 500 milligrams twice daily; depending on the patient's response to treatment, the dose may be increased to a maximum of 750 milligrams twice daily. If the patient experiences treatment-related adverse reactions (e.g., dizziness, nausea, or vomiting), a dose reduction to 500 milligrams or 375 milligrams twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued. 2. Method of administration Swallow this medicine whole; do not split, crush, or chew it. This medicine may be taken with food or on an empty stomach. 3. Administration to special populations 1) Patients receiving CYP3A4 and P-gp inhibitors Careful dose titration is recommended for patients treated with moderate CYP3A4 inhibitors (e.g., diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g., verapamil, cyclosporine). Do not coadminister with strong CYP3A4 inhibitors (see Precautions for Use, ‘1. Do not administer to the following patients’, ‘2. Administer with caution to the following patients’, and ‘5. Interactions’). 2) Older adults Dose titration in older adults should be performed carefully and cautiously. Exposure to ranolazine may be increased in older adults due to age-related decreases in renal function. The incidence of adverse reactions was higher in older adults (see Precautions for Use, ‘3. Adverse Reactions’). 3) Patients with renal impairment Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30 - 80 mL/min) (see Precautions for Use, ‘12. Information for Healthcare Professionals’). Do not administer this medicine to patients with severe renal impairment (creatinine clearance < 30 mL/min) (see Precautions for Use, ‘1. Do not administer to the following patients’). 4) Patients with hepatic impairment Careful dose titration is recommended in patients with mild hepatic impairment (see Precautions for Use, ‘12. Information for Healthcare Professionals’). Do not administer this medicine to patients with moderate or severe hepatic impairment (see Precautions for Use, ‘1. Do not administer to the following patients’).

This medication should not be used in patients with an allergic reaction to the active ingredient or excipients. It is safe not to administer it to patients with very poor kidney function or moderate to severe liver impairment. Co-administration with certain strong medications may dangerously increase the effects of this drug, so their use together should be avoided. Patients with lactose intolerance or related genetic disorders should avoid this medication due to the lactose content. Elderly patients, underweight patients, and those with slightly impaired kidney or liver function should have dosage adjustments and careful monitoring. Various side effects such as dizziness, headache, dyspepsia, and fatigue may occur, especially within two weeks after treatment starts. QT interval prolongation related to heart rhythm may occur, hence caution is advised for patients taking related medications or with such conditions. Pregnant or breastfeeding women should not use this medication as it is unsafe, and its safety in children has not been established. In cases of overdose, symptoms may include dizziness, nausea, vomiting, and fainting, thus immediate consultation with healthcare professionals is necessary. This medication requires caution when driving or operating machinery and should be stored in a place out of reach of children while adhering to the expiration date.

• Loss of appetite
• decreased appetite
• dehydration
• hyponatremia
• anxiety
• insomnia
• confusional state
• hallucinations
• disorientation
• dizziness

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to keep it at room temperature between 1°C and 30°C away from extremes of heat and cold.

Appearance

Light blue, bi-convex, oval-shaped film-coated tablet, engraved with '375' on one side.

Package unit

30 tablets/box [15 tablets/PTP*2], 60 tablets/box [20 tablets/PTP*3]