Rosuva EZ 5/10 Tablet

✔️ Dosage & Administration | Rosuva EZ 5/10 Tablet

• Recommended dose range: 5/10 mg to 40/10 mg once daily
• Dose selection should be individualized based on LDL-C levels, treatment goals, and cardiovascular risk

Administration Guidelines:

• Swallow tablets whole; do not crush, chew, or dissolve
• Take at least 2 hours before or 4 hours after bile acid sequestrants
• Take at least 2 hours before aluminium/magnesium-containing antacids

Special Populations:

• Severe renal impairment (not on dialysis): Start with 5/10 mg once daily; do not exceed 10/10 mg
• Pediatric patients: Safety and efficacy not established
• Geriatric patients: No dose adjustment required

Hepatic Impairment:

• Contraindicated in acute liver disease or decompensated cirrhosis
• Discontinue immediately if signs of liver injury (e.g., jaundice) appear

Renal Impairment:

• Severe impairment: start with lower dose (5/10 mg), maximum 10/10 mg
• No adjustment needed for mild to moderate impairment

✔️ Side Effects | Rosuva EZ 5/10 Tablet

• Headache, dizziness
• Nausea, abdominal discomfort, constipation or diarrhea
• Muscle pain (myalgia) and joint pain (arthralgia)
• Fatigue, weakness (asthenia)
• Respiratory infections, sinusitis, influenza-like symptoms
• Back pain and extremity pain

✔️ Use caution or avoid co-administration with:

• Cyclosporine or Gemfibrozil
• Certain antiviral medications
• Darolutamide and Regorafenib

Concomitant use with Niacin, fibrates, or colchicine may increase the risk of muscle-related adverse effects, including myopathy and rhabdomyolysis.

✔️ Contraindications

• Active liver disease or decompensated cirrhosis
• Hypersensitivity to any component of the formulation

✔️ Pregnancy & Lactation

• Contraindicated in women who are pregnant or planning pregnancy
• Not recommended during breastfeeding

✔️ Precautions & Warnings

Muscle Effects:

• Risk of myopathy and rhabdomyolysis, especially in:
  • Elderly patients (≥65 years)
  • Renal impairment
  • Uncontrolled hypothyroidism
  • Concomitant use of interacting drugs

Discontinue if significantly elevated creatine kinase (CK) levels or muscle symptoms occur.

Hepatic Effects:

• Elevated liver enzymes may occur
• Rare cases of serious liver injury have been reported
• Liver function tests should be performed before and during treatment as clinically indicated

✔️ Storage:

• Store below 30°C
• Protect from light and moisture
• Keep out of reach of children