Ruvan Z 20/10 Tablet

✔️ Rosuvastatin

Rosuvastatin reduces cholesterol levels by selectively inhibiting HMG-CoA reductase, an enzyme involved in hepatic cholesterol synthesis.

It also increases the number of LDL receptors on the surface of liver cells, which enhances the uptake and breakdown of LDL particles from the bloodstream. As a result, rosuvastatin reduces both hepatic LDL production and circulating LDL particle levels.

✔️ Ezetimibe

Ezetimibe lowers blood cholesterol by reducing the absorption of dietary and biliary cholesterol in the small intestine.

It acts primarily by inhibiting NPC1L1, a sterol transporter involved in the intestinal uptake of cholesterol and phytosterols. This reduces the amount of cholesterol delivered to the liver and contributes to lower circulating LDL-C levels.

✔️ Side Effects

• Headache
• Nausea
• Myalgia (muscle pain)
• Arthralgia (joint pain)
• Dizziness
• Asthenia or weakness
• Constipation
• Abdominal pain
• Diarrhea
• Upper respiratory tract infection
• Sinusitis
• Pain in the extremities
• Fatigue
• Influenza
• Back pain

✔️ Ruvan-Z is contraindicated in patients with:

• Active liver disease or decompensated cirrhosis
• Known hypersensitivity to rosuvastatin, ezetimibe, or any component of the formulation
• Pregnancy

✔️ Interaction

Concomitant use of rosuvastatin and ezetimibe with certain medicines may increase the risk of adverse effects, particularly muscle-related toxicity.

• Concomitant use with cyclosporine or gemfibrozil is not recommended.
• Dosage modifications may be required when used with certain antiviral medicines, darolutamide, or regorafenib.
• Niacin, fibrates, and colchicine may increase the risk of myopathy and rhabdomyolysis when used with rosuvastatin.
• Inform your doctor about all prescription medicines, over-the-counter medicines, vitamins, and supplements you are taking.

✔️ Administration Instructions

• Swallow the tablet whole with water.
• Do not crush, dissolve, or chew the tablet.
• When used with a bile acid sequestrant, administer Ruvan-Z at least 2 hours before or 4 hours after the bile acid sequestrant.
• When using an aluminium and magnesium hydroxide-containing antacid, administer Ruvan-Z at least 2 hours before the antacid.
• Take the medicine at approximately the same time each day for consistent treatment.

✔️ Dosage & Administration

The dosage range of Ruvan-Z is 5 mg/10 mg to 40 mg/10 mg once daily, depending on the indication, baseline and target LDL-C levels, and the patient's individual cardiovascular risk.

The tablet may be taken once daily as prescribed by the doctor.

Patients with Severe Renal Impairment

For patients with severe renal impairment (CrCl <30 mL/min/1.73 m²) who are not receiving hemodialysis:

• Recommended starting dose: 5 mg/10 mg once daily
• Maximum recommended dose: 10 mg/10 mg once daily

Pediatric Use

The safety and effectiveness of this combination have not been established in pediatric patients.

Geriatric Use

No routine dosage adjustment is required solely based on age.

✔️ Pregnancy & Lactation

Pregnancy

Ruvan-Z is contraindicated during pregnancy. Cholesterol and other products of cholesterol biosynthesis are essential for fetal development, and lipid-lowering therapy is generally not appropriate during pregnancy.

Women who are pregnant, planning pregnancy, or who may become pregnant should inform their healthcare professional before starting treatment.

Lactation

Breastfeeding is not recommended during treatment with Ruvan-Z because of the potential for adverse effects on the breastfed infant and the lack of adequate information regarding the use of the combination during lactation.

✔️ Hepatic Impairment

Ruvan-Z is contraindicated in patients with acute liver failure or decompensated cirrhosis.

Patients who develop signs of significant hepatic injury should be evaluated promptly, and treatment should be discontinued when clinically appropriate.

✔️ Renal Impairment

For patients with severe renal impairment (CrCl <30 mL/min/1.73 m²) who are not receiving hemodialysis:

• Starting dose: 5 mg/10 mg once daily
• Maximum dose: 10 mg/10 mg once daily

No dosage adjustment is generally recommended for patients with mild or moderate renal impairment.

✔️ Myopathy and Rhabdomyolysis

Rosuvastatin may rarely cause myopathy or rhabdomyolysis. The risk may be increased by factors such as:

• Age 65 years or older
• Uncontrolled hypothyroidism
• Renal impairment
• Higher doses of rosuvastatin
• Concomitant use of certain interacting medicines

Discontinue the medicine and seek medical evaluation if significant muscle symptoms occur or if myopathy is suspected.

Temporary discontinuation may be necessary in patients who develop an acute or serious condition associated with an increased risk of renal failure secondary to rhabdomyolysis.

✔️ Hepatic Dysfunction

Increases in serum transaminase levels may occur during treatment. Rare cases of serious, including fatal and non-fatal, hepatic injury have been reported.

Liver enzyme testing may be considered before initiating therapy and repeated when clinically indicated.

If serious liver injury accompanied by clinical symptoms, hyperbilirubinemia, or jaundice develops, treatment should be promptly discontinued and the patient evaluated.

✔️ Storage Conditions

• Store below 30°C.
• Protect from light and moisture.
• Keep the medicine in its original packaging.
• Keep out of the reach of children.
• Do not use after the expiry date.