Rosuless F 160/10mg Tablet 15s

Rosuless F 160 10mg Tablet 15s (Fenofibrate + Rosuvastatin) is a fixed-dose combination therapy for the comprehensive management of mixed dyslipidemia. This condition is characterised by elevated LDL-C (bad cholesterol) and triglyceride (TG) levels, often accompanied by low HDL-C (good cholesterol). The tablet combines two potent lipid-modifying agents: Rosuvastatin (10mg), a high-efficacy statin, and Fenofibrate, a fibric acid derivative. Rosuvastatin primarily works by blocking cholesterol production in the liver, leading to a drastic reduction in LDL-C and a reduction in significant cardiovascular risk. Fenofibrate mainly lowers triglyceride levels and increases HDL-C. This synergistic, single-pill approach is designed for patients whose complex lipid abnormalities cannot be adequately controlled by single-agent therapy, ensuring aggressive management of all critical lipid fractions to minimise the overall risk of heart attack and stroke.

Rosuless F 160 10mg Tablet 15s represents a state-of-the-art pharmacological intervention for managing mixed dyslipidemia, a condition recognised for its heightened atherogenic potential due to the clustering of unfavourable lipid factors. Successful management requires addressing both the cholesterol excess (primarily LDL-C) and the triglyceride-rich particle (TRP) excess, which is why a fixed-dose combination of a statin and a fibrate is often warranted.

The Rosuvastatin (10mg) component is pivotal for preventing cardiovascular events. Rosuvastatin is a competitive, selective inhibitor of HMG-CoA reductase, the rate-limiting enzyme in the liver's cholesterol synthesis. By reducing the intracellular cholesterol supply, Rosuvastatin upregulates the expression and activity of hepatic LDL receptors. These receptors efficiently clear cholesterol-loaded LDL-C particles from the systemic circulation. Furthermore, Rosuvastatin provides additional benefits, including modest TG reduction and anti-inflammatory pleiotropic effects within the vessel walls.

The complementary agent, Fenofibrate (160mg), is essential for correcting hypertriglyceridemia and low HDL-C status, which are often resistant to statin monotherapy. Fenofibrate is a highly effective activator (agonist) of the Peroxisome Proliferator-Activated Receptor Alpha (PPARα), a nuclear receptor found predominantly in the liver and muscle tissue. Activation of PPARα triggers a cascade of gene regulation leading to profound changes in fatty acid and lipoprotein metabolism:

1. Enhanced Catabolism of TGs: PPAR alpha activation markedly increases the synthesis and activity of Lipoprotein Lipase (LPL), the enzyme responsible for hydrolysing triglycerides found in circulating VLDL and chylomicrons.
2. Reduced Hepatic VLDL Secretion: Fenofibrate reduces the expression of ApoC-III, an inhibitor of LPL, and decreases the synthesis and hepatic secretion of VLDL particles.
3. Increased HDL-C Synthesis: It promotes transcription of apolipoproteins ApoA-I and ApoA-II, which are fundamental structural components of HDL-C, thereby boosting levels of "good cholesterol" and enhancing reverse cholesterol transport.

The combined use of Rosuless F 160 10mg Tablet 15s leverages distinct yet complementary mechanisms to maximise therapeutic impact across all three key lipid fractions: LDL-C, TGs, and HDL-C. The result is a robust normalisation of the lipid profile, which is crucial for reducing the aggregated cardiovascular risk associated with this complex form of dyslipidemia.

Rosuless F 160 10mg Tablet 15s (Fenofibrate 160mg + Rosuvastatin 10mg) is indicated as an adjunct to diet and exercise for the long-term management of adult patients with mixed dyslipidemia.

Mixed Dyslipidemia:

Used when high LDL-C, high triglycerides, and/or low HDL-C are present simultaneously and are not adequately controlled by a statin or fibrate alone.

Cardiovascular Risk Reduction:

Aggressively lowers atherogenic lipids (LDL-C and TGs) to reduce the overall risk of major cardiovascular events, including heart attack and stroke.

Severe Hypertriglyceridemia:

The Fenofibrate component is essential for lowering triglyceride levels (e.g., TGs > 500 mg/dL) to prevent acute pancreatitis.

Diabetic Dyslipidemia:

Often used in patients with Type 2 Diabetes to manage the complex lipid abnormalities common in this high-risk population.

The combination of Rosuvastatin and Fenofibrate in Rosuless F 160 10mg Tablet 15s provides substantial clinical advantages.

The main benefit is Comprehensive Lipid Control through the synergistic action of the two drugs. Rosuvastatin targets the core LDL-C risk, while Fenofibrate simultaneously corrects the often coexisting high triglyceride and low HDL-C. This dual correction provides a superior overall lipid profile compared to monotherapy.

This approach offers Enhanced Cardiovascular Protection. By powerfully reducing all atherogenic particles (LDL-C, TGs, and remnant particles), the combination provides a more robust defence against the development and progression of arterial plaque (atherosclerosis).

The fixed-dose regimen significantly Improves Patient Adherence. Consolidating long-term, multi-drug therapy into a single, once-daily tablet simplifies the patient's routine, which is crucial for achieving successful and sustained cardiovascular outcomes over time.

While generally well-tolerated, this combination carries risks associated with both drug classes.

Common Side Effects (Mild and temporary):

• Headache, Dizziness

• Nausea, Abdominal pain, Constipation, Diarrhoea

• Myalgia (Muscle pain) or Muscle Weakness

• Mild elevation of liver enzymes (ALT/AST)

• Increase in Creatinine Kinase (CK) levels

Serious Side Effects (Stop taking the medicine and seek urgent medical attention if you experience):

• Severe Muscle Symptoms (Rhabdomyolysis): Sudden, severe muscle pain, tenderness, or weakness, especially with fever or dark urine. This is a rare, life-threatening risk.

• Severe Allergic Reaction: Rash, swelling of the face, tongue, or throat, or difficulty breathing.

• Signs of Liver Damage (Hepatotoxicity): Yellowing of the skin or eyes (jaundice), persistent nausea, unexplained fatigue, or pain in the upper right abdomen.

• Gallstones (Cholelithiasis): Severe, persistent abdominal pain requires investigation, as Fenofibrate can increase the risk of gallstones.

• Dosing Schedule: Take one tablet (Fenofibrate 160mg + Rosuvastatin 10mg) once daily.

• Timing: Take the tablet at a consistent time each day.

• Administration: Swallow the tablet whole with water. It can be taken with or without food.

• Monitoring: Regular blood tests to check lipid levels, liver function (ALT/AST), and muscle enzymes (CK) are essential.

• Consistency: This is a life-long therapy; do not stop without consulting your doctor, even if lab results improve.

• Report Muscle Pain: Immediately report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.

• Mandatory Monitoring: Do not miss your scheduled blood tests for lipid levels, LFTs, and muscle enzymes (CK).

• Diet is Key: The medication is an adjunct; successful, long-term outcomes depend heavily on adherence to a low-fat, heart-healthy diet.

• Pre-Surgery Warning: Inform your doctor if you are scheduled for major surgery, as the medication may need to be temporarily stopped.

• Primary Goal: Understand that the treatment aims to lower LDL-C to protect the heart and TGs to prevent pancreatitis.

• Temperature: Store tablets at controlled room temperature, ideally between 20°C and 25°C (68°F and 77°F).
• Protection: Keep protected from heat, light, and moisture.
• Safety: Store securely, out of the reach and sight of children and pets.
• Disposal: Return unused medication to a pharmacy for safe disposal.

• Food Intake: NO INTERACTION. Can be taken with or without food.

• Alcohol: Limit consumption. Alcohol can independently raise triglyceride levels and increase the risk of statin-related liver injury.

• Grapefruit Products: NO KNOWN INTERACTION. Rosuvastatin is generally not significantly affected by grapefruit juice.

The combination increases the risk of muscle toxicity (myopathy and rhabdomyolysis) with certain co-administered drugs.

1. Cyclosporine: STRICTLY CONTRAINDICATED. Significantly increases Rosuvastatin levels, raising the risk of severe myopathy/rhabdomyolysis.
2. Gemfibrozil (Other Fibrate): CONTRAINDICATED. Combining two fibrates drastically increases the risk of severe muscle toxicity.
3. Coumarin Anticoagulants (e.g., Warfarin): SEVERE CAUTION. Fenofibrate can enhance Warfarin's effect, increasing the risk of bleeding. Anticoagulant dose must be closely monitored and often reduced upon initiation.
4. Colchicine: CAUTION. Concurrent use may increase the risk of myopathy.

• Active Liver Disease: STRICTLY CONTRAINDICATED. Both components carry a risk of hepatotoxicity.

• Severe Kidney Disease (Renal Impairment): SEVERE CAUTION. Impairment increases the risk of drug accumulation and myopathy. Avoid in severe renal failure.

• Gallbladder Disease: CONTRAINDICATED. Fenofibrate can increase the risk of gallstone formation.

• History of Myopathy/Rhabdomyolysis: CAUTION. Generally avoided in patients with a history of severe muscle toxicity from previous lipid agents.

The consistent daily dose is one tablet containing 160mg of Fenofibrate and 10mg of Rosuvastatin, taken once daily. This fixed regimen provides the established maintenance dose for comprehensive control of mixed dyslipidemia. The dosage must not be altered without explicit medical approval.

Overdose risks are primarily associated with severe muscle toxicity (rhabdomyolysis) and acute liver injury. Symptoms may include severe muscle pain, dark urine, and abdominal pain. If an overdose is suspected, seek emergency medical help immediately. Treatment is supportive and symptomatic, focusing on aggressive intravenous hydration to protect the kidneys from muscle breakdown products.

If you miss a scheduled dose of Rosuless F 160 10mg Tablet 15s:

• Same Day: If you remember the missed dose within 12 hours of the scheduled time, take it immediately.

• Next Day: If you do not remember until the next day, skip the missed dose entirely.

• Do Not Double Dose: Never take two tablets to make up for it. This significantly increases the risk of severe side effects, especially muscle toxicity. Resume your regular dosing schedule.