Rinvask

Pitavastatin Calcium Hydrate 2 mg: Biconvex, white tablet with the Yarindo logo on one side and a break line on the other side.
Each film-coated tablet contains: Pitavastatin Calcium Hydrate equivalent to Pitavastatin Calcium 2 mg.
Pitavastatin Calcium Hydrate 4 mg: Biconvex, white tablet with the Yarindo logo on one side and a break line on the other side.
Each film-coated tablet contains: Pitavastatin Calcium Hydrate equivalent to Pitavastatin Calcium 4 mg.
Excipients/Inactive Ingredients: Lactose Monohydrate, Hypromellose, Magnesium Aluminometasilicate, Low-Substituted Hydroxypropyl Cellulose LH-11, Colloidal Silicon Dioxide, Magnesium Stearate, Coating Agents (Macrogol Polyvinyl Alcohol Grafted Copolymer), Talc, Titanium Dioxide, Purified Water.

Pharmacology: Mechanism of Action: Pitavastatin competitively inhibits HMG-CoA reductase, an enzyme involved in the biosynthesis of cholesterol, thereby reducing cholesterol synthesis in the liver. As a result, there is an upregulation of LDL receptors, leading to increased uptake of LDL from the blood into the liver and a subsequent decrease in plasma total cholesterol (TC). Continued inhibition of hepatic cholesterol synthesis also reduces very low-density lipoprotein (VLDL) levels.

Drug therapy should be one component of a comprehensive intervention strategy for patients requiring modification of their lipid profile. Pitavastatin is used as an adjunct to a diet restricted in saturated fat and cholesterol when the response to diet and other non-pharmacological measures is inadequate.
Primary Hyperlipidemia and Mixed Dyslipidemia: Pitavastatin is indicated as adjunctive therapy to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.
Heterozygous Familial Hypercholesterolemia (HeFH): For pediatric patients aged 8 years and older with a history of heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.
Limitations of Use: Doses of Pitavastatin greater than 4 mg once daily may increase the risk of severe myopathy. The use of Pitavastatin should not exceed 4 mg per day. The effect of Pitavastatin on cardiovascular morbidity and mortality has not been established. Pitavastatin has not been studied in patients with Fredrickson Type I, III, and V dyslipidemia.

General Dosage Information: The dosage range for Pitavastatin is 1 to 4 mg once daily, with or without food. The recommended starting dose is 2 mg, with a maximum dose of 4 mg. The initial and maintenance doses of Pitavastatin should be individualized according to patient characteristics and therapeutic goals or response. Lipid levels should be checked after 4 weeks of therapy, and the dose should be adjusted accordingly.
Use of Pitavastatin in children should only be prescribed by physicians experienced in treating hyperlipidemia, and efficacy should be reviewed periodically.
Dosage in Patients with Renal Impairment: Patients with moderate and severe renal impairment (glomerular filtration rate of 30-59 mL/min/1.73 m² and 15-29 mL/min/1.73 m², respectively, who are not receiving hemodialysis) and patients with end-stage renal disease receiving hemodialysis are recommended to receive an initial dose of Pitavastatin 1 mg once daily, with a maximum dose of 2 mg once daily.
The recommended dose in pediatric patients with a history of renal impairment has not been established.
Concomitant Use with Erythromycin: In patients taking erythromycin, Pitavastatin dosage should not exceed 1 mg once daily (see Interactions).
Concomitant Use with Rifampin: In patients taking rifampin, Pitavastatin dosage should not exceed 2 mg once daily (see Interactions).

There is no specific treatment for pitavastatin overdose. In cases of overdose, patients should be treated symptomatically as needed. Hemodialysis is unlikely to be beneficial due to pitavastatin's high protein binding ratio.

Pitavastatin is contraindicated in the following conditions: Patients with hypersensitivity to any component of this product. Hypersensitivity reactions such as angioedema, rash, pruritus, and urticaria have been reported with Pitavastatin (see Adverse Reactions).
Patients with liver disease, including unexplained persistent elevations in hepatic transaminases (see Precautions).
Pregnant women or women planning to become pregnant. Pitavastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis and possibly affecting the synthesis of biologically active substances derived from cholesterol, and may cause fetal harm if administered to pregnant women. The safety and efficacy in pregnant women have not been established. If a patient becomes pregnant while taking Pitavastatin, they should be informed of the potential risks to the fetus and the lack of known clinical benefit (see Use in Pregnancy & Lactation).
Nursing mothers. Animal studies have shown that Pitavastatin is excreted into breast milk. As Pitavastatin inhibits HMG-CoA reductase and may cause adverse reactions in nursing infants, it is contraindicated in breastfeeding women (see Use in Pregnancy & Lactation).
Concomitant use with cyclosporine (see Interactions).

Skeletal Muscle Effects: Myopathy and rhabdomyolysis with acute kidney failure secondary to myoglobinuria have been reported with the use of HMG-CoA reductase inhibitors, including pitavastatin. These risks can occur at any dose level but may increase depending on the dose. Pitavastatin should be used with caution in patients with predisposing factors for myopathy. Predisposing factors include advanced age (>65 years), renal impairment, and poorly treated hypothyroidism. The risk of myopathy may be increased with concomitant administration of fibrates or lipids with niacin. Pitavastatin should be administered with caution in patients with impaired renal function, elderly patients, or when coadministered with fibrates or lipid modifiers with niacin (see Interactions and as follows). Immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, has been rarely reported with statin use. IMNM is characterized by proximal muscle weakness. Elevated serum creatine kinase, muscle necrosis without inflammation, and positive anti-HMG-CoA reductase (HMGCR) antibodies that persist despite discontinuation of statin therapy, muscle biopsy demonstrating myopathic necrosis without inflammation, improvement with immunosuppressive agents. Patients should be monitored carefully.
Pitavastatin therapy should be discontinued if elevated creatine kinase (CK) levels occur or if myopathy is diagnosed or suspected. Pitavastatin should be temporarily discontinued in patients with serious acute myopathic conditions or predisposition to secondary renal failure caused by rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disturbances, or uncontrolled seizures). Patients should be advised to report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever, or if muscle pain persists after discontinuation of pitavastatin.
Liver Enzyme Disorders and Monitoring: Elevations in serum transaminases (aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase, or alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase) have been reported with the use of HMG-CoA reductase inhibitors, including Pitavastatin. In most cases, these elevations are transient and resolve with continued therapy or follow-up therapy. Liver enzyme testing is recommended before using Pitavastatin and if symptoms of liver damage develop. All patients treated with Pitavastatin should be advised to promptly report any symptoms that may indicate liver damage, including fatigue, anorexia, right lower abdominal discomfort, dark urine, or jaundice. Fatal and non-fatal liver failure have been reported rarely in patients using statins, including Pitavastatin. If liver damage accompanied by clinical symptoms or hyperbilirubinemia or jaundice occurs during Pitavastatin use, Pitavastatin should be discontinued immediately. If symptoms do not improve, do not restart pitavastatin. Like other HMG-CoA reductase inhibitors, pitavastatin should be used with caution in patients who consume large amounts of alcohol. Liver disease, which may include persistent transaminase elevations, is a contraindication to pitavastatin use (see Contraindications).
Endocrine Function: Elevated HbA1c and fasting glucose levels have been reported with the use of HMG-CoA reductase inhibitors, including pitavastatin.
Diabetes Mellitus: Some evidence suggests that statins can increase blood glucose levels, leading to hyperglycemia in patients at risk for diabetes. However, this risk is outweighed by the potential benefits of statin therapy, and statin treatment should not be discontinued. Patients at risk for hyperglycemia (fasting glucose 5.6 to 6.9 mmol/L, BMI 2.30 kg/mL, elevated triglycerides, hypertension) should be monitored clinically and biochemically according to guidelines. However, there have been no confirmed reports of a diabetes risk associated with pitavastatin use.
Renal Impairment: Patients with moderate and severe renal impairment (glomerular filtration rate 30-59 mU/1.73 m² and 15-29 mU/1.73 m², respectively, not receiving hemodialysis) and end-stage renal disease receiving hemodialysis should receive an initial dose of pitavastatin 1 mg once daily and a maximum dose of pitavastatin 2 mg once daily. There are no recommended dosage data for pediatric patients with renal impairment (see Dosage & Administration).
Hepatic Impairment: Pitavastatin is contraindicated in patients with active liver disease, which may include persistent, unexplained elevations in liver transaminase levels.
Use in Children: There are no data on long-term use of Pitavastatin in pediatric patients.
The safety and effectiveness of pitavastatin as adjunctive therapy to reduce elevated TC, LDL-C, and ApoB in pediatric patients with HeFH aged 8 years and younger have been established. The safety and effectiveness of pitavastatin in pediatric patients with HeFH aged <8 years or in pediatric patients with other hyperlipidemias (other than HeFH) have not been established.
Use in the Elderly: There are no significant differences in efficacy or safety in elderly patients compared to younger patients. However, the sensitivity of elderly patients may be greater.

Pregnancy: Teratogenic effects: Pregnancy Category X.
Pitavastatin is contraindicated in women who are pregnant or planning to become pregnant. During pregnancy, blood cholesterol and triglycerides increase, which are crucial for fetal development. Discontinuing lipid-lowering medications during pregnancy has little effect on the treatment of primary hyperlipidemia because atherosclerosis is a chronic disease (see Contraindications). There are no studies on the efficacy and safety of pitavastatin in pregnant women, although there have been reports of congenital abnormalities following intrauterine use of HMG-CoA reductase inhibitors. Pitavastatin can cause fetal harm when administered to pregnant women. If a pregnant woman uses pitavastatin, the patient should be informed of the risk to the fetus and the lack of clinical benefit from continued use during pregnancy.
Nursing Mothers: It is unknown whether pitavastatin is excreted in human milk; however, small amounts of other drugs in this class have been shown to be excreted in breast milk. Because other drugs in this class are excreted in breast milk and HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women requiring pitavastatin treatment are advised to refrain from breastfeeding or discontinue pitavastatin use (see Contraindications).

Rhabdomyolysis with myoglobinuria and acute renal failure, and myopathy (including myositis) (see Precautions).
Liver enzyme abnormalities (see Precautions).
Adverse reactions observed in adult patients with primary hyperlipidemia and mixed dyslipidemia: Back pain, constipation, diarrhea, muscle pain, and pain in the extremities. Other reported adverse reactions include arthralgia, headache, influenza, and nasopharyngitis. Laboratory effects have also been reported: increased creatinine phosphokinase, transaminase, alkaline phosphatase, bilirubin, and glucose. Hypersensitivity reactions, including rash, pruritus, and urticaria, have also been reported with pitavastatin use. Other adverse events reported during post-marketing use of Pitavastatin include abdominal pain, indigestion, nausea, weakness, fatigue, malaise, hepatitis, jaundice, fatal and non-fatal liver failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction, and muscle spasms. Rarely reported side effects include cognitive impairment (such as memory loss, forgetfulness, memory loss, memory impairment, confusion). Cognitive impairment has been reported with statin use. Very rarely reported side effects include angioedema and immune-mediated necrotizing myopathy (IMNM).

Cyclosporine: Cyclosporine may increase pitavastatin concentrations. Coadministration of cyclosporine with pitavastatin is contraindicated (see Contraindications).
Erythromycin: Erythromycin may increase pitavastatin concentrations. In patients taking erythromycin, the pitavastatin dose should not exceed 1 mg once daily (see Dosage & Administration).
Rifampicin: Rifampin may increase pitavastatin concentrations. In patients taking rifampicin, the pitavastatin dose should not exceed than 2 mg once daily (see Dosage & Administration).
Gemfibrozil: Because of the increased risk of myopathy/rhabdomyolysis when co-administered with HMG-CoA reductase inhibitors, concomitant administration of pitavastatin with gemfibrozil should be avoided.
Other Fibrates: As the risk of myopathy may be increased when coadministered with HMG-CoA reductase inhibitors and fibrates, pitavastatin should be administered with caution when coadministered with fibrates (see Precautions).
Niacin: Muscle pain may increase when pitavastatin is coadministered with niacin; a pitavastatin dose reduction should be considered (see Precautions).
Warfarin: Pitavastatin has no pharmacokinetic interactions with R- and S-warfarin. Pitavastatin does not affect prothrombin time (PT) or international normalized ratio (INR) when administered to patients receiving chronic warfarin therapy. Patients receiving warfarin should have their prothrombin time (PT) and international normalized ratio (INR) monitored when co-administered with pitavastatin.
Pediatric population: No data available in the pediatric population.

Store at temperatures below 30°C. Protect from light.

Dyslipidaemic Agents

C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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