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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Zypitamag
Generic Name
Pitavastatin Magnesium
Active Ingredient
PitavastatinCategory
HMG-CoA Reductase Inhibitor [EPC]
Salt Form
Calcium
Variants
4
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 4 mg/1 | TABLET, FILM COATED | ORAL | 70771-1118 |
| 2 mg/1 | TABLET, FILM COATED | ORAL | 25208-201 |
| 4 mg/1 | TABLET, FILM COATED | ORAL | 25208-202 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Zypitamag, you must consult a qualified healthcare professional.
| 2 mg/1 | TABLET, FILM COATED | ORAL | 70771-1117 |
Detailed information about Zypitamag
Pitavastatin is a potent HMG-CoA reductase inhibitor (statin) used to manage lipid levels and reduce cardiovascular risk. It is distinguished by its unique metabolic pathway and high bioavailability.
For most adult patients, the recommended starting dose of Pitavastatin is 2 mg taken once daily. Depending on the patient's response and the specific lipid goals set by their healthcare provider, the dose may be increased to the maximum recommended dose of 4 mg once daily. It is important to note that the dose should be individualized based on the patient's baseline LDL-C levels, the goal of therapy, and the overall risk of cardiovascular disease.
Clinical studies have shown that the 2 mg and 4 mg doses provide significant reductions in LDL-C, often ranging from 30% to 45%. Because the liver synthesizes the majority of cholesterol during the night, some statins are recommended for evening administration; however, due to Pitavastatin's 12-hour half-life, it can be taken at any time of day, provided it is taken at the same time consistently.
Pitavastatin is FDA-approved for use in pediatric patients aged 8 years and older who have been diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH).
For patients with moderate to severe renal impairment (defined as a Glomerular Filtration Rate or GFR between 15 and 59 mL/min/1.73m²), the starting dose should be 1 mg once daily, with a maximum dose of 2 mg once daily. Pitavastatin is not recommended for patients with end-stage renal disease who are not on hemodialysis.
Pitavastatin is contraindicated (should not be used) in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. For those with a history of liver disease but currently stable, extreme caution and lower dosing strategies are required as determined by a physician.
In clinical trials, no overall differences in safety or effectiveness were observed between patients aged 65 and over and younger patients. However, because elderly patients are more likely to have decreased renal function or be taking multiple medications, healthcare providers usually monitor this population more closely for muscle-related side effects.
To ensure the maximum benefit from your medication, follow these guidelines:
If you miss a dose of Pitavastatin, take it as soon as you remember. However, if it is almost time for your next scheduled dose (within 12 hours), skip the missed dose and resume your regular dosing schedule. Do not take two doses at once to make up for a missed one, as this increases the risk of side effects.
In the event of an overdose, contact your local poison control center or seek emergency medical attention immediately. While there is no specific antidote for Pitavastatin overdose, healthcare providers will provide supportive care and monitor liver function and creatine phosphokinase (CPK) levels to check for muscle damage. Symptoms of overdose may include severe stomach pain, nausea, vomiting, or diarrhea.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as your cholesterol levels may rise rapidly upon discontinuation.
Pitavastatin is generally well-tolerated, but like all medications, it can cause side effects. The most commonly reported side effects (occurring in more than 10% of patients in some clinical contexts, though often less in controlled trials) include:
Pitavastatin is a powerful medication that requires careful monitoring. Patients should be aware that the risk of muscle-related side effects (myopathy) is dose-related and can be increased by certain factors, such as age (over 65), kidney problems, or untreated hypothyroidism. It is essential to maintain open communication with your healthcare provider regarding any new medications or changes in your health status while taking this drug.
No FDA black box warnings for Pitavastatin. While Pitavastatin is considered safe when used as directed, the absence of a black box warning does not mean the drug is without risk. All statins carry inherent risks for muscle and liver toxicity.
Pitavastatin can cause myopathy (muscle pain, tenderness, or weakness with creatine kinase [CK] values >10 times the upper limit of normal). The most extreme form is rhabdomyolysis, which can lead to acute renal failure. The risk is higher in patients taking certain other medications (see Interactions) or those with pre-existing renal impairment. If you experience unexplained muscle pain, especially if accompanied by fever or malaise, contact your doctor immediately.
There are certain medications that must NEVER be used with Pitavastatin due to the risk of severe toxicity:
Pitavastatin must NEVER be used in the following circumstances:
Pitavastatin is generally not recommended during pregnancy. Cholesterol and its derivatives are essential for the normal development of the fetus. By inhibiting cholesterol synthesis, Pitavastatin could theoretically cause fetal harm. In 2021, the FDA updated the labeling for statins to remove the 'Category X' classification to allow for more nuanced clinical decision-making, but for the vast majority of patients, the drug should be discontinued as soon as pregnancy is recognized. If you are planning to become pregnant, discuss a plan with your doctor to stop the medication at least one to two months before conception.
There is no definitive data on the presence of Pitavastatin in human milk. However, many other drugs in this class are excreted in milk. Because of the potential for disrupting the lipid metabolism of the nursing infant, women who require Pitavastatin therapy should not breastfeed. If the medication is essential for the mother's health, an alternative method of infant feeding should be used.
Pitavastatin is approved for children aged 8 to 17 years with Heterozygous Familial Hypercholesterolemia. Clinical trials have shown it to be effective in lowering LDL-C in this population with a safety profile similar to that of adults. Long-term effects on growth and sexual maturation have been studied, and no significant negative impacts have been observed over short-to-medium-term follow-up. However, it is not approved for children under 8 years of age.
Pitavastatin is a competitive inhibitor of the enzyme HMG-CoA reductase. This enzyme converts HMG-CoA into mevalonate, which is a precursor for cholesterol. By inhibiting this rate-limiting step, Pitavastatin reduces hepatic cholesterol synthesis. This triggers an 'upregulation' of LDL receptors on the surface of hepatocytes, which increases the clearance of LDL particles from the blood. Pitavastatin's unique cyclopropyl group allows for a more 'snug' fit into the enzyme's binding site, leading to potent inhibition at lower milligram doses compared to older statins like fluvastatin or pravastatin.
The dose-response relationship of Pitavastatin is well-characterized. A 1 mg dose typically reduces LDL-C by about 30%, while a 4 mg dose can achieve reductions of up to 45%. The onset of action begins within a few days of starting therapy, but the maximum effect on lipid levels is usually seen within 4 weeks. There is no evidence of the development of tolerance; the cholesterol-lowering effect remains consistent as long as the medication is taken.
| Parameter | Value |
Common questions about Zypitamag
Pitavastatin is a prescription medication used to treat high cholesterol (hyperlipidemia) and mixed dyslipidemia in adults and children at least 8 years old. It works by blocking an enzyme in the liver that produces cholesterol, thereby lowering 'bad' cholesterol (LDL) and triglycerides while raising 'good' cholesterol (HDL). By managing these lipid levels, Pitavastatin helps reduce the long-term risk of heart disease, heart attacks, and strokes. It is intended to be used alongside a heart-healthy diet and regular exercise. Your doctor may prescribe it if lifestyle changes alone have not been enough to reach your target cholesterol levels.
The most frequently reported side effects of Pitavastatin include muscle pain (myalgia), back pain, joint pain (arthralgia), and digestive issues such as diarrhea or constipation. Some patients also report mild headaches or symptoms similar to a common cold, like a sore throat. While most of these side effects are mild and temporary, muscle pain should always be reported to a doctor to rule out more serious conditions. It is important to remember that most people take this medication without experiencing significant problems. If side effects persist or become bothersome, your healthcare provider can discuss adjusting your dose or trying an alternative.
Moderate alcohol consumption is generally not strictly forbidden, but you should exercise caution. Because both Pitavastatin and alcohol are processed by the liver, heavy drinking can increase your risk of liver irritation or damage. Furthermore, alcohol can raise triglyceride levels, which may counteract the benefits of the medication. If you have a history of liver disease or are a heavy drinker, your doctor may advise you to avoid alcohol entirely. Always discuss your typical alcohol consumption with your healthcare provider before starting a statin regimen.
Pitavastatin is generally not recommended for use during pregnancy. Cholesterol is a vital building block for a developing fetus, and inhibiting its production could potentially cause harm to the unborn baby. While the FDA recently updated statin labels to allow for risk-benefit discussions in rare, high-risk cases, the standard medical advice is to stop taking Pitavastatin if you become pregnant or plan to become pregnant. If you are of childbearing age, it is recommended to use effective birth control while on this medication. Always consult your doctor immediately if you suspect you are pregnant while taking a statin.
Pitavastatin begins to lower your cholesterol levels within the first few days of starting the medication. However, it typically takes about 2 to 4 weeks of consistent use to reach the full therapeutic effect. Your doctor will likely schedule a follow-up blood test (lipid panel) about 4 to 12 weeks after you start the drug to see how well it is working and to determine if a dose adjustment is necessary. Even if you do not 'feel' different, the medication is working internally to improve your lipid profile. Consistency is key to seeing long-term results in cardiovascular health.
You should not stop taking Pitavastatin without first consulting your healthcare provider. When you stop taking a statin, your cholesterol levels will likely return to their previous high levels within a few weeks, which can increase your risk of heart attack or stroke. If you are experiencing side effects that make you want to stop, your doctor can help you taper off safely or switch you to a different medication that you might tolerate better. Statin therapy is usually a long-term commitment to maintaining heart health. Only a medical professional can safely manage the discontinuation of this drug.
If you miss a dose of Pitavastatin, take it as soon as you remember. However, if your next scheduled dose is less than 12 hours away, you should skip the missed dose and simply take your next one at the regular time. Never take two doses at the same time to 'catch up,' as this increases the risk of side effects like muscle pain or liver issues. Setting a daily alarm or using a pillbox can help you stay consistent with your medication. If you frequently miss doses, talk to your pharmacist about strategies to help you remember.
Weight gain is not a commonly reported side effect of Pitavastatin in clinical trials. However, some statins have been associated with a very slight increase in blood sugar levels, which can occasionally lead to metabolic changes. In most cases, any weight changes during statin therapy are more likely related to diet, lifestyle, or other underlying health conditions. If you notice a sudden or unexplained increase in weight while taking Pitavastatin, you should discuss it with your doctor. Maintaining a healthy diet and exercise routine remains the best way to manage weight while on this medication.
Pitavastatin can be taken with many other medications, but some important interactions exist. One of its main advantages is that it does not interact with many drugs that use the CYP3A4 pathway, such as certain antifungal or HIV medications. However, it should never be taken with Cyclosporine, and doses must be limited when taken with Erythromycin or Rifampin. It can also interact with other cholesterol-lowering drugs like gemfibrozil. Always provide your doctor and pharmacist with a complete list of all medications, supplements, and herbs you are taking to ensure your safety.
Yes, Pitavastatin is available as a generic medication. The FDA has approved generic versions of Pitavastatin calcium tablets, which are typically more affordable than the brand-name versions like Livalo. Generic medications are required to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. They must also meet the same rigorous standards for quality and effectiveness. If you are concerned about the cost of your medication, ask your doctor or pharmacist if a generic version of Pitavastatin is appropriate for you.
Other drugs with the same active ingredient (Pitavastatin)
These side effects may occur in a smaller percentage of patients:
Rare but documented side effects include:
> Warning: Stop taking Pitavastatin and call your doctor immediately if you experience any of the following serious symptoms:
With prolonged use, some patients and clinicians have noted the following:
No FDA black box warnings for Pitavastatin. Unlike some other medications, Pitavastatin does not currently carry the FDA's most severe warning label. However, it does carry significant 'Warnings and Precautions' regarding muscle and liver health that must be respected.
Report any unusual symptoms, especially unexplained muscle tenderness or weakness, to your healthcare provider immediately. Early intervention is key to preventing serious complications like kidney failure.
It is recommended that liver enzyme tests be performed before starting Pitavastatin and thereafter if signs or symptoms of liver injury occur (such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice). Persistent elevations in hepatic transaminases (ALT or AST >3 times the upper limit of normal) require a dose reduction or discontinuation of the drug.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors. Patients should be monitored for changes in blood sugar, especially if they are at high risk for developing diabetes.
Your healthcare provider will likely require the following tests:
Pitavastatin generally does not interfere with the ability to drive or operate machinery. However, if you experience dizziness or blurred vision as a side effect, you should avoid these activities until you know how the medication affects you.
Excessive alcohol consumption can increase the risk of liver damage when taking Pitavastatin. While an occasional drink may be acceptable for some, patients who drink heavily or have a history of liver disease should discuss their alcohol intake with their doctor. Alcohol can also raise triglyceride levels, potentially working against the goals of the medication.
Do not stop taking Pitavastatin suddenly without consulting your doctor. Cholesterol levels can return to their high baseline within weeks of stopping the drug. If you must stop due to side effects, your doctor will help you transition to an alternative therapy to ensure your cardiovascular risk remains managed.
> Important: Discuss all your medical conditions, including any history of liver disease, kidney disease, or thyroid problems, with your healthcare provider before starting Pitavastatin.
Pitavastatin can cause elevations in:
For each major interaction, the mechanism usually involves the inhibition of the OATP1B1 transporter (which helps the drug enter the liver) or the UGT metabolic pathway. When these are blocked, the drug stays in the blood longer, leading to increased toxicity. Management strategies usually involve dose reduction or choosing an alternative antibiotic or immunosuppressant.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter drugs.
These conditions require a careful risk-benefit analysis by your physician:
Patients who have experienced severe muscle pain or rhabdomyolysis with other statins (like atorvastatin, rosuvastatin, or simvastatin) may be at an increased risk of similar reactions with Pitavastatin. However, because Pitavastatin has a different metabolic profile, some patients who cannot tolerate other statins may be able to tolerate Pitavastatin under close medical supervision.
> Important: Your healthcare provider will evaluate your complete medical history, including any past reactions to cholesterol medications, before prescribing Pitavastatin.
Patients aged 65 and older may be more sensitive to the effects of Pitavastatin, particularly the risk of myopathy. This is often due to age-related declines in renal function or the presence of multiple comorbidities (other health conditions). While no specific dose adjustment is required based solely on age, doctors often start elderly patients at the lower end of the dosing range (1 mg or 2 mg) and monitor them closely for muscle weakness or pain.
The kidneys play a minor role in the elimination of Pitavastatin, but impairment can still affect the drug's concentration in the blood.
Pitavastatin is primarily cleared by the liver. In patients with mild hepatic impairment (Child-Pugh Class A), the drug should be used with caution, and doses should not exceed 2 mg. It is contraindicated in those with moderate to severe hepatic impairment or active liver disease.
> Important: Special populations require individualized medical assessment and more frequent laboratory monitoring to ensure safety and efficacy.
| Bioavailability | ~51% |
| Protein Binding | >99% (mainly Albumin) |
| Half-life | ~12 hours |
| Tmax | ~1 hour |
| Metabolism | Minimal CYP2C9/2C8; Primary Glucuronidation (UGT) |
| Excretion | Fecal 79%, Renal 15% |
Pitavastatin is a member of the 'statins' or HMG-CoA reductase inhibitors. It is often grouped with 'high-potency' or 'modern' statins because of its ability to achieve significant LDL reduction at very low doses. Related medications include Atorvastatin (Lipitor), Rosuvastatin (Crestor), and Simvastatin (Zocor). Pitavastatin is unique within this class due to its minimal reliance on the CYP3A4 metabolic pathway, which differentiates its drug interaction profile from many of its peers.