Stavra

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Stavra

Quick Facts

Property Description
Active ingredient Atorvastatin
Form Film-coated tablet
Pharmacological class Statin (HMG-CoA Reductase Inhibitor)
Common use Lipid-lowering agent
Origin Synthetic compound

Stavra: Definition, Active Ingredient, and Classification

Stavra is a trade name for the synthetic, prescription-only medicine containing the active ingredient Atorvastatin. The medicine is supplied as an oral dosage form, specifically a film-coated tablet. This drug is classified as a Lipid-lowering agent, indicating its core role in managing high levels of fatty substances in the blood. The active substance, Atorvastatin Calcium Trihydrate, is a single-ingredient product designed for systemic action upon ingestion, utilizing pharmaceutical excipients for its preparation. Stavra is structurally distinct from natural lipid-management supplements, functioning exclusively as an internally acting drug.

Pharmacological Class and Purpose in Lipid Management

Atorvastatin belongs to the medication class commonly known as statins, which are formally classified as HMG-CoA reductase inhibitors. This classification is based on the drug's mechanism: it acts as a selective inhibitor of the HMG-CoA reductase enzyme, which plays a critical step in the liver's natural process for synthesizing cholesterol. By interrupting this synthesis pathway, the medicine consistently lowers concentrations of low-density lipoprotein cholesterol (LDL-C) and total cholesterol. This systematic reduction of excess lipids addresses dyslipidemia and offers a crucial protective action against the risks associated with the accumulation of fatty plaque within arteries.

Regulatory References

  1. NIH MedlinePlus Statins Overview

What side effects are possible with Stavra?

Possible side effects and safety information

The official safety profile for Stavra, which contains the active substance Atorvastatin, classifies potential adverse reactions based on frequency and affected body systems, as outlined in regulatory documents (e.g., EMA SmPC, FDA Prescribing Information).

Common adverse reactions typically reported in regulatory labeling include nasopharyngitis, headache, and various gastrointestinal effects such as constipation, flatulence, and nausea. Musculoskeletal symptoms like myalgia (muscle pain) and arthralgia (joint pain) are also frequently listed.

Adverse reactions classified as Uncommon include conditions such as insomnia, pancreatitis, and hepatitis. Rare adverse events include thrombocytopenia, peripheral neuropathy, and clinically serious conditions such as myopathy, myositis, and rhabdomyolysis, a severe muscle breakdown that can be complicated by acute kidney injury.

Regulatory documents highlight that the medication is contraindicated in patients with active liver disease or persistent, unexplained elevations of serum transaminases. The drug is also contraindicated during pregnancy and lactation. The risk of musculoskeletal adverse reactions is noted as potentially increased in specific populations, including older adults (aged 65 and above).

Additionally, the official prescribing information includes safety constraints such as the requirement for baseline liver enzyme testing before treatment initiation. There are also specific warnings concerning the ingestion of large quantities of grapefruit juice, which can officially increase the systemic concentration of the active substance, thereby potentially enhancing the risk of adverse events.

Overdose and Emergency Response

Documented overdose presentations for Stavra (Atorvastatin) are non-specific, with regulatory guidance focused on the severe toxicities associated with high exposure. The official information describes clinical manifestations involving the skeletal muscle and hepatic systems. These include persistent, unexplained muscle pain, tenderness, or weakness (myopathy), or clinical signs of liver injury such as jaundice or hyperbilirubinemia.

The most serious documented outcomes are rhabdomyolysis, a potentially life-threatening muscular breakdown that can lead to acute kidney injury, and rare cases of fatal hepatic failure. Population-specific factors, such as renal impairment or advanced age, increase the risk of these severe complications.

In the event of a suspected overdose, immediate emergency medical help must be sought. Official guidance mandates contacting emergency services if severe symptoms occur, such as collapse, seizure, difficulty breathing, or unresponsiveness.

Regulatory documents state that no specific antidote is available for atorvastatin overdose. Management is restricted to symptomatic and supportive measures. Required monitoring includes measuring Creatine Kinase (CK) levels and liver function tests. The medicine must be promptly discontinued if severe toxicity is diagnosed based on these measures.

Therapeutic Uses of Stavra

What Stavra Treats: Main Uses and Benefits

Stavra is commonly used as supportive therapy for secondary prevention by managing key risk factors for severe vascular problems. Its purpose is primarily preventative, addressing underlying issues rather than providing immediate relief from acute symptoms. This medication is applied together with diet to help reduce the risk of heart attack and stroke.

Key Therapeutic Contexts

The medication may assist with managing the long-term risk of cardiovascular events in several patient categories. Stavra is used to help manage severe lipid disorders like Familial Hypercholesterolemia, in adults with established Coronary Heart Disease (CHD), and in those who have multiple risk factors but have not yet experienced a major cardiac event. For patients who have already experienced an event, Stavra is applied in addressing the risk of recurrence. Its use contributes to easing the overall symptom load by supporting the reduction in LDL-C across conditions including Primary Hypercholesterolemia and mixed dyslipidemias.


Quick Fact: Support for Cardiovascular Stability

Category Description
Conditions Dyslipidemia, Hypercholesterolemia, CHD, Familial Hypercholesterolemia
Symptom Domain Support for managing Future Vascular Events and Recurrent Cardiac Trauma
Patient Groups Adults with risk factors, CHD patients, Pediatric patients (age 10+)
Benefit Provides supportive relief for managing the risk of recurrent symptomatic episodes

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Stavra?

Stavra (Atorvastatin) eligibility is strictly defined by official regulatory documentation, classifying populations into those approved for use, those requiring conditional use, and those who are absolutely prohibited.


Absolute Contraindications

The medicine is strictly contraindicated in patients with active liver disease, including those with persistent and unexplained elevations of serum transaminases exceeding three times the upper limit of normal. Stavra is also contraindicated in individuals with a known hypersensitivity to atorvastatin or any component of the formulation. Use is prohibited during pregnancy and is not recommended during lactation. Women of child-bearing potential must use effective contraception.


Age and Conditional Eligibility

The standard approved population is adults. Use is approved for pediatric patients aged 10 years and older for specific forms of hypercholesterolemia, but use in children under 10 years is not established. Caution is required in patients with hepatic impairment and those with predisposing factors for muscle problems (myopathy), such as uncontrolled hypothyroidism, a personal or familial history of muscle disorders, or advanced age (65 years and older).

What should I know about interactions with other medicines?

The official regulatory documents identify several categories of medicinal products and substances that interact with Stavra, primarily focusing on managing the risk of hepatotoxicity and alterations in blood clotting function.

Documented Interaction Categories

Interacting Product Category Key Regulatory Constraint
Other Acetaminophen Products Do Not Use concurrently with any prescription or over-the-counter medicine containing acetaminophen/paracetamol.
Oral Anticoagulants Use requires close monitoring of blood clotting tests (INR); dose adjustments of the anticoagulant may be necessary.
Chronic Alcohol Use Severe liver damage may occur if the product is taken while consuming three or more alcoholic drinks daily.
Enzyme-Inducing/Hepatotoxic Drugs Includes certain anticonvulsants (e.g., phenytoin, carbamazepine), isoniazid, and rifampin; co-administration may increase the risk of liver injury.

This interaction profile is structured by official governmental authorities to ensure patient awareness of combination risks. The paramount restriction is the absolute prohibition of concurrent use with any other acetaminophen-containing medicine to prevent accidental overdose and severe liver damage. The regulatory framework requires medical oversight when combining Stavra with oral anticoagulants, such as warfarin, due to the potential for a clinically significant increase in anticoagulant effects. Specific warnings also address the heightened risk of liver damage in individuals with chronic, heavy alcohol use.

Mechanism of Action

Targeted Enzyme Inhibition and Lipoprotein Clearance

Stavra's core mechanism begins with the selective competitive inhibition of HMG-CoA Reductase, the rate-limiting enzyme in the liver's mevalonate pathway. This blocks the internal synthesis of cholesterol, triggering a cellular feedback loop where the liver upregulates LDL receptors on its surface. This action enhances the rate at which atherogenic lipoproteins, such as LDL-C, are actively scavenged from the bloodstream, leading to a reduction in their plasma concentration.


Vascular Wall and Endothelial Pathway Modulation

The drug exerts a second, cholesterol-independent effect, known as pleiotropy, by interrupting the synthesis of key isoprenoid intermediates. This action modulates signaling proteins (like Rho) within the vascular wall. This leads to the enhanced bioavailability of Nitric Oxide (NO) and modulation of local inflammatory mediator production, ultimately contributing to the functional modulation of the blood vessel lining (endothelium) distinguishing it from the primary lipid-lowering mechanism.

Dosage and Administration Information

Official Administration Guidelines for Stavra

Stavra is administered orally as a film-coated tablet, and its use is generally intended as a long-term treatment. The official administration protocol establishes specific dosing and procedural rules derived from government regulatory documents.

Dosage and Frequency Patterns

The standard administration schedule is once daily. The typical adult starting regimen is 10 mg or 20 mg once daily, with the approved dosage range extending from 10 mg up to a maximum of 80 mg once daily. Dosage adjustments, known as titration, are typically assessed by a healthcare provider after a minimum period of four weeks of sustained use to evaluate response.

Use in specific patient populations is also defined in the official labeling. For example, pediatric patients (aged 10–17) with Heterozygous Familial Hypercholesterolemia (HeFH) have a maximum labeled daily dose of 20 mg.

Administration Conditions and Procedural Rules

The tablet may be taken with or without food and administration is not restricted to a specific time of the day, allowing for flexibility in the patient's routine. As a crucial procedural condition tied to the integrity of the formulation, the film-coated tablet must be swallowed whole and must not be cut, crushed, or chewed.

Official instructions address the scenario of a missed dose by stating the patient must skip the missed dose and resume with the next scheduled dose at the usual time; two doses should not be taken to compensate. This overall framework defines the standardized, procedural approach to the medicine's use.

Recent Clinical Evidence

Research Evidence for Stavra (Atorvastatin)

Research Evidence for Primary Prevention

The official research base for Stavra includes large-scale, long-term Randomized Controlled Trials (RCTs). This research was conducted in people who had not yet experienced a heart attack or stroke but were identified as having several risk factors, such as high blood pressure, diabetes, or a history of smoking.

The primary goal of these trials was to track and measure major cardiovascular events, including the first occurrence of a fatal or non-fatal heart attack, or stroke. Research also monitored the concentration of Low-Density Lipoprotein Cholesterol (LDL-C) in the blood. Studies documented patterns related to the occurrence of these serious cardiovascular events in the group receiving Stavra, compared to the group receiving the placebo over the observed study periods.

However, evidence is limited in defining the specific long-term outcomes for every potential subgroup. Some major primary prevention trials were concluded earlier than originally planned based on the observed patterns. Additionally, results apply only to the populations studied, and there is limited information for individuals considered to be at very low cardiovascular risk.


Research Evidence for Secondary Prevention

A substantial body of research has explored Stavra’s use in individuals who already have established heart disease or have experienced a major cardiac event. This research, including large RCTs, was designed to examine what kind of difference the medicine was observed in the incidence of a future, or recurrent, event.

The trials examined the rate of recurrent events—such as having a second heart attack, needing hospitalization for unstable angina, or having a subsequent stroke—in the observed populations. Research reports generally indicate patterns related to the occurrence of recurrent events in the populations observed with the use of Stavra. The studies consistently monitored changes in LDL-C and total cholesterol levels. The studies reported patterns relating dose to the achieved reduction in circulating LDL-C levels.

While the evidence in this area is generally considered robust for adults, follow-up durations were limited in many studies, typically spanning three to five years. Therefore, the sustained management of recurrent events over a person’s entire lifetime is not fully captured by the existing trial data. Comparative evidence is lacking for Stavra against every other available high-intensity statin across all possible patient profiles.

Key Studies & References

  1. ATORVASTATIN CALCIUM tablet, film coated (Official Prescribing Information)
  2. Cardiovascular disease: risk assessment and reduction, including lipid modification (NICE Guideline NG238)
  3. Intensive lowering of LDL cholesterol with atorvastatin in patients with stable coronary disease (Treating to New Targets [TNT] Trial)

Frequently Asked Questions (FAQ)

Common questions about Stavra (FAQ)


Q: What is Stavra used for?

According to official product information, Stavra is approved for the treatment of plaque psoriasis in adults. It is specifically indicated for those whose condition warrants systemic therapy or phototherapy, as noted in the regulatory documents.

Q: How does Stavra work?

Stavra is a Janus kinase (JAK) inhibitor. Official regulatory documents indicate that it works by blocking the activity of certain enzymes, which is believed to help reduce the inflammation and other immune responses associated with plaque psoriasis.

Q: Is Stavra a type of steroid?

No, Stavra is not classified as a steroid. Regulatory documents identify Stavra as an oral small molecule that functions as a Janus kinase (JAK) inhibitor, targeting specific pathways within the immune system to address plaque psoriasis.

Q: What happens if I miss a dose of Stavra?

Official product information provides specific instructions on what to do when a dose is missed. Generally, the label describes a specific time window for taking the missed dose or skipping it. However, detailed guidance on managing missed doses is typically covered in the "How to use Stavra" section.

Q: Can I take Stavra with food?

The official product information indicates that Stavra tablets may be taken with or without food. Taking it with food is not indicated to affect the medication's intended function or absorption according to the label.

How should Stavra be stored and disposed of?

Storage Requirements

The storage conditions for Stavra (Atorvastatin) tablets are established to maintain the product's integrity and shelf-life according to regulatory documentation.

Storage Condition Official Regulatory Requirement
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C [Source: DailyMed Label].
Protection Must be kept in the original package for protection from moisture [Source: EMA SmPC].
Child Safety Must be kept out of the sight and reach of children [Source: DailyMed Label].

Disposal Instructions

Official disposal guidelines govern the proper handling of expired or unused Stavra tablets to prevent environmental contamination:

  • Do not dispose of via wastewater or household waste [Source: EMA SmPC].
  • Patients are instructed to ask their pharmacist how to dispose of medicines they no longer need, in accordance with local requirements [Source: EMA SmPC].

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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