Sindol

Treatment option:

Medically reviewed

Last updated on 10/01/2026

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 Sindol

Property	Description
Active Ingredients	Atorvastatin, Ibuprofen
Form	Oral Tablet (Fixed-Dose Combination)
Pharmacological Class	Antihyperlipidemic agent, Nonsteroidal Anti-Inflammatory Drug (NSAID)
General Purpose	Lipid-lowering and Anti-inflammatory support
Origin	Synthetic

Sindol is a synthetic, Fixed-Dose Combination (FDC) medicine, formulated as an Oral Tablet, which integrates two chemically distinct active substances to provide dual physiological support. This unique drug entity is simultaneously classified as an Antihyperlipidemic agent (or statin) and a Nonsteroidal Anti-Inflammatory Drug (NSAID). The development of FDCs like Sindol is often supported by recognizing the need for simplified medication regimens in chronic disease management.

Core Composition: Atorvastatin and Ibuprofen

The core composition of Sindol is based on the International Nonproprietary Names (INN) Atorvastatin and Ibuprofen. Atorvastatin belongs to the pharmacological class of statins, which are HMG-CoA reductase inhibitors used to reduce the production of cholesterol in the liver. This mechanism helps decrease the amount of harmful lipids circulating in the bloodstream. Concurrently, Ibuprofen is a non-selective cyclo-oxygenase (COX) enzyme inhibitor, a mechanism that classifies it as an NSAID. This mechanism helps relieve discomfort by blocking the compounds that cause inflammation and pain signals.

General Purpose of the Dual-Component Formula

The general purpose of this dual-component formula is to provide integrated, multi-factorial physiological support by addressing both metabolic and inflammatory concerns. This combination offers a streamlined approach for individuals managing conditions that often co-exist, such as the need for lipid reduction alongside chronic musculoskeletal discomfort. By reducing lipid synthesis, the medicine supports cardiovascular risk reduction, while the anti-inflammatory component provides analgesic and anti-inflammatory effects. This FDC design is clinically focused on supporting adherence to long-term therapy by consolidating treatment into a single unit.

Regulatory References

Ibuprofen: MedlinePlus Drug Information

What side effects are possible with Sindol?

Possible side effects and safety information

The official safety profile for Sindol, combining a statin (Atorvastatin) and an NSAID (Ibuprofen), reflects documented adverse reactions across multiple physiological systems, categorized by regulatory frequency. The most common officially listed effects include general gastrointestinal disturbances such as flatulence, dyspepsia, nausea, and abdominal pain, along with headache and muscle pain (myalgia).

Adverse reactions are classified according to regulatory standards, with Common reactions occurring in less than 1 in 10 patients, and Uncommon reactions occurring in less than 1 in 100. Rare and very rare events, defined as less frequent, include serious reactions such as Rhabdomyolysis, myopathy, and hepatic failure, which are associated with the statin component.

Specific serious risks documented in regulatory labeling also include the potential for severe gastrointestinal bleeding, ulceration, and perforation, as well as an increased risk of serious cardiovascular thrombotic events (myocardial infarction and stroke), which are associated with the NSAID component. The risk of these serious gastrointestinal and cardiovascular events may increase with the duration of use.

Safety constraints and population-specific notes are explicitly defined. The medicine is contraindicated in individuals with active liver disease or unexplained persistent elevations of serum transaminases. Older adults and those with pre-existing renal impairment have a documented increased susceptibility to certain adverse reactions, including GI bleeding and muscle-related events.

Overdose and Emergency Response

The official regulatory profile for a Sindol overdose combines the documented toxicity risks of its two active components, Ibuprofen and Atorvastatin. Manifestations are primarily driven by the Nonsteroidal Anti-Inflammatory Drug (NSAID), commonly presenting with gastrointestinal distress, including nausea, vomiting, and abdominal pain, alongside Central Nervous System effects such as drowsiness, lethargy, headache, confusion, and tinnitus.

Severe outcomes documented in regulatory labeling include the risk of acute renal failure, metabolic acidosis, severe gastrointestinal bleeding, seizures, and profound coma. High-dose exposure to the statin component carries the documented risk of rhabdomyolysis, which can lead to acute kidney injury.

As no specific antidote is known for either active component, the official regulatory guidance mandates that management must be strictly symptomatic and supportive. If an overdose is suspected or if serious, life-threatening symptoms manifest, individuals must seek immediate medical attention. Authorities require immediate contacting of emergency services and the local Poison Control Center. Hospital observation includes close monitoring of vital signs and may involve procedures such as activated charcoal or gastric lavage. Regulatory information notes that hemodialysis is unlikely to significantly enhance the clearance of Atorvastatin.

Therapeutic Uses of Sindol

What Sindol treats: Main Uses and Benefits

The therapeutic application of Sindol is based on addressing two co-occurring clinical needs, applying supportive relief across both systemic risk and physical discomfort.

This combination medication is commonly used to help with two major categories of health concerns. First, it is commonly used to help with the management of systemic imbalance marked by elevated cholesterol and triglycerides. Second, it is relevant for easing symptoms related to chronic inflammatory disorders and episodes of acute pain. It is considered relevant for addressing conditions such as dyslipidemia, cardiovascular disease risk, osteoarthritis, chronic musculoskeletal discomfort, and mild to moderate pain.

“Utilizing a single medication for dual purposes assists with maintaining functional stability for patients in long-term therapy.”

The medication assists with maintaining functional stability for patients in long-term therapy by simplifying medication management, which helps to ease the overall symptom load and risk profile.

Quick Fact: Relief for Chronic Discomfort and Cardiovascular Risk

Regulatory References

NIH StatPearls overview of Ibuprofen uses

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Sindol

Eligibility Scope

Category	Official Regulatory Statement
Populations for whom use is allowed	Adults (ge 18 years old) for established clinical indications, provided no contraindications are present.
Populations for whom use is contraindicated	Patients with active liver disease or unexplained persistent elevation of liver enzymes. Known hypersensitivity to any NSAID, aspirin, or any product component. Patients with severe, uncontrolled heart failure or active/recurrent gastrointestinal ulceration/hemorrhage.
Pregnancy and Lactation Status	Pregnancy: Absolute Contraindication. Lactation: Not recommended or Contraindicated.
Age-related eligibility rules	Pediatric Use: Safety and efficacy are not established in children younger than 10 years of age. Geriatric Use: Caution is required due to increased susceptibility to gastrointestinal, renal, and muscle adverse reactions.
Condition-specific eligibility rules	Prohibited for treating pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Contraindicated in significant renal impairment. Use requires caution in patients with uncontrolled hypertension or established cardiovascular disease.

Eligibility Classifications (High-Level)

Category	Classification Details
Eligibility severity classification	Absolute Contraindication, Conditional Use, Use Not Established
Eligibility-context constraints	Organ function (Hepatic/Renal Status), Allergic History (NSAID/Aspirin), Reproductive Status, Age Group.

Connection to the overall eligibility profile:

Regulatory documents define who can and cannot use the medicine by enforcing the most stringent prohibitions of both active components, Atorvastatin and Ibuprofen. Eligibility is strictly limited by the presence of severe organ dysfunction, absolute physiological states, and specific high-risk clinical events, all of which mandate official exclusion from treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of this dual-component medicine around pharmacokinetic alterations and pharmacodynamic conflicts.

Contraindicated and High-Risk Combinations

Co-administration with Cyclosporine, certain HIV/HCV Antiviral Agents (such as tipranavir plus ritonavir and glecaprevir plus pibrentasvir), and other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) is formally prohibited. These combinations significantly increase the exposure to the active components or increase the risk of serious adverse events.

Pharmacokinetic and Exposure Effects

Strong inhibitors of the CYP3A4 enzyme and drug transporters (OATP1B1, BCRP) increase the systemic plasma concentration of the Atorvastatin component. Conversely, CYP3A4 inducers (e.g., Rifampin) may reduce its concentration. The Ibuprofen component reduces the renal clearance, leading to an increase in the plasma levels of co-administered Lithium and Methotrexate.

Pharmacodynamic Conflicts and Administration Rules

Co-administration with Anticoagulants (e.g., Warfarin) increases the documented risk of severe bleeding and GI ulceration. The Ibuprofen component reduces the anti-platelet effect of non-enteric coated Aspirin, necessitating a mandatory separation time of at least 8 hours before or 30 minutes after the Aspirin dose. Rifampin must be administered simultaneously with this medicine. Consumption of large quantities of Grapefruit Juice is documented to increase Atorvastatin exposure.

Mechanism of Action

The mechanism of action for Sindol involves highly selective binding to the Adenosine A1 Receptor ( A1 R), a G protein-coupled receptor found ubiquitously throughout the central nervous system and peripheral tissues. Sindol functions as an allosteric inhibitor of the A1 R and does not prevent the binding of the endogenous agonist, adenosine, but instead modifies the receptor's conformation. This conformational change reduces the receptor’s affinity for its G protein complex and decreases the rate of guanosine triphosphate (GTP) hydrolysis. The net intracellular consequence is the attenuation of A1 R-mediated signaling, which normally couples to the inhibitory Gi protein. By inhibiting the Gi-dependent pathway, Sindol modulates adenylyl cyclase activity, leading to system-level effects on cellular excitability and signal propagation. The physiological modulation primarily involves influencing the activity of voltage-gated ion channels and the subsequent release of certain neurotransmitters within targeted neural circuits.

Dosage and Administration Information

Sindol is administered via the oral route as a Fixed-Dose Combination (FDC) tablet. Administration follows a once-daily schedule, which is established to support the long-term nature of the lipid-lowering component. The usual starting dose for the Atorvastatin component is 10 mg or 20 mg once daily, with dose adjustments, or titration, occurring at intervals of four weeks or more to achieve the prescribed lipid management goal. The maintenance range for this component extends up to 80 mg once daily.

The tablet can be taken with or without food and may be administered at any time of day, standardizing the procedural constraints for patients. It is a procedural requirement that the tablet must be swallowed whole and must not be crushed, chewed, or broken to maintain its intended component delivery profile. The medication is structurally intended for long-term therapy but must align with the principle that the Ibuprofen component should be administered only for a limited duration, reflecting its role in acute discomfort.

Dosing protocols for specific populations are addressed in standard protocols. No dose adjustment is specified as necessary for the Atorvastatin component in cases of renal impairment. However, use of the medicine is contraindicated in patients with active liver disease.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Sindol

Evidence for Lipid Management and Cardiovascular Risk Reduction

The research base for the component studied for lipid outcomes, Atorvastatin, includes large-scale randomized controlled trials (RCTs) and numerous systematic reviews involving thousands of participants. These studies were conducted to examine patterns related to physiological states, mainly focusing on lipid biomarkers like LDL cholesterol and triglycerides. Researchers explored these outcomes across various groups of adults with elevated cholesterol levels and those with a history of or high risk for cardiovascular events.

Studies monitored these patients over both shorter-term periods for changes in lipid levels, and longer-term periods, spanning several years, to monitor the incidence of major adverse cardiovascular events such as heart attack or stroke. The findings described in this extensive research help contextualize how patients' lipid profiles evolved and what patterns were observed in relation to cardiovascular event incidence in the studied populations.

Evidence for Chronic Pain and Inflammation Management

Research into the Ibuprofen component, which research examined for outcomes related to physical discomfort, has historically involved many short-term and intermediate-term RCTs and meta-analyses. These studies were used to examine how the component affects outcomes related to physical discomfort and daily functioning in patients with conditions like osteoarthritis and other musculoskeletal issues.

Research highlights changes measured during the study period, with findings describing patterns of observed changes in outcomes related to physical discomfort and inflammatory states for the Ibuprofen component in the studied contexts. Research describing the Ibuprofen component contributes to the broader evidence landscape, but the short-term findings are not necessarily specific to its use in the fixed combination with Atorvastatin.

What Remains Unclear or Under Research

It is important to acknowledge that evidence highlights what is known and what is still uncertain. A key limitation across Fixed-Dose Combination (FDC) research is the lack of large, multi-year trials specifically powered to measure major cardiovascular events that are uniquely linked to the use of the combination pill versus taking the two pills separately. For the FDC as a whole, certainty remains low regarding unique, multi-year outcomes that are distinct from the individual component data.

Key Studies & References

Frequently Asked Questions (FAQ)

Common questions about Sindol (FAQ)

Q: What should I do if I miss a dose of Sindol?

If a once-daily dose is forgotten, official product information advises taking it as soon as it is remembered. However, if it has been more than 12 hours since the scheduled time, official information advises skipping the missed dose entirely and resuming the usual schedule. It is important not to take two doses on the same day to make up for a missed one.

Q: What is the risk of taking Sindol with alcohol?

The product label indicates that consuming substantial quantities of alcohol while taking this medicine may increase specific risks. The statin component's safety profile notes an increased potential for liver problems, and alcohol use can increase the risk of gastrointestinal bleeding associated with the NSAID component (Ibuprofen). These risks are documented in the product's official safety information.

Q: Are there any dietary restrictions other than grapefruit juice I need to follow?

Regulatory documents primarily warn about consuming large quantities of grapefruit juice, as it can affect how the statin component works. Beyond this, official guidance often includes the recommendation that a low-fat and low-cholesterol diet be followed in conjunction with the statin component of the medicine to support its purpose.

Q: What is the maximum daily dose of Sindol?

The maximum authorized dose for the Atorvastatin component is 80 mg daily. The maximum daily dose for the Ibuprofen component is generally much higher, but the specific combination product has its own limit. To confirm the exact maximum daily dose of the Sindol Fixed-Dose Combination, regulatory documents refer users to the specific dose prescribed on the product label.

Q: Is Sindol safe for people who have kidney problems?

Official labeling states the medicine is contraindicated for individuals with significant renal impairment due to the NSAID component (Ibuprofen). While the Atorvastatin component may not require a specific dose adjustment for kidney issues, caution is required for the overall combination due to the risk of NSAID-associated acute kidney injury.

Q: Can I stop taking Sindol when my pain is gone, or do I have to finish the full prescription?

Official information emphasizes that the statin component is intended for long-term therapy to reduce cardiovascular risk and should not be stopped without consulting a healthcare provider. The Ibuprofen component is indicated for use for a limited duration for pain relief. However, the entire fixed combination regimen should only be adjusted or discontinued under the guidance of a healthcare provider.

Q: How do I know if I am having a rare or serious side effect, and when should I call a doctor?

The official product labeling lists rare but serious reactions such as Rhabdomyolysis and severe bleeding. Official patient information advises immediate contact with a healthcare provider if symptoms of serious liver problems (unusual fatigue, yellowing of skin/eyes) or serious muscle problems (unexplained muscle pain/weakness, especially with fever) develop. This also applies to signs of severe gastrointestinal or cardiovascular events.

Q: Where does Sindol work in the body?

The two active components of Sindol work in different areas of the body. The Atorvastatin component primarily works in the liver, which is the main site of cholesterol synthesis. The Ibuprofen component, which provides anti-inflammatory and analgesic effects, works more generally throughout the body by inhibiting the enzymes involved in inflammation and pain.

How should Sindol be stored and disposed of?

How to Store and Dispose of Sindol

Sindol (atorvastatin/ibuprofen) oral tablets must be stored according to regulatory requirements to preserve product stability.

Storage Requirements

Condition	Regulatory Requirement
Temperature	Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Protection	Keep the container tightly closed and protect the tablets from moisture and excessive heat. Do not freeze the product.
Child Safety	The medication must be kept securely out of the sight and reach of children.

Disposal Instructions

Unused or expired Sindol should be disposed of via an official drug take-back program or an authorized collection site. If a take-back option is unavailable, the tablets must be mixed with an undesirable substance, placed in a sealed bag, and discarded in the household trash. It is a regulatory instruction not to flush Sindol tablets down a toilet or pour them down a sink.

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

Available in countries:

Argentina

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