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Indobufen: A Closer Look at Its Historical Path, Characteristics, Applications, and Future

Historical Development

Development of Indobufen started in the 1970s in Italy. Researchers set out to find better solutions for antiplatelet therapy, motivated by the risks of the day’s standard drugs like aspirin, particularly the higher rates of gastrointestinal bleeding. Over several years, scientists explored derivatives of butylphenyl compounds, seeking alterations that could temper side effects while keeping activity. Indobufen took shape through these early pharmacological explorations, showing an impressive ability to inhibit platelet aggregation. European clinics began using the drug in the 1980s, focusing largely on patients who needed blood-thinning medication for chronic vascular conditions but who struggled with aspirin’s impact on the stomach. This legacy lives on, as Indobufen often steps in where adverse reactions to aspirin limit options.

Product Overview

Indobufen stands as a non-steroidal, anti-inflammatory drug (NSAID) with selectivity for platelet cyclooxygenase. Physicians use it mostly to reduce the risk of blood clots, which can trigger heart attacks or strokes, especially in folks with peripheral arterial disease or who face post-operative complications after heart procedures. This drug steps up as an alternative for patients with aspirin intolerance. Indobufen typically comes in the form of tablets for oral intake, each one containing dosages geared for steady platelet inhibition without tipping the scale toward higher bleeding risk. Labeling always underscores prescription-only use, bearing clear usage directions, warnings, and guidance about patient eligibility.

Physical & Chemical Properties

Indobufen appears as a white to off-white crystalline powder. Its molecular formula is C19H17NO4, and it tips the scales with a molecular weight around 323.34 g/mol. Water barely dissolves it, but methanol and acetone handle the task well. Melting usually clocks in near 140-143°C. Structurally, Indobufen belongs to the class of arylacetic acids, with a butylphenyl group anchoring its core, along with an indole fragment that shapes its pharmacological identity. Its physical stability makes it easy to handle in tablet production. Stability studies show Indobufen tolerates normal pharmaceutical storage without significant decomposition for several years, had the packaging kept airtight and cool.

Technical Specifications & Labeling

You often see Indobufen tablets carrying strengths like 100 mg or 200 mg. Manufacturers design the tablets for oral use, with guidance to take them with meals to cut down on potential gastrointestinal irritation. The product labels print batch number, expiry date, storage instructions—typically below 25°C away from moisture—and explicit cautionary notes about risks, like bleeding or allergy. Additionally, instructions urge users with peptic ulcer disease, hepatic insufficiency, or those taking anticoagulants to seek medical advice. Each batch runs through a spectrum of quality control tests. These include checks for purity (high-performance liquid chromatography), dose content, tablet hardness, dissolution rate, and microbial contamination. Labels always feature the generic and brand names, and regulatory numbers, in line with regional drug authority requirements.

Preparation Method

Synthesis of Indobufen involves multi-step organic chemistry. The foundational step starts by constructing the indole core, which involves cyclization reactions—often via Fischer indole synthesis, relying on hydrazines and ketones as building blocks. The next step attaches the butylphenyl group via Friedel-Crafts alkylation. Carboxylation reactions introduce the acetic acid side chain, and the final purification involves recrystallization, sometimes with organic solvents like ethanol or acetone. Each step demands close monitoring of reaction temperatures and pH, with chromatographic analysis to track intermediates and final yield. The high degree of purity remains essential, as residual solvents or byproducts might trigger side effects in patients.

Chemical Reactions & Modifications

Chemists have combed through analogs of Indobufen, modifying substituents on the indole ring and tweaking the acetic acid side chain to probe for improved pharmacokinetics and reduced toxicity. Typically, esterification, amidation, and halogenation reactions get tested, aiming for better absorption or metabolic stability. One challenge that stands out is finding tweaks that sharpen antiplatelet activity without tilting over into harmful NSAID-type effects, like gastric irritation. Over the years, efforts with prodrug strategies—masking the acidic group—tried to smooth out gastrointestinal tolerance, though only a handful of these modifications reached human trials. So the original Indobufen structure persists as the mainstay in clinical use.

Synonyms & Product Names

Indobufen appears under different trade labels in various markets. In Italy, you might spot it as Ibustrin, while other countries host names like Buflex and Tromalyt. A few databases list the compound under systematic names such as 2-(1-oxo-2-indolinyl)butylphenylacetic acid. Pharmacopoeias and medical references use the universal name “indobufen” which often appears in scientific articles and regulatory dossiers. Each synonym marks a chapter of its global distribution, with specific brand formulations tied to local licensing and pharmaceutical company strategies.

Safety & Operational Standards

Handling Indobufen in production environments draws on standard operating procedures shared across the pharmaceutical industry. Workers use gloves and occasionally protective masks during handling of the raw powder, as dust inhalation or skin contact can cause irritation. Production units keep records in compliance with Good Manufacturing Practice (GMP) standards, emphasizing cleanliness, traceability, and batch consistency. In clinical use, adverse reaction monitoring takes top priority—liver and renal function tracking, complete blood counts, and surveillance for bleeding symptoms run in parallel for long-term users. Pharmacies must hold tightly to the prescription-only status, preventing inappropriate over-the-counter use that might drive up preventable adverse events.

Application Area

Cardiology and vascular medicine use Indobufen for patients who need antiplatelet therapy—think of people with coronary artery disease, those recovering from bypass surgery, or cases of intermittent claudication due to restricted blood flow. Doctors often prescribe it after recognizing intolerance to aspirin or clopidogrel, so it fills a clear therapeutic gap. Indobufen has also earned respect for lowering risk of occlusion in patients who’ve received vascular grafts. The drug occasionally turns up in hospital settings as a bridge treatment during temporary aspirin withdrawal for surgical procedures. Use reaches into neurology as well, especially in secondary stroke prevention, though guidance usually weighs bleeding risk against benefits for each person.

Research & Development

Indobufen’s research history includes trials comparing its effectiveness and safety to aspirin and newer antiplatelet agents. Meta-analyses over the last two decades point toward non-inferior activity for prevention of vascular events, and notably lower rates of gastrointestinal bleeding. Recent years brought interest in combination therapy, where Indobufen pairs with proton pump inhibitors to protect the stomach lining. Animal studies and ex vivo assays drive continuing interest in how changes to its molecular structure might further blunt side effects or improve absorption. Genetic research explores how patient-specific factors—like polymorphisms in metabolic enzymes—influence the best fit for antiplatelet therapy. Results feed new ideas for personalizing choices, a trend that seems set to shape clinical guidelines in the future.

Toxicity Research

Toxicological studies reveal that Indobufen, like most NSAIDs, can alter gastrointestinal integrity and cause mild to moderate irritation at high doses or chronic exposure. Fatal outcomes remain rare and typically involve massive overdoses or compounding medical conditions. Standard dose ranges, validated by controlled studies, show little evidence for nephrotoxicity or liver injury, setting Indobufen apart from some older NSAIDs. Chronic studies in rodents and dogs flag no signals for carcinogenicity. Still, cross-reactivity in patients sensitive to sulfonamides or any constituent excipient needs consideration, as allergic phenomena crop up from time to time. Preclinical studies explore reproductive safety, noting the same kind of caution that underpins limits for pregnant or lactating patients for all NSAID-class drugs.

Future Prospects

The future of Indobufen likely ties in with ongoing demand for safer, patient-tailored antiplatelet regimens. As healthcare systems lean on risk prediction models, picking drugs that match a patient’s bleeding risk, allergy profile, and clinical goals puts options like Indobufen under the spotlight. New formulations aiming for once-daily dosing could help adherence. Research keeps pushing into machine learning models that draw on big datasets to identify which patient types do best with this molecule. Competition with newer agents like direct oral anticoagulants runs hot, but physicians weigh safety histories carefully, and Indobufen’s profile—reduced gastritis, reliable platelet inhibition—helps it keep a seat at the table. As international guidelines evolve, and access to quality generics grows, Indobufen looks set to play a supporting role, especially in settings where aspirin falls short or patients demand alternatives backed by decades of real-world evidence.




What is Indobufen used for?

Introduction to Indobufen's Role

Indobufen stands out as a medication that doctors prescribe to help keep blood flowing smoothly. Used mainly for its antiplatelet properties, it acts to keep platelets from clumping together and forming dangerous clots. My work with patients recovering from heart attacks keeps the need for reliable antiplatelet drugs front and center. Avoiding unwanted blood clots can mean the difference between continued health and a sudden medical emergency.

Why Platelet Inhibitors Matter

Blood clots have a bad habit of showing up when least expected. Inside damaged or narrowed arteries, clots can trigger a heart attack or stroke. Indobufen enters the scene as an alternative to classics like aspirin, especially for people who need something less harsh on the stomach or who can’t tolerate other blood-thinners. Clinical trials published in peer-reviewed journals have described how indobufen demonstrates both effectiveness and a manageable side effect profile. Results from large-scale research support its ability to reduce the risk of further cardiovascular events in people with a history of heart trouble or who just underwent surgery to open clogged arteries.

Indobufen in the Real World

Medicine becomes most meaningful outside the lab, right in the clinic or hospital. Doctors may recommend indobufen to help prevent clotting after procedures like angioplasty, or for people with heart rhythm problems such as atrial fibrillation, especially those who shouldn’t take conventional blood thinners for various reasons. I’ve seen patients with sensitive stomachs handle indobufen with fewer complaints about discomfort or bleeding compared to some alternatives.

It isn’t limited only to the heart. Indobufen gets used in certain cases to help people with blood flow problems in the legs, like peripheral artery disease. Some kidney specialists include it in treatment plans for people on dialysis to lower the risk of clots inside their access grafts. That sort of flexibility makes it a useful tool across several specialties.

The Science Supporting Its Use

Years of research into platelet function predictably land on one common thread: controlling unwanted clotting saves lives. Indobufen’s impact comes from its ability to block cyclooxygenase and disrupt the chemical signals that encourage platelets to stick together. By preventing platelet aggregation, it helps cut down the risk of heart attacks and strokes in people already at elevated risk. A meta-analysis in the European Heart Journal compared indobufen favorably with aspirin in certain settings, noting fewer gastrointestinal issues and similar levels of protection against blood clots.

Looking to the Future

Using indobufen comes with a responsibility to tailor decisions to the person sitting across the exam table. Every patient brings a unique set of challenges. One struggling with stomach ulcers might benefit from indobufen more than aspirin. Those with multiple medical problems find comfort in a medication proven to lower the risk of serious events without adding excessive risk. Regular monitoring matters, so the right dose lands safely in the therapeutic window. Pharmacists and doctors both encourage talking openly about all the medicines and supplements being used to spot risks before they become problems.

Access remains a hurdle. Indobufen hasn’t replaced aspirin everywhere, and some countries don’t offer it as widely. Collaboration between regulators and healthcare providers could expand the choices for those searching for an effective antiplatelet without stomach upset. The ultimate goal mirrors every conversation at a follow-up appointment: fewer emergencies, more peace of mind, and another chance for the heart to keep doing its job.

How should Indobufen be taken?

Understanding Its Purpose

Indobufen belongs to a group of medications known as antiplatelet agents. Doctors often recommend it to help prevent blood clots for people who are at higher risk of heart attacks or strokes. The drug works by making blood less sticky, lowering the chances of dangerous clotting in the veins and arteries. With something as serious as clot prevention, even small slip-ups in how you take your medicine can carry big risks.

How to Take It: What Works Best

The most important thing about indobufen is finding a routine that fits your life, so you don’t miss a dose. Most doctors suggest taking it at the same times each day, usually morning and evening. Some people wonder about taking it with or without food. From practical experience, taking doses with food or just after a meal lessens the chances of an upset stomach, which can make sticking with a long-term medication easier.

It’s pretty common for folks to struggle with taking daily medication. Skipping pills now and then might feel harmless, but indobufen isn’t very forgiving that way. It loses its blood-thinning effect fast after a missed dose. Those who’ve lived through minor strokes or heart scares know the high stakes. Taking your med every day turns into non-negotiable insurance.

Troubleshooting the Routine

No medicine is easy for everyone. Indobufen can leave some people dealing with belly pain or heartburn, especially early on. Listen to your body but don’t stop the medication cold turkey unless a doctor says so—missing doses could raise your risk of a clot. If side effects won’t let up, reaching out to your care team for some tweaks—like changing dose timing or switching to another medication—often smooths things out.

Some folks take a whole lineup of pills for blood pressure, cholesterol, and sugar. It’s tempting to lump everything together, but medication timing matters. Double-check with your doctor or pharmacist in case indobufen might clash with other meds or herbal remedies. Aspirin, other painkillers, or anticoagulants could double up the blood thinning and cause bleeding trouble—something nobody needs.

Remembering More Than Just a Pill

Many have found simple tricks to keep on track—phone alarms, pill boxes, and leaving meds next to a toothbrush. Older adults sometimes face memory hurdles. Bringing in family support or home nursing makes a difference. The goal goes far beyond swallowing a pill: it’s about holding onto solid brain health and keeping the heart beating steady.

Safe, Smart, and Personal

A lot of knowledge around indobufen comes from medical studies showing fewer heart and stroke events when people follow instructions consistently. But every body is different, and doctors take into account age, other diseases, and even cultural food habits. Keeping regular checkups helps spot problems early. Blood tests and pressure readings shine a light on whether the routine is working.

No drug comes without risks. Bleeding is a real concern, especially for those using other blood thinners. Dark stools, easy bruising, or nosebleeds need fast attention—waiting it out tends to do more harm than good. Sharing everything you take, including over-the-counter stuff and supplements, helps the medical team give safer advice.

Wrapping Up

Taking indobufen the right way means listening to your own body, asking questions, and sticking with long-term habits. The stakes are high because the risk of strokes and heart attacks always lurks in the background for many who rely on this medicine. Learning to manage the routine in real life helps build trust not only in your own instincts but in the partnership with your doctors and caregivers. That kind of teamwork keeps the odds in your favor.

What are the common side effects of Indobufen?

Understanding Indobufen Use in Everyday Life

Indobufen gets prescribed to help stop blood clots, much like aspirin. Doctors use it for people with heart or circulation problems, hoping to cut down on the risk of a heart attack or stroke. The benefits seem straightforward at first glance, but actually taking the tablets involves a bit more than that. Like anything that changes how blood flows, indobufen can come with a side order of trouble.

The Most Frequent Reactions: Blood and Gut Issues

Most folks notice stomach problems first. Indobufen can lead to pain or discomfort after meals, some heartburn, and at times, bouts of nausea. Once, after taking my own course of anti-inflammatory medication for a sports injury, the dull ache in my belly brought home just how much these pills can upset the system. Over-the-counter remedies offer some help, but talking to a pharmacist or doctor always seems a good step if the ache won’t quit.

Odds of bleeding go up as well. Some patients report nosebleeds, or notice blood when brushing their teeth. More seriously, there can be bleeding in the stomach or intestines. Blood in stool, black tarry bowel movements, or vomiting what looks like coffee grounds signal big red flags—proof that side effects can turn dangerous. No one likes to rush to urgent care, but these are signs that shouldn’t get ignored. Research published in the Annals of Internal Medicine backs up these worries. The risk rises with age or a history of ulcers.

Less Common, Still Troubling

Some people break out in a rash, or start itching more than usual. Destined for rare company, a handful might swell up, get wheezy, or feel their lips tingle. These signs can point to a real allergy that demands a quick call to the doctor. My own grandmother once developed hives after starting a new blood thinner—she stopped immediately, which turned out to be the right call since an allergic reaction can get serious fast.

Headaches pop up, along with dizziness. It’s easier to trip or feel wobbly, especially in the first week. Every bottle carries warnings, but the reality hits when someone stands up too fast and their vision swims. It pays to sit down and move slowly until the body adjusts. The European Society of Cardiology points out that mixing indobufen with certain blood pressure pills or alcohol can make these dizzy spells worse.

Keeping Side Effects in Check

Doctors check on kidney and liver health before and during treatment, since indobufen might put extra strain on these organs. Routine blood work keeps things on the right track. Everyone’s experience lands slightly different, but what always helps is staying honest about symptoms and keeping a full list of medicines ready. Pharmacy experts emphasize that using a lower dose or adding stomach-protecting medicine like a proton pump inhibitor reduces some risk, especially in folks with a track record of sensitive stomachs.

Deciding to continue with indobufen, or to switch, goes better with trustworthy information. Stories from patients carry weight, but healthcare professionals blend those stories with clinical research. Listening to patient concerns and responding to side effects quickly seem to matter most for staying healthy in the long run.

Are there any contraindications for using Indobufen?

Understanding Indobufen’s Use and Cautions

Indobufen shows up in the world of medicine as an antiplatelet drug, often prescribed to lower the risk of blood clots. Doctors usually reach for it to help patients avoid strokes or heart attacks, especially after certain heart procedures. Still, not everyone can safely take this medicine.

When Indobufen Is Not the Right Choice

If you or someone you care for takes blood thinners, you know that mixing medications gets tricky fast. Indobufen isn’t safe for people dealing with active bleeding, like a stomach ulcer that won’t heal or a major bleeding disorder such as hemophilia. Adding more blood-thinning action to an already risky situation can put lives at risk.

Anyone who’s allergic to drugs in the nonsteroidal anti-inflammatory (NSAID) family, like aspirin or ibuprofen, should stay away from indobufen. Allergic reactions may show up as rashes, swelling, breathing trouble, or more severe symptoms. These issues call for quick attention, so doctors prefer avoiding indobufen entirely in those cases.

Impact on the Digestive Tract

Long-term NSAID use wears down the stomach lining. Indobufen can turn a routine stomachache into something much worse for folks with a history of gastric ulcers, inflammatory bowel disease, or gastrointestinal bleeding. I’ve seen family members wrestle with unexpected side effects after starting an NSAID, and the risks aren’t worth the benefit if other options exist.

Heart Health and Blood Problems

Somebody with severe liver or kidney disease faces higher odds of bleeding complications. Both organs work hard to clear medications out of the system. If they slow down, the drug sticks around longer, raising the chance of problems. Studies have linked indobufen to unexpected bleeding events for patients with poor kidney or liver function. Regular monitoring helps, but physicians often pick safer drugs for these cases.

People with a history of low platelet counts, blood clotting issues, or blood disorders need specialized care. Indobufen may do more harm than good if the blood can’t clot when needed. Drug interactions can sneak up, too. Combining indobufen with anticoagulants like warfarin, or even some SSRIs, multiplies the risk of a bad bleed.

Risks During Pregnancy and Breastfeeding

Researchers haven’t pinned down every possible risk of indobufen during pregnancy. Still, most guidelines suggest steering clear during the third trimester. Like other NSAIDs, indobufen could mess with the baby’s heart or kidneys late in pregnancy. Mothers nursing babies should also avoid indobufen because it can pass through breast milk, and nobody can say exactly how safe it is for infants.

Finding Safer Paths Forward

Doctors rely on patient history and regular bloodwork to pick the right drug. A detailed chat during appointments can reveal allergies, past stomach troubles, and other deal-breakers. Pharmaceutical research has turned up a range of antiplatelet drugs, some safer in these scenarios. For instance, clopidogrel or ticagrelor may be better for patients with stomach issues or who take other blood thinners.

If you look after elderly relatives, keep an eye out for new bruising, black stools, or other strange symptoms. Any new sign should be shared with a healthcare team right away. Most complications can be prevented just by catching warning signs early and using a tailored approach for each patient.

References

Published guidelines from the American Heart Association. Data from peer-reviewed clinical studies on antiplatelet agents. My family’s firsthand experiences managing chronic heart and digestive conditions.

Can Indobufen interact with other medications?

Hard Truths About Mixing Indobufen with Other Drugs

Indobufen goes out under the flag of an antiplatelet drug, often found in prescriptions to lower the risk of clots in people with certain heart or blood vessel conditions. What doesn’t always make it into the quick doctor’s office chat is that, like many blood thinners, it doesn’t play well with everything in the medicine cabinet or with supplements. Having spent hours talking to patients about what’s safe to add or subtract, I’ve learned that even common medications—plus over-the-counter painkillers—can pile up risk without warning.

The Overlap with Other Blood Thinners

Anyone taking warfarin, aspirin, clopidogrel, or similar drugs has to watch for extra bruising or bleeding when Indobufen comes into the picture. Stacking similar drugs tips the body’s balance toward easy bleeding in the gums, nose, or even serious problems deep inside like stomach bleeds or brain bleeds. I’ve watched people wind up in the emergency room just because two prescribing doctors missed that both meds thin the blood. A study in the Journal of Clinical Pharmacology points to the heightened risk when antiplatelets join hands with anticoagulants. The message hits hard: every new medication needs a full run-through by a pharmacist who understands what’s already on the list.

Painkillers and Inflammation Drugs: Quiet Hazards

A lot of folks keep non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen or naproxen, in their kitchen drawer. These drugs numb pain, but lining them up with Indobufen pushes up the risk for stomach ulcers and intestinal bleeding. Doctors have seen ulcer complications climb when someone doesn’t think twice before combining these. Even familiar names like Advil or Aleve become more dangerous with an antiplatelet already working in the background.

Hidden Interactions: Diabetes and Blood Pressure Meds

People with heart troubles, blood sugar problems, and high blood pressure often rack up prescriptions out of necessity. Some drugs, especially those treating diabetes or controlling blood pressure, can quietly mix with Indobufen in a way that raises risks. ACE inhibitors or ARBs—like enalapril and losartan—may not look dangerous at first. But the extra bleeding these can support when combined with Indobufen, especially in folks with already thin blood or kidney issues, comes as a shock. Also, some diabetes pills like sulfonylureas can add to bleeding complications.

Supplements and Herbal Products: A Blind Spot

Patients sometimes forget to mention herbs and vitamins at appointments. Fish oil, ginkgo biloba, garlic, and vitamin E all sound harmless, but these can actually thin blood more and bump up the danger when Indobufen is in use. My own mother once landed in the ER with a nosebleed after adding a “harmless” fish oil to her heart medicine routine. No one asked, and she didn’t know to bring it up.

How to Stay Safe

A single new prescription can shift the whole balance for someone on Indobufen. Pharmacists see all the bottles lined up, but doctors might only see part of the picture. Patients do best when they keep a written list of every medication—including vitamins and supplements—and hand it over at every appointment. Regular check-ins with a doctor or pharmacist help spot problems before they boil over. I always recommend carrying a wallet card listing current meds, and pulling it out any time a doctor or dentist offers something new.

Mixing Indobufen with other drugs isn’t just a technical issue—it’s a real part of staying healthy and out of trouble. Smart communication, informed questions, and honest conversations beat emergencies any day.

Indobufen
Names
Preferred IUPAC name (2RS)-2-(4-(1-oxoisoindolin-2-yl)phenyl)butanoic acid
Other names Buflomedil
Indobufeno
Indobufene
Pronunciation /ɪnˈdoʊ.bjuː.fɛn/
Identifiers
CAS Number 58149-80-5
Beilstein Reference 62673
ChEBI CHEBI:76113
ChEMBL CHEMBL138922
ChemSpider 61214
DrugBank DB11693
ECHA InfoCard The ECHA InfoCard of product Indobufen is: **03aa8b8a-2f88-426b-8def-6e5fdaa0b67a**
EC Number EC 3.1.1.58
Gmelin Reference 731016
KEGG D01740
MeSH D016071
PubChem CID 6469
RTECS number NL5420000
UNII N8335316K6
UN number UN2811
Properties
Chemical formula C21H20O3
Molar mass 324.36 g/mol
Appearance White or almost white tablet
Odor Odorless
Density 1.17 g/cm³
Solubility in water slightly soluble
log P 1.98
Acidity (pKa) 4.32
Basicity (pKb) 13.27
Magnetic susceptibility (χ) -7.5e-6
Refractive index (nD) 1.578
Dipole moment 2.98 D
Thermochemistry
Std molar entropy (S⦵298) 528.3 J·mol⁻¹·K⁻¹
Std enthalpy of combustion (ΔcH⦵298) -7235 kJ/mol
Pharmacology
ATC code B01AC10
Hazards
Main hazards Main hazard: May cause gastrointestinal irritation, bleeding, allergic reactions, and impaired renal function.
GHS labelling GHS05, GHS07
Pictograms indobufen|gi-bleed|asthma|liver|renal|pregnancy
Hazard statements No hazard statements.
Precautionary statements Keep out of reach of children. If swallowed, seek medical advice immediately and show this container or label. Use only as directed by a physician. Store in a cool, dry place away from direct sunlight.
Flash point 110°C
Lethal dose or concentration Mouse oral LD50 > 1800 mg/kg
LD50 (median dose) LD50 (median dose) of Indobufen: "670 mg/kg (rat, oral)
NIOSH Not listed
PEL (Permissible) PEL (Permissible Exposure Limit) for Indobufen is not established.
REL (Recommended) 300 mg daily
Related compounds
Related compounds Buflomedil
Ketoprofen
Ibuprofen