Floctafenine (Idarac) - Uses, Dose, Side effects, MOA, Brands

Floctafenine (Idarac) is a non-selective non-steroidal anti-inflammatory drug that is used for the symptomatic treatment of mild to moderate pain.

Floctafenine Uses:

Note: Floctafenine is not approved in the US

Pain:
- Used for the short-term management of acute, mild-to-moderate pain

Floctafenine (Idarac) Dose in Adults

Floctafenine (Idarac) Dose for Pain relief:

Adults:
- Oral: 200 to 400 mg every 6 to 8 hours as needed
- The maximum dose: 1,200 mg per day

Use in Children:

Not indicated.

Pregnancy Category: C (D in late pregnancy)

Late pregnancy NSAIDs can cause premature closures of the ductus Arteriosus.
Floctafenic Acid, an active metabolite to floctafenine, crosses the placenta.

Floctafenine use during breastfeeding:

Breast milk contains floctafenine, which is an active metabolite.
The manufacturer does not recommend breastfeeding.

Floctafenine (Idarac) Dose in Kidney Disease:

Mild or moderate impairment:
- There are no specific dosage adjustments provided in the manufacturer’s labeling; use with extreme caution and consider reduced initial dosage and monitor closely.
Severe impairment (CrCl <30 mL/minute):
- Its use is contraindicated.

Dose in Liver disease:

Manufacturer labeling doesn't provide any dosage adjustments; if therapy is deemed necessary, monitor closely and use caution as well.
Use in significant hepatic impairment or active hepatic disease is contraindicated.

Side effects of Floctafenine (Idarac):

Cardiovascular:
- Flushing
- Tachycardia
- Edema
Central Nervous System:
- Bitter Taste
- Fatigue
- Headache
- Insomnia
- Irritability
- Malaise
- Nervousness
- Depression
- Dizziness
- Drowsiness
- Vertigo
Dermatologic:
- Skin Rash
- Diaphoresis
- Pruritus
- Urticaria
Endocrine & Metabolic:
- Hyperkalemia
- Increased Thirst
- Fluid Retention
Gastrointestinal:
- Abdominal Pain
- Constipation
- Gastrointestinal Perforation (With Gross Bleeding)
- Gastrointestinal Ulcer
- Heartburn
- Nausea
- Vomiting
- Diarrhea
- Dyspepsia
- Flatulence
- Gastrointestinal Hemorrhage
- Xerostomia
Genitourinary:
- Dysuria
- Hematuria
- Burning Sensation On Urination
- Cystitis
Hematologic & Oncologic:
- Agranulocytosis
- Neutropenia
- Thrombocytopenia
- Aplastic Anemia
- Hemorrhage
- Leukopenia
Hepatic:
- Increased Liver Enzymes
- Hepatotoxicity
Hypersensitivity:
- Angioedema
- Anaphylaxis
Ophthalmic:
- Vision Loss
- Blurred Vision
Otic:
- Tinnitus
Renal:
- Renal Insufficiency (Acute
- Reversible; With Or Without Oliguria Or Anuria)
- Urethritis
- Interstitial Nephritis
- Polyuria
- Urine Abnormality (Strong Smell)
Respiratory:
- Dyspnea (Asthmatic-Type)

Contraindications to Floctafenine (Idarac):

Hypersensitivity to floctafenine and aspirin or other NSAIDs, nor any component of the formulation
Active peptic ulcer;
Active inflammatory gastrointestinal disease
Ischemic cardiomyopathy or severe cardiac insufficiency;
significant hepatic impairment, or active liver disease
Grave renal impairment (CrCl lower than 30 mL/minute or worsening renal function).
Concurrent use of other NSAIDs
Coronary heart disease, severe heart failure
Use beta-blockers concurrently
Nasal polyp syndrome (complete and partial);
Patients who have "aspirin triad" experience "bronchial asthma, rhinitis complicated with polyps, and aspirin intolerance." They can be treated with aspirin, NSAID therapy, or aspirin.

Warnings and precautions

Anaphylactoid reactions
- Individuals who have the "aspirin trifecta" (bronchial asthma, aspirin intolerance, or rhinitis) may be more susceptible to experiencing anaphylactoid reactions than those who have not been exposed to them.
- Do not administer it to patients on NSAID or aspirin therapy for rhinitis, bronchospasm, asthma, or urticaria.
Cardiovascular events
- There is an increased risk of adverse cardiovascular events due to NSAIDs, such as stroke, MI, and new-onset hypertension or worsening.
- Avoid using in the event of heart failure.
- To reduce cardiovascular events, use the lowest effective dose for the most time. Patients at high risk should consider alternate therapies.
- There may be an increase in risk due to pre-existing or current cardiovascular disease or risk factors.
- Before prescribing, it is important to carefully assess each individual's cardiovascular risk profile.
- Fluid retention should be handled with caution
- It is not recommended for severe cardiac insufficiency, severe heart failure, ischemic cardiomyopathy, or coronary heart disease.
CNS effects
- It can cause blurred vision, dizziness, drowsiness and other neurologic effects that may lead to impairment of physical or mental abilities.
- It is important to warn patients about tasks that require mental alertness, such as driving or operating machinery.
Events GI:
- Gastrointestinal irritation, bleeding inflammation, ulceration, perforation, and bleeding are all risks that NSAIDs can exacerbate.
- These occurrences may occur at any point during therapy and occasionally result fatal or severe.
- If GI bleeding is detected or suspected/ confirmed ulceration occurs, discontinue treatment immediately.
- Take care when taking aspirin, anticoagulant or/and corticosteroid therapy, smoking and alcohol use.
- Patients with active peptic or history of ulcerative diseases, active GI disease, and active peptic ulcer are not recommended.
- A significant increase in the risk of GI issues (such as ulcers) occurs when used concurrently with =325 mg of aspirin; concurrent gastroprotective medication (such as proton pump inhibitors) is advised.
- To reduce the risk of GI adverse reactions, use the lowest effective dose for the shortest time. Patients at high risk should consider alternate treatments.
- Avoid non-aspirin NSAIDs in patients who have had a history or experience of severe lower GI bleeding.
Hematologic effects
- Rarely, NSAIDs have been linked to severe blood dyscrasias, such as thrombocytopenia or neutropenia.
- Patients who have coagulation abnormalities or who are using anticoagulants like warfarin should be properly watched since platelet adhesion and aggregation may be diminished, which could lengthen the bleeding duration.
- Anemia may happen. Individuals on long-term NSAID therapy must be carefully watched.
Hyperkalemia:
- NSAIDs can increase hyperkalemia risk, especially in elderly people, diabetics, and those who use concomitantly with other agents that induce hyperkalemia (eg ACE-inhibitors).
- Keep an eye on potassium levels.
Ophthalmic effects
- It can cause blurred vision or diminished vision. If this happens, discontinue using the product and have an eye exam.
- Long-term therapy should include periodic ophthalmic examinations.
Reactions to skin:
- NSAIDs can cause severe skin adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis and exfoliative dermatitis (TEN).
- Stop using the treatment immediately if you notice skin rash or hypersensitivity.
Aseptic meningitis
- Aseptic meningitis can be caused by NSAID therapy. Patients with autoimmune disorders (systemic lupus erymatosus, or mixed connective tissue diseases) might be more susceptible.
Asthma
- Patients with asthma that is aspirin-sensitive should not be given medication. Severe bronchospasm, which can lead to severe exacerbation, may occur.
- Patients with other forms or asthma should be cautious.
Coronary bypass surgery for coronary artery bypass graft:
- NSAIDs are not used to relieve perioperative pain during coronary artery bypass graft surgery (CABG).
- After CABG surgery, the risk of stroke and myocardial damage may increase.
Hepatic impairment
- Patients with impaired liver function should use caution. It should also be avoided by patients suffering from severe impairments or active diseases.
- Monitor patients with abnormal LFT closely.
- Rarely, severe hepatic reactions have been reported with NSAID treatment.
- If liver disease signs or symptoms develop or if there are systemic manifestations, discontinue treatment.
Renal impairment
- Take care and monitor your condition. You may want to consider starting therapy with a lower dosage.
- Patients with severe impairment or deteriorating function (CrCl 30 mg/minute) are contraindicated.
- Stop using this medication immediately if you experience any urinary symptoms, such as dysuria or hematuria, cystitis or urinary frequency, or bladder pain.
- Renal papillary necrosis may occur if long-term NSAID treatment is continued.
- NSAIDs can cause impairment of renal function. Dose-dependent decreases may occur in prostaglandin synthesis due to NSAID usage. This could lead to reduced renal blood flow, which could lead to renal decompensation.
- Patients with impaired renal function, heart disease, liver dysfunction, heart failure, or dehydration, as well as those who take diuretics and ACE inhibitors, are more at risk for renal toxicity.
- Before starting treatment, hydrate the patient and monitor your renal function.
- Hematuria, acute interstitial nephritis, and occasionally nephrotic syndrome have all been reported.

Floctafenine: Drug Interaction

Risk Factor C (Monitor therapy)
5-Aminosalicylic Acid Derivatives	Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.)	May enhance the antiplatelet effect of other Agents with Antiplatelet Properties.
Alcohol (Ethyl)	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of GI bleeding may be increased with this combination.
Aliskiren	Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Aliskiren. Management: Monitor renal function periodically in patients receiving aliskiren and any nonsteroidal anti-inflammatory agent. Patients at elevated risk of renal dysfunction include those who are elderly, are volume depleted, or have pre-existing renal dysfunction.
Aminoglycosides	Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Aminoglycosides. Data only in premature infants.
Aminolevulinic Acid (Topical)	Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical).
Angiotensin II Receptor Blockers	May enhance the adverse/toxic effect of Nonsteroidal AntiInflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function.
Angiotensin-Converting Enzyme Inhibitors	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors.
Anticoagulants	Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants.
Anticoagulants	Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Anticoagulants.
Bisphosphonate Derivatives	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern.
Cephalothin	Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased.
Collagenase (Systemic)	Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased.
Corticosteroids (Systemic)	May enhance the adverse/toxic effect of Nonsteroidal AntiInflammatory Agents (Nonselective).
Dasatinib	May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs.
Deferasirox	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased.
Deoxycholic Acid	Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased.
Desmopressin	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Desmopressin.
Digoxin	Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin.
Drospirenone	Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Drospirenone.
Eplerenone	Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Eplerenone. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Eplerenone.
Fat Emulsion (Fish Oil Based)	May enhance the adverse/toxic effect of Agents with Antiplatelet Properties.
Felbinac	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Glucosamine	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Haloperidol	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Haloperidol. Specifically including drowsiness and confusion.
HydrALAZINE	Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of HydrALAZINE.
Ibritumomab Tiuxetan	Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding.
Ibrutinib	May enhance the adverse/toxic effect of Agents with Antiplatelet Properties.
Inotersen	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Limaprost	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Multivitamins/Fluoride (with ADE)	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Multivitamins/Minerals (with ADEK, Folate, Iron)	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Multivitamins/Minerals (with AE, No Iron)	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Naftazone	May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents.
Obinutuzumab	Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased.
Omega-3 Fatty Acids	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Pentosan Polysulfate Sodium	May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents.
Pentoxifylline	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Porfimer	Photosensitizing Agents may enhance the photosensitizing effect of Porfimer.
Potassium-Sparing Diuretics	Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Potassium-Sparing Diuretics. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics.
PRALAtrexate	Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of PRALAtrexate. More specifically, NSAIDS may decrease the renal excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum levels and/or toxicity if used concomitantly with an NSAID. Monitor for decreased pralatrexate serum levels with NSAID discontinuation.
Probenecid	May increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents.
Prostacyclin Analogues	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Prostaglandins (Ophthalmic)	Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic).
Quinolones	Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones.
Salicylates	Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result.
Serotonin/Norepinephrine Reuptake Inhibitors	May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective).
Tacrolimus (Systemic)	Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tacrolimus (Systemic).
Thiazide and Thiazide-Like Diuretics	May enhance the nephrotoxic effect of Nonsteroidal AntiInflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics.
Thrombolytic Agents	Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents.
Tipranavir	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Tolperisone	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Tolperisone. Specifically, the risk of hypersensitivity reactions may be increased. Tolperisone may enhance the therapeutic effect of Nonsteroidal Anti-Inflammatory Agents.
Tricyclic Antidepressants (Tertiary Amine)	May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective).
Vancomycin	Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Vancomycin.
Verteporfin	Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin.
Vitamin E (Systemic)	May enhance the antiplatelet effect of Agents with Antiplatelet Properties.
Risk Factor D (Consider therapy modification)
Apixaban	Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Apixaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of apixaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding.
Bile Acid Sequestrants	May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents.
CycloSPORINE (Systemic)	Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider alternatives to nonsteroidal anti-inflammatory agents (NSAIDs). Monitor for evidence of nephrotoxicity, as well as increased serum cyclosporine concentrations and systemic effects (eg, hypertension) during concomitant therapy with NSAIDs.
Dabigatran Etexilate	Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of dabigatran and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding.
Edoxaban	Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of edoxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding.
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry)	May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Management: Avoid combination when possible. If used, monitor more closely for evidence of bleeding. Discontinue herbal products with anticoagulant or antiplatelet actions 2 weeks prior to surgical, dental, or invasive procedures.
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry)	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Management: Concomitant treatment with these agents should generally be avoided. If used concomitantly, increased diligence in monitoring for adverse effects (eg, bleeding, bruising, altered mental status due to CNS bleeds) must be employed.
Lithium	Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Lithium.
Loop Diuretics	Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Monitor for evidence of kidney injury or decreased therapeutic effects of loop diuretics with concurrent use of an NSAID. Consider avoiding concurrent use in CHF or cirrhosis. Concomitant use of bumetanide with indomethacin is not recommended.
Methotrexate	Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Methotrexate. Management: Alternative anti-inflammatory therapy should be considered whenever possible, especially if the patient is receiving higher, antineoplastic doses of methotrexate.
Rivaroxaban	Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of rivaroxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding.
Salicylates	Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Exceptions: Choline Magnesium Trisalicylate.
Selective Serotonin Reuptake Inhibitors	May enhance the antiplatelet effect of Nonsteroidal AntiInflammatory Agents (Nonselective). Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Consider using alternative analgesics, when appropriate, and/or addition of a gastroprotective agent. Monitor patients closely for signs/symptoms of bleeding, and for evidence of diminished SSRI effectiveness with concurrent use.
Sincalide	Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction.
Sodium Phosphates	May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with NSAIDs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely.
Tenofovir Products	Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose.
Vitamin K Antagonists (eg, warfarin)	Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the anticoagulant effect of Vitamin K Antagonists.
Risk Factor X (Avoid combination)
Acemetacin	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Aminolevulinic Acid (Systemic)	Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic).
Aspirin	Floctafenine may enhance the adverse/toxic effect of Aspirin. An increased risk of bleeding may be associated with use of this combination. Floctafenine may diminish the cardioprotective effect of Aspirin.
Beta-Blockers	Floctafenine may enhance the adverse/toxic effect of Beta-Blockers.
Dexibuprofen	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Dexibuprofen.
Dexketoprofen	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Ketorolac (Nasal)	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Ketorolac (Systemic)	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Macimorelin	Nonsteroidal Anti-Inflammatory Agents may diminish the diagnostic effect of Macimorelin.
Mifamurtide	Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Mifamurtide.
Morniflumate	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Nonsteroidal Anti-Inflammatory Agents	Floctafenine may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Omacetaxine	Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of nonsteroidal antiinflammatory drugs (NSAIDs) with omacetaxine in patients with a platelet count of less than 50,000/uL.
Pelubiprofen	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Phenylbutazone	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Talniflumate	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Tenoxicam	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.
Urokinase	Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase.
Zaltoprofen	May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.

Monitoring parameters:

CBC,
liver function tests,
renal functions;
edema;
GI effects (eg, abdominal pain, dyspepsia, bleeding);
vision

How to administer Floctafenine (Idarac)?

Administer after food or meal with a glass of water.

Mechanism of action of Floctafenine (Idarac):

It inhibits cyclooxygenase-1 (COX-1) enzyme s in a reversible manner, which causes a decrease in the formation of prostaglandin precursors.
It is an anti-inflammatory, analgesic and anti-pyretic agent.
Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

Duration:

6 to 8 hours

Absorption:

Rapid, well absorbed

Metabolism:

Hepatic to floctafenic acid (active metabolite) and other metabolites (inactive)

Half-life elimination:

The initial phase (distribution): 1 hour; second phase (elimination): 8 hours

Time to peak, plasma:

Floctafenic acid: 1 to 2 hours

Excretion:

Feces and bile (60%) predominantly as metabolites; urine (40%) (predominantly as metabolites)

International Brand Names of Floctafenine:

Idalon
Idarac
Idarac-D
Floctalax

Floctafenine Brand Names in Pakistan:

Floctafenine Tablets 200 mg in Pakistan
Idarac	Sanofi Aventis (Pakistan) Ltd.

Floctafenine (Idarac) - Uses, Dose, Side effects, MOA, Brands

Floctafenine Uses:

Pain:

Floctafenine (Idarac) Dose in Adults

Floctafenine (Idarac) Dose for Pain relief:

Adults:

Use in Children:

Pregnancy Category: C (D in late pregnancy)

Floctafenine use during breastfeeding:

Floctafenine (Idarac) Dose in Kidney Disease:

Mild or moderate impairment:

Severe impairment (CrCl <30 mL/minute):

Dose in Liver disease:

Side effects of Floctafenine (Idarac):

Cardiovascular:

Central Nervous System:

Dermatologic:

Endocrine & Metabolic:

Gastrointestinal:

Genitourinary:

Hematologic & Oncologic:

Hepatic:

Hypersensitivity:

Ophthalmic:

Otic:

Renal:

Respiratory:

Contraindications to Floctafenine (Idarac):

Warnings and precautions

Anaphylactoid reactions

Cardiovascular events

CNS effects

Events GI:

Hematologic effects

Hyperkalemia:

Ophthalmic effects

Reactions to skin:

Aseptic meningitis

Asthma

Coronary bypass surgery for coronary artery bypass graft:

Hepatic impairment

Renal impairment

Monitoring parameters:

How to administer Floctafenine (Idarac)?

Mechanism of action of Floctafenine (Idarac):

International Brand Names of Floctafenine:

Floctafenine Brand Names in Pakistan:

Floctafenine Tablets 200 mg in Pakistan

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