Indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis.
As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response.
Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.
►Fungal blepharitis, conjunctivitis and keratitis:
benzalkonium chloride
The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents.
Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. Systemic absorption should not be expected following topical administration of NATACYN® (natamycin ophthalmic suspension) 5%.
As with other polyene antibiotics, absorption from the gastrointestinal tract is very poor. Studies in rabbits receiving topical natamycin revealed no measurable compound in the aqueous humor or sera, but the sensitivity of the measurement was no greater than 2 mg/mL.
Consult package insert for additional information.
Contraindicated in individuals who have shown hypersensitivity to any of this drug's components.
None listed in package insert.
Indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including: Streptococcus pneumoniae; Escherichia coli; Haemophilus influenzae; Klebsiella/Enterobacter species Neisseria species; Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
►Steroid-responsive inflammatory ocular conditions:
Preservatives may vary across product manufacturers. Consult individual package inserts.
Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.
When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of all drugs is administered.
When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
The anti-infective components in neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms:
Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens (See INDICATIONS AND USAGE in package insert).
Contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
None listed in package insert.
Indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
►Superficial infections of the external eye and its adnexa:
►Recurrent corneal erosion:
None listed in package insert.
A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.
Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.
Neomycin sulfate, polymyxin B sulfate, and bacitracin zinc together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
Contraindicated in individuals who have shown hypersensitivity to any of this drug's components.
None listed in package insert.
Indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
►Superficial infections of the external eye and its adnexa:
thimerosal
A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.
Neomycin sulfate, polymyxin B sulfate, and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. NEOSPORIN® does not provide adequate coverage against Serratia marcescens.
Contraindicated in individuals who have shown hypersensitivity to any of this drug's components.
None listed in package insert.
Indicated for the treatment of pain and inflammation associated with cataract surgery.
►Pain and inflammation associated with cataract surgery:
benzalkonium chloride
NEVANAC™ suspension contains nepafenac (0.1%), a nonsteroidal antiinflammatory and analgesic prodrug. After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other non-steriodal anti-inflammatory drugs (NSAIDs).
None listed in package insert.
Indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [See WARNINGS in package insert], reserve NORCO® for use in patients for whom alternative treatment options (e.g., nonopioid analgesics):
►Pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
None listed in package insert.
Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
Contraindicated in patients with:
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STEATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
NORCO® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing NORCO®, and monitor all patients regularly for the development of these behaviors and conditions [See WARNINGS in package insert].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [See WARNINGS in package insert]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of NORCO®. Monitor for respiratory depression, especially during initiation of NORCO® or following a dose increase [See WARNINGS in package insert].
Accidental Ingestion:
Accidental ingestion of NORCO®, especially by children, can result in a fatal overdose of NORCO® [See WARNINGS in package insert].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of NORCO® during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [See WARNINGS in package insert]
Cytochrome P450 3A4 Interaction
The concomitant use of NORCO® with all Cytochrome P450 3A4 inhibitors may result in an increase in NORCO® plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P450 3A4 inducer may result in an increase in NORCO® plasma concentrations. Monitor patients receiving NORCO® and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS; Drug Interactions in package insert].
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [See WARNINGS, OVERDOSAGE in package insert].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [See WARNINGS and PRECAUTIONS; Drug Interactions in package insert].
Indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
Conjunctivitis:
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Pseudomonas aeruginosa
Gram-negative bacteria: Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa
Corneal ulcers:
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa, Serratia marcescens*
Anaerobic species: Propionibacterium acnes
*Efficacy for this organism was studied in fewer than 10 infections.
►Bacterial conjunctivitis, recommended:
►Bacterial corneal ulcer, recommended:
►Recurrent corneal erosion:
benzalkonium chloride
Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.
Consult package insert for additional information.
Contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (See Warnings in package insert).
None listed in package insert.
Indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
Conjunctivitis:
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Pseudomonas aeruginosa
Gram-negative bacteria: Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa
Corneal ulcers:
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa, Serratia marcescens*
Anaerobic species: Propionibacterium acnes
*Efficacy for this organism was studied in fewer than 10 infections.
►Bacterial conjunctivitis, recommended:
►Bacterial corneal ulcer, recommended:
►Recurrent corneal erosion, recommended:
Preservatives may vary across product manufacturers. Consult individual package inserts.
Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.
Consult package insert for additional information.
Contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (See Warnings in package insert).
None listed in package insert.
Is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing post-operative ocular pain.
►Cataract surgery or intraocular lens replacement:
None listed in package insert.
The two active pharmaceutical ingredients (API) in Omidria, phenylephrine and ketorolac, act to maintain pupil size by preventing intraoperative miosis, and reducing post-operative pain.
Phenylephrine is an α1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.
Contraindicated in patients with a known hypersensitivity to any of this medication's ingredients.
None listed in package insert.
Indicated in steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
►Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe:
benzalkonium chloride
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Corticosteroids are capable of producing a rise in intraocular pressure.
Contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Omnipred® (prednisolone acetate ophthalmic suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
None listed in package insert.
Used for the temporary relief of itching and redness caused by: pollen; ragweed; grass; animal hair and dander.
►Itching and redness caused by: pollen; ragweed; grass; animal hair and dander:
benzalkonium chloride
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.
Indicated in the treatment of sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
►Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids, recommended:
None listed in package insert.
Prednisolone is a synthetic adrenocortical steroid drug with predominantly glucocorticoid properties. Some of these properties reproduce the physiological actions of endogenous glucocorticosteroids, but others do not necessarily reflect any of the adrenal hormones' normal functions; they are seen only after administration of large therapeutic doses of the drug.
The pharmacological effects of prednisolone which are due to its glucocorticoid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion.
Depressed production of eosinophils and lymphocytes occurs, but erythropoiesis and production of polymorphonuclear leukocytes are stimulated. Inflammatory processes (edema, fibrin deposition, capillary dilatation, migration of leukocytes and phagocytosis) and the later stages of wound healing (capillary proliferation, deposition of collagen, cicatrization) are inhibited. Prednisolone can stimulate secretion of various components of gastric juice.
Suppression of the production of corticotropin may lead to suppression of endogenous corticosteroids. Prednisolone has slight mineralocorticoid activity, whereby entry of sodium into cells and loss of intracellular potassium is stimulated. This is particularly evident in the kidney, where rapid ion exchange leads to sodium retention and hypertension.
Contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.
None listed in package insert.
Additional information for Dosage and Administration:
For information on OTC tear supplements, click HERE. See OTC Tears link at the top of the page to sort by active ingredient, preservatives or viscosity.
N/A
N/A
N/A
N/A
N/A
N/A
Indicated for the treatment of neurotrophic keratitis.
►Neurotrophic keratitis, recommended:
None listed in package insert.
Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.
None listed in package insert.
None listed in package insert.
Additional information on Preparation for Administration:
Indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); the treatment of non-infectious uveitis affecting the posterior segment of the eye; and for the treatment of diabetic macular edema.
►Macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), posterior segment uveitis, or diabetic macular edema:
None listed in package insert.
Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
None listed in package insert.
Additional information for Dosage and Administration:
Indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. PAREMYD® provides clinically significant mydriasis with partial cycloplegia.
►Mydriasis for diagnostic procedures and in conditions requiring short-term pupil dilation:
benzalkonium chloride
PAREMYD® Solution combines the effects of the adrenergic agent, hydroxyamphetamine hydrobromide, and the anticholinergic agent, tropicamide.
Hydroxyamphetamine hydrobromide is an indirectly-acting sympathomimetic agent which, when applied topically to the eye, causes the release of endogenous norepinephrine from intact adrenergic nerve terminals resulting in mydriasis. Since hydroxyamphetamine hydrobromide has little or no direct activity on the receptor site, dilation does not usually occur if there is damage to the presynaptic nerve terminal, e.g., Horner’s Syndrome. However, it is not known whether damage to the presynaptic nerve terminal will influence the extent of mydriasis produced by PAREMYD®. Hydroxyamphetamine hydrobromide has minimal cycloplegic action.
Tropicamide is a parasympatholytic agent which, when applied topically to the eye, blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle. Tropicamide produces short-duration mydriasis. Although cycloplegia occurs with higher doses of tropicamide, there is evidence with 0.25% tropicamide that full cycloplegia does not occur.
Since both these agents act on different effector sites, their simultaneous use produces an additive mydriatic effect. PAREMYD® provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. The onset of action with PAREMYD® occurs within 15 minutes, followed by maximum effect within 60 minutes after instillation of one drop. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours, with recovery beginning at approximately 90 minutes and with complete recovery occurring in most patients in 6 to 8 hours. However, in some cases complete recovery may take up to 24 hours. Effectiveness may differ slightly in patients with light and dark irides, with those patients with light irides experiencing a slightly greater mydriasis.
Should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.
None listed in package insert.
Additional information for pediatric use:
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
►Allergic conjunctivitis, recommended:
benzalkonium chloride
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.
Indicated for the treatment of ocular itching associated with allergic conjunctivitis.
►Itching associated with allergic conjunctivitis, recommended:
benzalkonium chloride
Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
None listed in package insert.
None listed in package insert.
This medication was previously sold as Pazeo and was available only via prescription. It is now available over-the-counter as Pataday Once Daily Relief Extra Strength.
Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.
►Allergic conjunctivitis, recommended:
benzalkonium chloride
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.
Indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [See WARNINGS in package insert], reserve PERCOCET for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
►Pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate:
None listed in package insert.
Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
Contraindicated in patients with:
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY, and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse and Misuse
PERCOCET exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing PERCOCET, and monitor all patients regularly for the development of these behaviors and conditions [See WARNINGS in package insert].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [See Warnings in package insert]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:
Life-Threatening Respiratory Depression:
Serious, life-threatening, or fatal respiratory depression may occur with use of PERCOCET. Monitor for respiratory depression, especially during initiation of PERCOCET or following a dose increase [See WARNINGS in package insert].
Accidental Ingestion:
Accidental ingestion of PERCOCET, especially by children, can result in a fatal overdose of PERCOCET [See WARNINGS in package insert].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of PERCOCET during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [See WARNINGS in package insert].
Cytochrome P450 3A4 Interaction
The concomitant use of PERCOCET with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving PERCOCET and any CYP3A4 inhibitor or inducer [See CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions in package insert].
Hepatotoxicity:
Acetaminophen has been associated with cas es of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants:
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [See WARNINGS, PRECAUTIONS; Drug Interactions in package insert].
Important Dosage and Administration Instructions: