Indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 TYLENOL® with Codeine tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
►Mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate:
sodium metabisulfite
Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
TYLENOL® with Codeine is contraindicated for:
TYLENOL® with Codeine is contraindicated in patients with:
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse and Misuse
TYLENOL® with Codeine 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 TYLENOL® with Codeine tablets, 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 TYLENOL® with Codeine tablets. Monitor for respiratory depression, especially during initiation of TYLENOL® with Codeine tablets or following a dose increase (See WARNINGS in package insert).
Accidental Ingestion:
Accidental ingestion of TYLENOL® with Codeine tablets, especially by children, can result in a fatal overdose of TYLENOL® with Codeine tablets (See WARNINGS in package insert).
Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy and many of the children had evidence of being ultra-rapid metabolizers of codeine due to a cytochrome P450 (CYP) 2D6 polymorphism (See WARNINGS, PRECAUTIONS; Information for Patients/Caregivers, Nursing Mothers in package insert). TYLENOL® with Codeine is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (See CONTRAINDICATIONS in package insert). Avoid the use of TYLENOL® with Codeine tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine (See WARNINGS, PRECAUTIONS in package insert).
Neonatal Opioid Withdrawal Syndrome
Prolonged use of TYLENOL® with Codeine tablets 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, PRECAUTIONS in package insert).
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of CYP3A4 inducers, CYP3A4 inhibitors, or CYP2D6 inhibitors with codeine are complex. Use of CYP3A4 inducers, CYP3A4 inhibitors, or CYP2D6 inhibitors with TYLENOL with Codeine tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine (See WARNINGS, 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 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, Drug Interactions in package insert).
Important Dosage and Administration Instructions:
Note on pediatric use:
Indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
ULTRACET tablets are indicated for short-term use of 5 days or less.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [See Warnings and Precautions (5.1) in package insert], reserve ULTRACET 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, recommended:
None listed in package insert.
ULTRACET contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake, and acetaminophen. Although the mode of action of tramadol is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.
Opioid activity of tramadol is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound [See Clinical Pharmacology (12.3) in package insert].
Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol.
Acetaminophen is a non-opioid, non-salicylate analgesic. The site and mechanism for the analgesic effect of acetaminophen has not been determined but is thought to primarily involve central actions.
Contraindicated for:
ULTRACET is also contraindicated in patients with:
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
ULTRACET 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 ULTRACET, and monitor all patients regularly for the development of these behaviors and conditions [See Warnings and Precautions (5.1) 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 and Precautions (5.2) 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 ULTRACET. Monitor for respiratory depression, especially during initiation of ULTRACET or following a dose increase [See Warnings and Precautions (5.3) in package insert].
Accidental Ingestion
Accidental ingestion of even one dose of ULTRACET, especially by children, can result in a fatal overdose of tramadol [See Warnings and Precautions (5.3) in package insert].
Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism [See Warnings and Precautions (5.4) in package insert]. ULTRACET is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [See Contraindications (4) in package insert]. Avoid the use of ULTRACET in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol. [See Warnings and Precautions (5.4) in package insert].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of ULTRACET 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 and Precautions (5.5) in package insert].
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with ULTRACET requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1 [See Warnings and Precautions (5.6), Drug Interactions (7) in package insert].
Hepatotoxicity
ULTRACET contains tramadol hydrochloride and acetaminophen. 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 and Precautions (5.7) 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 (5.8) and Drug Interactions (7) in package insert].
Important Dosage and Administration Instructions:
Indicated in adults 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 and Precautions (5.1) in package insert], reserve ULTRAM 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.
ULTRAM® contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake. Although the mode of action is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin.
Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opioid antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound [See Clinical Pharmacology (12.2) in package insert].
Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.
Contraindicated for:
ULTRAM® is also contraindicated in patients with:
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
ULTRAM 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 ULTRAM, and monitor all patients regularly for the development of these behaviors and conditions [See Warnings and Precautions (5.1) 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 and Precautions (5.2) 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 ULTRAM. Monitor for respiratory depression, especially during initiation of ULTRAM or following a dose increase [See Warnings and Precautions (5.3) in package insert].
ACCIDENTAL INGESTION
Accidental ingestion of ULTRAM, especially by children, can be fatal. [See Warnings and Precautions (5.3) in package insert].
ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism [See Warnings and Precautions (5.4) in package insert]. ULTRAM is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [See Contraindications (4) in package insert]. Avoid the use of ULTRAM in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol [See Warnings and Precautions (5.4) in package insert].
NEONATAL OPIOID WITHDRAWAL SYNDROME
Prolonged use of ULTRAM 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 and Precautions (5.5) in package insert].
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with ULTRAM requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1 [See Warnings and Precautions (5.6); Drug Interactions (7) 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 (5.7); Drug Interactions (7) in package insert].
Additional information for Dosage and Administration:
Indicated for the treatment of acquired blepharoptosis in adults.
►Acquired blepharoptosis in adults:
None listed in package insert.
Oxymetazoline is an alpha adrenoceptor agonist targeting a subset of adrenoreceptors in Mueller’s muscle of the eyelid.
None listed in package insert.
None listed in package insert.
For adult patients, indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir for treatment of disseminated herpes zoster have not been established.
The efficacy and safety of valacyclovir have not been established in patients < 18 years of age with herpes zoster.
►Herpes zoster (shingles) in immunocompetent adults, recommended:
►Herpes simplex keratitis (acute) in immunocompetent adults, recommended:
►Herpes simplex keratitis (prophylaxis) in immunocompetent adults, recommended:
►Additional information about Renal Impairment is in Notes below.
Preservatives may vary across product manufacturers. Consult individual package inserts.
Valacyclovir is a nucleoside analogue DNA polymerase inhibitor. Valacyclovir hydrochloride is rapidly converted to acyclovir which has demonstrated antiviral activity against HSV types 1 (HSV-1) and 2 (HSV-2) and VZV both in cell culture and in vivo.
The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In biochemical assays, acyclovir triphosphate inhibits replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK.
Contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [See Adverse Reactions (6.3) in package insert].
None listed in package insert.
Additional information about Renal Impairment:
Indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
►Cytomegalovirus (CMV) retinitis in adult patients:
None listed in package insert.
Valganciclovir is an L-valyl ester (prodrug) of ganciclovir that exists as a mixture of two diastereomers. After oral administration, both diastereomers are rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human cytomegalovirus in vitro and in vivo.
In CMV-infected cells ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, pUL97. Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolized intracellularly (half-life 18 hours). As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells. The virustatic activity of ganciclovir is due to inhibition of viral DNA synthesis by ganciclovir triphosphate.
Consult package insert for additional information.
Contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [See Adverse Reactions (6.1) in package insert].
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
Additional information about Renal Impairment:
►Patients with renal impairment:
For adult patients, indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of VALTREX when initiated more than 72 hours after the onset of rash and the efficacy and safety of VALTREX for treatment of disseminated herpes zoster have not been established.
The efficacy and safety of VALTREX have not been established in patients < 18 years of age with herpes zoster.
►Herpes zoster (shingles) in immunocompetent adults, recommended:
►Herpes simplex keratitis (acute) in immunocompetent adults, recommended:
►Herpes simplex keratitis (prophylaxis) in immunocompetent adults, recommended:
►Additional information about Renal Impairment is in Notes below.
None listed in package insert.
Valacyclovir is a nucleoside analogue DNA polymerase inhibitor. Valacyclovir hydrochloride is rapidly converted to acyclovir which has demonstrated antiviral activity against HSV types 1 (HSV-1) and 2 (HSV-2) and VZV both in cell culture and in vivo.
The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In biochemical assays, acyclovir triphosphate inhibits replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK.
Contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [See Adverse Reactions (6.3) in package insert].
None listed in package insert.
Additional information about Renal Impairment:
Indicated for the treatment of the following infections: trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence; inclusion conjunctivitis caused by Chlamydia trachomatis.
Designated gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
Consult package insert for additional information.
►Trachoma or inclusion conjunctivitis caused by Chlamydia trachomatis:
►Recurrent corneal erosion:
►Ocular rosacea:
►Additional important Dosage and Administration instructions in Notes below.
None listed in package insert (capsules); butylparaben, propylparaben, sodium metabisulfite (oral syrup); methylparaben, propylparaben (oral suspension)
Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Doxycycline has bacteriostatic activity against a broad range of Gram-positive and Gram-negative bacteria. Cross resistance with other tetracyclines is common.
Consult package insert for additional information.
Contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
None listed in package insert.
Important Dosage and Administration Instructions:
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 hydrocodone bitartrate and acetaminophen tablets 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.
Hydrocodone is a 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.
Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with:
WARNING: ADDICTION, ABUSE, AND MISUSE; 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
Important Dosage and Administration Instructions:
Indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*; Micrococcus luteus*;Staphylococcus aureus; Staphylococcus epidermidis; Staphylococcus haemolyticus; Staphylococcus hominis; Staphylococcus warneri*; Streptococcus pneumoniae; Streptococcus viridans group; Acinetobacter lwoffii*; Haemophilus influenzae; Haemophilus parainfluenzae*; Chlamydia trachomatis.
*Efficacy for this organism was studied in fewer than 10 infections.
►Bacterial conjunctivitis caused by susceptible strains of the listed organisms:
►Recurrent corneal erosion:
None listed in package insert.
Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs.
The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.
Consult package insert for additional information.
Contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
None listed in package insert.
Used for temporary relief of itchy, red eyes due to pollen, ragweed, grass, and/or animal hair and dander.
►Itchy, red eyes due to pollen, ragweed, grass, and/or 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 for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.
►Predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis:
None listed in package insert.
VISUDYNE (verteporfin for injection) therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light.
Verteporfin is transported in the plasma primarily by lipoproteins. Once verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated. Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipo-oxygenase (leukotriene) and cyclo oxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of the choroidal neovascularization (CNV) following VISUDYNE therapy has been confirmed in humans by fluorescein angiography.
Contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation [See Adverse Reactions (6) in package insert].
None listed in package insert.
Additional information on lesion size determination, spot size determination, VISUDYNE administration, light administration, and concurrent bilateral treatment:
Indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: aspergillus endophthalmitis, aspergillus keratitis, or candida endophthalmitis (with or without vitritis).
Consult package insert for additional information.
►Aspergillus endophthalmitis:
►Aspergillus keratitis:
►Candida endophthalmitis, with or without vitritis, with voriconazole susceptibility:
Preservatives may vary across product manufacturers. Consult individual package inserts.
Voriconazole is an azole antifungal drug. The primary mode of action of voriconazole is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal activity of voriconazole.
None listed in package insert.
Indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
►Elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, recommended:
benzalkonium chloride
Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Intraocular pressure is a major modifiable risk factor for glaucoma progression. Reduction of intraocular pressure reduces risk of glaucomatous visual field loss.
None listed in package insert.
None listed in package insert.
Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
►Elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, recommended:
benzalkonium chloride
Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
Contraindicated in patients with known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.
None listed in package insert.
Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
►Elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, recommended:
potassium sorbate
Latanoprost is a prostaglandin F2α analogue that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.
Contraindicated in patients with known hypersensitivity to latanoprost, or any other ingredients in this product.
None listed in package insert.
Indicated for the treatment of blepharospasm in adult patients.
►Blepharospasm in adults, recommended:
None listed in package insert.
XEOMIN blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine. Impulse transmission is re-established by the formation of new nerve endings.
Contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [See Warnings and Precautions (5.3) and Description (11) in package insert].
Xeomin is also contraindicated in patients with infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [See Warnings and Precautions (5.1) in package insert].
Additional information for Dosage and Administration:
Indicated for the treatment of the signs and symptoms of dry eye disease.
►Signs and symptoms of dry eye disease:
►Recurrent corneal erosion:
None listed in package insert.
Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in dry eye disease is not known.
Contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [See Adverse Reactions (6.2) in package insert].
None listed in package insert.
Used to temporarily relieve these symptoms due to hay fever or other respiratory allergies: runny nose; sneezing; itchy, watery eyes; itching of the nose or throat.
►Symptoms due to hay fever or other respiratory allergies:
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.
Used to temporarily relieve these symptoms due to hay fever or other respiratory allergies: runny nose; sneezing; itchy, watery eyes; itching of the nose or throat.
►Symptoms due to hay fever or other respiratory allergies:
methylparaben, propylparaben
None listed in package insert.
None listed in package insert.
None listed in package insert.
None listed in package insert.