NDC 76420-760 Lidolog Kit

Lidocaine, Kenalog, Povidone Iodine

NDC Product Code 76420-760

NDC 76420-760-01

Package Description: 1 KIT in 1 CARTON * 25 VIAL in 1 CARTON (70121-1049-5) > 1 mL in 1 VIAL * .9 mL in 1 PACKET (67777-419-02) * 10 AMPULE in 1 CARTON (55150-160-72) > 2 mL in 1 AMPULE

NDC Product Information

Lidolog Kit with NDC 76420-760 is a a human prescription drug product labeled by Asclemed Usa, Inc.. The generic name of Lidolog Kit is lidocaine, kenalog, povidone iodine. The product's dosage form is kit and is administered via epidural; infiltration; intra-articular; intramuscular; topical form.

Labeler Name: Asclemed Usa, Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • NITROGEN (UNII: N762921K75)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intra-articular - Administration within a joint.
  • Intramuscular - Administration within a muscle.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Asclemed Usa, Inc.
Labeler Code: 76420
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-10-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lidolog Kit Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:Concentration0.5%1%1.5%2%mg/mL lidocaine HCl (anhyd.)5101520mg/mL sodium chloride876.56Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths.Lidocaine is a local anesthetic of the amide type.Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula:The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

Kenalog®-40 Injection (triamcinolone
acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid
with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR
AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION.Each mL of the sterile aqueous suspension provides 40 mg triamcinolone
acetonide, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol
as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate
80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5.
At the time of manufacture, the air in the container is replaced by nitrogen.The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with acetone. Its structural formula is:MW 434.50Triamcinolone acetonide occurs as a white to cream-colored, crystalline
powder having not more than a slight odor and is practically insoluble in
water and very soluble in alcohol.

Clinical Pharmacology

Mechanism of action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system and/or the beta-adrenergic receptor stimulating action of epinephrine when present. The net effect is normally a modest hypotension when the recommended dosages are not exceeded.Pharmacokinetics and metabolism: Information derived from diverse formulations, concentrations and usages reveals that lidocaine is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration.The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.The elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 mcg free base per mL. In the rhesus monkey arterial blood levels of 18-21 mcg/mL have been shown to be threshold for convulsive activity.

Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are readily absorbed from the gastrointestinal tract.Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining properties, are used as replacement
therapy in adrenocortical deficiency states. Synthetic analogs such as triamcinolone
are primarily used for their anti-inflammatory effects in disorders of many
organ systems.Kenalog-40 Injection has an extended duration of effect which may be sustained over a period
of several weeks. Studies indicate that following a single intramuscular dose
of 60 mg to 100 mg of triamcinolone acetonide, adrenal suppression occurs within
24 to 48 hours and then gradually returns to normal, usually in 30 to 40 days.
This finding correlates closely with the extended duration of therapeutic
action achieved with the drug.

Indications And Usage

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Contraindications

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components
of this product (see WARNINGS: General).Intramuscular corticosteroid preparations are contraindicated for
idiopathic thrombocytopenic purpura.

Warnings

LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND NERVE BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (See also ADVERSE REACTIONS and PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.Local anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.

General:

The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various regional anesthetic procedures.Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Syringe aspirations should also be performed before and during each supplemental injection when using indwelling catheter techniques. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and that the patient be monitored for central nervous system toxicity and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions that contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients and children should be given reduced doses commensurate with their age and physical condition. Lidocaine should also be used with caution in patients with severe shock or heart block. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the following conditions: existing neurological disease, spinal deformities, septicemia and severe hypertension.Local anesthetic solutions containing a vasoconstrictor should be used cautiously and in carefully circumscribed quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may result. Preparations containing a vasoconstrictor should be used with caution in patients during or following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur under such conditions.Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be accomplished after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of central nervous system toxicity.Since amide-type local anesthetics are metabolized by the liver, lidocaine should be used with caution in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations. Lidocaine should also be used with caution in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for the management of malignant hyperthermia should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using).Proper tourniquet technique, as described in publications and standard textbooks, is essential in the performance of intravenous regional anesthesia. Solutions containing epinephrine or other vasoconstrictors should not be used for this technique.Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.Use in the Head and Neck Area: Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression and/or respiratory arrest and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injections of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION).

Information For Patients:

When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body following proper administration of epidural anesthesia.

Clinically Significant Drug Interactions:

The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe prolonged hypertension.Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytoxic drugs may cause severe persistent hypertension or cerebrovascular accidents.

Drug Laboratory Test Interactions:

The intramuscular injection of lidocaine may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination without isoenzyme separation as a diagnostic test for the presence of acute myocardial infarction may be compromised by the intramuscular injection of lidocaine.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy:

Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Labor And Delivery:

Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity (See CLINICAL PHARMACOLOGY—Pharmacokinetics). The potential for toxicity depends upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system peripheral vascular tone and cardiac function.Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable.Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. In one study, paracervical block anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of cervical dilation. However, spinal and epidural anesthesia have also been reported to prolong the second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with motor function. The use of obstetrical anesthesia may increase the need for forceps assistance.The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. The long-term significance of these observations is unknown. Fetal bradycardia may occur in 20 to 30 percent of patients receiving paracervical nerve block anesthesia with the amide-type local anesthetics and may be associated with fetal acidosis. Fetal heart rate should always be monitored during paracervical anesthesia. The physician should weigh the possible advantages against risks when considering paracervical block in prematurity, toxemia of pregnancy and fetal distress. Careful adherence to recommended dosage is of the utmost importance in obstetrical paracervical block. Failure to achieve adequate analgesia with recommended doses should arouse suspicion of intravascular or fetal intracranial injection. Cases compatible with unintended fetal intracranial injection of local anesthetic solution have been reported following intended paracervical or pudendal block or both. Babies so affected present with unexplained neonatal depression at birth, which correlates with high local anesthetic serum levels, and often manifest seizures within six hours. Prompt use of supportive measures combined with forced urinary excretion of the local anesthetic has been used successfully to manage this complication.Case reports of maternal convulsions and cardiovascular collapse following use of some local anesthetics for paracervical block in early pregnancy (as anesthesia for elective abortion) suggest that systemic absorption under these circumstances may be rapid. The recommended maximum dose of each drug should not be exceeded. Injection should be made slowly and with frequent aspiration. Allow a 5-minute interval between sides.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.

Pediatric Use:

Dosages in pediatric patients should be reduced, commensurate with age, body weight and physical condition. See DOSAGE AND ADMINISTRATION.

Adverse Reactions

Systemic: Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.Cardiovascular System: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in multiple dose vials. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.Neurologic: The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic.In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally.These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures.There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration.

(listed alphabetically under each subsection)The following adverse reactions may be associated with corticosteroid
therapy:Allergic reactions: Anaphylaxis including death, angioedema.Cardiovascular: Bradycardia, cardiac arrest, cardiac
arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure,
fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants,
myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia,
thromboembolism, thrombophlebitis, vasculitis.Dermatologic: Acne, allergic dermatitis, cutaneous
and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema,
erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased
sweating, lupus erythematosus-like lesions, purpura, rash, sterile abscess,
striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp
hair, urticaria.Endocrine: Decreased carbohydrate and glucose
tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis,
increased requirements for insulin or oral hypoglycemic agents in diabetes,
manifestations of latent diabetes mellitus, menstrual irregularities, secondary
adrenocortical and pituitary unresponsiveness (particularly in times of stress,
as in trauma, surgery, or illness), suppression of growth in pediatric patients.Fluid and electrolyte disturbances: Congestive
heart failure in susceptible patients, fluid retention, hypokalemic alkalosis,
potassium loss, sodium retention.Gastrointestinal: Abdominal distention, bowel/bladder
dysfunction (after intrathecal administration [see WARNINGS: Neurologic]), elevation in serum liver enzyme
levels (usually reversible upon discontinuation), hepatomegaly, increased
appetite, nausea, pancreatitis, peptic ulcer with possible perforation and
hemorrhage, perforation of the small and large intestine (particularly in
patients with inflammatory bowel disease), ulcerative esophagitis.Metabolic: Negative nitrogen balance due to protein
catabolism.Musculoskeletal: Aseptic necrosis of femoral and
humeral heads, calcinosis (following intra-articular or intralesional use),
Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis,
pathologic fracture of long bones, post injection flare (following intra-articular
use), steroid myopathy, tendon rupture, vertebral compression fractures.Neurologic/Psychiatric: Convulsions, depression,
emotional instability, euphoria, headache, increased intracranial pressure
with papilledema (pseudotumor cerebri) usually following discontinuation of
treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality
changes, psychiatric disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia,
and sensory disturbances have occurred after intrathecal administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke (including brainstem) have been reported after epidural administration of corticosteroids (see WARNINGS: Neurologic).Ophthalmic: Exophthalmos, glaucoma, increased
intraocular pressure, posterior subcapsular cataracts, rare instances of blindness
associated with periocular injections.Other: Abnormal fat deposits, decreased resistance
to infection, hiccups, increased or decreased motility and number of spermatozoa,
malaise, moon face, weight gain.

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS, WARNINGS and PRECAUTIONS).Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur standard cardiopulmonary resuscitative measures should be instituted.Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.The oral LD50 of lidocaine HCl in non-fasted female rats is 459 (346−773) mg/kg (as the salt) and 214 (159−324) mg/kg (as the salt) in fasted female rats.

Treatment of acute overdosage is by supportive and symptomatic
therapy. For chronic overdosage in the face of severe disease requiring continuous
steroid therapy, the dosage of the corticosteroid may be reduced only temporarily,
or alternate day treatment may be introduced.

Dosage And Administration

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Lidocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.Epidural AnesthesiaFor epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampulsAlthough these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2−3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10−15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.In the event of the known injection of a large volume of local anesthetic solutions into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.Maximum Recommended DosagesNOTE: The products accompanying this insert do not contain epinephrine.Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One-half of the total dose is usually administered to each side. Inject slowly five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS).For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.Children: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used. Table 1Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various AnestheticProcedures in Normal Healthy AdultsLidocaine Hydrochloride Injection, USP (without Epinephrine)ProcedureConc. (%)Vol. (mL)Total Dose (mg)InfiltrationPercutaneous0.5 or 1.01−605−300Intravenous Regional0.510−6050−300Peripheral Nerve Blocks, e.g.Brachial1.515−20225−300Dental2.01−520−100Intercostal1.0330Paravertebral1.03−530−50Pudendal (each side)1.010100ParacervicalObstetrical Analgesia(each side)1.010100Sympathetic Nerve Blocks, e.g.Cervical (stellate ganglion)1.0550Lumbar1.05−1050−100Central Neural BlocksEpidural*Thoracic1.020−30200−300LumbarAnalgesia1.025−30250−300Anesthesia1.515−20225−3002.010−15200−300CaudalObstetrical Analgesia1.020−30200−300Surgical Anesthesia1.515−20225−300*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.Sterilization, Storage and Technical Procedures: Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.

How Supplied

Lidocaine Hydrochloride Injection, USP is supplied as follows:NDCContainerConcentrationSizeTotal (mg)Single-dose:0409-4278-01Glass Teartop Vial0.5% (5 mg/mL)50 mL2500409-4713-01Glass Ampul1% (10 mg/mL)2 mL (bulk – 400 units)200409-4713-02Glass Ampul1% (10 mg/mL)5 mL500409-4713-05Glass Ampul1% (10 mg/mL)5 mL (bulk – 400 units)500409-4713-20Glass Ampul1% (10 mg/mL)20 mL2000409-4713-32Glass Ampul1% (10 mg/mL)2 mL200409-4713-62Glass Ampul1% (10 mg/mL)2 mL (bulk – 800 units)200409-4713-65Glass Ampul1% (10 mg/mL)5 mL (bulk – 800 units)500409-4279-02Glass Teartop Vial1% (10 mg/mL)30 mL3000409-4270-01Sterile Glass Teartop Vial1% (10 mg/mL)30 mL3000409-4776-01Glass Ampul1.5% (15 mg/mL)20 mL3000409-4056-01Sterile Glass Ampul1.5% (15 mg/mL)20 mL3000409-4282-01Glass Ampul2% (20 mg/mL)2 mL400409-4282-02Glass Ampul2% (20 mg/mL)10 mL200Multiple-dose:0409-4275-01Plastic Fliptop Vial0.5% (5 mg/mL)50 mL2500409-4276-01Plastic Fliptop Vial1% (10 mg/mL)20 mL2000409-4276-02Plastic Fliptop Vial1% (10 mg/mL)50 mL5000409-4277-01Plastic Fliptop Vial2% (20 mg/mL)20 mL4000409-4277-02Plastic Fliptop Vial2% (20 mg/mL)50 mL1000Single-dose products are preservative-free.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: February, 2010Printed in USA                            EN-2421Hospira, Inc., Lake Forest, IL 60045 USA

Kenalog®-40 Injection (triamcinolone
acetonide injectable suspension, USP) is supplied in vials providing 40 mg
triamcinolone acetonide per mL.          40
mg/mL, 1 mL vialNDC 0003-0293-05          40
mg/mL, 5 mL vialNDC 0003-0293-20          40
mg/mL, 10 mL vialNDC 0003-0293-28

Intramuscular

Where oral therapy is not feasible, injectable corticosteroid therapy,
including Kenalog-40 Injection (triamcinolone acetonide injectable suspension,
USP) is indicated for intramuscular use as follows:Allergic states: Control of severe or incapacitating
allergic conditions intractable to adequate trials of conventional treatment
in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions,
perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.Dermatologic diseases: Bullous dermatitis herpetiformis,
exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme
(Stevens-Johnson syndrome).Endocrine disorders: Primary or secondary adrenocortical
insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic
analogs may be used in conjunction with mineralocorticoids where applicable;
in infancy, mineralocorticoid supplementation is of particular importance),
congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative
thyroiditis.Gastrointestinal diseases: To tide the patient
over a critical period of the disease in regional enteritis and ulcerative
colitis.Hematologic disorders: Acquired (autoimmune) hemolytic
anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of
secondary thrombocytopenia.Miscellaneous: Trichinosis with neurologic or
myocardial involvement, tuberculous meningitis with subarachnoid block or
impending block when used with appropriate antituberculous chemotherapy.Neoplastic diseases: For the palliative management
of leukemias and lymphomas.Nervous system: Acute exacerbations of multiple
sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.Ophthalmic diseases: Sympathetic ophthalmia, temporal
arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical
corticosteroids.Renal diseases: To induce diuresis or remission
of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.Respiratory diseases: Berylliosis, fulminating
or disseminated pulmonary tuberculosis when used concurrently with appropriate
antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic
sarcoidosis.Rheumatic disorders: As adjunctive therapy for
short-term administration (to tide the patient over an acute episode or exacerbation)
in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis;
psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-dose maintenance therapy). For the treatment
of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Intra-Articular

The intra-articular or soft tissue administration of
Kenalog-40 Injection is indicated as adjunctive therapy for short-term administration (to tide
the patient over an acute episode or exacerbation) in acute gouty arthritis,
acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis,
rheumatoid arthritis, synovitis, or osteoarthritis.

General

Exposure to excessive amounts of benzyl alcohol has been associated
with toxicity (hypotension, metabolic acidosis), particularly in neonates,
and an increased incidence of kernicterus, particularly in small preterm infants.
There have been rare reports of deaths, primarily in preterm infants, associated
with exposure to excessive amounts of benzyl alcohol. The amount of benzyl
alcohol from medications is usually considered negligible compared to that
received in flush solutions containing benzyl alcohol. Administration of high
dosages of medications containing this preservative must take into account
the total amount of benzyl alcohol administered. The amount of benzyl alcohol
at which toxicity may occur is not known. If the patient requires more than
the recommended dosages or other medications containing this preservative,
the practitioner must consider the daily metabolic load of benzyl alcohol
from these combined sources (see PRECAUTIONS: Pediatric Use).Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.Because Kenalog-40 Injection (triamcinolone acetonide injectable
suspension, USP) is a suspension, it should not be administered
intravenously.Unless a deep intramuscular injection is given, local
atrophy is likely to occur. (For recommendations on injection techniques,
see DOSAGE AND ADMINISTRATION.) Due to
the significantly higher incidence of local atrophy when the material is injected
into the deltoid area, this injection site should be avoided in favor of the
gluteal area.Increased dosage of rapidly acting corticosteroids is indicated
in patients on corticosteroid therapy subjected to any unusual stress before,
during, and after the stressful situation. Kenalog-40 Injection is a long-acting preparation, and is
not suitable for use in acute stress situations. To avoid drug-induced adrenal
insufficiency, supportive dosage may be required in times of stress (such
as trauma, surgery, or severe illness) both during treatment with Kenalog-40
Injection and for a year afterwards.Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Kenalog-40 Injection, should not be used for the treatment of traumatic brain injury.

Patients who are on corticosteroids are more susceptible to infections
than are healthy individuals. There may be decreased resistance and inability
to localize infection when corticosteroids are used. Infection with any pathogen
(viral, bacterial, fungal, protozoan, or helminthic) in any location of the
body may be associated with the use of corticosteroids alone or in combination
with other immunosuppressive agents. These infections may be mild to severe.
With increasing doses of corticosteroids, the rate of occurrence of infectious
complications increases. Corticosteroids may also mask some signs of current
infection.

This product, like many other steroid formulations, is sensitive
to heat. Therefore, it should not be autoclaved when it is desirable to sterilize
the exterior of the vial.The lowest possible dose of corticosteroid should be used to control
the condition under treatment. When reduction in dosage is possible, the reduction
should be gradual.Since complications of treatment with glucocorticoids are dependent
on the size of the dose and the duration of treatment, a risk/benefit decision
must be made in each individual case as to dose and duration of treatment
and as to whether daily or intermittent therapy should be used.Kaposi’s sarcoma has been reported to occur in patients
receiving corticosteroid therapy, most often for chronic conditions. Discontinuation
of corticosteroids may result in clinical improvement.

NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS).The initial dose of Kenalog-40 Injection may vary from 2.5 mg to 100 mg per day depending
on the specific disease entity being treated (see Dosage section
below). However, in certain overwhelming, acute, life-threatening situations,
administration in dosages exceeding the usual dosages may be justified and
may be in multiples of the oral dosages.IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE
AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND
THE RESPONSE OF THE PATIENT. After a favorable response is noted, the
proper maintenance dosage should be determined by decreasing the initial drug
dosage in small decrements at appropriate time intervals until the lowest
dosage which will maintain an adequate clinical response is reached. Situations
which may make dosage adjustments necessary are changes in clinical status
secondary to remissions or exacerbations in the disease process, the patient’s
individual drug responsiveness, and the effect of patient exposure to stressful
situations not directly related to the disease entity under treatment. In
this latter situation it may be necessary to increase the dosage of the corticosteroid
for a period of time consistent with the patient’s condition. If after long-term
therapy the drug is to be stopped, it is recommended that it be withdrawn
gradually rather than abruptly.

STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should
be shaken before use to ensure a uniform suspension. Prior to withdrawal,
the suspension should be inspected for clumping or granular appearance (agglomeration).
An agglomerated product results from exposure to freezing temperatures and
should not be used. After withdrawal, Kenalog-40 Injection should be injected without delay to
prevent settling in the syringe. Careful technique should be employed to avoid
the possibility of entering a blood vessel or introducing infection.

Cardio-Renal

Average and large doses of corticosteroids can cause elevation
of blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except
when they are used in large doses. Dietary salt restriction and potassium
supplementation may be necessary (see PRECAUTIONS).
All corticosteroids increase calcium excretion.Literature reports suggest an apparent association between use
of corticosteroids and left ventricular free wall rupture after a recent myocardial
infarction; therefore, therapy with corticosteroids should be used with great
caution in these patients.

As sodium retention with resultant edema and potassium loss may
occur in patients receiving corticosteroids, these agents should be used with
caution in patients with congestive heart failure, hypertension, or renal
insufficiency.

Endocrine

Corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency
after withdrawal of treatment.Metabolic clearance of corticosteroids is decreased in hypothyroid
patients and increased in hyperthyroid patients. Changes in thyroid status
of the patient may necessitate adjustment in dosage.

Drug-induced secondary adrenocortical insufficiency may be minimized
by gradual reduction of dosage. This type of relative insufficiency may persist
for months after discontinuation of therapy; therefore, in any situation of
stress occurring during that period, hormone therapy should be reinstituted.
Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid
should be administered concurrently.

Fungal Infections

Corticosteroids may exacerbate systemic fungal infections and therefore
should not be used in the presence of such infections unless they are needed
to control drug reactions. There have been cases reported in which concomitant
use of amphotericin B and hydrocortisone was followed by cardiac enlargement
and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents).

Special Pathogens

Latent disease may be activated or there may be an exacerbation
of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, or Toxoplasma.It is recommended that latent amebiasis or active amebiasis be
ruled out before initiating corticosteroid therapy in any patient who has
spent time in the tropics or in any patient with unexplained diarrhea.Similarly, corticosteroids should be used with great care in patients
with known or suspected Strongyloides (threadworm) infestation.
In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection
and dissemination with widespread larval migration, often accompanied by severe
enterocolitis and potentially fatal gram-negative septicemia.Corticosteroids should not be used in cerebral malaria.

Tuberculosis

The use of corticosteroids in patients with active tuberculosis
should be restricted to those cases of fulminating or disseminated tuberculosis
in which the corticosteroid is used for the management of the disease in conjunction
with an appropriate anti-tuberculosis regimen. If corticosteroids are indicated
in patients with latent tuberculosis or tuberculin reactivity, close observation
is necessary as reactivation of the disease may occur. During prolonged corticosteroid
therapy, these patients should receive chemoprophylaxis.

Vaccination

Administration of live or live, attenuated vaccines is contraindicated
in patients receiving immunosuppressive doses of corticosteroids. Killed or
inactivated vaccines may be administered. However, the response to such vaccines
cannot be predicted. Immunization procedures may be undertaken in patients
who are receiving corticosteroids as replacement therapy, eg, for Addison’s
disease.

Viral Infections

Chicken pox and measles can have a more serious or even fatal course
in pediatric and adult patients on corticosteroids. In pediatric and adult
patients who have not had these diseases, particular care should be taken
to avoid exposure. The contribution of the underlying disease and/or prior
corticosteroid treatment to the risk is also not known. If exposed to chicken
pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated.
(See the respective package inserts for complete VZIG and IG prescribing information.)
If chicken pox develops, treatment with antiviral agents should be considered.

Neurologic

Epidural and intrathecal administration of this product is not recommended. Reports of serious medical events, including death, have been associated with epidural and intrathecal routes of corticosteroid administration (see ADVERSE REACTIONS: Gastrointestinal and Neurologic/Psychiatric).

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts,
glaucoma with possible damage to the optic nerves, and may enhance the establishment
of secondary ocular infections due to bacteria, fungi, or viruses. The use
of oral corticosteroids is not recommended in the treatment of optic neuritis
and may lead to an increase in the risk of new episodes. Corticosteroids should
not be used in active ocular herpes simplex.Adequate studies to demonstrate the safety of Kenalog Injection
use by intraturbinal, subconjunctival, sub-Tenons, retrobulbar, and intraocular
(intravitreal) injections have not been performed. Endophthalmitis, eye inflammation,
increased intraocular pressure, and visual disturbances including vision loss
have been reported with intravitreal administration. Administration
of Kenalog Injection intraocularly or into the nasal turbinates is not recommended.Intraocular injection of corticosteroid formulations containing benzyl alcohol, such as Kenalog Injection, is not recommended because of potential toxicity from the benzyl alcohol.

Intraocular pressure may become elevated in some individuals. If
steroid therapy is continued for more than 6 weeks, intraocular pressure should
be monitored.

Gastrointestinal

Steroids should be used with caution in active or latent peptic
ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative
colitis, since they may increase the risk of a perforation.Signs of peritoneal irritation following gastrointestinal perforation
in patients receiving corticosteroids may be minimal or absent.There is an enhanced effect of corticosteroids in patients with
cirrhosis.

Intra-Articular And Soft Tissue Administration

Intra-articularly injected corticosteroids may be systemically
absorbed.Appropriate examination of any joint fluid present is necessary
to exclude a septic process.A marked increase in pain accompanied by local swelling, further
restriction of joint motion, fever, and malaise are suggestive of septic arthritis.
If this complication occurs and the diagnosis of sepsis is confirmed, appropriate
antimicrobial therapy should be instituted.Injection of a steroid into an infected site is to be avoided.
Local injection of a steroid into a previously infected joint is not usually
recommended.Corticosteroid injection into unstable joints is generally not
recommended.Intra-articular injection may result in damage to joint tissues
(see ADVERSE REACTIONS: Musculoskeletal).

Musculoskeletal

Corticosteroids decrease bone formation and increase bone resorption
both through their effect on calcium regulation (ie, decreasing absorption
and increasing excretion) and inhibition of osteoblast function. This, together
with a decrease in the protein matrix of the bone secondary to an increase
in protein catabolism, and reduced sex hormone production, may lead to inhibition
of bone growth in pediatric patients and the development of osteoporosis at
any age. Special consideration should be given to patients at increased risk
of osteoporosis (ie, postmenopausal women) before initiating corticosteroid
therapy.

Neuro-Psychiatric

Although controlled clinical trials have shown corticosteroids
to be effective in speeding the resolution of acute exacerbations of multiple
sclerosis, they do not show that they affect the ultimate outcome or natural
history of the disease. The studies do show that relatively high doses of
corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)An acute myopathy has been observed with the use of high doses
of corticosteroids, most often occurring in patients with disorders of neuromuscular
transmission (eg, myasthenia gravis), or in patients receiving concomitant
therapy with neuromuscular blocking drugs (eg, pancuronium). This acute
myopathy is generalized, may involve ocular and respiratory muscles, and may
result in quadriparesis. Elevation of creatinine kinase may occur. Clinical
improvement or recovery after stopping corticosteroids may require weeks to
years.Psychiatric derangements may appear when corticosteroids are used,
ranging from euphoria, insomnia, mood swings, personality changes, and severe
depression to frank psychotic manifestations. Also, existing emotional instability
or psychotic tendencies may be aggravated by corticosteroids.

Information For Patients

Patients should be warned not to discontinue the use of corticosteroids
abruptly or without medical supervision, to advise any medical attendants
that they are taking corticosteroids, and to seek medical advice at once should
they develop fever or other signs of infection.Persons who are on corticosteroids should be warned to avoid exposure
to chicken pox or measles. Patients should also be advised that if they are
exposed, medical advice should be sought without delay.

Drug Interactions

Aminoglutethimide: Aminoglutethimide may lead
to a loss of corticosteroid-induced adrenal suppression.Amphotericin B injection and potassium-depleting agents: When
corticosteroids are administered concomitantly with potassium-depleting agents
(ie, amphotericin B, diuretics), patients should be observed closely for
development of hypokalemia. There have been cases reported in which concomitant
use of amphotericin B and hydrocortisone was followed by cardiac enlargement
and congestive heart failure.Antibiotics: Macrolide antibiotics have been reported
to cause a significant decrease in corticosteroid clearance.Anticholinesterases: Concomitant use of anticholinesterase
agents and corticosteroids may produce severe weakness in patients with myasthenia
gravis. If possible, anticholinesterase agents should be withdrawn at least
24 hours before initiating corticosteroid therapy.Anticoagulants, oral: Coadministration of corticosteroids
and warfarin usually results in inhibition of response to warfarin, although
there have been some conflicting reports. Therefore, coagulation indices should
be monitored frequently to maintain the desired anticoagulant effect.Antidiabetics: Because corticosteroids may increase
blood glucose concentrations, dosage adjustments of antidiabetic agents may
be required.Antitubercular drugs: Serum concentrations of
isoniazid may be decreased.Cholestyramine: Cholestyramine may increase the
clearance of corticosteroids.Cyclosporine: Increased activity of both cyclosporine
and corticosteroids may occur when the two are used concurrently. Convulsions
have been reported with this concurrent use.Digitalis glycosides: Patients on digitalis glycosides
may be at increased risk of arrhythmias due to hypokalemia.Estrogens, including oral contraceptives: Estrogens
may decrease the hepatic metabolism of certain corticosteroids, thereby increasing
their effect.Hepatic enzyme inducers (eg, barbiturates, phenytoin,
carbamazepine, rifampin): Drugs which induce hepatic microsomal drug
metabolizing enzyme activity may enhance the metabolism of corticosteroids
and require that the dosage of the corticosteroid be increased.Ketoconazole: Ketoconazole has been reported to
decrease the metabolism of certain corticosteroids by up to 60%, leading to
an increased risk of corticosteroid side effects.Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant
use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids
increases the risk of gastrointestinal side effects. Aspirin should be used
cautiously in conjunction with corticosteroids in hypoprothrombinemia. The
clearance of salicylates may be increased with concurrent use of corticosteroids.Skin tests: Corticosteroids may suppress reactions
to skin tests.Vaccines: Patients on prolonged corticosteroid
therapy may exhibit a diminished response to toxoids and live or inactivated
vaccines due to inhibition of antibody response. Corticosteroids may also
potentiate the replication of some organisms contained in live attenuated
vaccines. Routine administration of vaccines or toxoids should be deferred
until corticosteroid therapy is discontinued if possible (see WARNINGS: Infections: Vaccination).

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies have been conducted in animals to determine
whether corticosteroids have a potential for carcinogenesis or mutagenesis.Steroids may increase or decrease motility and number of spermatozoa
in some patients.

Teratogenic Effects: Pregnancy Category C

Corticosteroids have been shown to be teratogenic in many species
when given in doses equivalent to the human dose. Animal studies in which
corticosteroids have been given to pregnant mice, rats, and rabbits have yielded
an increased incidence of cleft palate in the offspring. There are no adequate
and well-controlled studies in pregnant women. Corticosteroids should be used
during pregnancy only if the potential benefit justifies the potential risk
to the fetus. Infants born to mothers who have received corticosteroids during
pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk
and could suppress growth, interfere with endogenous corticosteroid production,
or cause other untoward effects. Caution should be exercised when corticosteroids
are administered to a nursing woman.

Pediatric Use

This product contains benzyl alcohol as a preservative. Benzyl
alcohol, a component of this product, has been associated with serious adverse
events and death, particularly in pediatric patients. The “gasping
syndrome” (characterized by central nervous system depression, metabolic
acidosis, gasping respirations, and high levels of benzyl alcohol and its
metabolites found in the blood and urine) has been associated with benzyl
alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional
symptoms may include gradual neurological deterioration, seizures, intracranial
hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure,
hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic
doses of this product deliver amounts of benzyl alcohol that are substantially
lower than those reported in association with the “gasping syndrome,”
the minimum amount of benzyl alcohol at which toxicity may occur is not known.
Premature and low-birth-weight infants, as well as patients receiving high
dosages, may be more likely to develop toxicity. Practitioners administering
this and other medications containing benzyl alcohol should consider the combined
daily metabolic load of benzyl alcohol from all sources.The efficacy and safety of corticosteroids in the pediatric population
are based on the well-established course of effect of corticosteroids which
is similar in pediatric and adult populations. Published studies provide evidence
of efficacy and safety in pediatric patients for the treatment of nephrotic
syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month
of age). Other indications for pediatric use of corticosteroids, eg, severe
asthma and wheezing, are based on adequate and well-controlled trials conducted
in adults, on the premises that the course of the diseases and their pathophysiology
are considered to be substantially similar in both populations.The adverse effects of corticosteroids in pediatric patients are
similar to those in adults (see ADVERSE REACTIONS).
Like adults, pediatric patients should be carefully observed with frequent
measurements of blood pressure, weight, height, intraocular pressure, and
clinical evaluation for the presence of infection, psychosocial disturbances,
thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients
who are treated with corticosteroids by any route, including systemically
administered corticosteroids, may experience a decrease in their growth velocity.
This negative impact of corticosteroids on growth has been observed at low
systemic doses and in the absence of laboratory evidence of HPA axis suppression
(ie, cosyntropin stimulation and basal cortisol plasma levels). Growth velocity
may therefore be a more sensitive indicator of systemic corticosteroid exposure
in pediatric patients than some commonly used tests of HPA axis function.
The linear growth of pediatric patients treated with corticosteroids should
be monitored, and the potential growth effects of prolonged treatment should
be weighed against clinical benefits obtained and the availability of treatment
alternatives. In order to minimize the potential growth effects of corticosteroids,
pediatric patients should be titrated to the lowest effective
dose.

Geriatric Use

No overall differences in safety or effectiveness were observed
between elderly subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly
and younger patients, but greater sensitivity of some older individuals cannot
be ruled out.

Systemic

The suggested initial dose is 60 mg, injected deeply into
the gluteal muscle. Atrophy of subcutaneous fat may occur if the injection
is not properly given. Dosage is usually adjusted within the range of 40 mg to
80 mg, depending upon patient response and duration of relief. However, some
patients may be well controlled on doses as low as 20 mg or less.Hay fever or pollen asthma: Patients with hay fever or pollen asthma
who are not responding to pollen administration and other conventional therapy
may obtain a remission of symptoms lasting throughout the pollen season after
a single injection of 40 mg to 100 mg.In the treatment of acute exacerbations of multiple sclerosis,
daily doses of 160 mg of triamcinolone for a week followed by 64 mg every
other day for one month are recommended (see PRECAUTIONS:
Neuro-Psychiatric).In pediatric patients, the initial dose of triamcinolone may vary
depending on the specific disease entity being treated. The range of initial
doses is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m2bsa/day).For the purpose of comparison, the following is the equivalent
milligram dosage of the various glucocorticoids:Cortisone, 25Triamcinolone, 4Hydrocortisone, 20Paramethasone, 2Prednisolone, 5Betamethasone, 0.75Prednisone, 5Dexamethasone,
0.75Methylprednisolone,
4These dose relationships apply only to oral or intravenous
administration of these compounds. When these substances or their derivatives
are injected intramuscularly or into joint spaces, their relative properties
may be greatly altered.

For systemic therapy, injection should be made deeply into
the gluteal muscle (see WARNINGS).
For adults, a minimum needle length of 1½ inches is recommended. In obese
patients, a longer needle may be required. Use alternative sites for subsequent
injections.

Local

Intra-articular administration: A single local injection
of triamcinolone acetonide is frequently sufficient, but several injections
may be needed for adequate relief of symptoms.Initial dose: 2.5 mg to 5 mg for smaller joints and from
5 mg to 15 mg for larger joints, depending on the specific disease entity being
treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for
larger areas have usually been sufficient. Single injections into several
joints, up to a total of 80 mg, have been given.

For treatment of joints, the usual intra-articular injection technique
should be followed. If an excessive amount of synovial fluid is present in
the joint, some, but not all, should be aspirated to aid in the relief of
pain and to prevent undue dilution of the steroid.With intra-articular administration, prior use of a local anesthetic
may often be desirable. Care should be taken with this kind of injection,
particularly in the deltoid region, to avoid injecting the suspension into
the tissues surrounding the site, since this may lead to tissue atrophy.In treating acute nonspecific tenosynovitis, care should be taken
to ensure that the injection of the corticosteroid is made into the tendon
sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating
the preparation into the area of greatest tenderness.

Storage

Store at controlled room temperature, 20°–25°C
(68°–77°F), avoid freezing and protect from light. Do not refrigerate.

Otc - Active Ingredient

Section TextActive Ingredient                                  PurposePovidone Iodine 10% v/v                        Antiseptic

Uses:

  • Section TextFirst aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.For preparation of the skin prior to surgery.Helps reduce bacteria that can potentially cause skin infections.

Warnings:

  • Section TextFOR EXTERNAL USE ONLY

Do Not Use:

  • As a first aid antiseptic for more than 1 week.In the eyes.Over large areas of the body.

Ask A Doctor Before Use If You Have:

  • Deep puncture woundsAnimal bitesSerious burns

Stop Use:

  • If irritation and redness developIf condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.

Directions Povidone Iodine:

  • Tear at notch, remove applicator, use only once.As a first aid antisepticclean affected areaapply 1 to 3 times dailymay be covered with a sterile bandage, if bandaged let dry.For preoperative patient skin preparationclean areaapply to operative site prior to surgery using the applicator

Other Information:

Store at room temperature.Avoid excessive heat

Indications & Usage

  • For use as an first aid antiseptic pre-operative skin preperation

Inactive Ingredients

Inactive ingredients: nonoxynol-9, water

* Please review the disclaimer below.