Kenalog 10 Injection

For Intra-articular or Intralesional Use Only

NOT FOR INTRAVENOUS, INTRAMUSCULAR, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE

DESCRIPTION

Kenalog®-10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a syntheticglucocorticoidcorticosteroidwith marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY.

Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced bynitrogen.

The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxy- pregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:

INDICATIONS

The intra-articular or soft tissue administrationof Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) 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.

The intralesional administrationof Kenalog-10 Injection is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. Kenalog-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

DOSAGE AND ADMINISTRATION

General

NOTE: CONTAINS BENZYL ALCOHOL (seePRECAUTIONS）.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.

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, 25	Triamcinolone, 4
Hydrocortisone, 20	Paramethasone, 2
Prednisolone, 5	Betamethasone, 0.75
Prednisone, 5	Dexamethasone, 0.75
Methylprednisolone, 4

These 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.

Intra-Articular Administration

Dosage

The initial dose of Kenalog-10 Injection for intra-articular administration may vary from 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. Single injections into several joints, up to a total of 20 mg or more, have been given.

Intralesional

For intralesional administration, the initial dose per injection site will vary depending on the specific disease entity andlesion接受治疗。注入和volume of injection should be carefully considered due to the potential forcutaneousatrophy.

Multiple sites separated by onecentimeteror more may be injected, keeping in mind that the greater the total volume employed the more corticosteroid becomes available for systemic absorption and systemic effects. Such injections may be repeated, if necessary, at weekly or less frequent intervals.

Localization of Doses

The lower dosages in the initial dosage range of triamcinolone acetonide may produce the desired effect when the corticosteroid is administered to provide a localized concentration. The site and volume of the injection should be carefully considered when triamcinolone acetonide is administered for this purpose.

Administration

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, inject without delay to prevent settling in the syringe.

Injection Technique

For treatment of joints, the usual intra-articular injection technique should be followed. If an excessive amount ofsynovial fluidis present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of thesteroid.

With intra-articular administration, prior use of a localanestheticmay often be desirable. Care should be taken with this kind of injection, particularly in thedeltoidregion, 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 Kenalog-10 Injection is made into thetendonsheath rather than the tendon substance.Epicondylitismay be treated by infiltrating the preparation into the area of greatest tenderness.

Intralesional

For treatment ofdermallesions, Kenalog-10 Injection should be injected directly into the lesion, ie, intradermally or subcutaneously. For accuracy of dosage measurement and ease of administration, it is preferable to employ atuberculinsyringe and a small-bore needle (23-25 gauge). Ethyl chloride spray may be used to alleviate the discomfort of the injection. ReferenceID: 296155718

HOW SUPPLIED

Kenalog®-10 Injection(triamcinolone acetonide injectable suspension, USP) is supplied in 5 mL multiple-dose vials (NDC0003-0494-20) providing 10 mg triamcinolone acetonide per mL.

Storage

Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light.

Bristol-Myers Squibb Company., Princeton, NJ 08543 USA. Product of Italy. Rev June 2011

SIDE EFFECTS

(listed alphabetically under each subsection)

The following adverse reactions may be associated with corticosteroid therapy:

Allergic reactions:Anaphylactoid reaction,anaphylaxisincluding anaphylactic reactions andanaphylactic shock,angioedema.

Cardiovascular:Bradycardia心脏骤停,心律失常,心脏enlargement,circulatorycollapse,congestive heart failure,fat embolism,hypertension,hypertrophic cardiomyopathyin premature infants, myocardialrupturefollowing recentmyocardial infarction(see警告),pulmonary edema,syncope,tachycardia,thromboembolism,thrombophlebitis,vasculitis.

Dermatologic:Acne, allergicdermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses andpetechiae, edema,erythema,hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating,lupuserythematosus-like lesions,purpura, rash, sterileabscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair,urticaria.

Endocrine:Decreasedcarbohydrateand glucose tolerance, development ofcushingoidstate, glycosuria,hirsutism,hypertrichosis, increased requirements forinsulinor oralhypoglycemicagents indiabetes, manifestations oflatentdiabetes mellitus, menstrual irregularities, secondary adrenocortical andpituitaryunresponsiveness (particularly in times ofstress, as intrauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and electrolyte disturbances:Congestiveheart failurein susceptible patients, fluid retention, hypokalemicalkalosis,potassiumloss, sodium retention.

Gastrointestinal:Abdominaldistention, bowel/bladderdysfunction (after intrathecal administration [see警告:Neurologic]), elevation in serum liver enzyme levels (usually reversible upon discontinuation),hepatomegaly, increased appetite, nausea,pancreatitis,peptic ulcerwith possible perforation andhemorrhage, perforation of the small andlarge intestine(particularly in patients withinflammatory bowel disease), ulcerativeesophagitis.

Metabolic:Negative nitrogen balance due to proteincatabolism.

Musculoskeletal:Aseptic necrosisoffemoraland humeral heads,calcinosis(following intra- articular or intralesional use), Charcot-likearthropathy, loss of muscle mass, muscle weakness,osteoporosis,pathologic fractureof long bones, post injection flare (following intra-articular use), steroidmyopathy, tendon rupture, vertebralcompressionfractures.

Neurologic/Psychiatric:Convulsions, depression, emotional instability,euphoria, headache, increased intracranial pressure withpapilledema(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 cordinfarction, paraplegia,quadriplegia,cortical blindness, andstroke(includingbrainstem) have been reported afterepiduraladministration of corticosteroids (see警告:Neurologic）.

Ophthalmic:Exophthalmos,glaucoma, increasedintraocular pressure,posteriorsubcapsular 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.

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 ofhypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antibiotics:Macrolideantibiotics 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 withmyasthenia 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,coagulationindices should be monitored frequently to maintain the desiredanticoagulanteffect.

Antidiabetics:Because corticosteroids may increaseblood glucoseconcentrations, 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:Estrogensmay decrease the hepaticmetabolismof 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.

酮康唑:酮康唑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 ofgastrointestinalside 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 inactivatedvaccinesdue to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in liveattenuatedvaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see警告:Infections:Vaccination）.

警告

General

Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolicacidosis), particularly in neonates, and an increased incidence ofkernicterus, 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 (seePRECAUTIONS:Pediatric Use）.

Because Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) is a suspension, it should not be administered intravenously. Strictaseptictechnique is mandatory.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (seeADVERSE REACTIONS）.严重的过敏反应和安娜phylacticshock, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.

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-10 Injection is a long-acting preparation, and is not suitable for use in acute stress situations.

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 withcranialtrauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Kenalog-10 Injection, should not be used for the treatment oftraumatic brain injury.

Cardio-Renal

Average and large doses of corticosteroids can cause elevation of blood pressure, salt andwater 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. All corticosteroids increase calcium excretion.

Literature reports suggest an apparent association between use of corticosteroids and leftventricularfree wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA)axissuppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased inhyperthyroidpatients. Changes inthyroidstatus of the patient may necessitate adjustment in dosage.

Infections

General

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 anypathogen(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 otherimmunosuppressiveagents. 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.

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 (seePRECAUTIONS: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 byAmoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, or Toxoplasma.

It is recommended that latentamebiasisor 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 suspectedStrongyloides(threadworm) infestation. In such patients, corticosteroid-inducedimmunosuppressionmay lead toStrongyloideshyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatalgram-negativesepticemia.

Corticosteroids should not be used in cerebralmalaria.

Tuberculosis

If corticosteroids are indicated in patients with latenttuberculosisor tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receivechemoprophylaxis.

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.Immunizationprocedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, eg, for Addison's disease.

Viral Infections

Chicken poxandmeaslescan 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,prophylaxiswithvaricellazoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis withimmunoglobulin(IG) may be indicated. (Seethe respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment withantiviralagents 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 (seeADVERSE REACTIONS:GastrointestinalandNeurologic/Psychiatric）.

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondaryocularinfections due to bacteria, fungi, orviruses. 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 ocularherpessimplex.

Adequate studies to demonstrate the safety of Kenalog Injection use by intraturbinal, subconjunctival,sub-Tenons, retrobulbar, andintraocular(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 thenasalturbinates 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.

PRECAUTIONS

General

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'ssarcomahas been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-Renal

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

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 therapyshould be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Gastrointestinal

Steroids should be used with caution in active or latent peptic ulcers,diverticulitis, fresh intestinal anastomoses, and nonspecificulcerative colitis, since they may increase the risk of a perforation.

Signs ofperitonealirritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

There is an enhanced effect of corticosteroids in patients withcirrhosis.

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 asepticprocess. A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive ofseptic arthritis. If thiscomplicationoccurs and the diagnosis ofsepsisis confirmed, appropriateantimicrobialtherapy 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.

皮质类固醇注射到不稳定的关节是generally not recommended.

Intra-articular injection may result in damage to joint tissues (seeADVERSE REACTIONS:Musculoskeletal）.

Musculoskeletal

Corticosteroids decrease bone formation and increase boneresorptionboth through their effect on calcium regulation (ie, decreasing absorption and increasing excretion) and inhibition ofosteoblastfunction. 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,postmenopausalwomen) before initiating corticosteroid therapy.

Neuro-Psychiatric

Although controlled clinical trials have shown corticosteroids to be effective in speeding theresolutionof acute exacerbations ofmultiple 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. (SeeDOSAGE AND ADMINISTRATION.)

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders ofneuromusculartransmission (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 inquadriparesis. 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.

Ophthalmic

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis ormutagenesis.

Steroids may increase or decrease motility and number of spermatozoa in some patients.

Pregnancy

Teratogenic Effects - Pregnancy Category C

Corticosteroids have been shown to beteratogenicin 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 ofcleft palatein 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 withendogenouscorticosteroid 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 bycentral nervous systemdepression, 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 gradualneurological恶化、癫痫、颅内出血,hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, andcardiovascularcollapse. 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, severeasthmaandwheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and theirpathophysiology被认为是实质性类似的在这两个吗populations.

The adverse effects of corticosteroids in pediatric patients are similar to those in adults (seeADVERSE 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 basalcortisolplasma 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.

OVERDOSE

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.

CONTRAINDICATIONS

Kenalog-10 Injection is contraindicated in patients who are hypersensitive to any components of this product (see警告:General）.

Intramuscularcorticosteroid preparations are contraindicated foridiopathicthrombocytopenic purpura.

CLINICAL PHARMACOLOGY

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from thegastrointestinal tract.

Naturally occurring glucocorticoids (hydrocortisone andcortisone), 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.

PATIENT INFORMATION

病人应该被警告不要停止se 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.