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INDICATIONS: KENALOG-10 INJECTION

Intra-Articular or Soft Tissue Administration

KENALOG-10 Injection is indicated as adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

Intralesional Administration

KENALOG-10 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. It may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

INDICATIONS: KENALOG-40 AND KENALOG-80 INJECTION

Intra-Articular or Soft Tissue Administration

KENALOG-40 AND KENALOG-80 Injection are indicated as adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

Intramuscular Administration

When oral therapy is not feasible, KENALOG-40 AND KENALOG-80 are indicated for:

  • 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)

INDICATIONS: KENALOG-40 AND KENALOG-80 INJECTION

Intramuscular Administration (KENALOG-40 AND KENALOG-80) (cont)

  • Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis
  • Gastrointestinal diseases: for 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: palliative management of leukemias and lymphomas
  • Nervous system: acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor or craniotomy

INDICATIONS: KENALOG-40 AND KENALOG-80 INJECTION

Intramuscular Administration (KENALOG-40 AND KENALOG-80) (cont)

  • 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 in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis. For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus

Click for additional indications

KENALOG-80 Injection:
Dosage and Administration

General Dosing Considerations1

The initial dose of KENALOG-80 Injection may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated. 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

Dosage requirements are variable and must be individualized to the disease and patient responses. 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 that will maintain an adequate clinical response is reached.

Situations that 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
  • The effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this 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/m2/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 (Local) Dosing

A single local injection of triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms.

The initial dose of KENALOG-80 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. 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.

Intramuscular (Systemic) Dosing

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.

Additional Considerations

  • 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

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, KENALOG-80 Injection should be injected without delay to prevent settling in the syringe. Careful technique should be taken to avoid the possibility of entering a blood vessel or introducing infection

Intra-Articular (Local) Administration

  • 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
  • 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

Please see the full Prescribing Information for KENALOG-40 and KENALOG-80 Injection for full WARNINGS and PRECAUTIONS related to Intra-Articular and Soft Tissue Administration.

Intramuscular (Systemic) Administration

For systemic therapy, injection should be made deeply into the gluteal muscle. 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.

For complete information, please refer to the Dosing and Administration section of the full Prescribing Information for KENALOG-40 and KENALOG-80.

IMPORTANT SAFETY
INFORMATION FOR KENALOG-10, KENALOG-40, AND KENALOG-80


KENALOG Injection is not for use in neonates. Contains benzyl alcohol.


KENALOG is not for intravenous, intraocular, epidural, or intrathecal use due to the potential for serious adverse events that could be life threatening or lead to death. Please see full Prescribing Information for additional information on potential adverse events associated with these routes of administration. Additionally, KENALOG-10 is not for intramuscular use; and KENALOG-40 and KENALOG-80 are not for intradermal use.

Contraindications

  • Use in patients who are hypersensitive to any components of this product
  • For intramuscular administration for idiopathic thrombocytopenic purpura

Warnings and Precautions

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 and also rare reports of death, particularly in preterm infants. The amount of benzyl alcohol at which toxicity occurs is unknown; consider the daily metabolic load from combined sources
  • Cases of serious anaphylaxis, including death, have been reported in patients receiving triamcinolone injection, regardless of route of administration
  • Should not be used in acute stress situations due to long-acting formulation
  • High doses should not be used for the treatment of traumatic brain injury due to an increase in early and late mortality in patients with cranial trauma
  • Treatment complications with glucocorticoids are dose and duration dependent; use the lowest possible dose to control the condition
  • Kaposi’s sarcoma has been reported in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation may lead to improvement
  • Additional KENALOG-40 and KENALOG-80 Warning:
    • Local atrophy is likely to occur unless a deep intramuscular injection is given
    • To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress during treatment and for a year afterward
  • Cardio-Renal:

    • Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary
    • Use with great caution in patients with left ventricular free wall rupture after a recent myocardial infarction, and with caution in patients with congestive heart failure, hypertension, or renal insufficiency

    Endocrine:

    • Reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency can occur after treatment withdrawal
    • Changes in thyroid status may necessitate dosage adjustment
    • Drug-induced secondary adrenocortical insufficiency may be minimized by gradual dosage reduction

    Infections:

    • Corticosteroids may increase susceptibility to a new infection, decrease resistance, cause inability to localize infection, mask some signs of current infection, and increase the risk of exacerbation of systemic fungal infections or reactivation/exacerbation of infections caused by special pathogens or latent tuberculosis; the rate of infectious complications increases with increasing dose
    • Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids
    • Vaccination: administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted

    Ophthalmic:

    • Corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections
    • Use is not recommended in the treatment of optic neuritis and active ocular herpes simplex
    • Monitor intraocular pressure when used for more than 6 weeks
    • Nasal turbinate use is not recommended

    Gastrointestinal:

    • Use with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, due to increased risk of a perforation. Signs of perforation 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
    • Examine any joint fluid present to exclude a septic process. If needed, institute antimicrobial therapy
    • Avoid injection into an infected site. Local injection into a previously infected joint or into unstable joints is not usually recommended. Intra-articular injection may damage joint tissues

    Musculoskeletal:

    • Corticosteroids may lead to inhibition of bone growth in pediatric patients and osteoporosis at any age
    • Use caution in patients at increased risk of osteoporosis

    Neuro-Psychiatric:

    • Although corticosteroids may be effective in acute exacerbations of multiple sclerosis, it is unknown if they affect the outcome or history of the disease
    • Acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with neuromuscular transmission disorders or receiving concomitant therapy with neuromuscular blocking drugs. The acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Improvement after discontinuation may take weeks to years
    • Psychiatric episodes may appear with corticosteroid use. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids

    Adverse Reactions

    From a BMS analysis of 14 published prospective randomized clinical trials or observational studies (N=1362), the most common adverse reactions (1-10%) in adults and pediatrics were: arthralgia (3.1%), infection (2.2%), headache (1.4%), and injection site reaction (1.1%).*

    Drug Interactions

    • Coadministration with amphotericin B, potassium-depleting diuretics, or digitalis may increase risk of hypokalemia
    • Macrolide antibiotics and estrogens, including oral contraceptives, may decrease corticosteroid clearance and/or metabolism
    • Coadministration with warfarin may result in inhibition of response to warfarin
    • Corticosteroids may increase blood glucose concentrations; antidiabetic agent dose may require adjustment
    • KENALOG is a substrate of CYP3A4. Consider the benefit-risk of concomitant use and monitor for systemic corticosteroid side effects when coadministering with strong CYP3A4 inhibitors. Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%. There have been post-marketing reports of clinically significant drug interactions with strong CYP3A4 inhibitors such as ritonavir
    • Hepatic enzyme inducers may enhance metabolism and require dose increase of corticosteroids
    • Coadministration with aspirin or nonsteroidal anti-inflammatory drugs increases risk of gastrointestinal side effects; use caution with aspirin in patients with hypoprothrombinemia

    Pregnancy

    • There are no adequate and well-controlled studies with corticosteroids in pregnant women. Corticosteroids are teratogenic in many species when given in doses equivalent to human doses. Animal studies have shown an increased incidence of cleft palate in the offspring; use only if the potential benefit justifies the potential risk
    • Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism

    Lactation

    • Use with caution in nursing mothers; corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects

    Please see full Prescribing Information for KENALOG-10 Injection.

    Please see full Prescribing Information for KENALOG-40 and KENALOG-80 Injection.

    *Data on File. TRIA001. Bristol-Myers Squibb Company, Princeton, NJ.

    Reference:

    Reference:

    1. KENALOG-10 (triamcinolone acetonide injectable suspension, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb.
    2. KENALOG-40 and KENALOG-80 (triamcinolone acetonide injectable suspension, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb.
    3. KENALOG-40 and KENALOG-80 (triamcinolone acetonide injectable suspension, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb.

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SELECTED IMPORTANT
SAFETY INFORMATION FOR KENALOG-10, KENALOG-40, AND KENALOG-80

KENALOG Injection is not for use in neonates. Contains benzyl alcohol.

KENALOG is not for intravenous, intraocular, epidural, or intrathecal use due to the potential for serious adverse events that could be life threatening or lead to death. Please see full Prescribing Information for additional information on potential adverse events associated with these routes of administration. Additionally, KENALOG-10 is not for intramuscular use; and KENALOG-40 and KENALOG-80 are not for intradermal use.