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kenalog
Overview
What is Pro-C-Dure 6 Kit?
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:
Triamcinolone 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.
What does Pro-C-Dure 6 Kit look like?
What are the available doses of Pro-C-Dure 6 Kit?
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What should I talk to my health care provider before I take Pro-C-Dure 6 Kit?
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How should I use Pro-C-Dure 6 Kit?
Where oral therapy is not feasible, injectable corticosteroid therapy,
including Kenalog-40 Injection (triamcinolone acetonide injectable suspension,
USP) is indicated
as follows:
Allergic states:
Dermatologic diseases:
Endocrine disorders:
Gastrointestinal diseases:
Hematologic disorders:
Miscellaneous:
Neoplastic diseases:
Nervous system:
Ophthalmic diseases:
Renal diseases:
Respiratory diseases:
Rheumatic disorders:
NOTE: CONTAINS BENZYL ALCOHOL (see
).
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
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.
What interacts with Pro-C-Dure 6 Kit?
Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components of this product (see ).
Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
What are the warnings of Pro-C-Dure 6 Kit?
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
).
Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see
). 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
be administered
intravenously.
Unless a
intramuscular injection is given, local
atrophy is likely to occur. (For recommendations on injection techniques,
see
.) 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.
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
).
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.
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.
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 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.
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
).
Special Pathogens
Latent disease may be activated or there may be an exacerbation
of intercurrent infections due to pathogens, including those caused by
,
,
,
,
,
, or
.
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
(threadworm) infestation.
In such patients, corticosteroid-induced immunosuppression may lead to
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
Array
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
and
).
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.
What are the precautions of Pro-C-Dure 6 Kit?
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’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.
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 therapy should 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 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
).
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
.)
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.
Ophthalmic
Intraocular pressure may become elevated in some individuals. If
steroid therapy is continued for more than 6 weeks, intraocular pressure should
be monitored.
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:
Amphotericin B injection and potassium-depleting agents:
Antibiotics:
Anticholinesterases:
Anticoagulants, oral:
Antidiabetics:
Antitubercular drugs:
Cholestyramine:
Cyclosporine:
Digitalis glycosides:
Estrogens, including oral contraceptives:
Hepatic enzyme inducers (eg, barbiturates, phenytoin,
carbamazepine, rifampin):
Ketoconazole:
Nonsteroidal anti-inflammatory drugs (NSAIDs):
Skin tests:
Array
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.
Pregnancy
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
).
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
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.
What are the side effects of Pro-C-Dure 6 Kit?
(listed alphabetically under each subsection)
The following adverse reactions may be associated with corticosteroid
therapy:
Allergic reactions:
Cardiovascular:
Dermatologic:
Endocrine:
Fluid and electrolyte disturbances:
Gastrointestinal:
Metabolic:
Musculoskeletal:
Neurologic/Psychiatric:
Ophthalmic:
Other:
What should I look out for while using Pro-C-Dure 6 Kit?
Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components
of this product (see
).
Intramuscular corticosteroid preparations are contraindicated for
idiopathic thrombocytopenic purpura.
What might happen if I take too much Pro-C-Dure 6 Kit?
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.
How should I store and handle Pro-C-Dure 6 Kit?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Kenalog -40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components of this product (see ).Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
Aminoglutethimide:
Amphotericin B injection and potassium-depleting agents:
Antibiotics:
Anticholinesterases:
Anticoagulants, oral:
Antidiabetics:
Antitubercular drugs:
Cholestyramine:
Cyclosporine:
Digitalis glycosides:
Estrogens, including oral contraceptives:
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin):
Ketoconazole:
Nonsteroidal anti-inflammatory drugs (NSAIDs):
Skin tests:
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.
(listed alphabetically under each subsection)
The following adverse reactions may be associated with corticosteroid therapy:
Allergic reactions:
Cardiovascular:
Dermatologic:
Endocrine:
Fluid and electrolyte disturbances:
Gastrointestinal:
Metabolic:
Musculoskeletal:
Neurologic/Psychiatric:
Ophthalmic:
Other:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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