SOLU-MEDROL- methylprednisolone sodium succinate injection, powder, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Available from:
Medical Purchasing Solutions, LLC
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: 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. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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 wi
Product summary:
SOLU-MEDROL Sterile Powder preserved with benzyl alcohol is available in the following packages: 1 gram (Multi-Dose Vial)   16 mL NDC 0009-0698-02 SOLU-MEDROL Sterile Powder preservative-free is available in the following packages: 40 mg Act-O-Vial System (Single-Dose Vial)   25 ×1 mL NDC 0009-0039-06 125 mg Act-O-Vial System (Single-Dose Vial)   25 × 2 mL NDC 0009-0047-04
Authorization status:
New Drug Application
Authorization number:
71872-7232-1

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SOLU-MEDROL- methylprednisolone sodium succinate injection, powder, for solution

Medical Purchasing Solutions, LLC

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SOLU-MEDROL

(methylprednisolone sodium succinate for injection, USP)

The formulations containing benzyl alcohol should not be used in neonates.

For Intravenous or Intramuscular Administration

DESCRIPTION

SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains

methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate,

USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white,

odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in

chloroform and is very slightly soluble in acetone.

The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-

carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular

weight is 496.53. The structural formula is represented below:

Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of

diluent and is well suited for intravenous use in situations where high blood levels of

methylprednisolone are required rapidly.

SOLU-MEDROL is available in preservative and preservative-free formulations:

Preservative-free Formulations

40 mg Act-O-Vial System (Single-Dose Vial)—Each mL (when mixed) contains

methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone; also 1.6 mg

monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25

mg lactose hydrous.

125 mg Act-O-Vial System (Single-Dose Vial)—Each 2 mL (when mixed) contains

methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg

monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried.

Formulations preserved with Benzyl Alcohol

1 gram Vial—Each 16 mL (when mixed as directed) contains methylprednisolone sodium

succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium

®

phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.

This package does not contain diluent. Recommended diluent (Bacteriostatic water) contains

benzyl alcohol as a preservative.

IMPORTANT — Use only the accompanying diluent or Bacteriostatic Water For Injection

with Benzyl Alcohol when reconstituting SOLU-MEDROL.

Use within 48 hours after mixing.

When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the

reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg

per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar. (Isotonic saline = 0.28

osmolar.)

CLINICAL 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. Their synthetic analogs

are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's

immune responses to diverse stimuli.

Methylprednisolone is a potent anti-inflammatory steroid with greater anti-inflammatory potency than

prednisolone and even less tendency than prednisolone to induce sodium and water retention.

Methylprednisolone sodium succinate has the same metabolic and anti-inflammatory actions as

methylprednisolone. When given parenterally and in equimolar quantities, the two compounds are

equivalent in biologic activity. Following the intravenous injection of methylprednisolone sodium

succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion

of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are

required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when

administered intramuscularly and is excreted in a pattern similar to that observed after intravenous

injection.

INDICATIONS AND USAGE

When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug

reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use

of SOLU-MEDROL Sterile Powder is indicated 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 (systemic therapy) and

ulcerative colitis.

Hematologic disorders

Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan

anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular

administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia.

Mis cellaneous

Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid

block or impending block when used concurrently 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, 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, temporal arteritis, polymyositis, and

systemic lupus erythematosus.

CONTRAINDICATIONS

SOLU-MEDROL Sterile Powder is contraindicated:

in systemic fungal infections and patients with known hypersensitivity to the product and its

constituents. The SOLU-MEDROL 40 mg presentation includes lactose monohydrate produced

from cow's milk. This presentation is therefore contraindicated in patients with a known or suspected

hypersensitivity to cow's milk or its components or other dairy products because it may contain trace

amounts of milk ingredients.

for intrathecal administration. Reports of severe medical events have been associated with this route

of administration.

Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Additional contraindication for the use of SOLU-MEDROL Sterile Powder preserved with benzyl

alcohol:

Formulations preserved with benzyl alcohol are contraindicated for use in premature infants. (See

WARNINGS and PRECAUTIONS, Pediatric Use.)

WARNINGS

Serious Neurologic Adverse Reactions with Epidural Administration

Serious neurologic events, some resulting in death, have been reported with epidural injection of

corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction,

paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been

reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration

of corticosteroids have not been established, and corticosteroids are not approved for this use.

General

Formulations with preservative (see DESCRIPTION) contain benzyl alcohol, which is potentially

toxic when administered locally to neural tissue. 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).

Injection of SOLU-MEDROL may result in dermal and/or subdermal changes forming depressions in the

skin at the injection site. In order to minimize the incidence of dermal and subdermal atrophy, care must

be exercised not to exceed recommended doses in injections. Injection into the deltoid muscle should be

avoided because of a high incidence of subcutaneous atrophy.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy

(see ADVERSE REACTIONS).

In patients receiving the 40 mg presentation of SOLU-MEDROL during the treatment for acute allergic

conditions and where these symptoms worsen or any new allergic symptoms occur, consideration

should be given to the potential for hypersensitivity reactions to cow's milk ingredients (see

CONTRAINDICATIONS). If appropriate, administration of SOLU-MEDROL should be stopped, and

the patient's condition should be treated accordingly. Alternative treatments, including the use of

corticosteroid formulations that do not contain ingredients produced from cow's milk, should be

considered for acute allergy management, where appropriate.

Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy

who are subjected to any unusual stress before, during, and after the stressful situation.

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 SOLU-MEDROL,

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 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 the 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

Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia.

Monitor patients for these conditions with chronic use.

Corticosteroids can produce reversible HPA axis suppression with the potential for

glucocorticosteroid insufficiency after withdrawal of treatment. 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.

Drug-Induced Liver Injury

Rarely, high doses of cyclically pulsed intravenous methylprednisolone (usually for the treatment of

exacerbations of multiple sclerosis at doses of 1 gram/day) can induce a toxic form of acute hepatitis.

The time to onset of this form of steroid-induced liver injury can be several weeks or longer.

Resolution has been observed after discontinuation of treatment. However, serious liver injury can

occur, sometimes resulting in acute liver failure and death. Discontinue intravenous methylprednisolone

if toxic hepatitis occurs. Since recurrence has occurred after re-challenge, avoid use of high dose

intravenous methylprednisolone in patients with a history of toxic hepatitis caused by

methylprednisolone.

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.

Infections 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, but can be severe and at times fatal. With increasing doses of

corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also

mask some signs of current infection. Do not use intra-articularly, intrabursally or for intratendinous

administration for local effect in the presence of acute local infection.

A study has failed to establish the efficacy of methylprednisolone sodium succinate in the treatment of

sepsis syndrome and septic shock. The study also suggests that treatment of these conditions with

methylprednisolone sodium succinate may increase the risk of mortality in certain patients (i.e., patients

with elevated serum creatinine levels or patients who develop secondary infections after

methylprednisolone sodium succinate).

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 CONTRAINDICATIONS and 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, 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. There is currently no evidence of benefit from

steroids in this condition.

Tuberculosis

The use of corticosteroids in 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 appropriate antituberculous 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 can not be predicted. Immunization procedures may be

undertaken in patients receiving corticosteroids as replacement therapy, e.g., 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

Reports of severe medical events have been associated with the intrathecal route of 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 be used cautiously in

patients with ocular herpes simplex because of corneal perforation. Corticosteroids should not be used

in active ocular herpes simplex.

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'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

Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma

renal crisis has been observed with corticosteroids, including methylprednisolone.

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.

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.

Gas trointes tinal

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 due to decreased metabolism of corticosteroids in patients with cirrhosis.

Mus culos keletal

Corticosteroids decrease bone formation and increase bone resorption both through their effect on

calcium regulation (i.e., 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 (i.e., postmenopausal women) before initiating

corticosteroid therapy.

Local injection of a steroid into a previously infected site is not usually recommended.

Neurologic-ps ychiatric

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 corticosteroids 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 (e.g., myasthenia gravis), or in

patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This

acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in

quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or recovery after

stopping corticosteroids may require weeks to years.

Psychic 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

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 (i.e.,

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

(see Drug Interactions, Hepatic Enzyme Inhibitors).

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 (e.g., barbiturates, phenytoin, carbamazepine, rifampin)

Drugs which induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of

corticosteroids and require that the dosage of the corticosteroid be increased.

Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and

troleandomycin)

Drugs which inhibit cytochrome P450 3A4 have the potential to result in increased plasma

concentrations of corticosteroids.

Ketoconazole

Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by

up to 60%, leading to an increased risk of corticosteroid side effects.

Nonsteroidal anti-inflammatory agents (NSAIDs):

Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) 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.

Corticosteroids have been shown to impair fertility in male rats.

Pregnancy

Teratogenic effects

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.

This product contains benzyl alcohol as a preservative.

Benzyl alcohol can cross the placenta. See PRECAUTIONS: Pediatric use.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere

with endogenous corticosteroid production, or cause other untoward effects. Because of the potential

for serious adverse reactions in nursing infants from corticosteroids, a decision should be made

whether to continue nursing, or discontinue the drug, taking into account the importance of the drug to

the mother.

Pediatric Use

Some formulations of this product contain benzyl alcohol as a preservative (see DESCRIPTION).

Carefully examine vials to determine formulation that is being used.

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 ordinarily delivers 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. The risk of benzyl alcohol toxicity depends

on the quantity administered and the hepatic capacity to detoxify the chemical. 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

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