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SOLU-CORTEF (Hydrocortisone sodium succinate for injection USP) Drug Interactions

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Drug Interactions

Overview

Hydrocortisone is metabolized by 11β‑hydroxysteroid dehydrogenase type 2 (11β‑HSD2) and the cytochrome P450 (CYP) 3A4 enzyme. The CYP3A4 enzyme catalyzes 6β-hydroxylation of steroids, the essential Phase I metabolic step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which have been shown to alter glucocorticoid metabolism by induction (upregulation) or inhibition of the CYP3A4 enzyme.

Drug-Drug Interactions

CYP3A4 INHIBITORS - May decrease hepatic clearance and increase the plasma concentrations of hydrocortisone. In the presence of a CYP3A4 inhibitor, the dose of hydrocortisone may need to be decreased to avoid steroid toxicity.

CYP3A4 INDUCERS - May increase hepatic clearance and decrease the plasma concentrations of hydrocortisone. In the presence of a CYP3A4 inducer, the dose of hydrocortisone may need to be increased to achieve the desired response.

CYP3A4 SUBSTRATES - In the presence of another CYP3A4 substrate, the hepatic clearance of hydrocortisone may be affected, with corresponding dosage adjustments required. It is possible that adverse events associated with the use of either drug alone may be more likely to occur with coadministration.

NON-CYP3A4-MEDIATED EFFECTS - Other interactions and effects that occur with hydrocortisone are described in Table 2 below.

Table 2 provides a list of drugs that may interact with hydrocortisone.

Table 2. Important drug or substance interactions/effects with hydrocortisone

Drug Class or Type

- DRUG or SUBSTANCE

Interaction/Effect

Antibacterial

- ISONIAZID

CYP3A4 INHIBITOR

Serum concentrations of isoniazid may be decreased.

Antibiotic, Antitubercular

- RIFAMPIN

CYP3A4 INDUCER

Antibiotic, Macrolides

- ERYTHROMYCIN

- CLARITHROMYCIN

CYP3A4 INHIBITOR (and SUBSTRATE)

Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.

Anticoagulants (oral)

The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effects.

Anticonvulsants

- CARBAMAZEPINE

CYP3A4 INDUCER (and SUBSTRATE)

Anticonvulsants, Sedatives, Hypnotics

- PHENYTOIN

- BARBITURATES

- PHENOBARBITAL

CYP3A4 INDUCERS

Anticholinergics

- NEUROMUSCULAR

BLOCKERS

Corticosteroids may influence the effect of anticholinergics.

An acute myopathy has been reported with the concomitant use of high doses of corticosteroids and anticholinergics, such as neuromuscular blocking drugs (see WARNINGS AND PRECAUTIONS, Musculoskeletal).

Antagonism of the neuromuscular blocking effects of pancuronium and vecuronium has been reported in patients taking corticosteroids. This interaction may be expected with all competitive neuromuscular blockers.

Anticholinesterases

Steroids may reduce the effects of anticholinesterases in myasthenia gravis.



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.

Antidiabetics

Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.


Antiemetic

- APREPITANT

- FOSAPREPITANT

CYP3A4 INHIBITORS (and SUBSTRATES)

Antifungals

- ITRACONAZOLE

- KETOCONAZOLE

CYP3A4 INHIBITORS (and SUBSTRATES)



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.

Antivirals

- HIV-PROTEASE

INHIBITORS

CYP3A4 INHIBITORS (and SUBSTRATES)

1) Protease inhibitors, such as indinavir and ritonavir, may increase plasma concentrations of corticosteroids.



2) Corticosteroids may induce the metabolism of HIV-protease inhibitors resulting in reduced plasma concentrations.

Aromatase Inhibitors

- AMINOGLUTETHIMIDE

Aminoglutethimide-induced adrenal suppression may exacerbate endocrine changes caused by prolonged glucocorticoid treatment.

Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.

Calcium Channel Blocker

- DILTIAZEM

CYP3A4 INHIBITOR (and SUBSTRATE)

Cardiac Glycosides

- DIGOXIN

Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels, should be monitored closely.

Cholestyramine

Cholestyramine may increase the clearance of corticosteroids.

Estrogens (including oral contraceptives containing estrogens)

CYP3A4 INHIBITOR (and SUBSTRATE)

Patients receiving both a corticosteroid and an estrogen should be observed for excessive corticosteroid effects. Estrogens may potentiate effects of hydrocortisone by increasing the concentration of transcortin and thus decreasing the amount of hydrocortisone available to be metabolized. Dosage adjustments of hydrocortisone may be required if estrogens are added to or withdrawn from a stable dosage regimen.

Hormones

- SOMATROPIN

Concomitant glucocorticosteroid therapy may inhibit the response to somatropin.

Hypoglycemics

Dosage adjustments of an antidiabetic drug may be necessary when corticosteroids are given to diabetics. Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dose.


Immunosuppressant

- CYCLOSPORINE

CYP3A4 INHIBITOR (and SUBSTRATE)

Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.

Convulsions have been reported with this concurrent use.

Immunosuppressant

- CYCLOPHOSPHAMIDE

- TACROLIMUS

CYP3A4 SUBSTRATES

Macrolide Antibacterial

- TROLEANDOMYCIN

CYP3A4 INHIBITOR

Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.

NSAIDs

- high-dose ASA

(acetylsalicylic acid)

There may be increased incidence of gastrointestinal bleeding and ulceration when corticosteroids are given with NSAIDs.

Corticosteroids may increase the clearance of high-dose ASA, which can lead to decreased salicylate serum levels. Discontinuation of corticosteroid treatment can lead to raised salicylate serum levels, which could lead to an increased risk of salicylate toxicity. ASA should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Potassium Depleting Agents

When corticosteroids are administered concomitantly with potassium depleting agents (i.e., diuretics), patients should be observed closely for development of hypokalemia. There is also an increased risk of hypokalemia with concurrent use of corticosteroids with amphotericin B, xanthines, or beta2 agonists. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

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 AND PRECAUTIONS, Immune, Vaccinations).

Drug-Food Interactions

Grapefruit juice is a CYP3A4 inhibitor. See DRUG INTERACTIONS, Overview, CYP3A4 INHIBITORS above.

Drug-Laboratory Interactions

Corticosteroids may suppress reactions to skin tests.

Drug-Lifestyle Interactions

Ability to drive and use machinery

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids. If affected, patients should not drive or operate machinery.

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