Corticotropin

Medically reviewed by Drugs.com. Last updated on July 8, 2020.

• Overview
• Side Effects
• Dosage
• Professional
• Interactions
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Pronunciation

(kor ti koe TROE pin)

Index Terms

• ACTH
• Acthar
• Adrenocorticotropic Hormone
• Corticotropin, Repository
• Repository Corticotropin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, Injection:

Acthar: 80 units/mL (5 mL) [contains phenol]

Brand Names: U.S.

• Acthar

Pharmacologic Category

• Adrenocorticotropin Stimulating Hormone

Pharmacology

Stimulates the adrenal cortex to secrete adrenal steroids (including cortisol), weakly androgenic substances, and aldosterone. Prolonged administration of large doses induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone, and weak androgens. Trophic effects on the adrenal cortex appear to be mediated by cyclic adenosine monophosphate. Also reported to bind to melanocortin receptors.

Absorption

IM: Over 8-16 hours

Excretion

Urine

Onset of Action

Maximum effect: Cortisol serum concentration: IM, SubQ: 3-12 hours

Duration of Action

Repository: 10-25 hours, up to 3 days

Half-Life Elimination

ACTH: 15 minutes

Use: Labeled Indications

Diuresis in nephrotic syndrome: To induce a diuresis or remission of proteinuria in patients with nephrotic syndrome without uremia of the idiopathic type or due to lupus erythematosus. Note: Based on the 2012 KDIGO clinical practice guidelines for glomerulonephritis, recommendations cannot be made for the use of corticotropin for initial therapy or relapses of idiopathic membranous nephropathy until more randomized, controlled trials are conducted. The KDIGO guidelines do not include recommendations for use of corticotropin in the treatment of proteinuria due to lupus nephritis (KDIGO 2012).

Infantile spasms: Treatment of infantile spasms in infants and children younger than 2 years. Note: Corticotropin is the preferred treatment in most patients (AAN [Go 2012])

Multiple sclerosis: Treatment of acute exacerbations of multiple sclerosis in adults. Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014). Corticotropin may be an alternative therapy if IV corticosteroids cannot be administered or are not tolerated (Simsarian 2011).

Ophthalmic diseases: Treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa (eg, keratitis, iritis, iridocyclitis, diffuse posterior uveitis, choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation). Note: FDA approved use; however, available data to support use in these conditions is limited.

Symptomatic sarcoidosis: Treatment of symptomatic sarcoidosis. Note: FDA approved use; however, available data to support use in this condition is limited. Glucocorticoids (eg, prednisone) are generally recommended as first-line treatment for sarcoidosis (Soto-Gomez 2016).

Contraindications

Hypersensitivity to proteins of porcine origin, scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, peptic ulcer, recent surgery, congestive heart failure (CHF), uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, infants with suspected congenital infections, coadministration of live or live attenuated vaccines, IV administration

Dosing: Adult

Note: Sudden withdrawal may lead to adrenal insufficiency or recurrent symptoms; tapering the dose and increasing the injection interval prior to discontinuation may be necessary following prolonged administration.

Multiple sclerosis, acute exacerbations (alternative therapy): IM, SubQ: 80 to 120 units/day for 2 to 3 weeks. Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014). Corticotropin may be an alternative therapy if IV corticosteroids cannot be administered or are not tolerated (Simsarian 2011).

Other indications: Manufacturer’s labeling: IM, SubQ: 40 to 80 units every 24 to 72 hours

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Sudden withdrawal may lead to adrenal insufficiency or recurrent symptoms; tapering the dose prior to discontinuation of therapy may be necessary following prolonged administration.

Infantile spasms:

Note: Expert consensus guidelines based on currently available evidence show that corticotropin (ACTH) appears to be more effective than oral corticosteroids or vigabatrin (monotherapy) for the treatment of infantile spasms in most patients and is used most frequently for initial management of infantile spasms. For patients with tuberous sclerosis complex, corticotropin may be used for non-responders to vigabatrin therapy (AAN [Go 2012]; ILAE [Wilmshurst 2015]; Knupp 2016).

Although various dosing regimens (primarily high-dose and moderate/low-dose) have been described in the literature, an optimal dosing regimen has not been defined (AAN [Go 2012]; Hancock 2013; Pellock 2010; Mackay 2004). With the high-dose regimen, initial efficacy response rates of 86% to 93% during the respective study periods have been reported (Baram 1996; Snead 1989); however, a randomized, comparative trial did not show the high-dose superior to low-dose ACTH; however, hypertension occurred more frequently in the high-dose group (Hrachovy 1994). Guidelines suggest consideration for low-dose ACTH regimens (as an alternative to high-dose); however, literature also suggests that the two dosing regimens are probably equally effective for short-term treatment (AAN [Go 2012]). A US consensus report recommends short duration of high-dose (~2 weeks), followed by a taper (Pellock 2010). In clinical practice, high-dose ACTH is used more often by neurologists than low-dose protocols (Mytinger 2012).

Infants and Children <2 years:

High dose: Body-surface area (BSA) directed dosing: IM: 75 units/m²/dose twice daily or 150 units/m²/dose once daily for 2 weeks, followed by a 2-week taper: 30 units/m²/dose once daily in the morning for 3 days, followed by 15 units/m²/dose once daily in the morning for 3 days, followed by 10 units/m²/dose once daily in the morning for 3 days and 10 units/m²/dose every other morning for 6 days (Hodgeman 2016; manufacturer's labeling). In practice, some centers have used maximum doses of 80 units/dose twice daily or 160 units/dose once daily based on currently available dosage forms.

Low dose: Fixed dosing: IM: Initial: 20 units/day for 2 weeks; if patient responds, taper and discontinue over a 1-week period; if patient does not respond, increase dose to 30 units/day for 4 weeks then taper and discontinue over a 1-week period. Dosing based on a prospective, single-blind study which reported no major difference in effectiveness between high-dose long-duration versus low-dose short-duration ACTH therapy (Hrachovy 1994).

Anti-inflammatory/immunosuppression: Note: Although FDA approved, use has been replaced by other agents; most expert guidelines do not address corticotropin as a therapeutic option (ACR [Ringold 2013]; CAARA [Huber 2010]; KDIGO 2012):

Children >2 years and Adolescents:

Fixed dosing: IM, SubQ: 40 to 80 units/dose every 24 to 72 hours.

Weight-directed dosing: IM: 0.8 units/kg/day or 25 units/m²/day divided every 12 to 24 hours (Kliegman 2007).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

IM, SubQ: For IM or SubQ use; do not administer IV. Warm gel to room temperature before administration. Do not over-pressurize vial prior to withdrawing product.

Dietary Considerations

May require increased dietary or supplemental intake of potassium; may require decreased dietary intake of sodium.

Storage

Store in the refrigerator at 2°C to 8°C (36°F to 46°F).

Drug Interactions

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Consider therapy modification

Axicabtagene Ciloleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Axicabtagene Ciloleucel. Management: Avoid use of corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity. Consider therapy modification

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Corticorelin: Corticosteroids (Systemic) may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Cosyntropin: Corticosteroids (Systemic) may diminish the diagnostic effect of Cosyntropin. Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification

Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Fexinidazole [INT]: Corticosteroids (Systemic) may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Management: Reduce the dose of corticosteroids, such as dexamethasone or oral methylprednisolone, by 50% when coadministered with fosaprepitant. Reduce intravenous methylprednisolone doses by 25% during coadministration with fosaprepitant. Consider therapy modification

Growth Hormone Analogs: Corticosteroids (Systemic) may diminish the therapeutic effect of Growth Hormone Analogs. Monitor therapy

Hyaluronidase: Corticosteroids (Systemic) may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Macimorelin: Corticosteroids (Systemic) may diminish the diagnostic effect of Macimorelin. Avoid combination

Mifamurtide: Corticosteroids (Systemic) may diminish the therapeutic effect of Mifamurtide. Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Avoid combination

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the adverse/toxic effect of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Monitor therapy

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Progestins: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Quinolones: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

Ritodrine: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Ritodrine. Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy

Sargramostim: Corticosteroids (Systemic) may enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Monitor therapy

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Monitor therapy

Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease the serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Talimogene Laherparepvec: Immunosuppressants may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk for disseminated herpetic infection may be increased. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tisagenlecleucel: Corticosteroids (Systemic) may diminish the therapeutic effect of Tisagenlecleucel. Management: Avoid use of corticosteroids as premedication or at any time during treatment with tisagenlecleucel, except in the case of life-threatening emergency (such as resistant cytokine release syndrome). Consider therapy modification

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Upadacitinib: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Upadacitinib. Monitor therapy

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone >2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Corticosteroids (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

May suppress the wheal and flare reactions to skin test antigens

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse events associated with infantile spasm treatment unless otherwise indicated. Other adverse events associated with corticosteroids may also occur.

>10%:

Cardiovascular: Hypertension (11%)

Central nervous system: Convulsions (12%)

Infection: Infection (20%)

1% to 10%:

Cardiovascular: Cardiac abnormality (3%)

Central nervous system: Irritability (7%)

Endocrine & metabolic: Cushingoid state (3%)

Gastrointestinal: Decreased appetite (3%), diarrhea (3%), vomiting (3%), weight gain (1%)

Infection: Candidiasis (≥2%)

Otic: Otitis media (≥2%)

Respiratory: Pneumonia (≥2%), upper respiratory tract infection (≥2%), nasal congestion (1%)

Miscellaneous: Fever (5%)

Frequency not defined:

Cardiovascular: Increased blood pressure (associated with cortisol elevation)

Central nervous system: Behavioral changes (associated with cortisol elevation), mood changes (associated with cortisol elevation)

Endocrine & metabolic: Decreased glucose tolerance (associated with cortisol elevation), fluid retention (associated with cortisol elevation)

Gastrointestinal: Increased appetite (associated with cortisol elevation), weight gain (associated with cortisol elevation)

<1%, postmarketing and/or case reports: Abdominal distention, carbohydrate intolerance (infants), cardiac failure, diaphoresis (adults), dizziness, epidermal thinning (adults), facial erythema, headache (adults), hirsutism (adults), hypersensitivity reaction, hypokalemic alkalosis (infants), impaired intestinal carbohydrate absorption, injection site reaction, intracranial hemorrhage (adults), myasthenia, nausea, necrotizing angiitis (adults), pancreatitis (adults), reversible cerebral atrophy (infants; usually secondary to hypertension), shock (adults), subdural hematoma, ulcerative esophagitis, vertebral compression fracture (infants), vertigo (adults)

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Symptoms of adrenal insufficiency may be difficult to detect in infants treated for infantile spasms.

• Electrolyte disturbances: May increase retention of sodium and wasting of calcium and potassium; sodium restriction and/or potassium supplementation may be required.

• Hypersensitivity reactions: Antibodies may develop following prolonged use and increase the risk of hypersensitivity reactions.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Close observation is required in patients with latent tuberculosis (TB) and/or TB reactivity; if therapy is prolonged, prophylaxis should be started.

• Psychiatric disturbances: Corticosteroids may cause psychiatric disturbances, including depression, euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and psychotic manifestations. Preexisting psychiatric conditions (eg, emotional instability, psychotic tendencies) may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with hypertension; use has been associated with fluid retention and hypertension; use is contraindicated with uncontrolled hypertension or congestive heart failure.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI disease (diverticulitis, ulcerative colitis, risk of impending perforation, fresh intestinal anastomoses) or abscess/pyogenic infections due to risk of gastric ulcer, GI perforation, and GI bleeding; use is contraindicated with peptic ulcer disease.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged corticosteroid use. Consider routine eye exams in chronic users. Contraindicated in patients with ocular herpes simplex.

• Osteoporosis: Use with caution in patients of any age at risk for osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures. Use is contraindicated in patients with osteoporosis.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Special populations:

• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Concurrent drug therapy issues:

• Vaccines: Concomitant use of live or live attenuated vaccines is contraindicated; use caution with inactivated vaccines (response may be variable).

Other warnings/precautions:

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

Monitoring Parameters

Blood pressure, cardiac function, weight; serum glucose, electrolytes; signs of adrenal insufficiency; signs of Cushing syndrome; secondary ocular infections

Following prolonged use: Bone mass density, growth in children, signs and symptoms of infection, cataract formation

Following discontinuation: Signs of infection, cardiac function, blood pressure, serum glucose, body weight, fecal blood

Pregnancy Risk Factor

C

Pregnancy Considerations

Endogenous corticotropin concentrations are increased near delivery (Smith, 2007).

Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Prada, 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010; Makol 2011; Østensen 2009).

Patient Education

What is this drug used for?

• It is used to treat MS (multiple sclerosis).

• It is used to treat infantile spasms.

• It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation

• Vomiting

• Weight gain

• Increased appetite

• Stuffy nose

• Acne

• Diarrhea

• Trouble sleeping

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• High blood sugar like confusion, fatigue, increased thirst, increased appetite, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Cushing syndrome like weight gain in upper back or abdomen; moon face; severe headache; or slow healing

• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat

• Shortness of breath

• Swelling of arms or legs

• Abdominal pain

• Black, tarry, or bloody stools

• Vomiting blood

• Excessive weight gain

• Vision changes

• Severe headache

• Severe dizziness

• Passing out

• Behavioral changes

• Bone pain

• Joint pain

• Mood changes

• Seizures

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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