Cosyntropin (tetracosactide): Pediatric drug information

(For additional information see "Cosyntropin (tetracosactide): Drug information" and see "Cosyntropin (tetracosactide): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Cortrosyn

Brand Names: Canada

Cortrosyn;
Synacthen Depot

Therapeutic Category

Adrenal Corticosteroid;
Diagnostic Agent, Adrenocortical Insufficiency

Dosing: Neonatal

Note: Dosing units may vary (ie, mcg, mcg/kg, or mcg/m²); use extra caution.

Adrenocortical insufficiency, diagnostic test

Adrenocortical insufficiency, diagnostic test (ACTH stimulation test): Limited data available in preterm neonates; dosing regimens variable; refer to institutional protocols. Note: The Endocrine Society practice guideline recommends the standard dose for diagnosing primary adrenal insufficiency and suggests that the low dose be used for diagnosing primary adrenal insufficiency only when cosyntropin is in short supply. Some doses, particularly the low dose, may require additional dilution; use extra caution to reduce dosing and administration issues (Ref).

Standard-dose ACTH stimulation test:

Weight-directed dosing: Neonates: IV: 15 mcg/kg/dose once (Ref).

Fixed dosing: Neonates: IM, IV: 125 mcg once (Ref).

Low-dose ACTH stimulation test:

Preterm neonates: IV: 1 mcg/kg/dose once; reported range: 0.1 to 3.5 mcg/kg/dose; maximum dose: 1 mcg (Ref).

Term neonates: IV: 1 mcg once (Ref).

Congenital adrenal hyperplasia, confirmatory evaluation

Congenital adrenal hyperplasia, confirmatory evaluation: Note: Testing should be deferred until 24 to 48 hours of life to avoid inaccurate results (Ref).

Very low-birth-weight neonates (eg, <1,500 g): IV: 125 to 250 mcg once (Ref).

Neonates: IV: 250 mcg once (Ref).

Dosing: Pediatric

Note: Dosing units may vary (ie, mcg, mcg/kg, or mcg/m²); use extra caution.

Adrenocortical insufficiency, diagnostic test

Adrenocortical insufficiency, diagnostic test (ACTH stimulation test): Note: The Endocrine Society practice guideline recommends the standard dose for diagnosing primary adrenal insufficiency and suggests that the low dose be used only when cosyntropin is in short supply (Ref). Refer to institutional protocols.

Standard-dose ACTH stimulation test:

Infants: IV: 15 mcg/kg/dose once; maximum dose: 125 mcg/dose (Ref).

Children <2 years: IM, IV: 125 mcg once (Ref).

Children ≥2 years and Adolescents: IM, IV: 250 mcg once (Ref). When greater cortisol stimulation is needed, an IV infusion may be used: 250 mcg administered over 6 hours (rate: 40 mcg/hour) (Ref).

Low-dose ACTH stimulation test: Limited data available: Note: Low doses require additional dilutions; use extra caution to reduce dosing issues (Ref).

Infants, Children, and Adolescents: IV: 1 mcg once or 1 mcg/m²/dose once; maximum dose: 1 mcg/dose (Ref).

Congenital adrenal hyperplasia, confirmatory evaluation

Congenital adrenal hyperplasia, confirmatory evaluation: Limited data available: Infants and Children: IV: 250 mcg once (Ref).

Canadian labeling: Synacthen Depot [Canadian product]: Note: Canadian product is for IM administration and dosing is presented in mg; since product is a depot formulation, standard dose equivalencies are not accurate and dose must be individualized.

Adrenocortical insufficiency, diagnostic test

Adrenocortical insufficiency, diagnostic test (ACTH stimulation test): Synacthen Depot [Canadian product]:

Children ≥3 years and Adolescents: IM: 1 mg administered as a single dose or once daily for 3 or 4 days (depending on method of testing; refer to manufacturer's labeling for detailed information). Note: For patients with severe adrenal insufficiency, some clinicians administer dexamethasone on days that cosyntropin is administered to provide steroid coverage.

Anti-inflammatory or immunosuppressive

Anti-inflammatory or immunosuppressive: Note: Titrate to lowest effective dose at the longest effective dosing interval. Synacthen Depot [Canadian product]:

Children 3 to ≤6 years: IM: Initial: 0.25 to 0.5 mg daily for ~3 days; maintenance: 0.25 to 0.5 mg every 2 to 8 days.

Children ≥7 years and Adolescents ≤15 years: IM: Initial: 0.25 to 1 mg daily for ~3 days; maintenance: 0.25 to 1 mg every 2 to 8 days.

Adolescents ≥16 years: IM: Initial for acute treatment: 1 mg daily for 3 days; maintenance dose: 0.5 to 1 mg every 2 to 3 days or twice weekly or 2 mg once weekly or less frequently.

Transferring from corticosteroids: Synacthen Depot [Canadian product]: Children ≥3 years and Adolescents: IM: Initial: 1 mg daily; gradually reduce steroid by 25% of original dose on successive days. Upon withdrawal from steroid, adjust cosyntropin depot dose as needed.

Transferring from animal-derived ACTH: Synacthen Depot [Canadian product]: Children ≥3 years and Adolescents: Conversion varies depending on product previously used. Manufacturer suggests that patients previously receiving ACTH gel 40 units daily should receive cosyntropin depot 0.5 mg every other day; adjust dose based on response, preferably by extending the dosing interval.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Adult

(For additional information see "Cosyntropin (tetracosactide): Drug information")

Diagnostic use

Diagnostic use: Screening of adrenocortical insufficiency: IM, IV:

Conventional dose: 0.25 mg; Note: Doses in the range of 0.25 to 0.75 mg have been used in clinical studies; however, maximal response is seen with 0.25 mg dose. When greater cortisol stimulation is needed, an IV infusion may be used: 0.25 mg administered at 0.04 mg/hour over 6 hours

Low-dose protocol (off-label dose): 1 mcg (Ref); Note: The use of the low-dose protocol has been advocated by some clinicians, particularly in mild or secondary adrenal insufficiency. The low-dose protocol is not recommended in critically ill patients (Ref). The Endocrine Society practice guideline recommends the conventional dose (ie, 0.25 mg) for diagnosing primary adrenal insufficiency and suggests that the low-dose be used only when cosyntropin is in short supply (Ref).

Synacthen Depot [Canadian product]: IM: 1 mg administered as a single dose or once daily for 3 or 4 days (depending on method of testing; refer to manufacturer labeling for detailed information). Note: For patients with severe adrenal insufficiency, some clinicians administer dexamethasone on days that Synacthen Depot is administered to provide steroid coverage.

Diagnostic use: Adrenal vein sampling (AVS) in primary aldosteronism (off- label use): IV: 50 mcg/hour continuous infusion started 30 minutes prior to adrenal vein catheterization and continued until procedure completion (Ref). Alternatively, may consider a 250 mcg bolus dose (with AVS performed prior to and after the bolus dose); however, some studies suggest that bolus administration followed by simultaneous AVS may fail to enhance the diagnostic accuracy of AVS (Ref).

Therapeutic use

Therapeutic use: Synacthen Depot [Canadian product]: IM (Note: Titrate to lowest effective dose at the longest effective dosing interval): Initial for acute treatment: 1 mg daily for 3 days; maintenance dose is individualized: 0.5 to 1 mg every 2 to 3 days or twice weekly or 2 mg once weekly or less frequently

Transferring from corticosteroids: Synacthen Depot [Canadian product]: IM: Initial: 1 mg daily; gradually reduce steroid by 25% of original dose on successive days. Upon withdrawal from steroid adjust Synacthen Depot dose as needed.

Transferring from animal-derived ACTH: Synacthen Depot [Canadian product]: IM: Conversion varies depending on product previously used. Manufacturer suggests that patients previously receiving ACTH gel 40 units daily should receive Synacthen Depot 0.5 mg every other day; adjust dose based on response, preferably by extending the dosing interval.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Adverse events associated with other corticosteroids may be observed when Synacthen Depot (Canadian product) is used for therapeutic purposes. Refer to corticosteroid monographs for comprehensive lists.

Cardiovascular: Bradycardia, hypertension, peripheral edema, tachycardia

Dermatologic: Skin rash, urticaria at injection site (with erythema)

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

<1%, postmarketing and/or case reports: Adrenal hemorrhage (Synacthen Depot)

Contraindications

Hypersensitivity to cosyntropin or any component of the formulation

Synacthen Depot [Canadian product]: Additional contraindications: Treatment of asthma or other allergic conditions (increased risk of anaphylactic reactions); use in premature babies and neonates <1 month; acute psychosis; untreated bacterial, fungal, and viral infections; active or latent peptic ulcer; refractory heart failure; Cushing syndrome; treatment of primary adrenocortical insufficiency; adrenogenital syndrome

Warnings/Precautions

Concerns related to adverse effects:

• Corticotropin allergy: Cortrosyn: Use with caution in patients with a history of allergic reactions to corticotropin or preexisting allergic disease.

• Hypersensitivity reactions: Synacthen Depot [Canadian product]: Hypersensitivity reactions (including severe reactions) may occur particularly in patients with asthma or other allergies and often within 30 minutes of administration; monitor for hypersensitivity for ~1 hour after administration. Prolonged use may increase the risk of allergic reactions.

Disease related concerns:

• Cardiovascular disease: Synacthen Depot [Canadian product]: Use caution in patients with hypertension or thromboembolic disease.

• Gastrointestinal disease: Synacthen Depot [Canadian product]: Use caution in patients with nonspecific ulcerative colitis, diverticulitis, or recent intestinal anastomosis.

• Hepatic disease: Synacthen Depot [Canadian product]: Enhanced effects may be observed in patients with cirrhosis of the liver.

• Infections: Synacthen Depot [Canadian product]: Use caution in patients with acute or chronic infections (especially varicella or vaccinia) or exanthematous and fungal diseases. Use with caution in patients with tuberculosis (TB) infection (latent TB); treatment may reactivate TB infection. Rule out amebiasis prior to initiating therapy; may activate latent amebiasis.

• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2 weeks of treatment); monitor for worsening MG (AAN [Narayanaswami 2021]).

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye exams in chronic users.

• Osteoporosis: Synacthen Depot [Canadian product]: Use caution in patients with osteoporosis.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Renal disease: Synacthen Depot [Canadian product]: Use caution in patients with renal insufficiency.

• Thyroid disease: Synacthen Depot [Canadian product]: Enhanced effects may be observed with hypothyroidism.

Dosage forms specific issues:

• Synacthen Depot [Canadian product]: Contains benzyl alcohol; avoid use in infants and children <3 years of age; contraindicated in neonates.

Other warnings/precautions:

• Immunizations: Synacthen Depot [Canadian product]: Live vaccines should not be given concurrently.

• Inaccurate test result: Cortrosyn: False cortisol levels may occur with certain medications or disease states. Discontinue glucocorticoids and spironolactone the day of testing; long-acting glucocorticoids may need to be stopped earlier. Discontinue estrogen-containing medications 4 to 6 weeks prior to testing. Levels may be low in patients with cirrhosis or nephrotic syndrome.

• Surgery/trauma: Synacthen Depot [Canadian product]: Augmentation or resumption of therapy may be necessary in patients undergoing surgery or subjected to trauma either during or within 1 year of therapy discontinuation; adjunctive rapid acting corticosteroids may be necessary during periods of stress.

Dosage Forms: US

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

Solution Reconstituted, Injection [preservative free]:

Cortrosyn: 0.25 mg (1 ea)

Generic: 0.25 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (Cortrosyn Injection)

0.25 mg (per each): $127.90

Solution (reconstituted) (Cosyntropin Injection)

0.25 mg (per each): $96.24

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Solution Reconstituted, Injection:

Cortrosyn: 0.25 mg (1 ea)

Suspension, Intramuscular:

Synacthen Depot: 1 mg/mL (1 mL) [contains benzyl alcohol]

Additional Information

250 mcg of cosyntropin results in a similar amount of adrenal cortex stimulation as 25 units of natural corticotropin.

Administration: Pediatric

Parenteral:

IM:

Cortrosyn: Reconstituted powder for injection only: Administer as 0.25 mg/mL (250 mcg/mL) concentration.

Synacthen Depot [Canadian product]: Shake ampule until uniform appearance; administer by deep IM injection. Self-administration by patient is not recommended.

IV: Reconstituted powder for injection only. Note: Synacthen Depot [Canadian product] should not be administered IV.

IV push: Administer over 2 minutes.

IV infusion: Infuse over 6 hours (~40 mcg/hour).

Administration: Adult

IV: May administer by IV injection over 2 minutes or as an IV infusion over 4 to 8 hours. Synacthen Depot [Canadian product] should not be administered IV.

Adrenal vein sampling (off-label): Administer as continuous infusion beginning 30 minutes before adrenal vein catheterization and continue throughout the procedure (Ref). Alternatively, a bolus regimen has been studied that requires a baseline AVS followed by bolus cosyntropin followed by repeat AVS (Ref).

IM: May administer IM.

Synacthen Depot [Canadian product]: Shake ampule until uniform appearance; administer by IM injection in the buttocks. Self-administration by patient is not recommended.

Storage/Stability

Powder for injection: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). After dilution for IV infusion, stable for 12 hours at room temperature.

Suspension for injection: Synacthen Depot [Canadian product]: Store refrigerated between 2°C to 8°C (36°F to 46°F). Protect from light.

Use

Diagnostic test to differentiate primary adrenal from secondary (pituitary) adrenocortical insufficiency (FDA approved in pediatric patients [age not specified] and adults); has also been used in the diagnosis of congenital adrenal hyperplasia.

Medication Safety Issues

Sound-alike/look-alike issues:

Cortrosyn may be confused with colchicine, corticorelin, corticotropin, Cotazym

Cosyntropin may be confused with corticorelin, corticotropin

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

ClonazePAM: Cosyntropin may enhance the hepatotoxic effect of ClonazePAM. Risk C: Monitor therapy

Corticosteroids (Orally Inhaled): May diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

Corticosteroids (Systemic): May diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

Cortisone: May diminish the diagnostic effect of Cosyntropin. Management: Patients receiving cortisone should omit their pre-test dose on the day selected for cosyntropin testing. Risk D: Consider therapy modification

DiazePAM: Cosyntropin may enhance the hepatotoxic effect of DiazePAM. Risk C: Monitor therapy

Estrogen Derivatives: May diminish the diagnostic effect of Cosyntropin. Management: Discontinue estrogen containing drugs 4 to 6 weeks prior to cosyntropin (ACTH) testing. Risk D: Consider therapy modification

Hydrocortisone (Systemic): May diminish the diagnostic effect of Cosyntropin. Management: Patients receiving hydrocortisone should omit their pre-test dose on the day selected for cosyntropin testing. Risk D: Consider therapy modification

Nitrazepam: Cosyntropin may enhance the hepatotoxic effect of Nitrazepam. Risk C: Monitor therapy

PHENobarbital: Cosyntropin may enhance the hepatotoxic effect of PHENobarbital. Risk C: Monitor therapy

Phenytoin: Cosyntropin may enhance the hepatotoxic effect of Phenytoin. Risk C: Monitor therapy

Primidone: Cosyntropin may enhance the hepatotoxic effect of Primidone. Risk C: Monitor therapy

Spironolactone: May diminish the diagnostic effect of Cosyntropin. Management: Patients receiving spironolactone should omit their pre-test dose on the day selected for cosyntropin testing. Risk D: Consider therapy modification

Valproate Products: Cosyntropin may enhance the hepatotoxic effect of Valproate Products. Management: Avoid concomitant use of Synacthen Depot (dosage form available in Canada) with valproic acid. Risk X: Avoid combination

Pregnancy Considerations

Animal reproduction studies have not been conducted with cosyntropin; adverse events have been observed with corticosteroids in animal reproduction studies. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 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). Cosyntropin is the recommended test to diagnose primary adrenal insufficiency during pregnancy. Pregnancy may alter cortisol levels, and higher concentrations are used to interpret the results based on trimester (Bornstein 2016).

Monitoring Parameters

Plasma cortisol concentration(s) as appropriate for specific test strategy.

Synacthen Depot [Canadian product]: Observe patient for ~1 hour after administration for signs/symptoms of hypersensitivity; with prolonged use monitor blood pressure, weight, urinalysis, glucose, electrolytes, signs and symptoms of infection, cataract formation, intraocular pressure, bone mass density and growth in children, ECG (in children).

Reference Range

Adrenocortical insufficiency, diagnostic test:

Response following standard dose: Peak cortisol concentration <18 mcg/dL (SI: <496.6 nmol/L) (assay dependent) at 30 or 60 minutes indicates adrenal insufficiency (ES [Bornstein 2016]).

Synacthen Depot [Canadian product]:

5-hour test: Plasma cortisol levels double in first hour then increase more gradually; normal values at 5 hours: 37 to 66 mcg/dL (SI: 1,020.8 to 1,820.9 nmol/L); 3-day test.

3-day test: There are multiple procedure methods; see manufacturer's labeling for details.

Congenital adrenal hyperplasia (CAH), confirmatory evaluation:

17-hydroxyprogesterone: >1 mcg/dL 60 minutes after administration indicates CAH due to 21-hydroxylase deficiency (ES [Speiser 2018]).

Mechanism of Action

Stimulates the adrenal cortex to secrete adrenal steroids (including hydrocortisone, cortisone), androgenic substances, and a small amount of aldosterone

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: IM, IV: Within 5 minutes increases in plasma cortisol concentrations are observed in healthy individuals

Maximum effect: IM, IV: 45-60 minutes peak plasma cortisol concentration

Duration of action: Synacthen Depot [Canadian product]: IM: Plasma concentrations of 200-300 pg/mL maintained for 12 hours

Absorption: Synacthen Depot [Canadian product]: IM: Rapid

Distribution: Synacthen Depot [Canadian product]: V_d: ~43% of body weight

Half-life elimination: Synacthen Depot [Canadian product]: 7 minutes

Time to peak, serum: IM, IV push: ~1 hour; plasma cortisol levels rise in healthy individuals within 5 minutes

Excretion: Urine

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Synacthen;
(AT) Austria: Synacthen;
(AU) Australia: Synacthen;
(BE) Belgium: Synacthen;
(BG) Bulgaria: Synacten;
(BR) Brazil: Cortrosina;
(CL) Chile: Synacthen;
(CO) Colombia: Synacthen;
(CZ) Czech Republic: Cortrosyn;
(DE) Germany: Synacthen;
(EC) Ecuador: Synacthen Deposito;
(EE) Estonia: Synacthen;
(EG) Egypt: Adrenocortine | Cortrosyn;
(ES) Spain: Nuvacthen;
(FI) Finland: S-cortrophine | Synacthen;
(FR) France: Tetracosactide Dci;
(GB) United Kingdom: Cortrosyn | Synacthen;
(GR) Greece: Cortrosyn | Nuvacthen | Synacthene;
(HU) Hungary: Cortrosyn;
(IE) Ireland: Synacthen;
(IL) Israel: Synacthen;
(IT) Italy: Cortrosyn | Synacthen;
(JP) Japan: Cortrosyn | Cortrosyn z;
(KW) Kuwait: Synacthen;
(LB) Lebanon: Synacthen;
(LT) Lithuania: Nuvacthen | Synacten | Synacthen;
(LU) Luxembourg: Synacthen;
(LV) Latvia: Synacten;
(MA) Morocco: Synacthen;
(NO) Norway: Synacthen depot cd;
(PL) Poland: Cortrosyn | Synacthen;
(PR) Puerto Rico: Cortrosyn | Cosyntropin;
(PT) Portugal: Synacthen Deposito;
(QA) Qatar: Synacthen Depot;
(RO) Romania: Cortrosyn;
(RU) Russian Federation: Synacten | Synacthen depot;
(SA) Saudi Arabia: Synacthen;
(SE) Sweden: Synacthen;
(SI) Slovenia: Synachten;
(SK) Slovakia: Synacthen;
(TN) Tunisia: Cortrosyn;
(TR) Turkey: Synacthen;
(TW) Taiwan: Cortrosyn;
(UA) Ukraine: Synacten;
(VE) Venezuela, Bolivarian Republic of: Synacthen;
(ZA) South Africa: Synachten | Synacthen

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Topic 13183 Version 172.0

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Cosyntropin (tetracosactide): Pediatric drug information