Cosyntropin

Before you receive cosyntropin, tell your doctor about all your medical conditions or allergies, and all the medicines you are using.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

• It is used during a test to check adrenal function.
• It may be given to you for other reasons. Talk with the doctor.

NDC 67457-227-02

Cosyntropin
for Injection
0.25 mg

For Diagnostic Use Only

For IM or IV Use

Rx only      10 x 0.25 mg Vials

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Each vial contains: Cosyntropin 0.25 mg
(equivalent to approx. 25 USP Units ACTH)
and Mannitol 10 mg. Prior to lyophilization
the pH may be adjusted with acetic acid
and/or sodium hydroxide.

Reconstitute with: 1 mL 0.9% Sodium
Chloride Injection, USP.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Made in India        Code No.: AP/DRUGS/103/97

MI:227:10C:R2

• Cortrosyn

• Corticosteroid, Systemic
• Diagnostic Agent

Diagnostic use: Screening of adrenocortical insufficiency:

Cosyntropin powder for injection (IM, IV) or cosyntropin solution for injection (IV only [manufacturer labeling does not recommend IM administration of solution for injection]):

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 (Abdu 1999); 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 (Marik 2008). 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 (ES [Bornstein 2016]).

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.

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.

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 intravenously.

IM: May administer IM (reconstituted powder for injection only); cosyntropin injection solution is not recommended for IM administration (manufacturer recommendation).

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

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

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

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

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

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

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

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. Avoid combination

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. Synacthen Depot [Canadian product] is contraindicated in patients with allergic conditions.

• 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 latent tuberculosis; treatment may reactivate latent tuberculosis. Rule out amebiasis prior to initiating therapy; may activate latent amebiasis.

• Myasthenia gravis: Synacthen Depot [Canadian product]: Use caution in patients with myasthenia gravis.

• 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.

• 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.

Synacthen Depot [Canadian product]: Observe patient for ~1 hour after administration for signs/symptoms of hypersensitivity; for diagnosis of adrenocortical Insufficiency measure plasma cortisol prior to and 4-6 hours after injection; 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)

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:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Data not available

Hypersensitivity reactions including rare anaphylaxis are possible. Therefore, prior to injection, appropriate measures should be in place to treat any possible acute hypersensitivity reaction.