Important: This page is general information, not medical advice. It does not recommend or prescribe any treatment. Always consult your doctor or pharmacist before starting, stopping or changing any medicine.
Quick facts
- Drug class
- Adrenocorticotropic Hormone [EPC]
- How it is given
- intramuscular, subcutaneous
- Type
- human prescription drug
- Brand names
- Purified Cortrophin Gel
- RxNorm ID
- 309541
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
INDICATIONS AND USAGE Purified Cortrophin Gel is indicated in the following disorders: 1. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute gouty arthritis. 2. Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). 3. Dermatologic diseases: Severe erythema multiforme (Stevens-Johnson syndrome). Severe psoriasis. 4. Allergic states: Atopic dermatitis Serum sickness. 5. Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis. Keratitis. Iritis and iridocyclitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Chorioretinitis. Anterior segment inflammation. 6. Respiratory diseases: Symptomatic sarcoidosis. 7. Edematous states: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. 8. Nervous system: Acute exacerbations of multiple sclerosis.
About this medicine
DESCRIPTION Purified Cortrophin Gel is a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin. It is made up of a complex mixture of ACTH, ACTH related peptides and other porcine pituitary derived peptides. The drug product is a sterile preparation containing 80 USP units per mL and it contains 0.5% phenol (as preservative), 15.0% gelatin (for prolonged activity), water for injection, and the pH is adjusted with hydrochloric acid and sodium hydroxide. Purified Cortrophin Gel contains the porcine derived ACTH (1-39) with the following amino acid sequence: Structure
Who should not take it
CONTRAINDICATIONS Purified Cortrophin Gel is contraindicated for intravenous administration. Purified Cortrophin Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins derived from porcine sources. Purified Cortrophin Gel is contraindicated in patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
Warnings
WARNINGS Chronic administration of corticotropin may lead to adverse effects which are not reversible. This product should not be administered for treatment until adrenal responsiveness has been verified with the route of administration which will be utilized during treatment, intramuscularly or subcutaneously. A rise in urinary and plasma corticosteroid values provides direct evidence of a stimulatory effect. Although the action of corticotropin is similar to that of exogenous adrenocortical steroids the quantity of adrenocorticoid may be variable. In patients who receive prolonged corticotropin therapy the additional use of rapidly acting corticosteroids before, during and after an unusual stressful situation is indicated. Masking Symptoms of Other Diseases Corticotropin may only suppress symptoms and signs of chronic disease without altering the natural course of the disease. Immunogenicity Potential Purified Cortrophin Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to Purified Cortrophin Gel after chronic administration and loss of endogenous ACTH and Purified Cortrophin Gel activity. Prolonged administration of Purified Cortrophin Gel may increase the risk of hypersensitivity reactions. Cases of anaphylaxis following administration have also been reported in the postmarketing setting. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise. Ophthalmic Effects Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves. Infections Corticotropin may mask some signs of infection, and new infections including those of the eye due to fungi or viruses may appear during its use. There may be decreased resistance and inability to localize infection when corticotropin is used. Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary. Corticotropin increases calcium excretion. […]
Reported side effects
ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention. Hypokalemic alkalosis. Fluid retention. Calcium loss. Potassium loss. Musculoskeletal Muscle weakness. Loss of muscle mass. Steroid myopathy. Osteoporosis. Vertebral compression fractures. Aseptic necrosis of femoral and humeral heads. Pathologic fracture of long bones. Gastrointestinal Peptic ulcer with possible perforation and hemorrhage. Abdominal distention. Ulcerative esophagitis. Pancreatitis. Dermatologic Injection site reactions. Impaired wound healing. Increased sweating. Thin fragile skin. Suppression of skin test reactions. Petechiae and ecchymoses. Acne. Hyperpigmentation. Facial erythema. Cardiovascular Hypertension. Congestive heart failure. Necrotizing angiitis. Neurological Convulsions. Increased intracranial pressure with papilledema (pseudo-tumor cerebri), usually after treatment. Headache. Vertigo. Endocrine Menstrual irregularities. Development of Cushingoid state. Suppression of growth in children. Secondary adrenocortical and pituitary insufficiency, particularly in times of stress, as in trauma, surgery or illness. Decreased carbohydrate tolerance. Manifestations of latent diabetes mellitus. Increased requirements for insulin or oral hypoglycemic agents in diabetics. Hirsutism. Ophthalmic Posterior subcapsular cataracts. Increased intraocular pressure. Glaucoma with possible damage to optic nerve. Exophthalmos. Metabolic Negative nitrogen balance due to protein catabolism. Allergic reactions Allergic reactions manifesting as dizziness, nausea and vomiting, skin reactions, anaphylaxis (anaphylactic shock, urticaria, respiratory compromise, edema), especially in patients with allergic responses to proteins. Miscellaneous Weight gain. Abscess. Development of antibodies and loss of stimulatory effect. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions with other medicines
Drug Interactions Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.
Storing it safely
Storage Store Purified Cortrophin Gel vials and prefilled syringes refrigerated at 2° to 8°C (36° to 46°F). Purified Cortrophin Gel vials and prefilled syringes may be stored at room temperature between 20° to 25°C (68° to 77°F) for up to 24 hours. After first use discard Purified Cortrophin Gel vials per the table below. Write the revised expiration date in the space provided on the carton labeling. Package Size Discard By 1 mL multiple-dose vial 6 months after first use or by the expiration date stamped on the vial, whichever occurs first. 5 mL multiple-dose vial 28 days after first use or by the expiration date stamped on the vial, whichever occurs first. Discard Purified Cortrophin Gel prefilled syringes immediately after use or by the expiration date stamped on the syringe. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10233 Rev 08/25 10716 Rev 08/25 logo
Before you take anything new
Tell your pharmacist or doctor about every medicine you take — including ones bought without a prescription, herbal products and supplements. Interactions are one of the most common avoidable causes of harm from medicines, and a pharmacist can check your full list in a couple of minutes.
This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 9 February 2026. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.