Repository Corticotropin
Generic Name: repository corticotropin
Brand Names:
Purified Cortrophin Gel
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.
Overview
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.
Uses
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.
Dosage
DOSAGE AND ADMINISTRATION Standard tests for verification of adrenal responsiveness to corticotropin may utilize as much as 80 units as a single injection or one or more injections of a lesser dosage. Verification tests should be performed prior to treatment with corticotropins. The test should utilize the route(s) of administration proposed for treatment. Following verification dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease, plasma and urine corticosteroid levels and the initial response of the patient. Only gradual change in dosage schedules should be attempted, after full drug effects have become apparent.
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.
Interactions
Drug Interactions Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.
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. 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.
Pregnancy
Pregnancy Since fetal abnormalities have been observed in experimental animals, use of this drug in pregnancy, nursing mothers, or women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticotropin during pregnancy should be carefully observed for signs of hypoadrenalism.
Storage
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.
Frequently Asked Questions
What is Repository Corticotropin used for?▼
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.
What are the side effects of Repository Corticotropin?▼
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.
Can I take Repository Corticotropin during pregnancy?▼
Pregnancy Since fetal abnormalities have been observed in experimental animals, use of this drug in pregnancy, nursing mothers, or women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticotropin during pregnancy should be carefully observed for signs of hypoadrenalism.
What are the important warnings for Repository Corticotropin?▼
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. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.