purified cortrophin gel
Pharmaranks rates Purified Cortrophin Gel 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Purified Cortrophin Gel (Corticotropin) is an adrenocorticotropic hormone used to treat Collagen Diseases, Erythema Multiforme, Multiple Sclerosis, Nephrotic Syndrome.
Corticotropin · by Ani Pharms
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Corticotropin
- Drug class
- Adrenocorticotropic Hormone
- Form
- Injectable
- Strength
- Corticotropin 40 UNITS/ML · Corticotropin 80 UNITS/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ani Pharms
- FDA application
- NDA008975
What is Purified Cortrophin Gel?
From the FDA label: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
How to use
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. This product may be administered subcutaneously or intramuscularly with the vial and subcutaneously with the prefilled syringe. In the treatment of acute exacerbations of multiple sclerosis daily subcutaneous or intramuscular doses of 80-120 units for 2-3 weeks. The chronic administration of more than 40 units daily may be associated with uncontrollable adverse effects. When reduction in dosage is indicated this should be accomplished gradually by either reducing the amount of each injection, or administering injections at longer intervals, or by a combination of both of the above. During reduction of dosage, careful consideration…
Side effects
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.…
Warnings
Important safety information
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. Vaccination While on corticotropin therapy, patients should not be vaccinated against smallpox. Other immunization procedures should be undertaken with caution in patients who are receiving corticotropin, especially when high doses are administered because of the possible hazards of neurological complications and lack of antibody response.
Who should not take Purified Cortrophin Gel
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.
Interactions
Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.
Drug class
May treat (source: NIH RxClass)
- collagen diseases
- erythema multiforme
- multiple sclerosis
- nephrotic syndrome
- optic neuritis
- rheumatic diseases
See how Purified Cortrophin Gel ranks — best-rated adrenocorticotropic hormone for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Purified Cortrophin Gel treat?
- Purified Cortrophin Gel (Corticotropin) may be used to treat collagen diseases, erythema multiforme, multiple sclerosis, nephrotic syndrome, optic neuritis, rheumatic diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Purified Cortrophin Gel rated?
- pharmaranks gives Purified Cortrophin Gel a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Purified Cortrophin Gel?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Purified Cortrophin Gel. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Purified Cortrophin Gel?
- Purified Cortrophin Gel is marketed by Ani Pharms. You can see Ani Pharms's full profile, rating, and other products on pharmaranks.
- Is Purified Cortrophin Gel a brand-name or generic drug?
- Purified Cortrophin Gel is a brand-name product with the active ingredient Corticotropin.
- Is Purified Cortrophin Gel available over the counter?
- No. Purified Cortrophin Gel is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Purified Cortrophin Gel come in?
- Purified Cortrophin Gel is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Purified Cortrophin Gel?
- Purified Cortrophin Gel is classified as adrenocorticotropic hormone, per the FDA's Established Pharmacologic Class.
- Is Purified Cortrophin Gel FDA-registered?
- Purified Cortrophin Gel is on record with the U.S. FDA under application number NDA008975. You can verify this on its official FDA label.
- Has Purified Cortrophin Gel been recalled by the FDA?
- Purified Cortrophin Gel has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Purified Cortrophin Gel safe?
- There's no single safe-or-not verdict. pharmaranks gives Purified Cortrophin Gel a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Purified Cortrophin Gel?
- Purified Cortrophin Gel's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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purified cortrophin gel
70/100