Purified Cortrophin Gel

— THERAPEUTIC CATEGORIES —
  • Allergies
  • Arthritis/rheumatic disorders
  • Atopic dermatitis
  • Miscellaneous dermatological conditions
  • Miscellaneous immune disorders
  • Miscellaneous ocular agents
  • Miscellaneous respiratory disorders
  • Miscellaneous urogenital disorders
  • Multiple sclerosis
  • Psoriasis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Serum sickness.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Short-term (acute episode or exacerbation) adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Atopic dermatitis.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Severe erythema multiforme. Stevens-Johnson syndrome.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus or systemic dermatomyositis (polymyositis).

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Severe acute/chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis, keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Symptomatic sarcoidosis.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    To induce diuresis or remission of proteinuria in nephrotic syndrome without idiopathic type uremia or that due to lupus erythematosus.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Acute exacerbations of multiple sclerosis.

    Purified Cortrophin Gel Dosage and Administration

    Adult

    See full labeling. Individualize. Give by IM inj. Use the lowest effective dose. 80–120 Units daily for 2–3 weeks. Max 40 Units daily for chronic administration.

    Children

    Not recommended.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

    Purified Cortrophin Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Repository corticotrophin 80 Units/mL; gel for IM or SC inj.

    Pharmacological Class

    Adrenocorticotropic hormone (ACTH) analogue.

    How Supplied

    Multiple-dose vial (1mL, 5mL)—1

    Manufacturer

    ANI Pharmaceuticals, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

    Purified Cortrophin Gel Indications

    Indications

    Severe psoriasis.

    Purified Cortrophin Gel Dosage and Administration

    Adults and Children

    See full labeling. Individualize. Give by SC or IM inj. Use the lowest effective dose. Up to 80 Units as a single injection, or 1 or more injections of a lesser dose. Max 40 Units daily for chronic administration.

    Purified Cortrophin Gel Contraindications

    Contraindications

    Intravenous administration. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

    Purified Cortrophin Gel Boxed Warnings

    Not Applicable

    Purified Cortrophin Gel Warnings/Precautions

    Warnings/Precautions

    Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Monitor BP, sodium, and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. Hypothyroidism. Cirrhosis. Psychic derangements. Emotional instability. Psychotic tendencies. Diabetes. Abscess. Pyogenic infections. GI disorders. Diverticulitis. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Renal insufficiency. Monitor growth in children on prolonged therapy. Avoid abrupt cessation. Pregnancy. Nursing mothers.

    Purified Cortrophin Gel Pharmacokinetics

    Absorption

    Median time (range) to reach peak cortisol concentration was 8 (3–12) hours.

    Baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

    Purified Cortrophin Gel Interactions

    Interactions

    Avoid concomitant smallpox vaccines; others, use caution. Concomitant with aspirin in hypoprothrombinemia; use caution.

    Purified Cortrophin Gel Adverse Reactions

    Adverse Reactions

    Fluid retention, electrolyte disturbances (eg, decreased Ca and K+, hypokalemic alkalosis), muscle weakness, steroid myopathy, osteoporosis, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, inj site reactions, impaired wound healing, acne, hyperpigmentation, increased sweating, facial, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions, weight gain, abscess, antibodies development, loss of stimulatory effect.

    Purified Cortrophin Gel Clinical Trials

    See Literature

    Purified Cortrophin Gel Note

    Not Applicable

    Purified Cortrophin Gel Patient Counseling

    See Literature

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