PURIFIED CORTROPHIN GEL Rx

Select therapeutic use:

Allergies:

Indications for: PURIFIED CORTROPHIN GEL

Serum sickness.

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Arthritis/rheumatic disorders:

Indications for: PURIFIED CORTROPHIN GEL

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

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Atopic dermatitis:

Indications for: PURIFIED CORTROPHIN GEL

Atopic dermatitis.

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Miscellaneous dermatological conditions:

Indications for: PURIFIED CORTROPHIN GEL

Severe erythema multiforme. Stevens-Johnson syndrome.

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Miscellaneous immune disorders:

Indications for: PURIFIED CORTROPHIN GEL

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

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Miscellaneous ocular agents:

Indications for: PURIFIED CORTROPHIN GEL

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.

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Miscellaneous respiratory disorders:

Indications for: PURIFIED CORTROPHIN GEL

Symptomatic sarcoidosis.

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Miscellaneous urogenital disorders:

Indications for: PURIFIED CORTROPHIN GEL

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

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Multiple sclerosis:

Indications for: PURIFIED CORTROPHIN GEL

Acute exacerbations of multiple sclerosis.

Adult Dosage:

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 Dosage:

Not recommended.

PURIFIED CORTROPHIN GEL 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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1

Psoriasis:

Indications for: PURIFIED CORTROPHIN GEL

Severe psoriasis.

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:

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 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 Classification:

Adrenocorticotropic hormone (ACTH) analogue.

PURIFIED CORTROPHIN GEL Interactions:

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

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, acne, hyperpigmentation, increased sweating, erythema, hypertension, CHF, convulsions, headache, vertigo, menstrual irregularities, decreased carbohydrate tolerance, hirsutism, increased intraocular pressure, glaucoma, exophthalmos, allergic reactions.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (5mL)—1