Application Information

This drug has been submitted to the FDA under the reference 008317/002.

Names and composition

"ACTH" is the commercial name of a drug composed of CORTICOTROPIN.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
008317/002 ACTH CORTICOTROPIN INJECTABLE/INJECTION 25 UNITS per VIAL
008317/004 ACTH CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per VIAL

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
007504/002 ACTHAR CORTICOTROPIN INJECTABLE/INJECTION 25 UNITS per VIAL
007504/003 ACTHAR CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per VIAL
008317/002 ACTH CORTICOTROPIN INJECTABLE/INJECTION 25 UNITS per VIAL
008317/004 ACTH CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per VIAL
008372/006 H.P. ACTHAR GEL CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per ML
008372/008 H.P. ACTHAR GEL CORTICOTROPIN INJECTABLE/INJECTION 80 UNITS per ML
008975/001 PURIFIED CORTROPHIN GEL CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per ML
008975/002 PURIFIED CORTROPHIN GEL CORTICOTROPIN INJECTABLE/INJECTION 80 UNITS per ML
010831/001 CORTICOTROPIN CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per ML
010831/002 CORTICOTROPIN CORTICOTROPIN INJECTABLE/INJECTION 80 UNITS per ML
088772/001 CORTICOTROPIN CORTICOTROPIN INJECTABLE/INJECTION 40 UNITS per VIAL

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Answered questions

Plasma ACTH test questions?
What is plasma acth how is it performed? Asked by Felton Selley 1 year ago.

ACTH or adrenocorticotrophic hormone is produced by the anterior pituitary gland.The hormone stimulates the adrenal cortex.So an over production or insufficiency will present with symptoms of the adrenal gland. This test is used to diagnose or exclude primary and secondary adrenal insufficiency, Addison's disease and related conditions. The health care provider will measure the cortisol in your blood before and 60 minutes after an ACTH injection. A blood sample is needed. Once the blood has been collected, the health care provider will use a needle to inject ACTH.Other timed specimens are also collected. Along with the blood tests, sometimes you may also have a urinary free cortisol test or urinary 17-ketosteroids test in which the urine is collected over a 24-hour period. The person must fast at least 8 hours before the test as close to 7 am as possible. Glucocorticoids, adrenal extract supplement,Spironolactone, contraceptives, licorice,estrogen therapy, androgen therapy and progesterone therapy can give false results.The test may also give false results to females in the reproductive age group when their natural hormone levels are high ,as around the time of ovulation. HOPE THIS HELPS :) Answered by Clark Henneman 1 year ago.


Anyone ever taken an ACTH test?
I have to take an ACTH hormone test tomorrow, and I need to know what to do to prepare. Do I have to fast? No one gave me anything about what to do before-hand, but I suspect there's at least something. I'm very nervous. Anyone have experiences to share? Asked by Dotty Devries 1 year ago.

The ACTH stimulation test measures the adrenal response or lack of response to stress by testing the amount of cortisol the adrenals produce after being stimulated by a synthetic form of ACTH (Adrenocorticotropic hormone). This is a simple test. Blood is drawn to get a starting or base cortisol level (serum ACTH should also be tested), next synthetic ACTH (Synacthen aka Tetracosactide or Cortrosyn aka Cosyntropin) is injected. Blood is drawn 30 min, sometimes 45 min, and at 60 minutes after the synthetic ACTH has been injected. The test must be done for at least 60 minutes. In healthy adrenal function, the cortisol level should double within 60 minutes. If the cortisol level was a 25 before the stimulation (base level), after the stimulation should reach at least 50. Most feel nothing during or after the test, but flushed skin, anxiety and nausea are possible. You may need to limit activities and eat a high-carbohydrate diet 12-24 hours before the test. You may be asked to fast for 6 hours before the test. But you should call your doctor just to make sure, they might want you to do something different. Answered by Jonelle Cowdrey 1 year ago.

See a doctor and get your blood examined (and regardless of else the wellness care provider what needs you to do). you have a blood affliction or maximum cancers. no longer something to make guesses approximately. Answered by Christian Nickel 1 year ago.


What is plasma acth and how is it performed?
The doctor asked me to do this test, how is it done? Asked by Delmy Ullery 1 year ago.

ACTH is Adrenocorticotropic Hormone, a hormone involved the stimulation of cortisol production. Like cortisol it's levels peak between 6-8/9 am and is collected via venupuncture into an EDTA or purple top vacutainer. A cortisol must always accompany an ACTH test as the interpretation of ACTH levels is dependant on cortisol levels. Low cortisol with high ACTH indicates primary adrenal insufficiency, whereas combined with low ACTH indicates secondary adrenal insufficiency. High cortisol (Cushings syndrome) with normal or high ACTH indicated ACTH-dependant Cushing's syndrome, whereas combined with low ACTH indicates a cortisol-producing adrenal adenoma or carcinoma, primary adrenal micromodular hyperplasia, or exogenous corticosteroid use. Answered by Jeanetta Brase 1 year ago.

this is a blood test which will look for levels of the hormone ACTH in your blood. levels of ACTH that are too high or too low could indicate a problem with your adrenal gland, which produces hormones in your body such as aldosterone (which affects how your kidneys process water and salt), corticosterone (affects how your body deals with stress), and others. the test would probably involve drawing one or two tablespoons of blood through a small needle inserted into one of the veins in your arm. Answered by Ileana Staup 1 year ago.


Is adrenocorticotropic hormone (ACTH) available as a supplement?
When an individual has an adrenal gland insufficiency and is not producing adequate aldosterone, doctors will prescribe Fludrocortisone Acetate as a supplement. This introduction of an exogenous cortisone, however, will have the effect that the pituitary gland will diminish its production of adrenocorticotropic... Asked by Zonia Bacman 1 year ago.

When an individual has an adrenal gland insufficiency and is not producing adequate aldosterone, doctors will prescribe Fludrocortisone Acetate as a supplement. This introduction of an exogenous cortisone, however, will have the effect that the pituitary gland will diminish its production of adrenocorticotropic hormone (ACTH) via the feedback-loop of the hypothalamus-pituitary-adrenal glands. This results in the atrophying of the adrenal glands so that they produce very little (if any) endogenous aldosterone. Do doctors then prescribe supplemental ACTH in order to prevent the adrenals from atrophying? Answered by Regine Booze 1 year ago.

ACTH is too expensive. It is also only IV. So it is only used for stimulation testing. For replacements, corticosteroids are given but nothing can prevent the adrenals from atrophy - once they are not working, they start to atrophy. Too much ACTH BTW, is Cushing's disease, and can lead to the adrenals becoming enlarged - and in turn, not functional, and even nodular. So giving ACTH is not ideal. I did read about it for MS patients though. One of my links shows normal adrenals, adrenals without ACTH, and with too much. I had Cushing's, mine were removed and were enlarged. Oddly, the CTs showed they were normal before and after removal. Answered by Jenice Hovnanian 1 year ago.

ACTH is a hormone secreted by using the pituitary gland. Its objective organ is the adrenal glands to stimulate production of adrenal hormones (cortisol, etc). ACTH is on no account linked to the thyroid gland. The pituitary hormone that stimulates the thyroid gland is declared as TSH (thyroid stimulating hormone. It reasons production of T3 and T4 by using the thyroid. This in turn has damaging comments inhibition on TRH (thyrotropin liberating hormone) secreted by using the hypothalamus. Answered by Lincoln Surgeon 1 year ago.


An ACTH-producing tumor of the pituitary gland. Explain if each of the following hormone levels.?
ACTH-producing tumor of the pituitary gland has been diagnose from a patient. Explain if each of the following hormone levels should be increased, decreased or unaffected (relative to normal), and explain why in just a few words.a.ANPb.ADHc.Aldod.Cortisole.EPIf.CRHg.T4h.GHIHi.Angiotensin... Asked by Rosita Orama 1 year ago.

ACTH-producing tumor of the pituitary gland has been diagnose from a patient. Explain if each of the following hormone levels should be increased, decreased or unaffected (relative to normal), and explain why in just a few words. a.ANP b.ADH c.Aldo d.Cortisol e.EPI f.CRH g.T4 h.GHIH i.Angiotensin II j.Androgens k.EPO Need some help. Answered by Eliz Fogelson 1 year ago.

By definition, an ACTH producing pituitary tumour is Cushing's disease. This is hypercortisolism. Cortisol is high. Cortisol, in high amounts, acts like aldosterone (like an overflow thing) but aldosterone shouldn't rise too much even though the cortisol will be performing actions similar to aldosterone on the same receptors. CRH would drop I would say, because of the HPA axis and negative feedback. We don't really measure CRH in practice much, but you can imagine that a high ACTH and therefore high cortisol would feedback negatively and decrease the CRH as CRH would increase in a case of low cortisol (in order to produce more cortisol). High corticol increases blood pressure, so the Ang II wouldn't be stimulated and would not be high (it goes up when the blood pressure is low). ADH also goes up when BP is low and so wouldn't be up if cortisol was high (although the primary reason for increased ADH is a high osmolality anyway - it's just that high osmolality is commonly found with dehydration and lower blood pressure). None of the rest have much to do with the case unless there is an effect of the tumour in the pituitary compressing things (where the other hormones produced by the pituitary e.g. TSH, GH would decrease), or if the tumour was made of more than just ACTH-producing cells e.g. thyrotrophs - would increase T4. ANP might increase as it goes up when the atria are stretched by a high blood volume/pressure which could occur in hypercortisolism (the result of excess ACTH). Answered by Naomi Ursino 1 year ago.


ACTH before and after an injection, Test results?
I had this test done and being that it is a time sensitive test the nurse was told to cool my blood in the fridge but he froze it in the freezer, did he alter the test result because he froze my blood? Asked by Gerard Kroft 1 year ago.

Maybe yes, maybe no. ACTH is a very very fussy test. Ideally the tubes should be chilled before they make the draws and they should be put on ice while they are drawing other tubes and then put in the centrifuge right after the draw. ACTH (and renin) degrade within a few minutes at room temperature. In reality, she should have just stuck them in the centrifuge as sitting is really bad, but at least they were very very cold - so that is better. I make my lab techs put it in the centrifuge immediately. But if they froze before they were spun... that is bad - they need to be spun to separate the parts then frozen promptly. If that happened, your lab report will show the specimens arrived improperly. Lab error messed up my diagnosis quite a bit and what was aggravating is that the doctors do not pick it up. I had Cushing's disease and my ACTH was normal (hmmm) the entire time yet my source was pituitary. Now my ACTH is over 2000 and when the lab goofs - it drops over 400 points and the range is only 4-27 so I can only imagine what that means to everyone. Answered by Aliza Bolte 1 year ago.


Why does ACTH injection not cause increased cortisol secretion?
please be detailed in your answer. Asked by Serita Valcourt 1 year ago.

ACTH is a pituitary hormone which will cause cortisol release from the adrenal glands. If the injection does not result in significantly increased cortisol levels then your adrenal glands are not functioning properly. This is a very serious condition which can quickly result in death and requires lifelong treatment with steroids and continued monitoring by an endocrinologist. If you get a rise in cortisol with ACTH injection but your serum levels have been low, the the problem lies in the pituitary not the adrenal glands. Answered by Kit Prader 1 year ago.

I might be understanding the question wrong but I thought such an injection would cause cortisol to be released from the adrenal gland? Answered by Kandy Kunert 1 year ago.


Where is ACTH produced?
In the pituitary gland or outside? I'm confused because I thought POMC was madde in the pituitary, and then POMC left the pituitary gland to turn into ACTH. But some sources say ACTH is made in the pituitary gland. Any help would be great, thank you so much! :) Asked by Elias Florance 1 year ago.

ACTH is produced in the anterior pituitary gland. POMC is a precursor and ACTH is only one of its end products. Stimulation of the pituitary gland is required for ACTH to be released. Answered by Lanelle Krupinsky 1 year ago.


Plasma ACTH test questions?
What is plasma acth how is it performed? Asked by Hubert Assante 1 year ago.

ACTH or adrenocorticotrophic hormone is produced by the anterior pituitary gland.The hormone stimulates the adrenal cortex.So an over production or insufficiency will present with symptoms of the adrenal gland. This test is used to diagnose or exclude primary and secondary adrenal insufficiency, Addison's disease and related conditions. The health care provider will measure the cortisol in your blood before and 60 minutes after an ACTH injection. A blood sample is needed. Once the blood has been collected, the health care provider will use a needle to inject ACTH.Other timed specimens are also collected. Along with the blood tests, sometimes you may also have a urinary free cortisol test or urinary 17-ketosteroids test in which the urine is collected over a 24-hour period. The person must fast at least 8 hours before the test as close to 7 am as possible. Glucocorticoids, adrenal extract supplement,Spironolactone, contraceptives, licorice,estrogen therapy, androgen therapy and progesterone therapy can give false results.The test may also give false results to females in the reproductive age group when their natural hormone levels are high ,as around the time of ovulation. HOPE THIS HELPS :) Answered by Rubie Glosser 1 year ago.


Anyone ever taken an ACTH test?
I have to take an ACTH hormone test tomorrow, and I need to know what to do to prepare. Do I have to fast? No one gave me anything about what to do before-hand, but I suspect there's at least something. I'm very nervous. Anyone have experiences to share? Asked by Mari Depietro 1 year ago.

The ACTH stimulation test measures the adrenal response or lack of response to stress by testing the amount of cortisol the adrenals produce after being stimulated by a synthetic form of ACTH (Adrenocorticotropic hormone). This is a simple test. Blood is drawn to get a starting or base cortisol level (serum ACTH should also be tested), next synthetic ACTH (Synacthen aka Tetracosactide or Cortrosyn aka Cosyntropin) is injected. Blood is drawn 30 min, sometimes 45 min, and at 60 minutes after the synthetic ACTH has been injected. The test must be done for at least 60 minutes. In healthy adrenal function, the cortisol level should double within 60 minutes. If the cortisol level was a 25 before the stimulation (base level), after the stimulation should reach at least 50. Most feel nothing during or after the test, but flushed skin, anxiety and nausea are possible. You may need to limit activities and eat a high-carbohydrate diet 12-24 hours before the test. You may be asked to fast for 6 hours before the test. But you should call your doctor just to make sure, they might want you to do something different. Answered by Echo Shiba 1 year ago.

See a doctor and get your blood examined (and regardless of else the wellness care provider what needs you to do). you have a blood affliction or maximum cancers. no longer something to make guesses approximately. Answered by Stephane Tobery 1 year ago.


What is plasma acth and how is it performed?
The doctor asked me to do this test, how is it done? Asked by Carmella Sacca 1 year ago.

ACTH is Adrenocorticotropic Hormone, a hormone involved the stimulation of cortisol production. Like cortisol it's levels peak between 6-8/9 am and is collected via venupuncture into an EDTA or purple top vacutainer. A cortisol must always accompany an ACTH test as the interpretation of ACTH levels is dependant on cortisol levels. Low cortisol with high ACTH indicates primary adrenal insufficiency, whereas combined with low ACTH indicates secondary adrenal insufficiency. High cortisol (Cushings syndrome) with normal or high ACTH indicated ACTH-dependant Cushing's syndrome, whereas combined with low ACTH indicates a cortisol-producing adrenal adenoma or carcinoma, primary adrenal micromodular hyperplasia, or exogenous corticosteroid use. Answered by Mariella Sokal 1 year ago.

this is a blood test which will look for levels of the hormone ACTH in your blood. levels of ACTH that are too high or too low could indicate a problem with your adrenal gland, which produces hormones in your body such as aldosterone (which affects how your kidneys process water and salt), corticosterone (affects how your body deals with stress), and others. the test would probably involve drawing one or two tablespoons of blood through a small needle inserted into one of the veins in your arm. Answered by Teena Heverly 1 year ago.


Is adrenocorticotropic hormone (ACTH) available as a supplement?
When an individual has an adrenal gland insufficiency and is not producing adequate aldosterone, doctors will prescribe Fludrocortisone Acetate as a supplement. This introduction of an exogenous cortisone, however, will have the effect that the pituitary gland will diminish its production of adrenocorticotropic... Asked by Maryann Brunjes 1 year ago.

When an individual has an adrenal gland insufficiency and is not producing adequate aldosterone, doctors will prescribe Fludrocortisone Acetate as a supplement. This introduction of an exogenous cortisone, however, will have the effect that the pituitary gland will diminish its production of adrenocorticotropic hormone (ACTH) via the feedback-loop of the hypothalamus-pituitary-adrenal glands. This results in the atrophying of the adrenal glands so that they produce very little (if any) endogenous aldosterone. Do doctors then prescribe supplemental ACTH in order to prevent the adrenals from atrophying? Answered by Lucrecia Mcgruder 1 year ago.

ACTH is too expensive. It is also only IV. So it is only used for stimulation testing. For replacements, corticosteroids are given but nothing can prevent the adrenals from atrophy - once they are not working, they start to atrophy. Too much ACTH BTW, is Cushing's disease, and can lead to the adrenals becoming enlarged - and in turn, not functional, and even nodular. So giving ACTH is not ideal. I did read about it for MS patients though. One of my links shows normal adrenals, adrenals without ACTH, and with too much. I had Cushing's, mine were removed and were enlarged. Oddly, the CTs showed they were normal before and after removal. Answered by Gilberte Wilmer 1 year ago.

ACTH is a hormone secreted by using the pituitary gland. Its objective organ is the adrenal glands to stimulate production of adrenal hormones (cortisol, etc). ACTH is on no account linked to the thyroid gland. The pituitary hormone that stimulates the thyroid gland is declared as TSH (thyroid stimulating hormone. It reasons production of T3 and T4 by using the thyroid. This in turn has damaging comments inhibition on TRH (thyrotropin liberating hormone) secreted by using the hypothalamus. Answered by Luigi Dollyhigh 1 year ago.


An ACTH-producing tumor of the pituitary gland. Explain if each of the following hormone levels.?
ACTH-producing tumor of the pituitary gland has been diagnose from a patient. Explain if each of the following hormone levels should be increased, decreased or unaffected (relative to normal), and explain why in just a few words.a.ANPb.ADHc.Aldod.Cortisole.EPIf.CRHg.T4h.GHIHi.Angiotensin... Asked by Sallie Ubaldo 1 year ago.

ACTH-producing tumor of the pituitary gland has been diagnose from a patient. Explain if each of the following hormone levels should be increased, decreased or unaffected (relative to normal), and explain why in just a few words. a.ANP b.ADH c.Aldo d.Cortisol e.EPI f.CRH g.T4 h.GHIH i.Angiotensin II j.Androgens k.EPO Need some help. Answered by Suzette Riveiro 1 year ago.

By definition, an ACTH producing pituitary tumour is Cushing's disease. This is hypercortisolism. Cortisol is high. Cortisol, in high amounts, acts like aldosterone (like an overflow thing) but aldosterone shouldn't rise too much even though the cortisol will be performing actions similar to aldosterone on the same receptors. CRH would drop I would say, because of the HPA axis and negative feedback. We don't really measure CRH in practice much, but you can imagine that a high ACTH and therefore high cortisol would feedback negatively and decrease the CRH as CRH would increase in a case of low cortisol (in order to produce more cortisol). High corticol increases blood pressure, so the Ang II wouldn't be stimulated and would not be high (it goes up when the blood pressure is low). ADH also goes up when BP is low and so wouldn't be up if cortisol was high (although the primary reason for increased ADH is a high osmolality anyway - it's just that high osmolality is commonly found with dehydration and lower blood pressure). None of the rest have much to do with the case unless there is an effect of the tumour in the pituitary compressing things (where the other hormones produced by the pituitary e.g. TSH, GH would decrease), or if the tumour was made of more than just ACTH-producing cells e.g. thyrotrophs - would increase T4. ANP might increase as it goes up when the atria are stretched by a high blood volume/pressure which could occur in hypercortisolism (the result of excess ACTH). Answered by Temeka Sedwick 1 year ago.


ACTH before and after an injection, Test results?
I had this test done and being that it is a time sensitive test the nurse was told to cool my blood in the fridge but he froze it in the freezer, did he alter the test result because he froze my blood? Asked by Amiee Kirschman 1 year ago.

Maybe yes, maybe no. ACTH is a very very fussy test. Ideally the tubes should be chilled before they make the draws and they should be put on ice while they are drawing other tubes and then put in the centrifuge right after the draw. ACTH (and renin) degrade within a few minutes at room temperature. In reality, she should have just stuck them in the centrifuge as sitting is really bad, but at least they were very very cold - so that is better. I make my lab techs put it in the centrifuge immediately. But if they froze before they were spun... that is bad - they need to be spun to separate the parts then frozen promptly. If that happened, your lab report will show the specimens arrived improperly. Lab error messed up my diagnosis quite a bit and what was aggravating is that the doctors do not pick it up. I had Cushing's disease and my ACTH was normal (hmmm) the entire time yet my source was pituitary. Now my ACTH is over 2000 and when the lab goofs - it drops over 400 points and the range is only 4-27 so I can only imagine what that means to everyone. Answered by Merrilee Mandril 1 year ago.


Why does ACTH injection not cause increased cortisol secretion?
please be detailed in your answer. Asked by Forest Machenry 1 year ago.

ACTH is a pituitary hormone which will cause cortisol release from the adrenal glands. If the injection does not result in significantly increased cortisol levels then your adrenal glands are not functioning properly. This is a very serious condition which can quickly result in death and requires lifelong treatment with steroids and continued monitoring by an endocrinologist. If you get a rise in cortisol with ACTH injection but your serum levels have been low, the the problem lies in the pituitary not the adrenal glands. Answered by Joshua Meinecke 1 year ago.

I might be understanding the question wrong but I thought such an injection would cause cortisol to be released from the adrenal gland? Answered by Normand Curls 1 year ago.


Where is ACTH produced?
In the pituitary gland or outside? I'm confused because I thought POMC was madde in the pituitary, and then POMC left the pituitary gland to turn into ACTH. But some sources say ACTH is made in the pituitary gland. Any help would be great, thank you so much! :) Asked by Frederic Hurtubise 1 year ago.

ACTH is produced in the anterior pituitary gland. POMC is a precursor and ACTH is only one of its end products. Stimulation of the pituitary gland is required for ACTH to be released. Answered by Ezra Merkey 1 year ago.


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