Rx Item-Acthrel corticorelin ovine 100mcg Vial 6ml By Ferring Pharm Refrigerated

Clinical Information
Gen. Code and Des.
32514 corticorelin ovine triflutate INTRAVEN VIAL 100 MCG
GCN and Des.
43381 corticorelin ovine triflutate INTRAVEN VIAL 100 MCG
Strength
100MCG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
36660000 PITUITARY FUNCTION
Active Ingredients
6761 corticorelin ovine triflutate


ACTHREL- corticorelin ovine triflutate injection, powder, lyophilized, for solution
Ferring Pharmaceuticals Inc.
For intravenous injection only DIAGNOSTIC USE ONLY
DESCRIPTION
ACTHREL? (corticorelin ovine triflutate for injection) is sterile, nonpyrogenic, lyophilized white cake powder, containing corticorelin ovine triflutate, trifluoroacetate salt of synthetic peptide that is used for the determination of pituitary corticotroph responsiveness. Corticorelin ovine has an amino acid sequence identical to ovine corticotropin-releasing hormone (oCRH). Corticorelin ovine is an analogue of the naturally occurring human CRH (hCRH) peptide. Both peptides are potent stimulators of adrenocorticotropic hormone (ACTH) release from the anterior pituitary. ACTH stimulates cortisol production from the adrenal cortex. The structural formula for corticorelin ovine triflutate is described below:
ACTHREL? for injection is available in vials containing 100 mcg corticorelin ovine (as the trifluoroacetate), 0.88 mg ascorbic acid, 10 mg lactose, and 26 mg cysteine hydrochloride monohydrate. Trace amounts of chloride ion may be present from the manufacturing process. The preparation is intended for intravenous administration.
INDICATIONS AND USAGE
ACTHREL? is indicated for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing?s syndrome.
CONTRAINDICATIONS
ACTHREL is contraindicated in patients with history of hypersensitivity reaction to ovine corticorelin or any of its excipients.
PRECAUTIONS
General
The severity of adverse effects to corticorelin injection appear to be dose-dependent. Dosages above mcg/kg are not recommended. While few adverse effects have been observed at the mcg/kg or 100 mcg dose, higher doses have been associated with transient tachycardia, decreased blood pressure, loss of consciousness, and asystole (see ADVERSE REACTIONS). These symptoms can be substantially reduced by administering the drug as 30-second intravenous infusion instead of bolus injection. At dose of 200 mcg corticorelin, of 60 volunteers and patients with disturbances of the hypothalamic-pituitary-adrenal (HPA) axis were reported to have had decreased blood pressures. One patient had severe hypotensive reaction with asystole. Three other patients had an ?absence-like? loss of consciousness lasting approximately minutes. In subsequent investigations by the same researchers over 3-year period using 100 mcg of corticorelin, one patient in approximately 150 to 200 experienced severe drop in blood pressure and loss of sinus rhythm after receiving 55 mcg of corticorelin, which may have been due to interaction with heparin (see PRECAUTIONS Drug Interactions).
Hypersensitivity
Hypersensitivity reactions have been reported in patients receiving ACTHREL. Reactions included urticaria, flushing of the face, neck and upper chest; dyspnea, wheezing, urticaria and angioedema involving tongue, lip and facial swelling (see ADVERSE REACTIONS). Should hypersensitivity reaction occur, discontinue ACTHREL, monitor and treat if indicated.
Drug Interactions
The plasma ACTH response to corticorelin injection is inhibited or blunted in normal subjects pretreated with dexamethasone. The use of heparin solution to maintain i.v. cannula patency during the corticorelin test is not recommended. possible interaction between corticorelin and heparin may have been responsible for major hypotensive reaction that occurred after corticorelin administration (see ADVERSE REACTIONS).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been conducted with corticorelin to evaluate carcinogenic potential, mutagenicity, or effect on fertility.
Pregnancy
(Pregnancy Category C)
Animal reproduction studies have not been conducted with corticorelin. It is also not known whether corticorelin can cause fetal harm when administered to pregnant woman or can affect reproductive capacity. ACTHREL? should be given to pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether corticorelin is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACTHREL? is administered to nursing woman.
PEDIATRIC USE
Only few tests have been performed on children. Dosages were mcg/kg body weight. Patient studies have involved only children with multiple hypothalamic and/or pituitary hormone deficiencies, or tumors. Only two studies with normal pediatric subjects have been conducted. No differences in response to the corticorelin test have been reported in the children studied.

Rx Item-Acthrel 100mcg Vial 6ml By Ferri
NDC No.55566-0302-01 UPC/GTIN No.3-55566-03021-4 MPN No. 30201 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Ferring Pharma Inc.

CORTICORELIN OVINE TRIFLU
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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