SYNACTHEN DEPOT SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TETRACOSACTIDE (TETRACOSACTIDE ZINC HYDROXIDE)

Available from:

ATNAHS PHARMA UK LIMITED

ATC code:

H01AA02

INN (International Name):

TETRACOSACTIDE

Dosage:

1MG

Pharmaceutical form:

SUSPENSION

Composition:

TETRACOSACTIDE (TETRACOSACTIDE ZINC HYDROXIDE) 1MG

Administration route:

INTRAMUSCULAR

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

ADRENOCORTICAL INSUFFICIENCY

Product summary:

Active ingredient group (AIG) number: 0106365001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-01-14

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
SYNACTHEN
®
DEPOT
Tetracosactide Zinc Injection, Mfr. Std.
(also known as cosyntropin injection)
1 mg/mL tetracosactide
Adrenocorticotropic Hormone (synthetic ACTH)
Atnahs Pharma UK Limited
DATE OF REVISION:
Sovereign House Miles Gray Road
January 13, 2020
Basildon, SS14 3FR
United Kingdom
Imported and Distributed by:
Valeo Pharma Inc.
Kirkland, Quebec
H9H 4R9
Submission Control No: 234042
SYNACTHEN is a registered trademark
©
2019 Atnahs Pharma UK Limited, All Rights Reserved
- 2 -
PRODUCT MONOGRAPH
Pr
SYNACTHEN
®
DEPOT
Tetracosactide Zinc Injection, Mfr. Std.
(also known as cosyntropin injection)
1 mg/mL tetracosactide
PHARMACOLOGICAL CLASSIFICATION
(Adrenocorticotropic Hormone (synthetic ACTH))
ACTIONS AND CLINICAL PHARMACOLOGY
Natural adrenocorticotropin is a straight-chain polypeptide containing
39 amino acids which, by
convention, are numbered from the N-terminal end of the molecule. The
sequence of amino-acid
occupying positions 25 to 33 varies among species and it is this part
of the molecule which is most
antigenic when ACTH of foreign origin is administered to man. In
contrast, the N-terminal 24 amino-
acid sequence is common to all species and is relatively
non-antigenic, and it is only these amino-acids
which are involved in its biological activities.
The most important physiological effects of ACTH involve the adrenal
cortex and include the
maintenance of adrenal weight and the control of adrenal
corticosteroid synthesis and release. In its
absence, adrenal blood flow is diminished, adrenal atrophy invariably
ensues and cortisol secretion is
markedly reduced. In addition to controlling corticosteroid secretion,
ACTH also increases the
synthesis and release of the other adrenal steroids, namely
aldosterone and the adrenal androgens. It
also has some degree of melanotropic activity and lipolytic effect.
SYNACTHEN DEPOT (tetracosactide zinc injection), a long-acting
synthetic β1-24-corticotropin,
exhibits the same activity as natural ACTH with regard to all its
biological activi