Axiron

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Testosterone 2%{relative}

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Testosterone 2% w/v

Dosage:

2% w/v

Pharmaceutical form:

Topical solution

Composition:

Active: Testosterone 2%{relative} Excipient: Ethanol Isopropyl alcohol Octisalate Povidone

Units in package:

Bottle, plastic, PP Bottle with internal polyester/aluminium/LDPE pouch, 110 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

NV Organon

Therapeutic indications:

Androgen replacement therapy for confirmed testosterone deficiency in males

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, PP Bottle with internal polyester/aluminium/LDPE pouch - 110 mL - 18 months from date of manufacture stored at or below 25°C 60 days opened stored at or below 25°C

Authorization date:

2012-12-14

Summary of Product characteristics

 
axiron-ds-v1-19nov12 

Page 1 of 13 
AXIRON
®

(testosterone) 2% w/v transdermal solution 

NAME OF THE MEDICINE 

AXIRON
®
 (testosterone). 

Testosterone AAN is a fragrance free white to practically white
crystalline powder chemically 
described as 17-beta hydroxyandrost-4-en-3-one. Testosterone has the empirical formula C
19
H
28
O
2

representing a molecular weight of 288.43. The CAS number for testosterone is 58-22-0. 

Pharmacotherapeutic group: Androgens, ATC code: G03BA03 

Testosterone has the following structural formula: 

DESCRIPTION 

AXIRON (testosterone)  transdermal
solution is a clear, colourless, fragrance free, single phase 
solution containing 30 mg
of testosterone in 1.5 mL of AXIRON solution for transdermal 
administration through the underarm. The active
pharmacologic ingredient in AXIRON is 
testosterone. The inactive
ingredients are ethanol, isopropyl alcohol, octyl salicylate, and
povidone. 

PHARMACOLOGY 

Testosterone and dihydrotestosterone
(DHT), endogenous androgens, are responsible for the 
normal growth
and development of the male sex organs and for the maintenance of secondary
sex 
characteristics. These
effects include the growth and maturation of the prostate, seminal vesicles, 
penis and scrotum; the
development of male hair distribution on the face, chest, axillae
and pubis; 
laryngeal enlargement, vocal chord thickening, alterations in body musculature
and fat distribution. 

Insufficient secretion of testosterone due to testicular failure, pituitary pathology or gonadotropin 
or luteinising hormone-releasing hormone deficiency results in
male hypogonadism and low serum 
testosterone
concentration. Symptoms associated with low testosterone include
decreased sexual 
desire with or without erectile
dysfunction, fatigue, loss of muscle mass, mood�