ARTG Entry
AXHIDROX
ARTG entry for AXHIDROX (glycopyrronium bromide), ARTG 513368 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Actor Pharmaceuticals
- Active ingredient: glycopyrronium bromide
- Therapeutic area: Dermatology
What it is
Axhidrox is glycopyrronium (as bromide) cream, with 1 gram of cream containing glycopyrronium bromide equivalent to 8 mg of glycopyrronium. One actuation of the pump delivers 270 mg cream which contains 2.2 mg glycopyrronium. The product is a white, glossy, homogeneous cream.
Approved indications
— Topical treatment of confirmed severe primary axillary hyperhidrosis in adults.
Dosing overview
The recommended dosage of Axhidrox is two pump actuations per armpit (equivalent to 540 mg of cream or 4.4 mg glycopyrronium per armpit). During the first 4 weeks of treatment, Axhidrox is applied to each armpit evenly, once a day, preferably in the evening. From the 5th week on, the frequency of application of Axhidrox may be reduced to twice a week, depending on the reduction of axillary sweating. Continuous treatment of primary axillary hyperhidrosis with Axhidrox is required to maintain the effect.
Key safety warnings
Under conditions of fever, elevated ambient temperatures, or physical exertion, reduced sweating may occur, potentially leading to heat prostration, including symptoms such as fever and heat stroke; exercise extreme caution when administering the product in high-temperature environments or to pyrexic patients. Discontinue use if patients experience a generalized absence of sweating when exposed to hot or very warm environmental conditions. Axhidrox must not get into the eyes since glycopyrronium can cause temporary dilation of the pupils and blurred vision. In case of contact with the mouth or nose, a reduction in the production of saliva or nasal secretions cannot be ruled out; if the eyes, nose or mouth come in contact with the cream, these areas should be rinsed immediately with plenty of water to reduce the risk of local side effects. Axhidrox should be used with caution in patients with severe prostatic hyperplasia, bladder-neck obstruction or a history or presence of urinary retention; in these patients, doctors and patients should be alert for signs and symptoms of urinary retention (such as difficulty passing urine or distended bladder) and patients must be instructed to immediately discontinue the use of Axhidrox and to consult a doctor if any of these signs or symptoms develop. Since the use of Axhidrox can cause dry mouth, increased risk of caries due to the reduced salivation cannot be ruled out; careful dental hygiene and regular dental health checks are therefore recommended.
Contraindications
Axhidrox is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in medical conditions that can be exacerbated by the anticholinergic effect of Axhidrox, including glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren syndrome autonomic neuropathy, and in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension or hyperthyroidism since an increase in heart rate may occur.
Regulatory history
Axhidrox (glycopyrronium bromide 2.7 mg/actuation cream) was first listed on the ARTG on 26 September 2025.