Consumer medicine information

Boxed Warnings

Teratogenicity. Pulmoris may cause birth defects and is contraindicated in pregnancy (see Section 4.3 Contraindications).

1 Name of Medicine

Ambrisentan.

2 Qualitative and Quantitative Composition

Pulmoris 5 mg film-coated tablets. Each film-coated tablet contains 5 mg ambrisentan.
Excipients with known effect. Contain sugars as lactose and soya bean products.
Pulmoris 10 mg film-coated tablets. Each film-coated tablet contains 10 mg ambrisentan.
Excipients with known effect. Contains lactose and soya bean products.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pulmoris 5 mg film-coated tablets. Pulmoris 5 mg tablets are pale pink, square shaped, biconvex, film-coated tablets debossed with "CL" on one side and "5" on the other side.
Pulmoris 10 mg film-coated tablets. Pulmoris 10 mg tablets are pink, oval shaped, biconvex, film-coated tablets debossed with "CL" on one side and "10" on the other side.

4 Clinical Particulars

4.9 Overdose

In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea, and nasal congestion. Due to its mechanism of action, an overdose of ambrisentan also could potentially result in hypotension.
In case of pronounced hypotension, active cardiovascular support may be required. No specific antidote is available.
For information on the management of overdose, please contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxicity of ambrisentan was assessed in a comprehensive battery of in vitro and in vivo studies. Ambrisentan was clastogenic when tested at high concentrations in mammalian cells in vitro. No evidence for genotoxic effects of ambrisentan was seen in bacteria or in two in vivo rodent studies.
Carcinogenicity. There was no evidence of carcinogenic potential in 2 year oral studies in mice and rats treated with ambrisentan at low relative exposures (ca. 5 or less based on AUC). There was a small increase in mammary fibroadenomas, a benign tumor, in male rats at the highest dose only.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Pulmoris film-coated tablets contain ambrisentan which is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist (ERA) that is selective for the endothelin type A (ET_A) receptor. The chemical name (IUPAC) for ambrisentan is (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropionic acid.
Ambrisentan is a white to off-white coloured powder. Ambrisentan is freely soluble in dimethyl sulphoxide, sparingly soluble in dimethyl formamide and methanol; practically insoluble in water.
The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMBRIS.gif Molecular formula: C₂₂H₂₂N₂O₄.
Molecular weight: 378.42.
CAS number. 177036-94-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PULMORST.gif