A formulation approved both for use in the eye/ear is classified in S03, while formulations only licensed for use in the eye or the ear are classified in S01 and S02, respectively.
Small amounts of antiseptics in eye preparations do not influence the classification, e.g. benzalconium.
See also S03 - Ophthalmological and otological preparations.
|DDDs have been assigned for antiglaucoma preparations only.|
S01E ANTIGLAUCOMA PREPARATIONS AND MIOTICS
This group comprises preparations for local and systemic treatment of glaucoma.
Drugs used for producing miosis are classified in this group, even if the main indication is not glaucoma.
|The DDDs are based on single dose (or single package) and administration frequencies. A single dose is defined as two eye drops (one in each eye) corresponding to 0.1 ml. For eye drops administered once daily the DDD is 0.1 ml, for eye drops administered twice daily the DDD is 0.2 ml, etc. For single use packages one dose is the volume of one package. This also applies for combinations. In eye ointments one dose corresponds to about 10 mm (20 mg) per eye thus corresponding to 40 mg for both eyes.|
Combinations with beta blocking agents are classified in S01ED.
|The DDD for pilocarpine lamellas has been obtained by dividing two lamellas by seven days (the recommended dose is 1 lamella/|
Last updated: 2013-12-19