Current through Reg. 50, No. 187; September 24, 2024
The formulary of topical ocular pharmaceutical agents
consists of pharmaceutical agents that are appropriate to treat or diagnose
ocular disease and disorders and which a certified optometrist is qualified to
administer and prescribe in the practice of optometry pursuant to Section
463.0055(2)(a),
F.S. The topical ocular pharmaceutical agents in the formulary include the
following legend drugs alone or in combination in concentrations up to those
specified, or any lesser concentration:
(1) CYCLOPLEGIC AND MYDRIATICS
(a) atropine sulfate - 1.0% (solution and
ointment);
(b) phenylepherine
hydrochloride - 2.5%;
(c)
cyclopentolate hydrochloride - 1.0%;
(d) scopolamine hydrobromide -
0.25%;
(e) homatropine hydrobromide
- 5.0%;
(f) tropicamide -
1.0%;
(g) hydroxyamphetamine
hydrobromide - 1.0% (in combination).
(2) LOCAL ANESTHETICS
(a) tetracaine - 0.5%;
(b) proparacaine hydrochloride -
0.5%;
(c) benoxinate HCl - 0.4% (in
combination with fluorescein);
(d)
lidocaine hydrochloride ophthalmic gel or solution - 4.0%.
(3) DIAGNOSTIC PRODUCTS
(a) fluorescein paper strips - 9 mg per
strip;
(b) Lissamine Green - 1.5 mg
per strip;
(c) Rose Bengal - 1.3 mg
per strip;
(d) phenol red
thread;
(e) Schirmer test
strips;
(f) hypromellose ophthalmic
demulcent solution - 2.5%.
(4) ANTIBACTERIAL
(a) erythromycin - 0.5%;
(b) bacitracin - 500 units/g (ointment alone
and in combination);
(c) polymyxin
- 10, 000 units/g (only in combination);
(d) neomycin - 3.50 mg/g (only in
combination);
(e) gentamicin - 0.3%
(solution and ointment);
(f)
tobramycin - 0.3% (solution and ointment in combination);
(g) gramicidin - 0.025 mg/ml (only in
combination);
(h) ciprofloxacin
hydrochloride - 0.3% (solution and ointment);
(i) trimethoprim - 1.0 mg/ml (only in
combination);
(j) ofloxaxin -
0.3%;
(k) levofloxacin -
1.5%;
(l) gatifloxacin -
0.5%;
(m) moxifloxacin -
0.5%;
(n) sodium sulfacetamide -
10.0% (alone and in combination);
(o) azithromycin - 1.0 %; and,
(p) besifloxacin ophthalmic suspension -
0.6%.
(5) NON-STEROIDAL
AND STEROIDAL ANTI-INFLAMMATORY AGENTS
(a)
medrysone - 1.0%;
(b) prednisolone
acetate - 1.0% (alone and in combination);
(c) prednisolone sodium phosphate - 1.0%
(alone and in combination);
(d)
flurometholone - 0.25% (suspension and ointment, alone and in
combination);
(e) dexamethasone -
1.0% (suspension and ointment, alone and in combination), 0.4 mg ophthalmic
insert;
(f) fluorometholone acetate
- 0.1%;
(g) rimexolone -
1.0%;
(h) loteprednol etabonate -
0.5% (alone and in combination);
(i) diclofenac sodium - 0.1%;
(j) ketorolac tromethamine - 0.5%;
(k) hydrocortisone - 1.0% (only in
combination);
(l) bromfenac -
0.09%;
(m) nepafenac -
0.1%;
(n) difluprednate ophthalmic
emulsion - 0.05%
(o) loteprednol
etabonate ophthalmic suspension - 1.0%.
(6) ANTIHISTAMINES, MAST CELL STABILIZERS AND
ANTI-ALLERGY AGENTS
(a) cromolyn sodium -
4.0%;
(b) lodoxamide tromethamine -
0.1%;
(c) olopatadine hydrochloride
- 0.7%;
(d) nedocromil sodium -
2.0%;
(e) azelastine hydrochloride
- 0.05%:
(f) pemirolast potassium -
0.1%;
(g) epinastine hydrochloride
- 0.05%;
(h) bepotastine besilate -
1.5%;
(i) alcaftadine -
0.25%;
(j) cetirizine ophthalmic
solution - 0.24%.
(7)
ANTIVIRAL AGENTS
(a) trifluridine -
1.0%;
(b) ganciclovir -
0.15%;
(c) povidone-iodine
ophthalmic solution - 5.0%
(d)
acyclovir ophthalmic ointment - 3.0%
(8) ANTI-GLAUCOMA AGENTS
(a) Beta Blockers.
1. betaxolol hydrochloride - 0.5%;
2. levobunolol hydrochloride -
0.5%;
3. metipranolol hydrochloride
- 0.3%;
4. timolol maleate or
hemihydrate - 0.5% (solution and gel, alone and in combination);
5. carteolol hydrochloride -
1.0%.
(b) Miotics,
Direct-acting
1. carbachol - 3.0%;
2. pilocarpine hydrochloride -
4.0%;
(c) Prostaglandins
1. latanoprost - 0.005%;
2. bimatoprost - 0.03%;
3. travoprost - 0.004%;
4. tafluprost - 0.0015%;
5. unoprostone isoprophyl - 0.15%;
6. latanoprostene bunod ophthalmic solution -
0.024%.
(d)
Alpha2 Adrenergic Agonist
1. brimonidine tartrate - 0.2%;
2. apraclonidine hydrochloride -
0.5%.
(e) Carbonic
Anhydrase Inhibitors (CAI's)
1. brinzolamide -
1.0%;
2. dorzolamide hydrochloride
- 2.0% (alone and in combination).
(f) Rho Kinase Inhibitor
1. netarsudil -
0.02%.
(9)
MISCELLANEOUS
(a) hydroxypropyl cellulose
ophthalmic insert;
(b) dapiprazole
- 0.5%;
(c) cyclosporine emulsion
or solution - 0.1%;
(d) polyvinyl
pyrrolidone solution - 2.0%;
(e)
natamycin ophthalmic suspension 5.0%;
(f) lifitegrast ophthalmic solution 5.0%;
and,
(g) cenergermin-bkbj -
0.002%;
(h) oxymetazoline
hydrochloride ophthalmic solution 0.1%;
(i) hypochlorous acid - 0.02%
(j) varenicline solution - 0.03mg
(k) lotilaner ophthalmic solution -
0.25%
(l) 100% perfluorohexyloctane
ophthalmic solution
Rulemaking Authority 463.005, 463.0055(2)(a) FS. Law
Implemented 463.0055 FS.
New 3-30-87, Amended 4-5-88, 5-7-90, Formerly 21-18.002,
Amended 5-10-92, 1-29-93, Formerly 21Q-18.002, Amended 8-31-93, 7-30-94,
Formerly 61F8-18.002, Amended 2-11-96, 4-21-96, 1-12-97, 6-8-97, Formerly
59V-18.002, Amended 6-15-00, 6-7-05, 6-10-06, 6-26-08, 10-16-08, 3-23-09,
6-28-09, 10-18-09, 4-21-10, 12-26-10, 7-21-11, 11-11-12, 11-29-13, 12-9-13,
4-10-14, 8-14-15, 1-20-17, 8-31-18, 1-25-19, 8-5-19, 3-13-20, 1-5-21, 9-4-21,
5-23-22, 12-12-23.
