PILOGEL® ophthalmic gel
(and dosage form):
PILOGEL® ophthalmic gel
Pilocarpine hydrochloride 40 mg per g
Preserved with 0,008% benzalkonium chloride
A.15.4 Ophthalmic preparations, other.
Pilocarpine hydrochloride is a cholinomimetic agent which acts directly on the autonomic effector cells and ganglionic stimulation may contribute to its overall response pattern. Pilocarpine causes a significant reduction of intraocular pressure. This reduction is thought to be due to the contraction of the ciliary muscle which in turn transmits increased tension to the scleral spur. This results in a decrease in the resistance of aqueous outflow as the trabecular outflow channels become enlarged.
PILOGEL Ophthalmic Gel contains more than 90% water and employs Carbopol 940 (a synthetic high molecular weight polymer of acrylic acid) to impart a high viscosity which provides a prolonged retention time in the eye. Since an equivalent duration of response is obtained with a single instillation of the gel as with four instillations of a 4% solution, the total daily dosage of pilocarpine can be reduced from 8 mg/day to 2 mg/day.
Dose response studies show that the maximum effect normally occurs at 6-8 hours after administration and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose. The action of PILOGEL Ophthalmic Gel decreases towards the end of the 24 hour period.
PILOGEL Ophthalmic Gel is effective in maintaining reduced intraocular pressures during the early a.m. hours. Studies show that, after bedtime application, intraocular pressure reductions are greatest in the early morning and slowly decrease throughout the day.
PILOGEL Ophthalmic Gel is indicated as initial therapy for the control of intraocular pressure in patients with chronic open-angle glaucoma. In patients who respond inadequately to multiple antiglaucoma therapy, the addition of PILOGEL Ophthalmic Gel may produce a further reduction of intracular pressure.
To prevent contaminating the tip of the tube and gel, avoid contact with the eyelids or surrounding areas. As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
DOSAGE AND ADMINISTRATION:
Initial glaucoma therapy: The usual dose of PILOGEL Ophthalmic Gel is a 15 mm ribbon applied in he conjunctival sac of the affected eye(s) once a day at bedtime. In patients without recent pilocarpine experience, consideration should be given to initiating treatment with a low concentration of pilocarpine drops for short periods before beginning with PILOGEL Ophthalmic Gel therapy.
Replacement with PILOGEL Ophthalmic Gel: When patients are being transferred to PILOGEL Ophthalmic Gel from antiglaucoma agents other than pilocarpine solution, the previous medication should be continued on the first day PILOGEL Ophthalmic Gel therapy is added.
On the following day, the previously used antiglaucoma therapy should be discontinued and continued with PILOGEL Ophthalmic Gel.
In transferring patients from conventional pilocarpine therapy to PILOGEL Ophthalmic Gel, discontinue the pilocarpine solution and institute the PILOGEL Ophthalmic Gel regimen.
Addition of PILOGEL Ophthalmic Gel: When patients on other antiglaucoma agents require additional therapy, add PILOGEL Ophthalmic Gel, a 5 mm ribbon once a day at bedtime.
Concomitant therapy: For patients whose glaucoma is difficult to control, PILOGEL Ophthalmic Gel may be added to other agents such as timolol maleate, epinephrine, dipivefrin hydrochloride, carbachol, echothiophate iodide or acetazolamide.
The intraocular pressure of patients using PILOGEL Ophthalmic Gel should be determined at the end of the 24 hour period to ensure that reduced intraocular pressure is maintained throughout this period.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Systemic: Systemic reactions following topical administration have included hypertension, tachycardia, bronchospasm, pulmonary oedema, salivation, sweating, nausea, vomiting and diarrhoea. Ocular: The following adverse reactions have been reported: keratitis, conjunctivitis, ocular irritation, symptoms of discomfort, burning and brow ache.
Dermatitis has been reported. Visual disturbances, including blurred vision, have been reported.
Adverse reactions associated with the use of pilocarpine hydrochloride include ciliary spasm, conjunctival vascular congestion, lacrimation and induced myopia. Miotic agents may also cause retinal detachment; thus care should be exercised with all miotic therapy especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects above.
Treatment is symptomatic.
A clear, colourless, sterile, aqueous gel.
Ointment tube with ophthalmic tip containing 5 g.
Store at room temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (S.A.) (Pty) Ltd.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 December 1983
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