Ganfort PF Special Precautions

Ganfort PF should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Ganfort PF should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased iridial pigmentation are not known. Iris color changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Neither nevi nor freckles of the iris appear to be affected by treatment.
Ganfort PF has been reported to cause changes to pigmented tissues. The most frequently reported pigmentary changes have been increased pigmentation of periocular skin and eyelash darkening. Periorbital tissue pigmentation has been reported to be reversible in some patients.
There is the potential for hair growth to occur in areas where Ganfort PF solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Ganfort PF as instructed and to avoid it running onto the cheek or other skin areas.
In bimatoprost ophthalmic solution 0.03% studies in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP-lowering effect. Patients using bimatoprost ophthalmic solutions with other prostaglandin analogs should be monitored for changes to their intraocular pressure.
Ganfort PF has not been studied in patients with inflammatory ocular conditions, neovascular glaucoma, inflammatory glaucoma, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
As with other topically applied ophthalmic drugs, the active substances, bimatoprost and timolol, in Ganfort PF may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances have been observed.
Due to the beta-adrenergic component, timolol, adverse reactions typical of systemic beta-adrenoceptor blocking agents may occur and include the following.
Cardiac disorders: Although rare, cardiac reactions have been reported including, death due to cardiac failure.
Ganfort PF should be used with caution in patients with cardiovascular disease (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension. Patients with a history of cardiovascular diseases should be watched for signs of deterioration of these diseases.
Vascular disorders: Patients with severe peripheral circulatory disturbance/disorders (i.e. Raynaud's phenomenon) should be treated with caution.
Respiratory disorder: Although rare, respiratory reactions have been reported, including death, due to bronchospasm. Ganfort PF should be administered with caution in patients with mild or moderate chronic obstructive pulmonary disease.
Anaphylaxis: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
Diabetes Mellitus: Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) as beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.
Hyperthyroidism: Beta-adrenergic blocking agents may mask signs of hyperthyroidism.
Corneal diseases: Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.
Choroidal detachment: Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g., timolol).
Other beta-blocking agents: Caution should be exercised when used concomitantly with systemic beta-adrenergic blocking agents because of the potential for additive effects on systemic beta-blockade. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended.
Surgical anesthesia: Ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension when used in conjunction with anesthetics. The anesthetist must be informed if the patient is using Ganfort PF.
Liver and renal function: Ganfort PF has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
Use with Contact Lenses: Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of the Ganfort PF solution and wait at least 15 minutes after instilling Ganfort PF before reinserting soft contact lenses.
General: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eyedrops.
Each vial is intended only for a single treatment in the affected eye(s). Discard any remaining solution in the vial immediately after use.
Effects on ability to drive and use machines: Ganfort PF has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
Use in Children: Safety and effectiveness have not been demonstrated with Ganfort PF in pediatric patients.
Use in the Elderly: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.