Xelpros

Ophthalmic Prostaglandins including Analogs and Receptor Agonists

Instruct the patient on proper instillation of the eye solution.
Wash hands before and after use.
Remove contact lenses before instilling ophthalmic drops. Lenses may be reinserted 15 minutes after drug administration.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and gently close eyes for 1 to 2 minutes. Do not blink.
Care should be taken to avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surfaces.
Latanoprost may be used concomitantly with other ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. In vitro studies have shown precipitation occurs when ophthalmic drugs that contain thimerosal are mixed with latanoprost.[63552]
A delivery aid (i.e., Xal-Ease) is available for administering the ophthalmic solution.[41692]

keratitis / Delayed / 1.0-10.0
visual impairment / Early / 4.0-8.0
corneal erosion / Delayed / Incidence not known
uveitis / Delayed / Incidence not known
macular edema / Delayed / Incidence not known
bronchospasm / Rapid / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known

conjunctival hyperemia / Early / 8.0-15.0
blurred vision / Early / 4.0-8.0
blepharitis / Early / 1.0-3.0
photophobia / Early / 2.0-2.0
ocular inflammation / Early / Incidence not known
corneal edema / Early / Incidence not known
conjunctivitis / Delayed / Incidence not known
iritis / Delayed / Incidence not known
dyspnea / Early / Incidence not known
angina / Early / Incidence not known
chest pain (unspecified) / Early / Incidence not known
palpitations / Early / Incidence not known

ocular pain / Early / 3.0-55.0
ocular irritation / Rapid / 7.0-55.0
foreign body sensation / Rapid / 2.0-13.0
ocular discharge / Delayed / 12.0-12.0
ocular pruritus / Rapid / 5.0-8.0
iridal discoloration / Delayed / 7.0-7.0
lacrimation / Early / 4.0-4.0
blepharedema / Early / 1.0-3.0
xerophthalmia / Early / 3.0-3.0
infection / Delayed / 3.0-3.0
back pain / Delayed / 1.0-1.0
myalgia / Early / 1.0-1.0
musculoskeletal pain / Early / 1.0-1.0
arthralgia / Delayed / 1.0-1.0
rash / Early / 1.0-1.0
skin hyperpigmentation / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
pharyngitis / Delayed / Incidence not known
influenza / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
dizziness / Early / Incidence not known
headache / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known

IYUZEH, Xalatan, Xelpros

Rx

Ophthalmic analog of prostaglandin F2-alpha
Used for increased intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Associated with increased pigmentation of iris, eyelid, and eyelashes

1 drop (1.5 mcg) applied to each affected eye once daily in the evening. More frequent administration may decrease the intraocular pressure-lowering effect or cause paradoxical elevations in intraocular pressure.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Latanoprost should be used with caution in patients with hepatic impairment; data are lacking in these patients.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Latanoprost should be used with caution in patients with renal impairment; data are lacking in these patients.
 
Intermittent hemodialysis
No dosage adjustment is needed.

There are no drug interactions associated with Latanoprost products.

Latanoprost/Xalatan Ophthalmic Sol: 0.005%
Xelpros Ophthalmic Emulsion: 0.005%

1 drop/day per affected eye.

1 drop/day per affected eye.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Latanoprost is a selective agonist at a subtype of prostaglandin receptors known as the FP receptor. By acting on the FP receptor, latanoprost increases the outflow of aqueous humor thereby reducing intraocular pressure. According to the manufacturer, studies in both animals and man suggest that increased uveoscleral outflow is the primary mechanism of action.[41692] [63552]

Latanoprost is administered topically to the eye as an isopropyl ester prodrug. Once in systemic circulation, the biologically active latanoprost acid is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4- tetranor metabolites via fatty acid beta-oxidation with an elimination half-life of 17 minutes. The metabolites are mainly eliminated by the kidneys, with 88% of the topically administered dose being recovered in the urine.[41692] [63552]
Affected cytochrome P450 isoenzymes: none

Ophthalmic Route
Following ocular administration, latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Peak aqueous humor concentrations are reached about 2 hours after topical administration. Reduction of intraocular pressure starts approximately 3 to 4 hours after administration and peaks after 8 to 12 hours. Plasma levels of the acid of latanoprost can only be measured during the first hour after local administration.[41692] [63552]

No adequate and well-controlled studies have been conducted to evaluate the use of latanoprost during human pregnancy. In animal studies involving rats and rabbits, the administration of intravenous latanoprost (at clinically relevant doses) throughout the period of organogenesis resulted in malformations, embryofetal lethality, and spontaneous abortion. In rabbits, intravenous latanoprost given on gestation days 6 through 18 resulted in post-implantation loss due to late resorption [1.3-times maximum recommended human ophthalmic dose (RHOD)], spina bifida and abortion (32-times RHOD), and total litter loss due to early resorption (324-times RHOD). In rats, intravenous latanoprost given on gestation days 6 through 15 resulted in cleft palate (3.2-times RHOD), brain porencephalic cysts (162-times RHOD), and skeletal anomalies (811-times RHOD). In an observational study involving 11 pregnant women taking latanoprost for glaucoma, there were no congenital anomalies in 9 cases with complete follow-up, 1 case was lost to follow-up, and 1 case experienced an early spontaneous abortion. Limited experience in human pregnancy has not resulted in clinically significant risk to the fetus. A minimal amount of drug reaches systemic circulation after ophthalmic administration, suggesting exposure of the drug to the fetus is low.

According to the manufacturer, it is not known whether latanoprost or its metabolites are excreted in breast milk. Because systemic plasma concentrations of latanoprost are low and the half-life is short after ophthalmic administration, clinically significant amounts of the drug would not be expected to be excreted in breast-milk. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. According to the manufacturer, caution should be exercised when latanoprost is administered during breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.