Protan

Each 100 mL of eye drops contains Latanoprost 0.005 g. It also contains the following excipients: Sodium chloride, benzalkonium chloride 0.02% w/v (as a preservative), sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, water for injections.

One drop contains approximately Protan 1.5 mcg.

Protan Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Protan is used to treat certain kinds of glaucoma. It is also used to treat a condition called hypertension of the eye. Protan appears to work by increasing the outflow of fluid from the eye. This lowers the pressure in the eye.

Protan is available only with your doctor's prescription.

The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal.

The dosage of Protan Ophthalmic Solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including Protan Ophthalmic Solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular pressure (IOP) lowering effect or cause paradoxical elevations in IOP.

Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Protan Ophthalmic Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of Protan Ophthalmic Solution, and may be reinserted 15 minutes after administration.

See also:
What is the most important information I should know about Protan?

Known hypersensitivity to Protan, benzalkonium chloride, or any other ingredients in this product.

Use Protan drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use Protan drops in the evening unless your doctor tells you otherwise.
• Soft contact lenses may absorb a chemical in Protan drops. Remove contact lenses before you use Protan drops; lenses may be placed back in the eyes 15 minutes after use of Protan drops.
• Wash your hands before and after using Protan drops.
• Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Use Protan drops at least 5 minutes apart from any other medicine that you put in your eye, especially eye drops that contain thimerosal.
• Continue to use Protan drops even if you feel well. Do not miss any doses.
• If you miss a dose of Protan drops, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Protan drops.

Protan is used to treat high pressure inside the eye due to glaucoma (open angle type) or other eye diseases (e.g., ocular hypertension). It is similar to a natural chemical in the body (prostaglandin) and works by regulating the flow of fluid within the eye which results in lower pressure. Lowering high pressure inside the eye helps to prevent blindness.

How to use Protan ophthalmic

Apply this medication in the affected eye(s) usually once daily in the evening, or as directed by your doctor. Do not use this medication more frequently than prescribed; using more can decrease effectiveness.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using this medication and keep them out of your eyes for at least 15 minutes after applying Protan.

Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and apply the prescribed number of drops. Look downward and gently close your eye for 1 to 2 minutes. Place one finger at the inside corner of your eye near the nose and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye.

Do not rinse the dropper. Replace the dropper cap after each use.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It is important to continue using Protan even if you feel well. Most people with glaucoma or high pressure in the eye do not feel sick.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other products. Use eye drops before eye ointments to allow the eye drops to enter the eye.

In vitro studies have shown that precipitation occurs when eye

drops containing thimerosal are mixed with this drug. If such drugs are used they

should be administered at least five (5) minutes apart.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Protan was not

mutagenic in bacteria, in mouse lymphoma or in mouse micronucleus tests.

Chromosome aberrations were observed in vitro with human lymphocytes.

Protan was not carcinogenic in either mice or rats when administered by oral gavage

at doses of up to 170 μg/kg/day (approximately 2,800 times the recommended maximum

human dose) for up to 20 and 24 months, respectively.

Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were

negative. Protan has not been found to have any effect on male or female fertility in

animal studies.

See also:
What are the possible side effects of Protan?

The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:

• Iris pigmentation changes
• Eyelid skin darkening
• Eyelash changes (increased length, thickness, pigmentation, and number of lashes)
• Intraocular inflammation (iritis/uveitis)
• Macular edema, including cystoid macular edema

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Protan Ophthalmic Solution was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL Protan Ophthalmic Solution once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.

Less than 1% of the patients treated with Protan Ophthalmic Solution required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Postmarketing Experience

The following reactions have been identified during postmarketing use of Protan Ophthalmic Solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Protan Ophthalmic Solution, or a combination of these factors, include:

Nervous System Disorder: dizziness, headache, and toxic epidermal necrolysis

Eye Disorder: eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; periorbital and lid changes resulting in deepening of the eyelid sulcus

Respiratory, Thoracic and Mediastinal Disorders: asthma and exacerbation of asthma; dyspnea

Skin and Subcutaneous Tissue Disorders: eyelid skin darkening

Infections and Infestations: Herpes keratitis