Netarsudil and latanoprost (ophthalmic route)


    Brand Name

    US Brand Name

    Rocklatan


    Description

    Netarsudil and latanoprost combination eye drops is used alone or together with other medicines to lower pressure inside the eye that is caused by open-angle glaucoma or ocular (eye) hypertension.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of netarsudil and latanoprost combination eye drops in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of netarsudil and latanoprost combination eye drops in the elderly.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Aphakia (no lens in the eyes) or
    • Eye inflammation (eg, iritis or uveitis), history of or
    • Herpes simplex eye infection, history of or
    • Patients with torn artificial lenses—Use with caution. May make these conditions worse.
    • Eye infection or inflammation, active—Should not be used in patients with this condition.

    Proper Use

    Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use if for a longer time than your doctor ordered. To do so may increase the chance of side effects.

    To use the eye drops:

    • Wash your hands with soap and water before and after you use this medicine.
    • Tilt the head back. Press your finger gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.
    • You should not use the eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 15 minutes after you use the medicine before putting the contact lenses back in.
    • If you will be using netarsudil/latanoprost eye drops with other eye medicines, use them at least 5 minutes apart from each other.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For ophthalmic solution dosage form (eye drops):
      • For glaucoma or ocular hypertension:
        • Adults—One drop in the affected eye(s) once a day in the evening.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store in the refrigerator. Do not freeze.

    You may also store it at room temperature to higher temperatures for up to 14 days when travelling. Keep the opened bottle until the expiration date.


    Precautions

    It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

    If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor right away.

    This medicine contains latanoprost, which can cause the iris (colored part) of your treated eye to become more brown in color. This is more likely to happen if you have blue-brown, gray-brown, green-brown, or yellow-brown eyes. You may notice this change usually within several months or years from the start of treatment. You may also have darkening of the eyelid skin color or longer, thicker, and darker eyelashes. These changes to the iris, eyelid, and lashes may be permanent even if you stop using this medicine. However, any of these changes will affect only the eye being treated. Check with your doctor if you have any concerns about this.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Bloody eye
    • blurred vision or any other change in vision
    • eye redness, irritation, or pain
    • redness of the eye

    Rare

    • Body aches or pain
    • burning and stinging of the eye
    • change in color vision
    • chills
    • cough
    • diarrhea
    • difficulty in breathing
    • difficulty seeing at night
    • difficulty swallowing
    • dizziness
    • dry eye
    • ear congestion
    • excessive tearing
    • eyelid discomfort, swelling, or redness
    • fast heartbeat
    • fever
    • general feeling of discomfort or illness
    • headache
    • hives, itching, skin rash
    • increased sensitivity of the eyes to sunlight
    • joint pain
    • loss of appetite
    • loss of voice
    • nausea
    • painful irritation of the clear front part of the eye
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • runny or stuffy nose
    • shivering
    • sneezing
    • sore throat
    • sweating
    • tightness in the chest
    • trouble sleeping
    • unusual tiredness or weakness
    • vomiting

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Eye itching
    • pain and discomfort at the instillation site

    Less common

    • Increase in brown color in the colored part of the eye
    • redness of the white part of the eyes or the inside of the eyelids

    Rare

    • Back pain
    • crusting in the corner of the eye
    • difficulty in moving
    • discoloration of the white part of the eye
    • feeling of having something in the eye
    • joint pain or swelling
    • muscle pain, cramps, or stiffness

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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